Product Information safety updates - November 2025

Epiduo Forte

Galderma Australia Pty Ltd

4.2 - Dose and method of administration

• Added recommendation for discontinuing or restarting therapy if severe local inflammatory response develops.

4.4 - Special warnings and precautions for use

Added:

• Use not recommended in severe nodular or deep nodulocystic acne
• Contains polysorbate 80 (E433)

Malarone Tablets / Malarone Junior Tablets

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added severe cutaneous adverse reactions (SCARs)

4.8 - Adverse effects (undesirable effects)

Added:

• Drug reaction with eosinophilia and system symptoms (DRESS)
• Erythema multiforme

Onureg

Bristol-Myers Squibb Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

Added:

• Sepsis
• Neutropenic sepsis

Buvidal Monthly / Buvidal Weekly

Camurus 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 '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, buprenorphine 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.
• 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 buprenorphine 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. Hormonal changes, including androgen deficiency, may present with low libido, impotence, erectile dysfunction, amenorrhea, or infertility.

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 sphincter of Oddi dysfunction 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

Norspan / Bupredermal

Mundipharma Pty Ltd

4.4 - Special warnings and precautions for use

• 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, administered with caution in patients with pancreatitis and diseases of the biliary tract.
• 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 should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as NORSPAN/BUPREDERMAL 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 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.

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

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Dalacin T / Dalacin V

Pfizer Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Update to remove reference to “oral or intravenous” clindamycin

Frisium

Atnahs Pharma Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

Added:

• Possibility of miscarriage
• Warning for use in first trimester

Tafinlar

Novartis Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added tattoo-associated skin reaction

Prolia / Corora

Amgen Australia Pty Ltd

4.2 - Dose and method of administration

• Updated statement under subheading 'Dosage (dose and interval)'. If Prolia treatment is discontinued, consideration should be given to transitioning to an alternative antiresorptive therapy.

4.4 - Special warnings and precautions for use

• Updated statement under subheading 'Osteonecrosis of the jaw'. In patients who develop ONJ during treatment with Prolia, a temporary interruption of Prolia treatment should be considered based on individual risk/benefit assessment until the condition resolves.
• Updated warning under subheading 'Multiple vertebral fractures (MVF) following discontinuation of Prolia treatment'. MVF may occur following discontinuation of treatment with Prolia, particularly in patients with a history of vertebral fracture. New vertebral fractures occurred as early as 7 months after the last dose of PROLIA. Patients being treated with Prolia, should be advised not to interrupt Prolia therapy without prior consultation with their treating physician. The individual benefit/risk should be evaluated before discontinuing treatment with Prolia. If Prolia treatment is discontinued, consideration should be given to transitioning to an alternative antiresorptive therapy.

Nocdurna

Ferring Pharmaceuticals Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added anaphylactic reaction with a frequency of not known

Valium

Atnahs Pharma Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation

Added:

• Possibility of miscarriage
• Warning for use in first trimester

Lanoxin / Lanoxin Adults / Lanoxin Infants / Lanoxin Paediatric Elixir / Lanoxin PG

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added falsely elevated serum levels in patients receiving enzalutamide

4.5 - Interactions with other medicines and other forms of interactions

• Added interaction with enzalutamide

Trulicity

Eli Lilly Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Psychiatric disorders'. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviours, and/or any unusual changes in mood or behaviour. Consider the benefits and risks for individual patients prior to initiating or continuing therapy in patients with suicidal thoughts or behaviours or have a history of suicidal attempts.

Padcev

Astellas Pharma Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added under subheading 'PADCEV as monotherapy', skin hyperpigmentation, skin discoloration, pigmentation disorder with a frequency of not known
• Added under subheading 'PADCEV in combination with pembrolizumab', skin hyperpigmentation, skin discoloration, pigmentation disorder with a frequency of not known

Erlotinib Sandoz

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading ‘Hepatotoxicity'. Serious cases of drug induced liver injury (DILI) including hepatitis, acute hepatitis and hepatic failure and hepatorenal syndrome (including fatalities) have been reported during use of erlotinib. Risk factors may include pre-existing liver disease or concomitant hepatotoxic medications. Periodic liver function testing is recommended during treatment with erlotinib. The frequency of monitoring of liver function should be increased in patients with pre-existing hepatic impairment or biliary obstruction. Prompt clinical evaluation and measurement of liver function tests should be performed in patients who report symptoms that may indicate liver injury. Erlotinib treatment should be interrupted or discontinued if changes in liver function are severe. Erlotinib is not recommended for use in patients with severe hepatic dysfunction.

