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.
The name of your medicine is Cyclizine Injection. 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.
Do not take this medicine if: • If you are allergic to cyclizine lactate or any of the other ingredients of this medicine (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)(listed in section 6)
• you have been drinking alcohol. The anti-vomiting properties of Cyclizine Injection may increase the toxicity of alcohol.
Warnings and precautions Talk to your doctor or pharmacist before being treated with 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 (tumor 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 including those you have obtained without a prescription especially the following:
• 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.
Cyclizine Injection with food and drink and Alcohol Alcohol should be avoided when you are being treated with Cyclizine Injection.
Pregnancy, breast-feeding and fertility You should not be given Cyclizine Injection if you are pregnant or planning to become pregnant or if you are breast-feeding.
Driving and using machines You can drive while being treated with cycIizine but do not drive until you know how it affects you. lt may make you feel dizzy. If it affects you in this way, do not drive or operate any machinery.
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 normaI operation: your doctor will give the first dose of cyclizine by injection into a vein, approximately 20 minutes before the end of the operation.
The use of the injectable form of CycIizine has been associated with cases of transient paralysis following administration of the medicine. The onset of paralysis is usually within minutes of administration, affects the limbs, and fully resolves within hours of discontinuation of the medicine.
If you receive more Cyclizine Injection than you should As this medicine is given to you by a doctor, 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.
If you notice: • Itching or skin rashes;
• Swelling of the face, lips or throat;
• Difficulty in breathing or wheeziness.
Tell your doctor immediately. These may be signs of an allergic reaction
The following side effects are reported for either compound 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;
• decrease in muscle tone that can cause irregular body movements;
• unusual body movements, particularly of your hands, arms or legs;
• 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 Iiver (hepatitis) or problems with the liver;
• injection site reactions such as redness, pain, swelling or blistering;
• sensations of heaviness, 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).
• Unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome.)
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 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.
Cyclizine Injection will be stored by the hospital pharmacy before it is given to you. They will follow the instructions below.
Cyclizine Injection should be stored in a safe place below 25°C. Keep the ampoule in the outer carton in order to protect from light. For single use only. Discard any remaining contents immediately after use.
Do not use this medicine if you notice that the solution is discoloured or contains particles.
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 Injection contains Cyclizine Injection comes as a 1ml ampoule containing 50 mg of the active ingredient, cyclizine lactate, dissolved in water for Injections.
The injection also contains the inactive ingredient, lactic acid.
What Cyclizine Injection looks like and contents of the pack Cyclizine Injection is a clear, colourless solution. Each pack contains 10 ampoules of 1ml
Marketing Authorisation Holder and Manufacturer: Macarthys Laboratories Limited T/A Martindale Pharma.
Bampton Road
Romford
Essex
RM3 8UG
United Kingdom
Product Licence No: PL 01883/0270
This leaflet was last revised in: 02/2024
MARTINDALE PHARMA
Bampton Road
Harold Hill
Romford
RM3 8UG
UK
D06187
Martindale Pharma, an Ethypharm Group Company
Address
Jupiter House, Mercury Park, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0HH, UK
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http://ethypharm.co.uk/
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+44 (0) 1277 266 600
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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.
Cyclizine 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 injection, 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 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
For the prevention of postoperative nausea and vomiting, administer the first dose by slow intravenous injection 20 minutes before the anticipated end of surgery.
Adults
50 mg intramuscularly or intravenously up to three times daily.
When used intravenously, Cyclizine 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
Not licensed for use in children.
Method of Administration:
Intramuscularly or intravenously
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 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 injection 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.
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.
Pregnancy
In the absence of any definitive human data, the use of Cyclizine 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 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.
Blood and lymphatic system disorders
Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia.
Cardiac disorders
Tachycardia palpitations, arrhythmias (see section 4.4),
Eye disorders
Blurred vision, oculogyric crisis
Gastrointestinal system disorders
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
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
Hepatic dysfunction (see section 4.4), hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine.
Immune system disorders
Hypersensitivity reactions, including anaphylaxis have occurred.
Musculoskeletal and connective tissue disorders
Twitching, muscle spasms
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, Restless leg syndrome, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia, paralysis* and generalised chorea.
*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)
Ear and labyrinth disorders
Tinnitus.
There have been rare case reports of patients experiencing depressed levels of consciousness/loss of consciousness.
Psychiatric disorders
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
Urinary retention
Respiratory, thoracic and mediastinal disorders
Bronchospasm, apnoea
Skin and subcutaneous tissue disorders
Urticaria, pruritus, drug rash, angioedema, allergic skin reactions, fixed drug eruption, photosensitivity
Vascular disorders
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:
United Kingdom
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, 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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