Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Cyclizine Injection contains the active ingredient cyclizine lactate, 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 Injection may be used by adults. Cyclizine Injection may be used if you suffer from travel or motion sickness; nausea caused by cancer treatment (radiotherapy) or other medicines; or if you have had an operation, as general anaesthetics can sometimes cause sickness.
Cyclizine Injection can also be used to treat sickness caused by some inner ear problems such as Meniere's disease.
You should not be given this medicine:
• if you have ever had an allergic reaction to cyclizine 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 antivomiting properties of Cyclizine Injection may increase the toxicity of alcohol.
Warnings and precautions
Talk to your doctor or nurse before you are given Cyclizine Injection if you:
• suffer from an eye disease caused by a rise of pressure within the eye (glaucoma); • suffer from urinary retention (experience difficulty passing urine); • have an obstructive bowel condition; • have any liver problems; • suffer from phaeochromocytoma (tumour of the medulla of the adrenal glands); • suffer from high blood pressure; • have epilepsy; • are a man and you suffer from an enlarged prostate gland (difficulty or slowness passing urine); • have been told your heart is not working properly (heart failure); • suffer from an inherited disorder which can lead to a sensitivity to sunlight (porphyria); • suffer from low blood pressure.
Other medicines and Cyclizine Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially the following: • medicines for problems such as depression, anxiety or difficulty in sleeping; • strong painkillers such as pethidine; • any medicine which belongs to a group of medicines called anticholinergics.
-------------------------------------------------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only: PREPARATION GUIDE:
Cyclizine Lactate 50 mg/ml Solution for Injection
Please refer to the Summary of Product Characteristics for full prescribing and other information.
Therapeutic indications This medicinal product is indicated in adults for the prevention and treatment of nausea and vomiting including: • Motion sickness when the oral route cannot be used. • 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.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
The name of this medicine is Cyclizine Lactate 50 mg/ml Solution for Injection but it will be referred to as Cyclizine Injection throughout the remainder of this leaflet.
Cyclizine Injection with alcohol
Alcohol should be avoided when you are being treated with Cyclizine Injection.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Driving and using machines
You can drive while being treated with Cyclizine Injection but do not drive until you know how it affects you. It may make you feel dizzy. If it affects you in this way, do not drive and use machines.
How Cyclizine Injection is given
You will be given Cyclizine Injection under supervision and your doctor will decide on a dose which is right for you.
Cyclizine Injection can be given as a slow injection into a vein (intravenously) or by injection into a muscle (intramuscularly).
The recommended dose for adults is 50 mg up to three times a day.
For prevention of sickness after a normal operation: Your doctor will give the first dose of Cyclizine Injection by injection into a vein, approximately 20 minutes before the end of the operation.
If you receive more Cyclizine Injection than you should
As this medicine is given to you by a doctor or nurse, it is very unlikely that an overdose will happen. Should an overdose occur, the doctor will treat any symptoms that follow. 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately, if you notice: • itching or skin rashes; • swelling of the face, lips or throat; • difficulty in breathing or wheeziness. These may be signs of an allergic reaction.
The following side effects are reported for with a not known frequency (frequency cannot be estimated from the available data)
Side effects may include: • skin rashes or itching; • muscle twitches, spasms or tremors; • restlessness;
• Cyclizine, by the intravenous route, is also indicated pre-operatively in patients undergoing emergency surgery in order to reduce the hazard of regurgitation and aspiration of gastric contents during induction of general anaesthesia. Cyclizine Injection may be of value in relieving vomiting and attacks of vertigo associated with Menière's disease and other forms of vestibular disturbance when the oral route cannot be used.
• decrease in muscle tone that can cause irregular body movements; • unusual body movements, particularly of your hands, arms or legs; • Unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome); • lack of coordination; • blurred vision or involuntary rolling of the eyes; • paralysis especially in patient who are already suffering from disorder of nerves and muscles; • convulsions, seizures; • nervousness; • seeing or hearing things that are not really there (hallucinations); • ringing in the ears; • euphoria; • headache; • fast heartbeat, irregular heartbeat; • drowsiness or general feelings of weakness/ tiredness; • a dry mouth, nose or throat; • heartburn (reflux); • stomach pain; • nausea; • vomiting; • diarrhoea; • loss of appetite; • difficulty in passing water; • constipation; • difficulty in sleeping; • being confused, disorientated or unaware; • dizziness; • decreased consciousness/loss of 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; • inflammation of the liver (hepatitis) or problems with the liver; • injection site reactions such as redness, pain, swelling or blistering; • sensations of heaviness, flushing, feeling cold or agitated or experiencing a decrease in blood pressure; • reduced rate of breathing (apnoea); • reduction in the production of a type of white blood cell making infection more likely (agranulocytosis).
Tell your doctor if you feel very tired, experience unexpected bruising or bleeding or more infections (e.g. colds and sore throats) than usual. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.
The use of cyclizine, when given by an injection, has been linked to cases of temporary excessive muscle relaxation (paralysis). The onset of paralysis is usually within the first few minutes after you have been given this medicine and affects the arms and legs. The normal function of your muscles will return within hours of this medicine being stopped.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep the ampoule in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton and ampoule. The expiry date refers to the last day of that month.
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The following information is intended for healthcare professionals only: (Continued from overleaf)
Cyclizine Lactate 50 mg/ml Solution for Injection
Cyclizine Injection is a clear, colourless to slightly yellow solution, free from visible particles.
pH 3.3-3.7
Administration Intramuscular or intravenous use.
