Product Information safety updates - June 2026

Calquence

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions

• Updated warning under subheading 'Cardiac arrhythmias including atrial fibrillation and flutter'. Serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. In the combined safety database of 1478 patients with haematological malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 7.4% of patients and Grade 3 or higher occurred in 2.3% of patients. Monitor for symptoms of cardiac arrhythmia, including atrial fibrillation and atrial flutter, (e.g., palpitations, dizziness, syncope, chest pain, dyspnoea) and obtain an ECG as appropriate.
• Added new warning under subheading 'Hepatotoxicity, including drug-induced liver injury'. Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE. Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE.

4.8 - Adverse effects (Undesirable effects)

Added:

• cardiac arrhythmias.
• hepatotoxicity.
• drug-induced liver injury

Kalma

Alphapharm Pty Ltd

4.9 - Overdose

• Updated management information

Augmentin Duo / Augmentin Duo Forte

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added haemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS)

4.6 - Fertility, pregnancy and lactation

• Added excretion in breastmilk

4.8 - Adverse effects (undesirable effects)

Added to haematopoietic and lymphatic systems:

• haemolytic anaemia
• haemophagocytic lymphohistiocytosis/macrophage activation syndrome
• anaphylaxis  
• angioneurotic oedema
• serum sickness-like syndrome
• hypersensitivity vasculitis

APX-Clopidogrel/Aspirin / Clopidogrel Winthrop Plus Aspirin / Duoplidogrel / Duocover

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added Kounis syndrome related to aspirin use

Tenormin atenolol tablet

Atnahs Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated concomitant use of beta-blockers with sulfonylureas

4.5 - Interactions with other medicines and other forms of interactions

• Updated concomitant use of beta-blockers with sulfonylureas

Vegzelma

Celltrion Healthcare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added hyaline occlusive glomerular microangiopathy

Comirnaty JN.1

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Myocarditis and pericarditis'. Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY. Cases have occurred following first and second vaccinations and following booster doses. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often, but not exclusively in younger males (adolescents and young adults). There have been reports in females. Based on accumulating data, the reporting rates of myocarditis and pericarditis after primary series in children ages 5 through to 12 years are lower than in ages 12 to 17 years.

Apretude

ViiV Healthcare Pty Ltd

4.8 - Adverse Effects (Undesirable Effects)

• Added new description of selected adverse reaction 'Injection site reaction (pain* and discomfort, site nodule, induration) in table 6: Adverse Reactions. *May rarely result in temporary gait disturbance.

Cftriax

Steriscience Pty Ltd

4.4 - Special warnings and precautions

• Updated warning under subheading 'Hypersensitivity to cephalosporins, penicillins or other drugs'. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction).

4.8 - Adverse effects (undesirable effects) 

• Added Kounis syndrome with a frequency of not known

Mavenclad / Cladritab

Merck Healthcare Pty Ltd

4.6 - Fertility, Pregnancy and Lactation

• Updated information under subheading 'Use in Lactation'. Limited data from case reports have shown that cladribine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, breast-feeding is contraindicated during treatment with MAVENCLAD and for 1 week after the last dose.

Forxiga / Dapagliflozin AZN

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Ketoacidosis'. Ketoacidosis and glucosuria may be prolonged after discontinuation of FORXIGA in some patients, i.e. it may last longer than expected based on the plasma half-lives of dapagliflozin. Consider monitoring for ketoacidosis and glucosuria in patients on dapagliflozin, even if drug treatment has been interrupted or discontinued.
• Updated warning under subheading 'Surgery'. Treatment with FORXIGA should be ceased prior to major surgery or procedures associated with prolonged fasting. An increase in other glucose lowering agents may be required during this time.
• Added new warning under heading 'Effects on laboratory tests', subheading 'Increased Haematocrit'. Increased haematocrit has been observed with dapagliflozin treatment. Patients with pronounced elevations in haematocrit should be monitored and investigated for underlying haematological disease.

