CYCLIZINE Tablet Ref.[9318] Active ingredients: Cyclizine

As with other anticholinergic agents, Cyclizine Hydrochloride may precipitate incipient glaucoma and it should be used with caution and appropriate monitoring in patients with glaucoma, urinary retention, obstructive disease of the gastrointestinal tract, hepatic disease, phaeochromocytoma, hypertension, epilepsy and in males with possible prostatic hypertrophy.

Cyclizine should be used with caution in patients with severe heart failure or acute myocardial infarction. In such patients, cyclizine may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure and pulmonary wedge pressure.

Cyclizine should be avoided in porphyria.

There have been reports of abuse of cyclizine, either oral or intravenous, for its euphoric or hallucinatory effects. The concomitant misuse of Cyclizine Hydrochloride with large amounts of alcohol is particularly dangerous, since the antiemetic effect of cyclizine may increase the toxicity of alcohol (see also sections 4.3 and 4.5).

Cyclizine Hydrochloride contains lactose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Cyclizine Hydrochloride may have additive effects with alcohol and other central nervous system depressants e.g. hypnotics, tranquillisers, anaesthetics antipsychotics, barbiturates.

Cyclizine Hydrochloride enhances the soporific effect of pethidine.

Cyclizine Hydrochloride may counteract the haemodynamic benefits of opioid analgesics.

Because of its anticholinergic activity cyclizine may enhance the side-effects of other anticholinergic drugs, and have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs).

Cyclizine Hydrochloride may mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibacterials.

Pregnancy

In the absence of any definitive human data, the use of Cyclizine Hydrochloride in pregnancy is not advised.

Breast-feeding

Cyclizine is excreted in human milk; however, the amount has not been quantified

Fertility

In a study involving prolonged administration of cyclizine to male and female rats, there was no evidence of impaired fertility after continuous treatment for 90-100 days at dose levels of approximately 15 and 25 mg/kg/day. There is no experience of the effect of Cyclizine Hydrochloride on human fertility.

Studies designed to detect drowsiness did not reveal sedation in healthy adults who took a single oral therapeutic dose (50 mg) of cyclizine.

Patients should not drive or operate machinery until they have determined their own response.

Although there are no data available, patients should be cautioned that Cyclizine Hydrochloride may have additive effects with alcohol and other central nervous system depressants, e.g. hypnotics and tranquillisers.

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known: cannot be estimated from the available data.

Blood and lymphatic system disorders

Not known: Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia

Cardiac disorders

Not known: Tachycardia, palpitations, arrhythmias

Ear and labyrinth disorder

Not known: Tinnitus

Eye disorders

Not known: Blurred vision, oculogyric crisis

Gastrointestinal disorders

Not known: Dryness of the mouth, nose and throat, constipation increased gastric reflux. Nausea, vomiting, diarrhoea stomach pain. Loss of appetite

General disorders and administration site conditions

Not known: Asthenia

Hepatobiliary disorders

Not known: Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine

Immune system disorders

Not known: Hypersensitivity reactions, including anaphylaxis have occurred

Musculoskeletal and connective tissue disorders

Not known: Twitching, muscle spasms

Nervous system disorders

Not known: Effects on the central nervous system have been reported with cyclizine these include somnolence, drowsiness, incoordination headache, dystonia, dyskinesia, extrapyramidal motor disturbances, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia and generalised chorea

Psychiatric disorders

Not known: Disorientation, restlessness, nervousness, euphoria, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded

Renal and urinary disorders

Not known: Urinary retention

Respiratory, thoracic and mediastinal disorders

Not known: Bronchospasm, apnoea

Skin and subcutaneous tissue disorders

Not known: Urticaria, drug rash, angioedema, allergic skin reactions, fixed drug eruption photosensitivity

Vascular disorders

Not known: Hypertension, hypotension

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.