Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Cyclizine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR Cyclizine Hydrochloride Tablets contain the active substance cyclizine hydrochloride, which belongs to a group of medicines called antihistamines which can be used to help stop you feeling sick (nausea) or being sick (vomiting). Cyclizine Hydrochloride Tablets may be used by adults and children aged 6 years and over. Cyclizine Hydrochloride Tablets may be used if you suffer from travel or motion sickness; nausea caused by cancer treatment (radiography) or other medicines; or if you have had an operation, as general anaesthetics can sometimes cause sickness. Cyclizine Hydrochloride Tablets can also be used to treat sickness caused by some inner ear problems such as Meniere's disease.
E CYCLIZINE HYDROCHLORIDE TABLETS Do not take Cyclizine Hydrochloride Tablets:
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Cyclizine Hydrochloride Tablets if you:
CYCLIZINE HYDROCHLORIDE TABLETS Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure. Adults The recommended dose is one tablet up to three times daily. Use in children and adolescents
Children over 12 years The recommended dose is one tablet up to three times daily. Children from 6 to 12 years The recommended dose is half a tablet up to three times a day. The tablet can be divided into equal doses along the line scored on one side of the tablet. Children under 6 years Do not give this medicine to children under the age of 6. The tablets should be swallowed with a little water. If you take more Cyclizine Hydrochloride Tablets than you should Symptoms of overdose include dry mouth, nose and throat, blurred vision, fast or irregular heartbeat, difficulty passing urine, drowsiness, dizziness, lack of balance and coordination, weakness, excitability, disorientation, impaired judgement, hallucinations, muscle spasm, involuntary movements, convulsions, high temperature and difficulty breathing. If you take more Cyclizine Hydrochloride Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Remember to take this leaflet and/or the package with you to show the doctor what you have taken. If you forget to take Cyclizine Hydrochloride Tablets If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose to make up for a forgotten tablet.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice:
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects, you can help provide more information on the safety of this medicine.
CYCLIZINE HYDROCHLORIDE TABLETS Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Store this medicine in a safe place below 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Cyclizine Hydrochloride Tablets contains Each tablet contains 50 mg of the active ingredient, cyclizine hydrochloride. The other ingredients include: lactose, potato starch, acacia and magnesium stearate. What Cyclizine Hydrochloride Tablets look like and contents of the pack Cyclizine Hydrochloride Tablets are white with a single score line and the marking "T4A" on the same side. They are available in bottles of 100 tablets. Marketing Authorisation Holder Amdipharm UK Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom
Manufacturer: CENEXI SAS, 52 Rue Marcel et Jacques Gaucher, 94120, Fontenay sous Bois, France This leaflet was last revised in January 2024.
Cyclizine 50mg Tablets comes as tablet containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Cyclizine 50mg Tablets is cyclizine hydrochloride.
Medicines with the same active substance, strength and form include: Valoid 50 mg Tablets, Cyclizine Hydrochloride 50mg Tablets, Cyclizine hydrochloride 50 mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Cyclizine 50mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Cyclizine Hydrochloride is indicated in adults and in children aged 6 years and over for the prevention and treatment of nausea and vomiting including:-
• Motion sickness.
• Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period.
• Vomiting associated with radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels.
Cyclizine Hydrochloride may be of value in relieving vomiting and attacks of vertigo associated with Menière's disease and other forms of vestibular disturbance.
Posology
To prevent motion sickness Cyclizine Hydrochloride should be taken about one to two hours before departure.
Elderly
There have been no specific studies of Cyclizine Hydrochloride in the elderly. Experience has indicated that normal adult dosage is appropriate.
Paediatric population
Children less than 6 years of age:
Cyclizine Hydrochloride tablets are not recommended for children less than 6 years of age.
Children 6 to 12 years of age:
25 mg orally, which may be repeated up to three times a day.
Children over 12 years of age:
50 mg orally, which may be repeated up to three times a day.
Adults
50 mg orally, which may be repeated up to three times a day.
Method of administration:
Oral
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Cyclizine is contraindicated in the presence of acute alcohol intoxication. The anti-emetic properties of cyclizine may increase the toxicity of alcohol.
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.
System Organ Class
Frequency
Adverse reactions
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, restless leg syndrome, 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.
Symptoms:
Symptoms of acute toxicity from cyclizine arise from peripheral anticholinergic effects and effects on the central nervous system.
Peripheral anticholinergic symptoms include dry mouth, nose and throat, blurred vision, tachycardia and urinary retention. Central nervous system effects include drowsiness, dizziness, incoordination, ataxia, weakness, hyperexcitability, disorientation, impaired judgement, hallucinations, hyperkinesia, extrapyramidal motor disturbances, convulsions, hyperpyrexia and respiratory depression.
An oral dose of 5 mg/kg is likely to be associated with at least one of the clinical symptoms stated above. Younger children are more susceptible to convulsions. The incidence of convulsions, in children less than 5 years, is about 60% when the oral dose ingested exceeds 40 mg/kg.
Management:
In the management of acute overdosage with Cyclizine Hydrochloride, gastric lavage and supportive measures for respiration and circulation should be performed if necessary. Convulsions should be controlled in the usual way with parenteral anticonvulsant therapy.
Ask anything about Cyclizine 50mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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