4.8 - Adverse effects (undesirable effects)

• Updated adverse event under subheading 'Genital infections'. Cases of phimosis/acquired phimosis have been reported with dapagliflozin concurrent with genital infections and in some cases, circumcision was required.
• Added Increased haematocrit with a frequency of common
• Added tubulointerstitial nephritis with a frequency of very rare

Qtern 5/10

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Ketoacidosis'. Ketoacidosis and glucosuria may be prolonged after discontinuation of QTERN in some patients, i.e. it may last longer than expected based on the plasma half-lives of dapagliflozin. Consider monitoring for ketoacidosis and glucosuria in patients on dapagliflozin, even if drug treatment has been interrupted or discontinued.
• Updated warning under subheading 'Surgery'. Treatment with QTERN should be ceased prior to major surgery or procedures associated with prolonged fasting. An increase in other glucose lowering agents may be required during this time.
• Added new warning under heading 'Effects on laboratory tests', subheading 'Increased Haematocrit'. Increased haematocrit has been observed with dapagliflozin treatment. Patients with pronounced elevations in haematocrit should be monitored and investigated for underlying haematological disease.

4.8 - Adverse effects (undesirable effects)

• Updated adverse event under subheading 'Genital infections'. Cases of phimosis/acquired phimosis have been reported with dapagliflozin concurrent with genital infections and in some cases, circumcision was required.
• Added Increased haematocrit with a frequency of common
• Added tubulointerstitial nephritis with a frequency of very rare

Sidapvia

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Ketoacidosis'. Ketoacidosis and glucosuria may be prolonged after discontinuation of SIDAPVIA in some patients, i.e. it may last longer than expected based on the plasma half-lives of dapagliflozin. Consider monitoring for ketoacidosis and glucosuria in patients on dapagliflozin, even if drug treatment has been interrupted or discontinued.
• Updated warning under subheading 'Surgery'. Treatment with SIDAPVIA should be ceased prior to major surgery or procedures associated with prolonged fasting. An increase in other glucose lowering agents may be required during this time.
• Added new warning under heading 'Effects on laboratory tests', subheading 'Increased Haematocrit'. Increased haematocrit has been observed with dapagliflozin treatment. Patients with pronounced elevations in haematocrit should be monitored and investigated for underlying haematological disease.

4.8 - Adverse effects (undesirable effects)

• Updated adverse event under subheading 'Genital infections'. Cases of phimosis/acquired phimosis have been reported with dapagliflozin concurrent with genital infections and in some cases, circumcision was required.
• Added new adverse event Increased haematocrit with a frequency of common
• Added new adverse event Tubulointerstitial nephritis with a frequency very rare

Infanrix Heva

GlaxoSmithKline Australia Pty Ltd

4.2 - Dose and method of administration 

• Updated wording on reconstitution and formatting of pictogram

Tivicay

ViiV Healthcare Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Serum lipids and blood glucose'. Serum lipid and blood glucose levels may increase during antiretroviral therapy. Disease control and lifestyle changes may also be contributing factors. Consideration should be given to the measurement of serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate.

Juluca

ViiV Healthcare Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Serum lipids and blood glucose'. Serum lipid and blood glucose levels may increase during antiretroviral therapy. Disease control and lifestyle changes may also be contributing factors. Consideration should be given to the measurement of serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate.

Trulicity

Eli Lilly Australia Pty Ltd

4.8 - Adverse Effects (undesirable effects)

• Added new adverse event under subheading 'Eye disorders' - Events of non-arteritic anterior ischaemic optic neuropathy (NAION), a rare condition associated with the potential for decreased vision including permanent loss of vision, have been reported in patients treated with products with GLP-1 receptor agonist activity. A sudden loss of vision should lead to ophthalmological examination.

Added:

• dysaesthesia.
• dysgeusia.
• alopecia.

Duodart / Doubluts

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use 

Added:

• mood alterations and depression
• allergic-type reactions from colouring agent

Vyepti

Lundbeck Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypertension'. Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the post-marketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalisation. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative aetiology or blood pressure is inadequately controlled.

4.8 - Adverse effects (undesirable effects)

• Added hypertension with a frequency of unknown

Columvi

Roche Products Pty Ltd

4.2 - Dose and method of administration

• Added haemophagocytic lymphohistiocytosis (HLH) under ‘Management of Cytokine Release Syndrome (CRS)’.

