Product Information safety updates - July 2025

Prostin VR

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added warning about ethanol content

Nuvigil

Teva Pharma Australia Pty Ltd

4.3 - Contraindications 

• Added use during pregnancy 

4.4 - Special warnings and precautions for use 

• Updated information on fetal harm

4.6 - Fertility, pregnancy and lactation 

• Added congenital malformations and spontaneous abortion when used during pregnancy

Bavencio

Merck Healthcare Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added cytokine release syndrome

Bavencio

Merck Healthcare Pty Ltd

4.4 - Special warnings and precautions for use 

Added:

• clinically important immune-mediated adverse reactions were reported in clinical studies or in post-marketing
• gastritis  

4.8 - Adverse effects (undesirable effects) 

• Added gastritis

Lioresal

Novartis Pharmaceuticals Australia Pty Ltd

4.2 - Dose and method of administration 

• Clarification of divisibility of tablets – 10 mg has a functional dosing score line where 25 mg tablet is to be divided for ease of swallowing only

Norspan / Bupredermal

Mundipharma Pty Ltd

4.4 - Special warnings and precautions for use 

• Inclusion of warning statements concerning (OUD) Opioid Use Disorder

4.5 - Interactions with other medicines and other forms of interactions 

• Updated warning statements for concomitant use with gabapentioids and anticholinergics

4.8 - Adverse effects (undesirable effects) 

• Addition of a Drug dependence section

Crysvita

Kyowa Kirin Australia Pty Ltd

4.2 - Dose and method of administration 

• Added requirement to assess vitamin D 

4.4 - Special warnings and precautions for use 

Added:

• hypercalcaemia  
• hyperparathyroidism  

4.5 - Interactions with other medicines and other forms of interactions 

• Update to calcimimetics 

4.6 - Fertility, pregnancy and lactation 

• Added contraceptive warning for women of childbearing potential 

4.8 - Adverse effects (undesirable effects) 

Added:

• urticaria  
• toothache  
• injection site reaction

Litak

Viatris Pty Ltd

4.6 - Fertility, pregnancy and lactation 

• Updated information about excretion in human milk

Mersyndol Forte / Mersyndol Caplets / Mersyndol

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis 

4.5 - Interactions with other medicines and other forms of interactions 

• Updated interaction with ‘flucloxacillin’ to include HAGMA due to pyroglutamic acidosis 

4.8 - Adverse effects (undesirable effects) 

• Updated ‘Metabolism and nutrition system disorders’ to include HAGMA due to pyroglutamic acidosis with ‘unknown frequency’

Comfarol Forte / Prodeine / Paracetamol/Codeine Gh 500/30 / Prodeinextra / Codapane Forte 500/30 / Apx-Paracetamol/Codeine / Panamax Co / Panadeine Forte / Prodeine Forte 

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis 

4.5 - Interactions with other medicines and other forms of interactions 

• Updated interaction with ‘flucloxacillin’ to include HAGMA due to pyroglutamic acidosis 

4.8 - Adverse effects (undesirable effects) 

• Updated ‘Metabolism and nutrition system disorders’ to include HAGMA due to pyroglutamic acidosis with ‘unknown frequency’

Quadracel

Sanofi-Aventis Australia Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added injection site vesicles.

Elrexfio

Pfizer Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added new or reactivated viral infections, including cytomegalovirus (CMV) infection/ reactivation

4.8 - Adverse effects (undesirable effects) 

• Cytomegalovirus infection

Jardiance

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use 

• Added prolonged ketoacidosis and glucosuria
• Updated Fournier’s gangrene 

4.8 - Adverse effects (undesirable effects) 

• Added phimosis

Glyxambi

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use 

• Added prolonged ketoacidosis and glucosuria
• Updated Fournier’s gangrene 

4.8 - Adverse effects (undesirable effects) 

• Added phimosis

Jardiamet

Boehringer Ingelheim Pty Ltd

4.4 - Special warnings and precautions for use 

• Added prolonged ketoacidosis and glucosuria
• Updated Fournier’s gangrene 

4.8 - Adverse effects (undesirable effects) 

• Added phimosis

Entecavir Sandoz 

Sandoz Pty Ltd

4.4 - Special warnings and precautions for use 

Added:

• lactic acidosis and severe hepatomegaly with steatosis
• exacerbations of hepatitis after discontinuation of treatment
• decompensated liver disease
• resistance and specific precaution for lamivudine-refractory patients

Nexium / Esopreze

AstraZeneca Pty Ltd

4.4 Special warnings and precautions for use

• Added additional 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 esomeprazole treatment. Patients should be advised of the signs and symptoms and seek immediate medical advice when observing any indicative signs and symptoms. Esomeprazole should be discontinued immediately upon signs and symptoms and additional medical care/close monitoring should be provided. Re-challenge should not be undertaken in patients with EM/SJS/TEN/DRESS.

