Product Information safety updates - October 2025

ARX-Aciclovir

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added renal insufficiency or acute renal failure

4.5 - Interactions with other medicines and other forms of interactions

• Added concomitant theophylline use

4.6 - Fertility, pregnancy and lactation

• Added largely reversible adverse effects on spermatogenesis in rats and dogs

4.8 - Adverse effects (undesirable effects)

Added:

• alopecia
• erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
• crystalluria, peripheral oedema
• myalgia, visual abnormalities
• diarrhea, gastrointestinal distress and nausea

Bretaris Genuair

A Menarini Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added patients with cardiac arrhythmias, a history of cardiac arrhythmias or with risk factors for cardiac arrhythmias

4.8 - Adverse effects (undesirable effects)

• Added cardiac arrhythmias

Brimica Genuair

A Menarini Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added patients with cardiac arrhythmias, a history of cardiac arrhythmias or with risk factors for cardiac arrhythmias

4.8 - Adverse effects (undesirable effects)

• Added cardiac arrhythmias

Rapifen

Piramal Critical Care Pty Ltd

4.4 - Special warnings and precautions for use

• Added new subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with RAPIFEN should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as RAPIFEN may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, RAPIFEN has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

• Added central sleep apnoea syndrome with a frequency of not known.
• Added pancreatitis with a frequency of not known.
• Added spasm of sphincter of Oddi with a frequency of not known.
• Added adrenal insufficiency and androgen deficiency with a frequency of not known.

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose.

Aspalgin

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Sleep-related Breathing Disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Adrenal Insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with ASPALGIN should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids, such as ASPALGIN, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal Withdrawal Syndrome'. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, ASPALGIN has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or noncardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Updated subheading 'Use in Pregnancy'. Regular use of codeine during pregnancy may cause physical dependence in the fetus, leading to withdrawal symptoms in the neonate also known as neonatal withdrawal syndrome.

4.8 - Adverse effects (undesirable effects)

• Added adrenal insufficiency and androgen deficiency with a frequency of not known
• Added pancreatitis with a frequency of not known
• Added spasm of sphincter of Oddi with a frequency of not known
• Added central sleep apnoea syndrome with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy

Inlyta

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added pancreatitis

Subutex / Subutex FDT / Bupradex

Indivior Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with SUBUTEX should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as SUBUTEX may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, SUBUTEX has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known.
• pancreatitis with a frequency of not known.
• spasm of sphincter of Oddi with a frequency of not known.
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose.

Temgesic

Echo Therapeutics Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Off-label, chronic use and in high dose'. TEMGESIC is indicated for the short-term treatment of severe pain and should not be used for longer than 7 days. Chronic use of buprenorphine, especially in high doses beyond Temgesic’s maximum daily dose, as well as other opioids, may lead to the following safety issues;
• Added new warning under subheading 'Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Neonatal Withdrawal Syndrome'. Chronic use of buprenorphine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth. Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
• Added new warning under subheading 'Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Added new warning under subheading 'Endocrine effects'. Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, opioids have to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known.
• pancreatitis with a frequency of not known.
• spasm of sphincter of Oddi with a frequency of not known.
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Suboxone Film

Indivior Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with SUBOXONE FILM should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as SUBOXONE FILM may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, SUBOXONE FILM has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Suboxone / Bupradone

Indivior Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with SUBOXONE should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids, such as SUBOXONE, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, SUBOXONE has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Cabometyx

Ipsen Pty Ltd

4.4 - Special warnings and precautions for use

• Added increased risk of cardiac failure

Truqap

AstraZeneca Pty Ltd

4.2 - Dose and method of administration

• Added co-administration with moderate CYP3A4 inhibitors

4.8 - Adverse effects (undesirable effects)

Added:

• update of ADR frequencies
• hypokalaemia
• pyrexia
• decrease in weight

Libtayo

Medison Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added pancreatitis

4.8 - Adverse effects (undesirable effects)

• Added pancreatitis

Alvesco

Chiesi Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children)

4.8 - Adverse effects (undesirable effects)

Added:

• psychomotor hyperactivity
• sleep disorders
• aggression

Omnaris

Chiesi Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Addition of warning regarding concomitant administration with ketoconazole or other potent CYP3A inhibitors

4.8 - Adverse effects (undesirable effects)

Added:

• cough
• bronchitis
• influenza
• back pain
• urinary tract infection

APO-Ciprofloxacin / APX-Ciprofloxacin / Ciprol

Arrotex Pharmaceuticals Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction under subheading 'Levothyroxine'. Oral ciprofloxacin may decrease the absorption of levothyroxine. An interval of 6 hours between the administration of the two medications is recommended.

