CIZERE

What it is

CIZERE contains the active ingredients cinnarizine and dimenhydrinate. Each tablet contains 20 mg of cinnarizine and 40 mg of dimenhydrinate. CIZERE 20 mg/40 mg tablets are white to almost white, round, biconvex uncoated tablets 8 mm in diameter.

Approved indications

— Short-term, symptomatic treatment of vertigo of various causes, in adults who have not responded to alternative treatments.

Dosing overview

The recommended dose for adults is one tablet three times daily. The lowest dose for the shortest duration to achieve symptom control should be used. CIZERE tablets should be swallowed without chewing with some liquid after meals to minimise any gastric irritation. In general, the duration of treatment should not exceed four weeks.

Key safety warnings

Extrapyramidal effects including tremor, dyskinesia, parkinsonism, tardive dyskinesia and akathisia have been reported rarely with cinnarizine. These effects are more likely to occur in older patients over 60 years, women, those on high doses greater than 150 mg daily and those with prolonged exposure to cinnarizine. Patients should be advised to cease treatment with CIZERE immediately and seek medical advice if any abnormal movements such as shaking, twitching or twisting movements, muscle stiffness, restless legs, stiff posture, slowed shuffling walk or a need to be in constant motion arise. The most frequently reported adverse drug reactions in patients taking CIZERE in clinical trials are somnolence (including drowsiness, tiredness, fatigue, daze), dry mouth and headache. These reactions are usually mild and disappear within a few days even if treatment is continued. CIZERE may cause drowsiness, especially at the start of treatment. Patients affected in this way should not drive or operate machinery. In common with other antihistamines, CIZERE may potentiate the sedative effects of central nervous system depressants including alcohol, barbiturates, narcotic analgesics and tranquillisers. Patients should be advised to avoid alcoholic drinks.

Contraindications

CIZERE is contraindicated in patients with hypersensitivity to cinnarizine, dimenhydrinate, diphenhydramine, other antihistamines of a similar structure, or to any of the excipients. CIZERE is contraindicated in patients with a creatinine clearance of ≤ 25 mL/min (severe renal impairment). CIZERE is contraindicated in patients with severe hepatic impairment. CIZERE is contraindicated in patients with angle-closure glaucoma, convulsions, suspicion of raised intracranial pressure, alcohol abuse or urine retention due to urethroprostatic disorders. CIZERE is contraindicated for use in children under 6 years of age because of the potential for fatal respiratory depression, psychiatric and central nervous system events.

Regulatory history

The TGA approval decision was made on 21 December 2018. CIZERE was first listed on the ARTG on 8 January 2019 (ARTG 288567). The TGA's evaluation concluded that the product met chemistry and quality control standards, and bioequivalence to an overseas reference product was demonstrated. Both active ingredients and their combination have a lengthy history of clinical use, supporting the nonclinical assessment.