Product Information safety updates - August 2026

Andriga

Actor Pharmaceuticals Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added panniculitis

Curam

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• crystalluria (including acute renal injury) observed very rarely in patients with reduced urine output
• may cause false test results for aspergillus infection

4.5 - Interactions with other medicines and other forms of interactions

Added:

• penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity
• interaction with mycophenolate mofetil

4.6 - Fertility, pregnancy and lactation

• Added breastfeeding - diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant.

4.8 - Adverse effects (undesirable effects)

Added:

• drug reaction with eosinophilia and systemic symptoms (DRESS)
• symmetrical drug-related intertriginous and flexural exanthema (SDRIFE)

Scemblix

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added arterial occlusive events

Imuran

Aspen Pharmacare Australia Pty Ltd

4.2 - Dose and method of administration

• Food or milk changed to milk or dairy products

4.4 - Special warnings and precautions for use

• Additional information about contraception
• Added Neuromuscular agents
• Added Posterior reversible encephalopathy syndrome (PRES)

4.6 - Fertility, pregnancy and lactation

• Additional information about contraception

4.8 - Adverse effects (undesirable effects)

Added:

• posterior reversible encephalopathy syndrome (PRES)
• cardiac dysfunction

Welireg

Merck Sharp & Dohme (Australia) Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Clarified in patients with reduced activity of both UGT2B17 and CYP2C19, coadministration of WELIREG with CYP3A4 inhibitors may increase the risk of adverse reactions of WELIREG

Cosudex

AstraZeneca Pty Ltd

4.4 - Special warnings and precautions for use

• Added interstitial lung disease

Zolacos CP

AstraZeneca Pty Ltd

4.2 - Dose and method of administration

• Addition of information on administration of goserelin implant

4.4 - Special warnings and precautions for use

• Added interstitial lung disease (ILD)

4.5 - Interactions with other medicines and other forms of interactions

• Added androgen deprivation treatment may prolong the QT interval

Clozaril

Viatris Pty Ltd

4.4 Special warnings and precautions for use

• Updated warning under subheading 'Gastrointestinal hypomotility with severe complications'. Early diagnosis and treatment of constipation at the start of clozapine therapy is important in preventing serious gastrointestinal-related complications (e.g. appendicitis). Appendicitis, including perforated appendicitis, have been reported in post-marketing cases in patients treated with clozapine of any duration, regardless of age or gender. Some of these cases have reported fatal outcomes. Appendicitis and perforated appendicitis require intervention with medicine and surgery.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction, concomitant treatment of clozapine and valproic acid may increase the risk of clozapine-induced myocarditis. If concomitant use of clozapine with valproic acid is necessary, careful monitoring for this event is required.

4.8 Adverse effects (undesirable effects)

• Added appendicitis*.
• Added appendicitis perforated*

*May be fatal.

Tafinlar

Novartis Pharmaceuticals Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Potentiation of radiation toxicity'. Cases of radiation recall and radiation sensitisation have been reported in patients treated with radiation either prior, during or subsequent to treatment with dabrafenib as monotherapy or in combination with trametinib. Most cases were cutaneous in nature, but some cases involved other locations including the spinal cord. Dabrafenib should be used with caution when given concomitantly or sequentially with radiation treatment.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Radiation treatment'. Potentiation of radiation treatment toxicity has been reported in patients receiving dabrafenib as monotherapy or in combination with trametinib.

4.8 Adverse effects (undesirable effects)

• Added potentiation of radiation toxicity with a frequency of common.

Sprycel

Bristol-Myers Squibb Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added side effects in the paediatric population is similar to that of the adult population

Soliris

Alexion Pharmaceuticals Australasia Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added liver injury with a frequency with not known
• Relocated the following adverse events under SOC 'Hepatobiliary disorders': Alanine aminotransferase increased, Aspartate aminotransferase increased and Gamma-glutamyltransferase increased.