4.8 - Adverse effects (undesirable effects)

Added:

• Hepatitis with a frequency of rare
• Acute hepatitis with a frequency of unknown
• Pneumatosis intestinalis with a frequency of rare

Erlotinib ARX

Accelagen Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading ‘Hepatotoxicity'. Serious cases of drug induced liver injury (DILI) including hepatitis, acute hepatitis and hepatic failure and hepatorenal syndrome (including fatalities) have been reported during use of erlotinib. Risk factors may include pre-existing liver disease or concomitant hepatotoxic medications. Periodic liver function testing is recommended during treatment with erlotinib. The frequency of monitoring of liver function should be increased in patients with pre-existing hepatic impairment or biliary obstruction. Prompt clinical evaluation and measurement of liver function tests should be performed in patients who report symptoms that may indicate liver injury. Erlotinib is not recommended for use in patients with severe hepatic dysfunction.

4.8 - Adverse effects (undesirable effects)

Added:

• Hepatitis with a frequency of rare
• Acute hepatitis with a frequency of unknown
• Pneumatosis intestinalis with a frequency of rare

Erlotinib Cipla

Cipla Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading ‘Hepatotoxicity'. Serious cases of drug induced liver injury (DILI) including hepatitis, acute hepatitis and hepatic failure and hepatorenal syndrome (including fatalities) have been reported during use of erlotinib. Risk factors may include pre-existing liver disease or concomitant hepatotoxic medications. Periodic liver function testing is recommended during treatment with erlotinib. The frequency of monitoring of liver function should be increased in patients with pre-existing hepatic impairment or biliary obstruction. Prompt clinical evaluation and measurement of liver function tests should be performed in patients who report symptoms that may indicate liver injury. Erlotinib is not recommended for use in patients with severe hepatic dysfunction.

4.8 - Adverse effects (undesirable effects)

Added:

• Hepatitis with a frequency of rare
• Acute hepatitis with a frequency of unknown
• Pneumatosis intestinalis with a frequency of rare

Durogesic

Janssen-Cilag Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Neonatal withdrawal 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.
• 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, DUROGESIC 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:

• Pancreatitis with a frequency of not known
• Spasm of sphincter of Oddi with a frequency of not known
• Adrenal insufficiency with a frequency of not known

Actiq

Teva Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use

• 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, ACTIQ 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.
• Updated warning under subheading 'Endocrine Effects'. Androgen deficiency may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.

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

DBL Fentanyl

Pfizer Australia 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 '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 ‘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 '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 adrenal insufficiency and androgen deficiency with a frequency of not known.

4.9 - Overdose

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

Itovebi

Roche Products Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Added breast-feeding restriction for 1 week after completing treatment. 

4.8 - Adverse effects (undesirable effects)

• Increased frequency of ketoacidosis from ‘rare’ to ‘uncommon.’

Lazcluze

Janssen-Cilag Pty Ltd

4.2 - Dose and method of administration

• Addition of hepatotoxicity as adverse reaction with dose modification. Hepatotoxicity (Grade 3-4): Withhold LAZCLUZE and amivantamab. Upon recovery to ≤ Grade 1, resume both medicinal products at the same dose or consider dose reduction, preferentially reducing the dose of amivantamab first.

4.8 - Adverse effects (undesirable effects)

• Added hepatotoxicity as adverse reaction in Table 3.
• Added description of hepatotoxicity. Hepatotoxicity-related reactions occurred in 47% of patients treated with lazertinib in combination with amivantamab. Most events were Grade 1-2, with Grade 3-4 hepatotoxicity occurring in 9% of patients. Most events were related to elevations of serum transaminases (36% alanine elevations of transaminases were able to continue study treatment without modification of study treatment while a small number were managed with a dose interruption or with a dose reduction. There were no cases of liver failure or fatal cases of hepatotoxicity in clinical studies.

Arava

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• DRESS complicated by HLH, including MAS.
• HLH/MAS

4.8 - Adverse effects (undesirable effects)

• Added pulmonary nodule

Saxenda

Novo Nordisk Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Suicidal behaviour and ideation'. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists.

Pentasa

Ferring Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning 'Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine should be considered'.
• Updated warning under subheading 'Use in renal impairment'. Mesalazine treatment should be discontinued immediately if renal function deteriorates.

4.8 - Adverse effects (undesirable effects)

• Added idiopathic intracranial hypertension with a frequency of not known

Biodone Forte

Biomed Aust 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 Biodone Forte should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as Biodone Forte 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 methadone 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, Biodone Forte 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

Oncotice Bcg

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added haemophagocytic lymphohistiocytosis

Cellcept

Roche Products Pty Ltd

4.3 - Contraindications

• Added anaphylaxis

4.4 - Special warnings and precautions for use

Added:

• Hypersensitivity
• Anaphylaxis

4.6 - Fertility, pregnancy and lactation

• Added excretion in human breast milk

4.8 - Adverse effects (undesirable effects)

Added:

• Hypersensitivity
• Anaphylaxis

4.9 - Overdose

• Updated to report a fatal case of overdose

Zyprexa / Zyprexa IM / Zyprexa Zydis

Pharmaco Australia Ltd

4.8 - Adverse effects (undesirable effects) General disorders and administration site conditions

Added:

• Hypothermia
• Hyperthermia

Zyprexa Relprevv

Pharmaco Australia Ltd

4.8 - Adverse effects (undesirable effects) General disorders and administration site conditions