Ciprofloxacin-BL / Roflo

Ipca Pharma (Australia) Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction under subheading 'Levothyroxine'. Oral ciprofloxacin may decrease the absorption of levothyroxine. An interval of 6 hours between the administration of the two medications is recommended.

IPC-Ciprofloxacin

Ipca Pharma (Australia) Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction under subheading 'Levothyroxine'. Oral ciprofloxacin may decrease the absorption of levothyroxine. An interval of 6 hours between the administration of the two medications is recommended.

Cleviprex

Chiesi Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added increased blood triglycerides

Actacode

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Added new warning under subheading 'Endocrine effects'. Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal Withdrawal Syndrome'. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, administer with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Added updated subheading ' Use in Lactation'. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of codeine during pregnancy.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Aspen Codeine

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome'. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading ‘Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, administer with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• pancreatitis with a frequency of not known.
• central sleep apnoea syndrome with a frequency of not known.
• adrenal insufficiency and androgen deficiency with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Gold Cross Codeine Linctus

iNova Pharmaceuticals (Australia) Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Added new warning under subheading 'Endocrine effects'. Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal Withdrawal Syndrome'. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, administer with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Added updated subheading ' Use in Pregnancy'. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of codeine during pregnancy.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Tecfidera

Biogen Australian Pty Ltd

4.4 - Special warnings and precautions for use

• Added a new warning under subheading 'Serious Gastrointestinal Reactions'. Serious gastrointestinal reactions, including perforation, ulceration, haemorrhage, and obstruction, some with fatal outcomes, have been reported in the post-marketing setting with the use of fumaric acid esters, including TECFIDERA, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation. In controlled clinical trials, the incidence of serious gastrointestinal adverse events was 1% in patients treated with TECFIDERA; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain.

Vumerity

Biogen Australian Pty Ltd

4.4 - Special warnings and precautions for use

• Added a new warning of under subheading 'Serious Gastrointestinal Reactions'. Serious gastrointestinal reactions, including perforation, ulceration, haemorrhage, and obstruction, some with fatal outcomes, have been reported in the post-marketing setting with the use of fumaric acid esters, including VUMERITY, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation. In controlled clinical trials, the incidence of serious gastrointestinal adverse events was 1% in patients treated with VUMERITY; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%).

Xtandi

Astellas Pharma Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Enzalutamide interference with the Chemiluminescent Microparticle Immunoassay (CMIA), resulting in falsely elevated digoxin plasma level results

Epkinly

Abbvie Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Tumour Lysis Syndrome (TLS)'. TLS has been reported in patients receiving epcoritamab. Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.
• Added new warning under subheading 'Tumour flare'. Tumour flare has been reported in patients treated with epcoritamab. Manifestations could include localised pain and swelling. Consistent with the mechanism of action of epcoritamab, tumour flare is likely due to the influx of T-cells into tumour sites following epcoritamab administration. There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ. Patients treated with epcoritamab should be monitored and evaluated for tumour flare at critical anatomical sites.

Bijuva 1/100

Theramex Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added ALT elevations with concomitant antiviral treatment for HCV infections

4.5 - Interactions with other medicines and other forms of interactions

• Added ALT elevations with concomitant antiviral treatment for HCV infections

Velsipity

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added ophthalmic evaluation within 3-4 months of starting treatment for all patients

Ausfam

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• increases in gamma GT
• increases in alkaline phosphatase
• increases in bilirubin

Abstral

A Menarini Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Endocrine Effects'. Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with ABSTRAL should be considered.
• Added new warning under subheading 'Gastrointestinal toxicity/Opioid-induced oesophageal dysfunction'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.
• Added new warning under subheading ‘Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, ABSTRAL has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under Use in Pregnancy, under subheading ‘Neonatal Abstinence Syndrome'. Chronic use of fentanyl by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g., hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.