Nexium IV 

AstraZeneca Pty Ltd

4.4 Special warnings and precautions for use

• Added additional 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 esomeprazole treatment. Patients should be advised of the signs and symptoms and seek immediate medical advice when observing any indicative signs and symptoms. Esomeprazole should be discontinued immediately upon signs and symptoms and additional medical care/close monitoring should be provided. Re-challenge should not be undertaken in patients with EM/SJS/TEN/DRESS.

Nexium Hp7 

AstraZeneca Pty Ltd

4.4 Special warnings and precautions for use

• Added additional 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 esomeprazole treatment. Patients should be advised of the signs and symptoms and seek immediate medical advice when observing any indicative signs and symptoms. Esomeprazole should be discontinued immediately upon signs and symptoms and additional medical care/close monitoring should be provided. Re-challenge should not be undertaken in patients with EM/SJS/TEN/DRESS.

Artiss

Baxter Healthcare Pty Ltd

4.3 - Contraindications 

• Added ‘life-threatening’ to inadvertent intravascular injection

Tachosil

Adjutor Healthcare Pty Ltd

4.2 - Dose and method of administration 

• Added adhesion issue information
• Update to sponge preparation instructions 

4.4 - Special warnings and precautions for use 

• Update to batch and name recording instructions 

4.8 - Adverse effects (undesirable effects) 

Added:

• Granuloma  
• Product adhesion issues

Kerendia

Bayer Australia Ltd

4.8 - Adverse effects (undesirable effects) 

• Added blood creatinine increased

Gilenya

Novartis Pharmaceuticals Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation 

• Update to Use in pregnancy based on new human data (GPR and PRIM studies)

Diflucan

Pfizer Australia Pty Ltd

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction ‘Everolimus: Although not studied in vivo or in vitro, fluconazole may increase serum concentrations of everolimus through inhibition of CYP3A4.’

Arixtra

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added multiple adverse events (post ‐operative wound, infections, anaemia, post‐operative haemorrhage, uterovaginal haemorrhage, haemoptysis, haematuria, haematoma, gingival bleeding, purpura, epistaxis, gastrointestinal bleeding, hemarthrosis, ocular bleeding, bruise, thrombocytopenia, thrombocythemia, platelet abnormal, coagulation disorder retroperitoneal bleeding, hepatic, intracranial/intracerebral bleeding, allergic reaction (including very rare reports of angioedema, anaphylactoid/anaphylactic reaction), hypokalaemia, non-proteinnitrogen (Npn) increased, headache, anxiety, confusion, dizziness, somnolence, vertigo, hypotension, dyspnoea, coughing, nausea, vomiting, abdominal pain, dyspepsia, gastritis, constipation, diarrhoea, abnormal liver function tests, hepatic enzymes increased, bilirubinaemia, rash erythematous, pruritus, oedema, oedema peripheral, pain, fever, chest pain, wound secretion, reaction at injection site, leg pain, fatigue, flushing, syncope, hot flushes, oedema genital)

Karvezide / Avapro Hct 

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added intestinal angioedema 

4.8 - Adverse effects (undesirable effects) 

Added intestinal angioedema

Karvea

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added intestinal angioedema 

4.8 - Adverse effects (undesirable effects) 

• Added intestinal angioedema

Orudis SR / Oruvail SR 

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• New warning added re: ‘Risk of fetal death’

4.6 - Fertility, pregnancy and lactation 

• Addition of symptoms relating to fetal death following administration during pregnancy  

4.8 - Adverse effects (undesirable effects) 

• Added ‘fetal death’ event under ‘Pregnancy, puerperium and perinatal conditions’ with ‘Not known’ frequency

Lamictal

Aspen Pharmacare Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added HLA-B*1502 allele and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN

4.8 - Adverse effects (undesirable effects) 

Added:

• motor and/or phonic tics
• pseudolymphoma  

4.9 - Overdose 

• Added intravenous lipid therapy for the treatment of cardiotoxicity

Lenvima

Eisai Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added tumour lysis syndrome (TLS) 

