Clomethiazole 192 Mg Capsules
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stand (datum): 06.01.2016 format: 420 x 120 mm farben: 1/1-farbig schwarz mat.-nr.: 9000528/14 schriftgroBe: 9 pt
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Clomethiazole 192 mg Capsules
clomethiazole
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Clomethiazole Capsules are and what they are used for
2. Before you take Clomethiazole Capsules
3. How to take Clomethiazole Capsules
4. Possible side effects
5. How to store Clomethiazole Capsules
6. Further information
• Treat feelings of restlessness and agitation.
• Help you if you are unable to sleep (short-term treatment).
• Relieve the symptoms of alcohol withdrawal.
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:
Do not take Clomethiazole Capsules if:
• You are allergic (hypersensitive) to clomethiazole or any of the other ingredients in Clomethiazole Capsules (see Section 6: Further information).
• 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.
Take special care with Clomethiazole Capsules
Check with your doctor or pharmacist before taking Clomethiazole Capsules if:
• You often have difficulty in breathing.
• You have a condition called ’sleep apnoea syndrome‘ (interrupted breathing when you are asleep).
• 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, 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 low 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‘).
Taking Clomethiazole Capsules with food and drink
• 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
Talk to your doctor before taking Clomethiazole Capsules if you are pregnant, may become pregnant or are breast-feeding. 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 low 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).
Important information about some of the ingredients of Clomethiazole Capsules
Clomethiazole Capsules contain sorbitol. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. One Clomethiazole Capsule contains 10 mg of sorbitol. When taken as recommended, each dose contains up to 40 mg of sorbitol.
Always take Clomethiazole Capsules exactly as your doctor has told you. You should 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.
Adults
The usual dose of Clomethiazole Capsules depends on what you are taking them for.
• 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.
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.
Children
Clomethiazole Capsules should not be taken by children.
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.
Like all medicines, Clomethiazole Capsules can cause side effects, although not everybody gets them.
Severe allergic reactions (these are rare, affecting less than 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.
• Rash which may be itchy.
• 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.
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, 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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
• Keep out of the reach and sight of children.
• Do not store above 25°C (room temperature). Store your medicine in the original package in order to protect from light and moisture.
• Do not use Clomethiazole Capsules after the expiry date which is stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
What Clomethiazole Capsules contain
The active substance is clomethiazole. There is 192 mg of clomethiazole in each capsule. The other ingredients are medium-chain tri glycerides, gelatin, glycerol, titanium dioxide (E171), sorbitol (E420), mannitol, oligosaccharides and brown iron oxide (E172).
What Clomethiazole Capsules look like and contents of the pack
Clomethiazole Capsules are soft and greyish-brown. They are available in bottles of 60 capsules.
Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH, Bahnhofstr. 1a,
17498 Mesekenhagen, Germany.
Clomethiazole Capsules are distributed by Intrapharm Laboratories Ltd, The Courtyard Barns,
Choke Lane, Cookham Dean, Maidenhead, Berkshire SL6 6PT, United Kingdom
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Clomethiazole Capsules
Reference number 27041/0001
This is a service provided by the Royal National Institute of the Blind.
This leaflet was last revised in June 2015.
9000528/14