4.6 - Fertility, pregnancy and lactation

• Added Neonatal Abstinence Syndrome cross-reference

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Fentanyl Medsurge

Medsurge Pharma Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with FENTANYL MEDSURGE should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids, such as FENTANYL MEDSURGE, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, FENTANYL MEDSURGE has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

Fentanyl Juno

Juno Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with Fentanyl Juno should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as Fentanyl Juno may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Fentanyl Juno has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• adrenal insufficiency and androgen deficiency with a frequency of not known
• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known

Fentora

Teva Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Endocrine Effects and adrenal insufficiency'. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, fentanyl has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of uncommon.
• pancreatitis with a frequency of not known.
• spasm of sphincter of Oddi with a frequency of not known

Fentanyl GH

Generic Health Pty Ltd

4.4 - Special warnings and precautions for use

• Added new subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with fentanyl should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as fentanyl may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, fentanyl has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

Sublimaze

Piramal Critical Care Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with SUBLIMAZE should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids, such as SUBLIMAZE, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, SUBLIMAZE has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

Heparinised Saline

Pfizer Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added concomitant use of heparin with andexanet alfa may reduce the effectiveness of heparin

Hydrocortisone Juno

Juno Pharmaceuticals Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added panniculitis

Dilaudid + Dilaudid-HP

Mundipharma Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Updated warning under subheading 'Endocrine Effects', with androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome’. Chronic use of hydromorphone by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.
• Added new warning under subheading 'Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, administer with caution in patients with pancreatitis and diseases of the biliary tract.

4.8 - Adverse effects (undesirable effects)

Added:

• adrenal insufficiency and androgen deficiency with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known

Plaquenil

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added Hemolytic Anaemia Associated with G6PD Deficiency

Zepzelca

Specialised Therapeutics Pharma Pty Ltd

4.2 - Dose and method of administration

• Added guidance for withholding drug if neutropenia associated with infection or sepsis present

4.4 - Special warnings and precautions for use

• Added contraception update

4.6 - Fertility, pregnancy and lactation

• Added contraception update

4.7 - Effects on ability to drive and use machines

• Added update based on possible adverse events

Morphine Juno

Juno Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

• Updated subheading 'Gastrointestinal'. Cases of oesophageal disorder (e.g. oesophageal motility disorder, lower oesophageal sphincter relaxation impaired, oesophageal peristalsis decreased) have been reported with opioid therapy'.
• Added adrenal insufficiency and androgen deficiency with a frequency of not known
• Added central sleep apnoea syndrome with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Ordine / Morphine Hydrochloride ARX

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Adrenal insufficiency'. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Added new warning under subheading ‘Endocrine effects'. Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome'. Chronic use of morphine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading ‘Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

DBL Morphine Sulfate

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• adrenal insufficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication

Morphine Sulfate Medsurge / Morphine Sulfate Medicianz

Medsurge Pharma Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

• Updated subheading 'Gastrointestinal Disorders'. Cases of oesophageal disorder (e.g. oesophageal motility disorder, lower oesophageal sphincter relaxation impaired, oesophageal peristalsis decreased) have been reported with opioid therapy.
• Added central sleep apnoea syndrome with a frequency of not known
• Added adrenal insufficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Ms Contin / Ms Mono / Sevredol

Mundipharma Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Updated warning under subheading 'Endocrine Effects'. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal withdrawal syndrome'. Chronic use of morphine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

• Added adrenal insufficiency and androgen deficiency with a frequency of not known
• Added pancreatitis with a frequency of not known

Paracetamol/Codeine Gh 500/30 / APX-Paracetamol/Codeine / Comfarol Forte / Prodeine Forte / Panadeine Forte / Codapane Forte 500/30 / Paracetamol/Codeine-Wgr 500/30 / Prodeinextra / Prodeine

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as codeine may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal withdrawal syndrome'. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, codeine has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Added under subheading 'Use in Pregnancy', neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of codeine during pregnancy.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose 

• Added toxic leukoencephalopathy has been observed with opioid overdose.

