Patient leaflet - Clomethiazole 192 mg capsules
What Clomethiazole Capsules are and what they are used for
Clomethiazole Capsules contain a medicine called clomethiazole. This belongs to a group of medicines called hypnotics and sedatives. It has a calming (sedative) effect on your nervous system. Clomethiazole Capsules are used to:
* Treat feelings of restlessness and agitation.
* Help you if you are unable to sleep (short-term treatment). * Relieve the symptoms of alcohol withdrawal.
What you need to know before you take Clomethiazole Capsules
Do not take Clomethiazole Capsules:
* if you are allergic to clomethiazole or any of the other ingredients of this medicine (listed in section 6).
* if you have lung or breathing problems which have recently got worse. Do not take Clomethiazole Capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Clomethiazole Capsules.
Warning and precautions
Talk to your doctor or pharmacist before taking Clomethiazole Capsules: * if you often have difficulty in breathing.
* if you have a condition called ‘sleep apnoea syndrome’ (interrupted breathing when you are asleep).
* if you have ever had liver or kidney problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Clomethiazole Capsules.
Children and adolescents
Clomethiazole Capsules should not be taken by children and adolescents under 18 years of age.
Other medicines and Clomethiazole Capsules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Clomethiazole Capsules can affect the way some medicines work and some medicines can have an effect on Clomethiazole Capsules.
Tell your doctor or pharmacist if you are taking any of the following: * Propranolol (for high blood pressure).
* Diazoxide (for high blood pressure or low blood sugar). * Cimetidine (for stomach ulcers or heartburn).
* Carbamazepine (for anxiety, epilepsy, mood swings or a painful condition of the face called ‘trigeminal neuralgia’).
* Other medicines used to treat epilepsy.
* Sedatives (to help you relax or sleep).
* Painkillers.
* Antidepressants (to treat depression or prevent it recurring). * Antibacterials (to treat or prevent an infection).
* Anaesthetics. If you need an operation which requires a general anaesthetic, tell the doctor or dentist before your operation that you are taking Clomethiazole Capsules.
Clomethiazole Capsules with alcohol
* Do not drink alcohol while you are taking Clomethiazole Capsules. * If you are taking Clomethiazole Capsules to help with alcohol problems, you must tell your doctor if you have recently had a drink containing alcohol.
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 taking this medicine. Your doctor will decide whether you can take Clomethiazole Capsules during this time.
If you are pregnant or breast-feeding and you are already taking diazoxide (a medicine to treat high blood pressure or low blood sugar), do not take Clomethiazole Capsules.
Driving and using machines
Do not drive or use any tools or machines while taking Clomethiazole Capsules. This is because the medicine can make you feel drowsy (sleepy).
Clomethiazole Capsules contain sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. One Clomethiazole Capsule contains 7 mg of sorbitol. When taken as recommended, each dose contains up to 28 mg of sorbitol.
How to take Clomethiazole Capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
* The instructions on the label will remind you of what the doctor said. They will tell you how many capsules to take and how often. Do not take more than you have been told to.
* Swallow the capsule(s) whole with a drink of water. Do not chew, crush or break the capsules.
Use in adults
The usual dose of Clomethiazole Capsules depends on what you are taking them for.
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Patient Information Leaflet (continued)
* To help you to sleep at night, the usual dose is one or two capsules before bed.
Your doctor will give you this medicine for a short period of time. * To stop you feeling restless or agitated, the usual dose is one capsule three times a day.
* To help you to withdraw from alcohol, your doctor will start you on a high dose. Your doctor will then gradually reduce the dose. Do not take Clomethiazole Capsules for longer than your doctor has told you to. The maximum amount of time is usually 9 days.
If you have liver or kidney problems, the dose depends on how well your kidneys are working. Your doctor may start you on a low dose and gradually increase it.
If you take more Clomethiazole Capsules than you should If you take too many Clomethiazole Capsules, talk to a doctor or go to a hospital straight away. Take the medicine bottle or carton with you so that it can be identified. The following effects may happen: shallow breathing, low blood pressure (this may make you feel dizzy or faint), low body temperature and coma (being unconscious).
If you forget to take Clomethiazole Capsules
If you forget to take a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Clomethiazole Capsules
Your doctor may prescribe Clomethiazole Capsules for longer than the usual time period. With longer term use your doctor may need to increase your dose to get the same effect. If you take more than the usual dose for a long period of time, when you stop taking the medicine, you may get withdrawal symptoms such as shaking (tremors) or fits.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions
(these are rare, affecting up to 1 in 1,000 people)
If you have a severe allergic reaction, stop taking Clomethiazole Capsules and see a doctor straight away. You may need urgent medical treatment. The signs may include a sudden onset of:
* Rash, itching or hives on the skin.
* Blistering of the skin.
* Swelling of the face, lips, tongue or other parts of the body. * Shortness of breath, wheezing or trouble breathing.
Other possible side effects:
* Tingling or blocked nose. This can occur within 15 to 20 minutes of taking a dose of Clomethiazole Capsules.
* Sore eyes and headache.
* Runny nose and chest phlegm.
* Stomach upset.
* Changes in how your liver is working (shown by blood tests). * Feeling over-excited or confused.
* Feeling very sleepy. This is more likely if you are taking a high dose of the medicine or if you are elderly and you are taking the medicine during the day.
* ‘Hangover’ effects may occur in the elderly.
* Withdrawal symptoms such as shaking (tremors) and fits. Do not be concerned by this list of side effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
How to store Clomethiazole Capsules
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 25°C.
Store in the orginal package to protect from light and moisture. Do not take this medicine after the expiry date shown on the carton or bottle label. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via water waste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What this medicine contains:
Each capsule contains 192mg of clomethiazole. The active substance is clomethiazole.
The other ingredients are: medium-chain triglycerides, gelatin, glycerol, titanium dioxide (E171), sorbitol (E172), mannitol, hydrogenated hydrolysed starch and brown iron oxide (E172).
What this medicine looks like and contents of the pack Clomethiazole are Greyish-brown, soft gelatin capsules.
Each bottle contains 30 Capsules.
Manufacturer and Licence Holder
This medicine is manufactured by CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
PL 15184/1358 Clomethiazole 192mg Capsules
Revision date: 18/03/2025
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Tel: 01527 505414 to obtain the leaflet in a format suitable for you
POM
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