Product Information safety updates - June 2025

Atomoxetine Sandoz 

Sandoz Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Serotonin Syndrome’. Serotonin syndrome has been reported following concomitant use of atomoxetine with other serotonergic medicinal products (e.g. serotonin-norepinephrine reuptake inhibitors [SNRIs], selective serotonin reuptake inhibitors [SSRIs], other SNRIs, triptans, opioids, and tricyclic and tetracyclic antidepressants). If concomitant use of atomoxetine with a serotonergic medicinal product is warranted, prompt recognition of the symptoms of serotonin syndrome is important. These symptoms may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
• Added additional warning under subheading ‘Aggressive Behaviour or Hostility’. Severe cases have been reported concerning paediatric patients, including reports of physical assault, or threatening behaviour and thoughts of harming others. Families and caregivers of paediatric patients treated with atomoxetine should be counselled to alert a healthcare professional immediately if significant changes in mood or patterns of behaviour are noted, particularly after starting treatment or changing the dose. Physicians should evaluate the need for dose adjustment or treatment discontinuation in patients experiencing behavioural changes.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction under subheading ‘Serotoninergic medications’. Atomoxetine should be used with caution in combination with serotonergic medicinal products, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), opioids as tramadol, and tetracyclic or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased.

4.8 Adverse effects (undesirable effects)

• Added bruxism in paediatric patients with frequency not known

4.9 Overdose

• Added serotonin syndrome

Bavencio

Merck Healthcare Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added new subheading ‘Immune checkpoint inhibitor class effects’. There have been cases of the following adverse reactions reported during treatment with other immune checkpoint inhibitors which might also occur during treatment with avelumab: pancreatic exocrine insufficiency, coeliac disease and aplastic anaemia.

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 and 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. - 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’

Cardizem

Cardizem CD

Vasocardol  

Vasocardol CD

Diltiazem Sandoz CD

Sanofi-Aventis Australia Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added lupus-like syndrome with a frequency of not known.

empagliflozin / linagliptin   

empagliflozin 

empagliflozin / metformin hydrochloride 

Glyxambi 

Jardiance 

Jardiamet 

Boehringer Ingelheim Pty Ltd 

5. - Special warnings and precautions for use 

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

Artiss

Baxter Healthcare Pty Ltd

4.3 – Contraindications

• Added ‘life-threatening’ to inadvertent intravascular injection

Kerendia  

Bayer Australia Ltd

4.8 - Adverse effects (undesirable effects)

• Added blood creatinine increased 

Luvox

Movox

Viatris Pty Ltd

4.9 Overdose

• Removed existing overdose information and replaced with ‘Occasionally, more serious complications have been observed in cases of deliberate overdosage of fluvoxamine in combination with other drugs. Deaths due to an overdose of fluvoxamine alone have also been reported.’

Arixtra  

Aspen Pharmacare Australia Pty Ltd

4.8 - Adverse effects (undesirable effects)

• Added:
  • 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-protein-nitrogen (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

Imbruvica

Janssen-Cilag Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added Acute kidney injury with a frequency of common
• Added pyogenic granuloma with a frequency of uncommon

Fluquadri 

Sanofi-Aventis Australia Pty Ltd

4.8 Adverse effects (undesirable effects)

• Added rash and Henoch-Schönlein purpura with transient renal involvement

Betaferon 

Bayer Australia Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘Pulmonary Arterial Hypertension’. Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products. PAH has occurred in patients in the absence of other contributory factors. Many of the reported cases required hospitalisation, including one case of lung transplant. PAH has developed at various time points after initiating therapy and may occur several years after starting treatment. Patients who develop unexplained symptoms (e.g., dyspnoea, new or increasing fatigue) should be assessed for PAH. If alternative aetiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated.

4.8 Adverse effects (undesirable effects)

• Added Pulmonary Arterial Hypertension

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, and 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)

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)

Paracetamol-Aft

Aft Pharmaceuticals Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘High Anion Gap Metabolic Acidosis’. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction ‘Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors.’

4.8 Adverse effects (undesirable effects)

• Added High anion gap metabolic acidosis with frequency ‘Not known’. Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol. Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 

Mydol 15 

Pharmacor Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘High Anion Gap Metabolic Acidosis’. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction ‘Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors.’

4.8 Adverse effects (undesirable effects)

• Added high anion gap metabolic acidosis with frequency ‘Not known’. Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol. Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

Maxigesic IV

Aft Pharmaceuticals Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘High Anion Gap Metabolic Acidosis’. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction under subheading ‘Flucloxacillin’

4.8 Adverse effects (undesirable effects)

• Added high anion gap metabolic acidosis with extra description. 

paracetamol, codeine phosphate hemihydrate, doxylamine succinate

Trust Analgesic Calmative

Pharmacor Pty Ltd

4.4 Special warnings and precautions for use

• Added new warning under subheading ‘High Anion Gap Metabolic Acidosis’. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

4.5 Interactions with other medicines and other forms of interactions

• Added new interaction ‘Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors.’

4.8 Adverse effects (undesirable effects)

• Added High anion gap metabolic acidosis with frequency ‘Not known’. Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol. Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

Shingrix  

GlaxoSmithKline Australia Pty Ltd

4.4 - Special warnings and precautions for use 

• Update to Guillain-Barré syndrome

4.8 - Adverse effects (undesirable effects) 

• Update to Guillain-Barré syndrome

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