4.4 - Special warnings and precautions for use

• Added haemophagocytic lymphohistiocytosis (HLH)

4.8 - Adverse effects (undesirable effects) 

• Added haemophagocytic lymphohistiocytosis (HLH)

Coversyl Plus LD / Coversyl Plus

Servier Laboratories (Aust) Pty Ltd

4.4 - Special warnings and precautions for use

• Updated angioedema

Fluzone Inactivated Trivalent Influenza Vaccine

Sanofi-Aventis Australia Pty Ltd

4.8 - Adverse effects (Undesirable effects)

• Added Henoch-Schonlein purpura, with transient renal involvement in certain cases
• Added rash

Arava

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated existing warning under subheading 'Use in males'. Teriflunomide (A771726), the active metabolite of Arava, is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Arava and undergo a washout procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite (A771726) must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

4.6 - Fertility, pregnancy and lactation

• Updated the existing safety information under subheading 'Use in males'. Teriflunomide (A771726), the active metabolite of Arava, is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Arava and undergo a washout procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite (A771726) must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

Trajentamet

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypothyroidism'. Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism. Regular monitoring of TSH levels is recommended in patients with hypothyroidism. Studies have shown that metformin reduces plasma TSH levels, often to subnormal levels, when it is administered to patients with untreated hypothyroidism or to hypothyroid patients effectively treated with Levothyroxine. The metformin-induced reduction of plasma TSH levels is not observed when metformin is administered to patients with normal thyroid function. Metformin has been suggested to enhance the inhibitory modulation of thyroid hormones on TSH secretion. Levothyroxine can reduce the hypoglycaemic effect of metformin. Careful monitoring of blood glucose levels is recommended in patients with hypothyroidism treated with Levothyroxine, especially when thyroid hormone therapy is initiated, changed, or stopped.

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Levothyroxine'. Levothyroxine can reduce the hypoglycaemic effect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated, changed, or stopped, and dosage adjusted as necessary.

4.8 - Adverse effects (undesirable effects)

• Added new adverse event under subheading 'Metformin'. Reduction of TSH level in patients with treated or untreated hypothyroidism.

Metformin GH

Generic Health Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypothyroidism'. Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism. Regular monitoring of TSH levels is recommended in patients with hypothyroidism. Studies have shown that metformin reduces plasma TSH levels, often to subnormal levels, when it is administered to patients with untreated hypothyroidism or to hypothyroid patients effectively treated with Levothyroxine. The metformin-induced reduction of plasma TSH levels is not observed when metformin is administered to patients with normal thyroid function. Metformin has been suggested to enhance the inhibitory modulation of thyroid hormones on TSH secretion. Levothyroxine can reduce the hypoglycaemic effect of metformin. Careful monitoring of blood glucose levels is recommended in patients with hypothyroidism treated with Levothyroxine, especially when thyroid hormone therapy is initiated, changed, or stopped.

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Levothyroxine'. Levothyroxine can reduce the hypoglycaemic effect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated, changed, or stopped, and dosage adjusted as necessary.

4.8 - Adverse effects (undesirable effects)

• Added new adverse event under subheading 'Reduction of TSH level'. Reduction of TSH level in patients with treated or untreated hypothyroidism.

Metformin Lupin XR

Generic Health Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypothyrodism'. Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism. Regular monitoring of TSH levels is recommended in patients with hypothyroidism. Studies have shown that metformin reduces plasma TSH levels, often to subnormal levels, when it is administered to patients with untreated hypothyroidism or to hypothyroid patients effectively treated with Levothyroxine. The metformin-induced reduction of plasma TSH levels is not observed when metformin is administered to patients with normal thyroid function. Metformin has been suggested to enhance the inhibitory modulation of thyroid hormones on TSH secretion. Levothyroxine can reduce the hypoglycaemic effect of metformin. Careful monitoring of blood glucose levels is recommended in patients with hypothyroidism treated with Levothyroxine, especially when thyroid hormone therapy is initiated, changed, or stopped.
• Added new warning under subheading 'Patients with known or suspected mitochondrial diseases'. In patients with known mitochondrial diseases such as Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternal inherited diabetes and deafness (MIDD), metformin is not recommended due to the risk of lactic acidosis exacerbation and neurologic complications which may lead to worsening of the disease. In case of signs and symptoms suggestive of MELAS syndrome or MIDD after the intake of metformin, treatment with metformin should be withdrawn immediately and prompt diagnostic evaluation should be performed.

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Levothyroxine'. Levothyroxine can reduce the hypoglycaemic effect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated, changed, or stopped, and dosage adjusted as necessary.

