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stand (datum): 06.01.2016 [11:50 Uhr] (1)
format: 297 x 210 mm, DIN A4
farben: 1/1-farbig schwarz
schriftgröße: 9 pt
mat.-nr.: 9000555/13


Clomethiazole 31.5 mg/ml Syrup
(as clomethiazole edisilate)
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

• This medicine has been prescribed for you. Do not pass it on
to others. lt 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
In this leaflet:
1. What Clomethiazole Syrup is and what it is used for
2. Before you take Clomethiazole Syrup
3. How to take Clomethiazole Syrup
4. Possible side effects

5. How to store Clomethiazole Syrup
6. Further information

1. What Clomethiazole Syrup is and what it is used for
Clomethiazole Syrup contains a medicine called clomethiazole.
This belongs to a group of medicines called hypnotics and
sedatives. lt has a calming (sedative) effect on your nervous
Clomethiazole Syrup is 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.

2. Before you take Clomethiazole Syrup
Do not take Clomethiazole Syrup if:
• You are allergic (hypersensitive) to clomethiazole or any of the
other ingredients in Clomethiazole Syrup (see Section 6: Further
• You have lung or breathing problems which have recently
got worse.

Do not take Clomethiazole Syrup if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking
Clomethiazole Syrup.

In particular, 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 Syrup with food and drink
• Do not drink alcohol while you are taking Clomethiazole Syrup.
• If you are taking Clomethiazole Syrup 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 Syrup if you are
pregnant, may become pregnant or are breast-feeding. Your
doctor will decide whether you can take Clomethiazole Syrup
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 Syrup.
Driving and using machines
Do not drive or use any tools or machines while taking
Clomethiazole Syrup. This is because the medicine can make you
feel drowsy (sleepy).
Important information about some of the ingredients of
Clomethiazole Syrup
• Clomethiazole Syrup contains small amounts of alcohol (ethanol).
lt contains less than 100 mg per dose.
• Clomethiazole Syrup contains 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 ml of Clomethiazole Syrup
contains 350 mg of sorbitol. When taken as recommended,
each dose contains up to 7 g of sorbitol. lt can cause stomach
upset and diarrhoea.

3. How to take Clomethiazole Syrup
Always take Clomethiazole Syrup exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure.

Take special care with Clomethiazole Syrup
Check with your doctor or pharmacist before taking Clomethiazole
Syrup if:
• You often have difficulty in breathing.

The instructions on the label will remind you of what the doctor
said. They will tell you how much syrup to take and how often.
Do not take more than you have been told to.

• You have ever had liver or kidney problems.

• To help you to sleep at night, the usual dose is one to two
5 ml spoonfuls before bed. Your doctor will give you this
medicine for a short period of time.

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 Syrup can affect the way some
medicines work and some medicines can have an effect on
Clomethiazole Syrup.

• To stop you feeling restless or agitated, the usual dose is
one 5 ml spoonful three times a day.

• You have a condition called ’sleep apnoea syndrome‘
(interrupted breathing when you are asleep).

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Clomethiazole Syrup.

The usual dose of Clomethiazole Syrup depends on what you are
taking it for.

• 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 Syrup 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 Syrup 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.
Clomethiazole Syrup should not be taken by children.
If you take more Clomethiazole Syrup than you should
If you take too much Clomethiazole Syrup, 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
If you forget to take Clomethiazole Syrup
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
Like all medicines, Clomethiazole Syrup 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
Syrup 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 Syrup.
• Sore eyes and headache.
• Runny nose and chest phlegm.
• Rash which may be itchy.

5. How to store Clomethiazole Syrup
• Keep out of the reach and sight of children.

• Store between 2 and 8°C in the fridge, but not frozen.

• Do not use Clomethiazole Syrup 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.

6. Further information
What Clomethiazole Syrup contains
The active substance is clomethiazole (as clomethiazole
edisilate). There is 31.5 mg of clomethiazole in each millilitre
(ml) of syrup.
The other ingredients are purified water, liquid sorbitol (noncrystallising) (E420), ethanol, cineole, sodium hydroxide and
What Clomethiazole Syrup looks like and contents of the pack
Clomethiazole Syrup is a clear, colourless solution. lt is available
in 300 ml bottles.
Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH, Bahnhofstr. 1a
17498 Mesekenhagen, Germany
Clomethiazole Syrup is 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
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name

Clomethiazole Syrup

Reference number 27041/0002
This is a service provided by the Royal National
Institute of the Blind.

• Stomach upset.
• Changes in how your liver is working (shown by blood tests).

This leaflet was last revised in June 2015.

• 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: By reporting side
effects you can help provide more information on the safety of
this medicine.


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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.