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.
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The name of your medicine is Cyclizine Hydrochloride 50mg Tablets. Cyclizine Hydrochloride Tablets contains the active substance Cyclizine hydrochloride, which belongs to a group of medicines known as antihistamines. Antihistamines help to prevent feelings of sickness (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 for the following conditions:• • • •
travel and motion sickness post-operative nausea and vomiting, as general anesthetics can sometimes cause sickness nausea associated with cancer treatment (radiography) or other medicines treatment of sickness due to inner ear problems, such as Meniere's disease
You must talk to a doctor if you do not feel better or if you feel worse.
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e Cyclizine Hydrochloride Tablets
Do not take Cyclizine Hydrochloride Tablets: –
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if you are allergic to Cyclizine hydrochloride or any of the other ingredients of this medicine listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing). if you have been drinking alcohol. The anti-vomiting properties of Cyclizine hydrochloride may increase the toxicity of alcohol.
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Warnings and precautions Talk to your doctor or pharmacist or nurse before taking Cyclizine hydrochloride Tablets: Take special care with Cyclizine Hydrochloride Tablets, and tell your doctor or pharmacist if you: • • • • • • • • • • •
suffer from an eye disease caused by a rise of pressure within the eye (glaucoma) have an obstructive bowel conditions have any liver problems suffer from epilepsy are male and have an enlarged prostate gland (difficulty and slowness passing urine) have been told your heart is not working properly (heart failure) have an inherited disorder which can lead to a sensitivity of sunlight called porphyria have been told by your doctor that you have an intolerance to some sugars suffer from urinary retention (experience difficulty passing urine) suffer from phaeochromocytoma (tumour of the medulla of the adrenal glands) suffer from high blood pressure
Children Cyclizine Hydrochloride Tablets should not be used in children under six years of age. Other medicines and Cyclizine Hydrochloride Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. including those obtained without a prescription. In particular, tell your doctor about the following medicines: • • • •
medicines for problems such as depression, anxiety or difficulty in sleeping; strong painkillers such as pethidine; any medicine which belong to a group of medicines called anticholinergics. drugs which can damage the ear (ototoxic) for example aminoglycoside antibacterials
Cyclizine Hydrochloride Tablets with alcohol You should avoid taking alcohol whilst you are on Cyclizine Hydrochloride Tablets. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby,ask your doctor or pharmacist for advice before taking this medicine. Do not take these tablets if you are breast-feeding. Driving and using machines You can drive while taking Cyclizine Hydrochloride Tablets but do not drive until you know how the tablets affect you. Cyclizine Hydrochloride Tablets may make you feel dizzy. If they affect you in this way, do not drive or operate any machinery. Cyclizine Hydrochloride Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
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Cyclizine Hydrochloride Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is as follows: 3
Adults and children over 12 years: The usual dose is one tablet (50mg) up to three times daily. Children from 6 to 12 years: The usual dose is half a tablet (25mg) up to three times a day. Children under 6 years: Do not give this medicine to children under the age of 6. For preventing motion sickness, take the recommended dose 1-2 hours before travelling. Method of administration Swallow these tablets 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 heart beat, difficulty passing urine, drowsiness, dizziness, lack of balance and coordination, weakness, excitability, disorientation, impaired judgement, hallucinations, muscle spasms, involuntary movements, convulsion, high temperature and difficulty breathing. If you take more 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 HydrochlorideTablets 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 dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking the tablets and tell your doctor immediately if you experience any of the following symptoms: • itching or skin rashes • swelling of the face, lips or throat • difficulty in breathing or wheeziness. These may be signs of an allergic reaction. Other side effects include: • • • • • • • • • •
skin rashes or itching drowsiness headache a dry mouth, nose or throat blurred vision fast heartbeat irregular heart beat difficulty in passing water constipation restlessness 4
• • • • • • • • • • • • •
nervousness difficulty in sleeping seeing or hearing things that are not really there (hallucinations) lack of coordination heart burn (reflux) feeling sick being sick diarrhoea stomach pain loss of appetite euphoria ringing in the ears Unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome).