Mersyndol / Mersyndol Forte

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal withdrawal syndrome'. Chronic use of codeine by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, administer with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Added under subheading 'Use in Pregnancy', neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use during pregnancy.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Sifrol / Sifrol ER

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Dopamine Dysregulation Syndrome'. Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of dopaminergic agonists, including SIFROL. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS.

Thymoglobuline

Sanofi-Aventis Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

Added:

• anaemia
• hyperbilirubinaemia

Remifentanil Viatris

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with REMIFENTANIL VIATRIS should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as REMIFENTANIL VIATRIS may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal withdrawal syndrome'. Chronic use of remifentanil by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Added under subheading 'Use in Pregnancy', neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of remifentanil during pregnancy.

4.8 - Adverse effects (undesirable effects), post-marketing experience

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy

Remifentanil-AFT

AFT Pharmceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading ‘Sleep-related breathing disorders'. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
• Added new warning under subheading ‘Adrenal Insufficiency’. Adrenal insufficiency has been reported with opioid use, more often following long-term use. Symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure. If adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with Remifentanil-AFT should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids, such as Remifentanil-AFT, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading ‘Neonatal Withdrawal Syndrome’. Chronic use of remifentanil by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading ‘Hepatobiliary disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Remifentanil-AFT has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal Toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.6 - Fertility, Pregnancy and Lactation

• Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of remifentanil during pregnancy.

4.8 - Adverse effects (undesirable effects)

Added:

• central sleep apnoea syndrome with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known
• adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose.

Norvir

Abbvie Pty Ltd

4.2 - Dose and method of administration

• Reduce maximum daily dose (200 mg)

4.5 - Interactions with other medicines and other forms of interactions

• Removed of information related to taking tablets with food (as prescribers are now instructed to refer to the Product Information of the Protease Inhibitor for further information)

Appese / Repreve

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added psychiatric disorders

4.8 - Adverse effects (undesirable effects)

• Deed compulsive eating

Epilim + Epilim Iv + Valpro + Valproate Winthrop + Valproate Sandoz

Sanofi-Aventis Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added pneumonia

Sugammadex Sandoz

Sandoz Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added hypersensitivity

Imigran / Imigran Fdt

Aspen Pharmacare Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Updated sumatriptan excreted in breast milk

4.8 - Adverse effects (undesirable effects)

• Added breast pain

Mounjaro / Mounjaro Kwikpen

Eli Lilly Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated wording under subheading ‘Psychiatric disorders'. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists.

4.5 - Interactions with other medicines and other forms of interactions

• Updated interaction under subheading 'Oral contraceptives'. Reduced efficacy of oral contraceptives cannot be excluded, it is therefore advised that patients using oral hormonal contraceptives switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with MOUNJARO.

Tramal

Seqirus Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Endocrine Effects'. Opioids such as Tramal may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Hormonal disturbances that have been observed include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
• Added new warning under subheading 'Neonatal withdrawal syndrome'. Chronic use of tramadol by the mother at the end of pregnancy may result in a withdrawal syndrome (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus, convulsions, apnoea or bradycardia) in the neonate. In many reported cases the withdrawal was serious and required treatment. The syndrome is generally delayed for several hours to several days after birth.
• Added new warning under subheading 'Hepatobiliary Disorders'. Opioids may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Therefore, Tramal has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
• Added new warning under subheading 'Gastrointestinal toxicity'. Reports of significant oesophageal dysfunction have been observed via high-resolution manometry in patients taking opioid medicines on a long-term basis. Discontinuation or weaning of opioids should be considered in patients presenting with oesophageal complaints including but not limited to dysphagia, regurgitation, or non-cardiac chest pain.

4.8 - Adverse effects (undesirable effects)

Added:

• adrenal insufficiency and androgen deficiency with a frequency of not known
• pancreatitis with a frequency of not known
• spasm of sphincter of Oddi with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Briumvi

Accelagen Pty Ltd

4.8 - Adverse effects (undesirable effects)

Added:

• encephalitis  
• meningitis  
• meningoencephalitis

Imovane

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added haemolysis

4.9 - Overdose

• Added haemolysis/haemolytic anaemia as a symptom for overdose