Added:

• Hypothermia  
• Hyperthermia

Losec/ Acimax / Omepral

Pharmaco Australia Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading ‘Severe cutaneous adverse reactions (SCARs)'. SCARs such as erythema multiforme (EM), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) which can be life-threatening or fatal, have been reported very rarely in association with omeprazole treatment. Patients should be advised of the signs and symptoms of the severe skin reaction EM/SJS/TEN/DRESS and should seek medical advice from their prescriber immediately when observing any indicative signs or symptoms. Omeprazole should be discontinued immediately upon signs and symptoms of severe skin reactions and additional medical care/close monitoring should be provided as needed. Rechallenge should not be undertaken in patients with EM/SJS/TEN/DRESS.

Prodalone

Phebra 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 Proladone should be considered.
• Added new warning under subheading 'Endocrine effects'. Opioids, such as Proladone, 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 oxycodone 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 noncardiac chest pain.
• Added new warning under subheading 'Hepatobilary 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, Proladone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.

4.6 - Fertility, Pregnancy and Lactation

• Updated information under subheading 'Use in Pregnancy'. During labour, narcotic analgesics may cause respiratory depression in the newborn infant. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of Proladone during pregnancy.

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 adrenal insufficiency and androgen deficiency with a frequency of not known

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Oxycontin / Oxynorm (Capsules / Liquid) / Oxynorm Injection

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 oxycodone 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.

Targin / MPL-Oxycodone/Naloxone / ARX-Oxycodone/Naloxone

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 with oxycodone/naloxone modified release tablets 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 oxycodone 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.
• Updated warning under subheading 'Biliary tract disorders'. Therefore, oxycodone/naloxone modified release tablets has to be administered 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
• Added pancreatitis with a frequency of not known

APX-Pravastatin / Lipostat / Pravachol

Arrotex Pharmaceuticals Pty Ltd

4.3 - Contraindications

• Added rhabdomyolysis with renal dysfunction secondary to myoglobinuria

Retevmo

Eli Lilly Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading ‘Hypothyroidism'. Treat with thyroid hormone replacement as clinically indicated, however patients could have an insufficient response to substitution with levothyroxine (T4) as selpercatinib may inhibit the conversion of levothyroxine to triiodothyronine (T3) and supplementation with liothyronine may be needed.

Ozempic

Novo Nordisk Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Psychiatric disorders'. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviours, and/or any unusual changes in mood or behaviour. Consider the benefits and risks for individual patients prior to initiating or continuing therapy in patients with suicidal thoughts or behaviours or have a history of suicidal attempts.

4.8 - Adverse effects (undesirable effects)

• Added dysaesthesia

Wegovy

Novo Nordisk Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Psychiatric disorders'. Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviours, and/or any unusual changes in mood or behaviour. Consider the benefits and risks for individual patients prior to initiating or continuing therapy in patients with suicidal thoughts or behaviours or have a history of suicidal attempts.

Palexia IR / Palexia SR

Seqirus 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 with PALEXIA should be considered.
• Added new warning under subheading 'Endocrine Effects'. Opioids such as PALEXIA 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 tapentadol 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, Biodone Forte 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.
• Added drug dependence with a frequency of not known. Repeated use of PALEXIA can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient's individual risk factors, dosage, and duration of opioid treatment.

4.9 - Overdose

• Added toxic leukoencephalopathy has been observed with opioid overdose

Testogel

Besins Healthcare Australia Pty Ltd

4.2 - Dose and method of administration

• Updated information relating to skin-to-skin transfer

4.4 - Special warnings and precautions for use

• Update to statement on patients suffering severe cardiac, hepatic or renal insufficiency or ischaemic heart disease
• Update to statement regarding antidiabetic medication
• Added spermatogenesis
• Added gynecomastia
• Update to Excipient with known effect section (ethanol)
• Update to potential testosterone transfer
• Added ethanol and risk in neonates

4.5 - Interactions with other medicines and other forms of interactions

• Added use with sunscreens

4.8 - Adverse effects (undesirable effects)

Added post-marketing adverse events:

• Hot flushes/flushing
• Pruritis
• Hirsutism
• PSA increased
• Nausea
• Hypertension
• Parathesia generalised
• Headache
• Anxiety
• Decreased libido
• Emotional lability
• Gynaecomastia
• Prostate abnormalities
• Prostatomegaly
• Prostatic disorders
• Spermatogenesis
• Semen disorders
• Testicular atrophy

Brilinta / Brilinta ODT / ARX-Ticagrelor

AstraZeneca Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Update to interaction between ticagrelor and rosuvastatin

Mekinist

Novartis Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added tattoo associated skin reaction

Vfend

Pfizer Australia Pty Ltd

4.3 - Contraindications

Added:

• Eplerenone  
• Voclosporin  

4.5 - Interactions with other medicines and other forms of interactions

Added:

• Eplerenone  
• Voclosporin