4.8 - Adverse effects (undesirable effects) 

• Added tumour lysis syndrome (TLS)

M-M-R II 

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added skin granuloma

Proquad

Merck Sharp & Dohme (Australia) Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added skin granuloma

Salofalk

Dr Falk Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added idiopathic intracranial hypertension 

4.8 - Adverse effects (undesirable effects) 

• Added idiopathic intracranial hypertension

Flagyl S 

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added drug reaction with eosinophilia and systemic symptoms (DRESS) 

4.8 - Adverse effects (undesirable effects) 

• Added drug reaction with eosinophilia and systemic symptoms (DRESS)

Mitocin

Echo Therapeutics Pty Ltd

4.4 - Special warnings and precautions for use 

• Update to extravasation (fat tissue necrosis, bladder perforation, fistula and abscess) 

4.8 - Adverse effects (undesirable effects) 

• Update to intravesical administration (bladder perforation, fat necrosis of surrounding area, vesical fistula, abscesses)

Keytruda

Merck Sharp & Dohme (Australia) Pty Ltd

4.4 Special warnings and precautions for use

• Added additional warning under subheading ‘Other immune-mediated adverse reactions’ to include aplastic anaemia
• Added new warning under subheading ‘Patients with pre-existing autoimmune disease (AID)’. In patients with pre-existing AID, data from observational studies suggests that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID. In addition, flares of the underlying AID occurred, but the majority were mild and manageable. 

4.8 Adverse effects (undesirable effects)

• Added coeliac disease
• Added infusion-related reactions (including cytokine release syndrome)

Nardil

Neon Healthcare Pty Limited

4.3 - Contraindications 

• Updated drug interactions for phenelzine with sympathomimetic drugs, MAOIs, 5HT1 agonists, dibenzazepine derivatives
• Added concomitant use of pizotifen contraindicated 

4.5 - Interactions with other medicines and other forms of interactions 

• Added serotonin syndrome and relevant drug interactions for 5HT3 antagonists and methylthioninium chloride 

4.8 - Adverse effects (undesirable effects) 

• Added suicidal ideation and suicidal behaviour to common side effects
• Added hypertension to severe side effects

Seroquel XR-

Luye Pharma Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added risk of serotonin syndrome when co-administered with other serotonergic agents. 

4.5 - Interactions with other medicines and other forms of interactions 

• Added caution when used in combination with serotonergic products

Abrysvo

Pfizer Australia Pty Ltd

4.8 - Adverse effects (undesirable effects) 

• Added to blood and lymphatic system disorders: lymphadenopathy
• Added to immune system disorders: anaphylaxis
• Added increased frequency of hypersensitivity
• Changed reactions from ‘very rare’ to ‘rare’

Shingrix

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Update to text relation to Guillain-Barré syndrome 

4.8 - Adverse effects (undesirable effects) 

• Update to text relation to Guillain-Barré syndrome

Risperidone Lupin 

Generic Health Pty Ltd

4.2 Dose and Method of Administration

• Added new dosing instructions and figures for the oral solution under subheading ‘Directions for Opening the Bottle and using the Pipette for the Oral Solution’.

Ventolin Cfc-Free Inhaler / Ventolin Nebules 

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Update to warning statement related to SABA overuse

Ventolin Inhaler 

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Update to warning statement related to seeking medical advice
• Added instructions to avoid inadvertent use of an empty salbutamol pMDI

Technescan HDP

Landauer Radiopharmaceuticals Pty Ltd

4.4 - Special warnings and precautions for use 

• Added interactions with cations 

4.5 - Interactions with other medicines and other forms of interactions 

• Added interactions with cations

Epilim IV / Valproate Winthrop EC / Sodium Valproate Sandoz / Epilim EC / Epilim Syrup / Epilim / Valpro EC / Epilim Liquid 

Sanofi-Aventis Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Added risk of lower weight at birth for the gestational age 

4.6 - Fertility, pregnancy and lactation 

• Added in utero exposure in animals decreased fetal weight, intra-uterine growth restriction and reduction in crown rump length compared to unexposed animals

Aldactone

Pfizer Australia Pty Ltd

4.5 - Interactions with other medicines and other forms of interactions 

• Updated to add ‘reduces the renal clearance of lithium’

Zelboraf

Roche Products Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added Sarcoidosis with frequency rare

Navelbine

Pierre Fabre Australia Pty Ltd

4.6 - Fertility, pregnancy and lactation 

• Extension of timeframe for men and women to use contraception post treatment