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CLOMETHIAZOLE 192MG CAPSULES

Active substance(s): CLOMETHIAZOLE

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Heminevrin® 192 mg Capsules/
Clomethiazole 192 mg Capsules
(clomethiazole)
Your medicine is available using any of the above-names but will be referred
to as Heminevrin Capsules throughout this leaflet.
Patient Information Leaflet
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 gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Heminevrin Capsules are and what they are used for
2) Before you take Heminevrin Capsules
3) How to take Heminevrin Capsules
4) Possible side effects
5) How to store Heminevrin Capsules
6) Further information

1) What Heminevrin Capsules are and what they are used for

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 Heminevrin Capsules with food and drink
 Do not drink alcohol while you are taking Heminevrin Capsules.
 If you are taking Heminevrin 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 Heminervrin Capsules if you are pregnant,
may become pregnant or are breast-feeding. Your doctor will decide whether
you can take Heminevrin Capsules during this time.
If you are pregnant or breast-feeding and you are already taking diazoxide (a
medicine to teat low blood pressure or low blood sugar), do not take
Heminevrin Capsules.

Heminevrin 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.

Driving and using machines
Do not drive or use any tools or machines while taking Heminevrin Capsules.
This is because the medicine can make you feel drowsy (sleepy).

Heminevrin 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.

Important information about some of the ingredients of Heminevrin
Capsules
Heminevrin 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 Heminevrin
capsule contains 10 mg of sorbitol. When taken as recommended, each dose
contains up to 40mg of sorbitol.

2) Before you take Heminevrin Capsules
Do not take Heminevrin Capsules if:
 You are allergic (hypersensitive) to clomethiazole or any of the other
ingredients in Heminevrin Capsules (see Section 6: Further information).
 You have lung or breathing problems which have recently got worse.
Do not take Heminevrin Capsules if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Heminevrin
Capsules.
Take special care with Heminevrin Capsules
Check with your doctor or pharmacist before taking Heminervrin Capsules if:
 You often have difficulty breathing.
 You have a sleep 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 Heminevrin 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 Heminevrin Capsules can
affect the way some medicines work and some medicines can have an effect
on Heminevrin Capsules.

3) How to take Heminevrin Capsules
Always take Heminevrin 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 Heminevrin 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
Hemnevrin 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 Heminevrin 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 (tremors) or fits.
Children
Heminevrin Capsules should not be taken by children.
If you take more Heminevrin Capsules than you should
If you take too many Heminevrin 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 Heminevrin 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.

4) Possible side effects.

 If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6) Further information.
What Heminevrin Capsule contains
Each Heminevrin capsule contains 192 mg of the active ingredient,
Clomethiazole.
Heminevrin Capsules themselves are made of the following: Medium-chain
triglycerides, gelatin, glycerol (85%), sorbitol, D-Mannitol, oligosaccharides,
titanium dioxide (E171) and brown iron oxide (E172).
What Heminevrin Capsule looks like and the contents of the pack
The unmarked, soft capsules are greyish-brown coloured.
Heminevrin Capsules are available as 30 capsules in amber glass bottles.

Like all medicines, Heminevrin Capsules can cause side effects, although not
everybody gets them.

PL 10383/2047

Severe allergic reactions (these are rare, affecting less than 1 in 1,000
people) If you have a severe allergic reaction, stop taking Heminevrin
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.

Who makes and repackages your medicine:
Your medicine is manufactured by Cheplapharm Arzneimittel GmbH,
Bahnhofstrasse 1a, Mesekenhagen, D-17498 Germany. Procured from within
the EU and repackaged by the Product Licence holder: Primecrown Ltd., 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Other possible side effects:
 Tingling or blocked nose. This can occur within 15 to 20 minutes of taking a
dose of Heminevrin 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 this
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.
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.

5) How to store Heminevrin Capsules
 Do not use after the expiry date printed on the bottle label
 Do not store above 25°C. Store in the original container in order to protect
from light and moisture.
 Keep all medicines out of the sight and reach of children.
 If your doctor tells you to stop taking the capsules, please take them back to
the pharmacist for safe disposal. Only keep the capsules if your doctor tells
you to.

Heminevrin 192mg Capsules/
Clomethiazole 192mg Capsules

Leaflet date: 08.03.2013

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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