Dilution This medicinal product can be diluted to a concentration of 5 mg/ml with glucose 50 mg/ml (5%), sodium chloride 9 mg/ml (0.9%) or water for injections.
The solution should be examined visually following dilution and immediately prior to administration and should not be used if any cloudiness or particulate matter is present.
Do not use this medicine if you notice any particles floating in it.
Do not use this medicine if the solution appears cloudy or coloured.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Cyclizine Injection contains
- The active substance is cyclizine lactate. 1 ml of
solution contains 50 mg cyclizine lactate. - The other excipients are lactic acid and water for
injections.
What Cyclizine Injection looks like and contents of the pack
Cyclizine Injection is a clear, colourless to slightly yellow solution free from visible particles supplied in 1 ml glass one-point-cut (OPC) ampoules.
Each pack contains 5 or 10 ampoules.
Marketing Authorisation Holder
hameln pharma ltd Gloucester, GL3 4AG United Kingdom
Manufacturer
HBM Pharma s.r.o Sklabinská 30 036 80 Martin Slovak Republic
hameln rds s.r.o. Horná 36 900 01 Modra Slovak Republic
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last revised in February 2024.
Shelf life Diluted solution: Chemical and physical in-use stability has been demonstrated 24 hours at 25°C for the diluted solution. From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Cyclizine Lactate 50 mg/ml Solution for Injection comes as injection containing 50mg/ml. 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 Lactate 50 mg/ml Solution for Injection is cyclizine lactate.
Medicines with the same active substance, strength and form include: Valoid 50 mg/ml Injection, Cyclizine 50 mg/ml solution for injection, Cyclizine Lactate 50 mg/ml Injection. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Cyclizine Lactate 50 mg/ml Solution for Injection, 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.
This medicinal product is indicated in adults for the prevention and treatment of nausea and vomiting including:
• Motion sickness when the oral route cannot be used.
• 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, by the intravenous route, is also indicated pre-operatively in patients undergoing emergency surgery in order to reduce the hazard of regurgitation and aspiration of gastric contents during induction of general anaesthesia.
Cyclizine Injection may be of value in relieving vomiting and attacks of vertigo associated with Menière's disease and other forms of vestibular disturbance when the oral route cannot be used.
Posology Adults The recommended dose is 50 mg intramuscularly or intravenously up to three times daily. When used intravenously, Cyclizine Injection should be injected slowly into the bloodstream, with only minimal withdrawal of blood into the syringe. For the prevention of postoperative nausea and vomiting, administer the first dose by slow intravenous injection 20 minutes before the anticipated end of surgery. Cyclizine given intravenously, in half the recommended dose, increases the lower oesophageal sphincter tone and thereby reduces the hazard of regurgitation and aspiration of gastric contents if given to patients, undergoing emergency surgery, before induction of general anaesthesia. Elderly There have been no specific studies of cyclizine in the elderly. Experience has indicated that normal adult dosage is appropriate. Paediatric population The safety and efficacy of Cyclizine Injection has not been established in the paediatric population. Method of administration Intramuscular or intravenous use. For instructions on dilution of the medicinal product before administration, see section 6.6. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
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. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
As with other anticholinergic agents, cyclizine 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, pheochromocytoma, hypertension, epilepsy and in males with possible prostatic hypertrophy. Cyclizine may have a hypotensive effect. 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 with large amounts of alcohol is particularly dangerous, since the antiemetic effect of cyclizine may increase the toxicity of alcohol (see also section 4.5). Case reports of paralysis have been received in patients using intravenous cyclizine. Some of the patients mentioned in these case reports had an underlying neuromuscular disorder. Thus intravenous cyclizine, should be used with caution in all patients and with particular care in patients with underlying neuromuscular disorders. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
Cyclizine may have additive effects with alcohol and other central nervous system depressants e.g. hypnotics, tranquillisers, anaesthetics, antipsychotics, barbiturates. Cyclizine enhances the soporific effect of pethidine. Cyclizine may counteract the haemodynamic benefits of opioid analgesics. Because of its anticholinergic activity, cyclizine may enhance the side-effects of other anticholinergic drugs, and may have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs). Cyclizine may mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibacterials. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Pregnancy
In the absence of any definitive human data, the use of cyclizine in pregnancy is not advised.
Breastfeeding
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 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, sedation of short duration was reported by subjects receiving intravenous 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 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. The following undesirable effects have been reported with a frequency of Not known. 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 (see section 4.4). Ear and labyrinth disorders Not Known Tinnitus. There have been rare case reports of patients experiencing depressed levels of consciousness/loss of consciousness. Eye disorders Not Known Blurred vision, oculogyric crisis. Gastrointestinal system 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, malaise. Injection site reactions including vein tracking, erythema, pain, thrombophlebitis and blisters. A sensation of heaviness, chills, flushing, agitation and pruritus have been reported rarely. Rapid IV administration can lead to symptoms similar to overdose. Hepatobiliary disorders Not Known Hepatic dysfunction (see section 4.4), 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 legs syndrome, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia, paralysis* and generalised chorea. Psychiatric disorders Not Known Disorientation, restlessness or agitation, 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, pruritus, drug rash, angioedema, allergic skin reactions, fixed drug eruption, photosensitivity. Vascular disorders Not Known Hypertension, hypotension. *Case reports of paralysis have been received in patients using intravenous cyclizine. Some of the patients mentioned in these case reports had an underlying neuromuscular disorder (see section 4.4). 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. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
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, 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 Lactate 50 mg/ml Solution for Injection. 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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