4.8 - Adverse effects (undesirable effects)

• Added reduction of TSH level in patients with treated or untreated hypothyroidism

Metformin Sandoz

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use

• Added warning under subheading 'Hypothyroidism'. Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism. Regular monitoring of TSH levels is recommended in patients with hypothyroidism. Studies have shown that metformin reduces plasma TSH levels, often to subnormal levels, when it is administered to patients with untreated hypothyroidism or to hypothyroid patients effectively treated with levothyroxine. The metformin-induced reduction of plasma TSH levels is not observed when metformin is administered to patients with normal thyroid function. Metformin has been suggested to enhance the inhibitory modulation of thyroid hormones on TSH secretion. Levothyroxine can reduce the hypoglycaemic effect of metformin. Careful monitoring of blood glucose levels is recommended in patients with hypothyroidism treated with levothyroxine, especially when thyroid hormone therapy is initiated, changed, or stopped.

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Levothyroxine'. Levothyroxine can reduce the hypoglycaemic effect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated, changed, or stopped, and dosage adjusted as necessary.

4.8 - Adverse effects (undesirable effects)

• Added reduction of TSH level in patients with treated or untreated hypothyroidism with a frequency of unknown

Trexject

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

4.8 - Adverse effects (undesirable effects)

Added:

• acute paronychia
• exanthema
• increase in rheumatic nodules
• pericardial tamponade
• dyspepsia
• inflammation and ulceration of the urinary bladder
• inflammation and ulceration of the vagina
• gynaecomastia
• electrolyte disturbances
• bronchial asthma
• pleural effusion
• depression
• confusion
• retinopathy
• impaired vision

Solu-Medrol / Solu-Medrol Act-O-Vial

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Endocrine effects'. Thyrotoxic Periodic Paralysis (TPP) can occur in patients with hyperthyroidism and with methylprednisolone-induced hypokalaemia. TPP must be suspected in patients treated with methylprednisolone presenting signs or symptoms of muscle weakness, especially in patients with hyperthyroidism. If TPP is suspected, levels of blood potassium must be immediately monitored and adequately managed to ensure the restoration of normal levels of blood potassium.

Depo-Medrol / Depo-Nisolone

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Endocrine effects'. Thyrotoxic Periodic Paralysis (TPP) can occur in patients with hyperthyroidism and with methylprednisolone-induced hypokalaemia. TPP must be suspected in patients treated with methylprednisolone presenting signs or symptoms of muscle weakness, especially in patients with hyperthyroidism. If TPP is suspected, levels of blood potassium must be immediately monitored and adequately managed to ensure the restoration of normal levels of blood potassium.

Allegron

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Added warning under subheading 'Cardiovascular '. Unmasking of Brugada syndrome has been reported in patients treated with nortriptyline. Brugada syndrome is a rare hereditary disease of the cardiac sodium channel with characteristic ECG changes (ST segment elevation and T wave abnormalities in the right precordial leads), which may lead to cardiac arrest and/or sudden death. Nortriptyline should generally be avoided in patients with Brugada syndrome or those suspected of having Brugada syndrome. Caution is advised in patient with risk factors such as a family history of cardiac arrest or sudden death.

4.8 - Adverse effects (Undesirable effects)

• Added Brugada syndrome (unmasking)
• Added hyponatraemia

4.9 - Overdose

• Added Brugada syndrome (unmasking) and Brugada ECG pattern (BEP) have been reported in post-marketing surveillance in association with nortriptyline overdose

Coversyl / Prexum

Servier Laboratories (Aust) Pty Ltd

4.4 - Special warnings and precautions for use

• Updated angioedema

Noxafil

Merck Sharp & Dohme (Australia) Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Flucloxacillin'. Flucloxacillin (a CYP450 inducer) may decrease plasma posaconazole concentrations. Concomitant use of posaconazole and flucloxacillin should be avoided unless the benefit to the patient outweighs the risk.

Lyrica

Viatris Pty Ltd

4.8 - Adverse effects (undesirable effects)

Added:

• jaundice with a frequency of not known.
• hepatic failure with a frequency of not known.
• hepatitis with a frequency of not known

Propofol-Lipuro

B Braun Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

Added:

• hepatitis
• acute hepatic failure

Comirnaty LP.8.1

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Updated warning under subheading 'Myocarditis and pericarditis'. Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY. Cases have occurred following first and second vaccinations and following booster doses. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often, but not exclusively in younger males (adolescents and young adults). There have been reports in females. Based on accumulating data, the reporting rates of myocarditis and pericarditis after primary series in children ages 5 through to 12 years are lower than in ages 12 to 17 years.