Rare side effects include: • • • • • • • • • • • • • • • •
decrease in muscle tone unusual body movements, particularly of your hands, arms or legs muscle twitches, spasms or tremors seizures being confused, disoriented or unaware dizziness feeling weak decreased consciousness temporary difficulty in speaking high blood pressure low blood pressure pins and needles yellowing of the skin and the whites of your eyes (jaundice) a red or brownish patch which appears at the same spot each time you take the medicine a increase in sensitivity to sunlight (photosensitivity) inflammation of liver (hepatitis) or problems with the liver
Very rare side effects include: • •
reduced rate of breathing (apnoea) reduction in the production of a type of white blood cell making infection more likely (agranulocytosis)
If you feel very tired, experience unexpected bruising or bleeding or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms. Reporting of side effects If you get any side effects , talk to your doctor or 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 at Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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Cyclizine Hydrochloride Tablets
Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. 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.
6.
What Cyclizine Hydrochloride Tablets contain The active substance is cyclizine hydrochloride. Each tablet contains 50mg of the active ingredient, cyclizine hydrochloride. The other ingredients are maize starch, lactose, povidone and magnesium stearate. What Cyclizine Hydrochloride Tablets look like and contents of the pack Cyclizine Hydrochloride Tablets are circular, white tablets with a breakline on one side and plain on the reverse. These tablets are available in blisters of 1, 10, 28, 30, 40, 50, 84, 100 and 500 tablets. They are also available in a bottle containing 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Limited 5, Marryat Close Hounslow West Middlesex TW4 5DQ UK.
This leaflet was last revised in 05/2021.
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Cyclizine Hydrochloride 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 Hydrochloride 50mg Tablets is cyclizine hydrochloride.
Medicines with the same active substance, strength and form include: Valoid 50 mg Tablets, Cyclizine 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 Hydrochloride 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 Tablets are indicated for:-
• 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 Tablets may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance.
Method of administration:
Oral
Adults and children over 12 years of age:
50mg orally, which may be repeated up to three times a day
Children 6- 12 years of age:
25mg orally, which may be repeated up to three times a day
Children less than 6 years of age:
Cyclizine Hydrochloride are not recommended for use in children under 6 years of age.
Elderly
There have been no specific studies with Cyclizine Hydrochloride in the elderly. Experience has indicated that the normal adult dose is appropriate.
For the prevention of motion sickness, Cyclizine Hydrochloride should be taken one to two hours before departure.
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 section 4.3 and 4.5 ).
Cyclizine Hydrochloride contains lactose
Patients with rare hereditary problems of galactose intolerance, total 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.
The following side effects have been reported with cyclizine hydrochloride:
Blood and lymphatic system disorders
Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia.
Immune system disorders
Hypersensitivity reactions, including anaphylaxis have occurred
Psychiatric disorders
Disorientation, restlessness, nervousness, euphoria, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded.
Nervous system disorders
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, generalised chorea and Restless leg syndrome.
Ear and labyrinth disorders
tinnitus
Eye disorders
Blurred vision, oculogyric crisis
Cardiac disorders
Tachycardia, palpitations, arrhythmias
Vascular disorders
Hypertension, hypotension
Respiratory, thoracic and mediastinal disorders
Bronchospasm, apnoea
Gastrointestinal system disorders
Dryness of the mouth, nose and throat, constipation increased gastric reflux
Nausea, vomiting, diarrhea, stomach pain
Loss of appetite
Hepatobiliary disorders
Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine.
Skin and subcutaneous tissue disorders
Urticaria, drug rash, angioedema, allergic skin reactions, fixed drug eruption, photosensitivity
Musculoskeletal and connective tissue disorders
Twitching, muscle spasms
Renal and urinary disorders
Urinary retention
General disorders and administration site conditions
Asthenia
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 at Website: www.mhra.gov.uk/yellowcard.
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.
Treatment:
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 Hydrochloride 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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