Vyepti

Lundbeck Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added constipation - in patients predisposed to constipation look for new or worsening symptoms during treatment

Glucovance

Alphapharm Pty Ltd

4.6 - Fertility, pregnancy and lactation

• Added must not be used for the treatment of diabetes during pregnancy

Glimepiride Sandoz

Sandoz Pty Ltd

4.3 - Contraindications

• Added severe renal impairment

4.4 - Special warnings and precautions for use

• Added timing of administration

4.5 - Interactions with other medicines and other forms of interactions

Added:

• in vivo interaction study
• products that may potentiate or attenuate hypoglycaemia

4.7 - Effects on ability to drive and use machines

• Updated ability to drive or operate machinery

4.9 - Overdose

• Updated overdose treatment
• Added specific information for paediatric overdose

Columvi

Roche Products Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• haemophagocytic lymphohistiocytosis (HLH)
• progressive multifocal leukoencephalopathy (PML)

4.8 - Adverse effects (undesirable effects)

Added:

• haemophagocytic lymphohistiocytosis (HLH)
• progressive multifocal leukoencephalopathy (PML)

Xultophy

Novo Nordisk Pharmaceuticals Pty Ltd

4.8 Adverse Effects (undesirable effects)

• Added alopecia with a frequency not known.
• Added dysaesthesia with a frequency not known.
• Added non-arteritic anterior ischaemic optic neuropathy (NAION)* with a frequency not known.

*Cases of NAION have been reported with GLP-1 RAs, including liraglutide. A sudden loss of vision should lead to ophthalmological examination.

Zeffix

Arrotex Pharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use

• Updated co-infection with HIV

Lithicarb / Quilonum SR

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added exacerbation of Darier’s disease

Artige / Ritalin / Ritalin LA

Novartis Pharmaceuticals Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added stimulants, including non-pharmacotherapeutics (e.g., energy drinks, caffeine) should be used with caution

Betmiga

Astellas Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added anti neutrophil cytoplasmic antibody (ANCA) associated vasculitis

Somac

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added drug fever

Somac

Takeda Pharmaceuticals Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added drug fever

Orion Phenobarbital Elixir

Orion Laboratories Pty Ltd T/A Evaris Pharma

4.4 - Special warnings and precautions for use

• Updated withdrawal of CNS depressants

4.5 - Interactions with other medicines and other forms of interactions

Added:

• posaconazole
• antivirals - abacavcir, amprenavir, darunavir, lopinavir, indinavir, nelfinavir, saquinavir
• HIV-protease inhibitors
• etoposide, irinotecan
• folic acid supplements
• stiripentol

4.8 - Adverse effects (undesirable effects)

Added:

• circulatory disorders
• blood count changes such as eosinophilia, leucocytosis, leucopenia
• gingival enlargement
• upper abdominal discomfort
• disorders of sexual function
• allergic cross-reactions with other antiepileptics
• renal failure
• reduction of serum concentrations of thyroid hormones

Pipertaz Sandoz

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use

Added:

• hypersensitivity reactions which progressed to Kounis syndrome.
• false positive direct Coombs test.

4.8 - Adverse effects (undesirable effects)

• Added linear IgA disease
• Updated wording to ‘Tubulointerstitial nephritis’.

Diprivan

Aspen Pharmacare Australia Pty Ltd

4.4 Special warnings and precautions for use

• Updated warning under subheading 'Use for Sedation During Intensive Care'. Life-threatening adverse events known as Propofol Infusion Syndrome (PRIS), occurring together or in combinations, of cardiac failure, arrhythmias, metabolic acidosis, rhabdomyolysis Brugada-type ECG (elevated ST-segment and coved T-wave) and/or rapidly progressive cardiac failure (in some cases with a fatal outcome), hyperkalaemia, hepatomegaly, hyperlipidaemia and renal failure associated with propofol when used for sedation during intensive care. There have been very rare reports of occurrence of PRIS (in some cases with a fatal outcome) in adults treated for more than 48 hours with propofol infusions in excess of 5 mg/kg/hour. These reports have mainly (but not exclusively) been in patients with serious head injuries treated with high doses of propofol, inotropes and vasoconstrictors. The following appear to be major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropes and/or propofol. If these adverse events occur propofol administration must immediately be discontinued.