Sitagliptin/ Metformin Sandoz

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use

• Added new warning under subheading 'Hypothyroidism'. Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism. Regular monitoring of TSH levels is recommended in patients with hypothyroidism. Studies have shown that metformin reduces plasma TSH levels, often to subnormal levels, when it is administered to patients with untreated hypothyroidism or to hypothyroid patients effectively treated with levothyroxine. The metformin-induced reduction of plasma TSH levels is not observed when metformin is administered to patients with normal thyroid function. Metformin has been suggested to enhance the inhibitory modulation of thyroid hormones on TSH secretion. Levothyroxine can reduce the hypoglycaemic effect of metformin. Careful monitoring of blood glucose levels is recommended in patients with hypothyroidism treated with levothyroxine, especially when thyroid hormone therapy is initiated, changed, or stopped.
• Added new warning under subheading 'Patients with known or suspected mitochondrial diseases'. In patients with known mitochondrial diseases such as Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternal inherited diabetes and deafness (MIDD), metformin is not recommended due to the risk of lactic acidosis exacerbation and neurologic complications which may lead to worsening of the disease. In case of signs and symptoms suggestive of MELAS syndrome or MIDD after the intake of metformin, treatment with metformin should be withdrawn immediately and prompt diagnostic evaluation should be performed.

4.5 - Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Levothyroxine'. Levothyroxine can reduce the hypoglycaemic effect of metformin. Monitoring of blood glucose levels is recommended, especially when thyroid hormone therapy is initiated, changed, or stopped, and dosage adjusted as necessary. 

4.8 - Adverse effects (undesirable effects)

• Added reduction of TSH level in patients with treated or untreated hypothyroidism

Teri-EM

Emcure Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Updated existing warning under subheading 'Use in males'. Teriflunomide (A771726) is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite (A771726) must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

4.6 - Fertility, pregnancy and lactation

• Updated the existing safety information under subheading 'Use in males'. Teriflunomide (A771726) is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite (A771726) must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

Teriflunomide GH

Generic Health Pty Ltd

4.4 - Special warnings and precautions for use

• Updated existing warning under subheading 'Use in males'. Teriflunomide (A771726) is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite (A771726) must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02 mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

4.6 - Fertility, pregnancy and lactation

• Updated the existing safety information under subheading 'Use in males'. Teriflunomide (A771726) is detected in human semen. Animal studies to specifically evaluate the risk of male mediated foetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of Teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, plasma levels of the active metabolite (A771726) must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02 mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated foetal toxicity is considered very low.

Terimide

Alphapharm Pty Ltd

4.4 - Special warnings and precautions for use

• Updated existing warning under subheading 'Use in males'. Teriflunomide (A771726) is detected in human semen. Animal studies to specifically evaluate the risk of male mediated fetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, teriflunomide plasma levels must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02 mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated fetal toxicity is considered very low.

4.6 - Fertility, pregnancy and lactation

• Updated the existing safety information under subheading 'Use in males'. Teriflunomide (A771726) is detected in human semen. Animal studies to specifically evaluate the risk of male mediated fetal toxicity have not been conducted. To minimise any possible risk, men not wishing to father a child and their female partners should use reliable contraception. Men wishing to father a child should discontinue use of teriflunomide and undergo an accelerated elimination procedure or wait 2 years after treatment cessation. In either case, teriflunomide plasma levels must be verified to be less than 0.02 mg/L on two separate tests at an interval of at least 14 days apart. If the plasma concentration is less than 0.02 mg/L on both tests, and after a waiting period of at least 3 months, the risk of male-mediated fetal toxicity is considered very low.

Tobi Podhaler

Viatris Pty Ltd

4.4 - Special warnings and precautions for use

• Added acute kidney injury

4.8 - Adverse effects (undesirable effects)

• Added acute kidney injury

Stelara

Janssen-Cilag Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added hypersensitivity reactions in patients with alpha-gal syndrome, allergy to mammalian meat or meat products, or anti-alpha-gal IgE