4.8 Adverse effects (undesirable effects)

• Added new adverse effect under subheading 'Propofol Infusion Syndrome (PRIS)'. Symptoms include metabolic acidosis, notably lactic acidosis, hyperlipidaemia, hyperkalaemia, rhabdomyolysis typically indicated by a marked increase of the blood creatine phosphokinase, renal impairment or failure, Brugada type ECG, hepatomegaly and cardiac failure not responding to inotropic medication. Cases of fatal outcome have been reported. Propofol Infusion Syndrome may present with varying combinations of these symptoms.

Rifadin

Sanofi-Aventis Australia Pty Ltd

4.3 - Contraindications

• Updated contraindications for daclatasvir, sofosbuvir, telaprevir and lurasidone

4.5 - Interactions with other medicines and other forms of interactions

• Added interactions with lurasidone, sofosbuvir, daclatasvir, telaprevir, cabotegravir, fostemsavir and lenacapavir
• Added simeprevir

Koselugo

Alexion Pharmaceuticals Australasia Pty Ltd

4.4 - Special warnings and precautions for use

• Added cases of asymptomatic subretinal fluid in the paediatric population
• Added retinal pigment epithelial detachment (RPED)/ central serous retinopathy (CSR)

4.8 - Adverse effects (undesirable effects)

Added:

• retinal pigment epithelium
• central serous chorioretinopathy
• serous retinal detachment
• serous retinopathy
• retinal detachment

Mayzent

Novartis Pharmaceuticals Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions

• Updated CYP2C9 and CYP3A4 inhibitors and inducers

4.8 - Adverse effects (undesirable effects)

• Added hypersensitivity

Janumet & Janumet XR & Velmetia

Merck Sharp & Dohme (Australia) Pty Ltd

4.4 Special warnings and precautions for use

• 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.
• 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 reduction of TSH level in patients with treated or untreated hypothyroidism has been reported with postmarketing use of metformin

Talvey

Janssen-Cilag Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Hypogammaglobulinaemia'. Hypogammaglobulinaemia has been reported in patients receiving TALVEY. Immunoglobulin levels should be monitored during treatment with TALVEY. Intravenous or subcutaneous immunoglobulin therapy was used to treat hypogammaglobulinaemia patients. Patients should be treated according to local institutional guidelines, including infection precautions, antibiotic or antiviral prophylaxis, and administration of immunoglobulin replacement.

Tramal

Seqirus Pty Ltd

4.2 - Dose and method of administration

• Added reduction of total daily dose from 600 mg to 400 mg for TRAMAL solution for injection for postoperative pain

Mekinist

Novartis Pharmaceuticals Australia Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading 'Potentiation of radiation toxicity'. Cases of radiation recall and radiation sensitisation have been reported in patients treated with radiation either prior, during or subsequent to treatment with trametinib in combination with dabrafenib. Most cases were cutaneous in nature, but some cases involved other locations including the spinal cord. Trametinib in combination with dabrafenib should be used with caution when given concomitantly or sequentially with radiation treatment.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction under subheading 'Radiation treatment'. Potentiation of radiation treatment toxicity has been reported in patients receiving trametinib in combination with dabrafenib.

4.8 Adverse effects (undesirable effects)

• Added potentiation of radiation toxicity in combination with Tafinlar, with a frequency of common

Tukysa

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use

• Added that due to risk of hepatoxicity, monitor more frequently during the first two months

4.8 - Adverse effects (undesirable effects)

• Added in clinical studies, incidence and severity of transaminase elevations were higher in Japanese patients

Venclexta

AbbVie Pty Ltd

4.8 Adverse effects (undesirable effects), postmarketing experience

• Added oedema
• Added peripheral oedema

Voxzogo

BioMarin Pharmaceutical Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added increased risk of femur fracture with injury