Heminevrin 31.5 Mg/Ml Syrup
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koepcke.publishing
stand (datum): 22.02.2016 [13:50 Uhr] format: 297 x 210 mm, DIN A4 farben: 1/1-farbig schwarz schriftgroBe: 9 pt mat.-nr.: 9000555/12
PACKAGE LEAFLET: INFORMATION FOR THE USER
Heminevrin® 31.5 mg/ml Syrup
clomethiazole
(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 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 Heminevrin Syrup is and what it is used for
2. Before you take Heminevrin Syrup
3. How to take Heminevrin Syrup
4. Possible side effects
5. How to store Heminevrin Syrup
6. Further information
Heminevrin Syrup contains 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.
Heminevrin 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.
Do not take Heminevrin Syrup if:
• You are allergic (hypersensitive) to clomethiazole or any of the other ingredients in Heminevrin Syrup (see Section 6: Further information).
• You have lung or breathing problems which have recently got worse.
Do not take Heminevrin Syrup if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Heminevrin Syrup.
Take special care with Heminevrin Syrup
Check with your doctor or pharmacist before taking Heminevrin Syrup 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 Heminevrin Syrup.
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 Syrup can affect the way some medicines work and some medicines can have an effect on Heminevrin 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 Heminevrin Syrup with food and drink
• Do not drink alcohol while you are taking Heminevrin Syrup.
• If you are taking Heminevrin 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 Heminevrin Syrup if you are pregnant, may become pregnant or are breast-feeding. Your doctor will decide whether you can take Heminevrin 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 Heminevrin Syrup.
Driving and using machines
Do not drive or use any tools or machines while taking Hemi-nevrin Syrup. This is because the medicine can make you feel drowsy (sleepy).
Important information about some of the ingredients of Heminevrin Syrup
• Heminevrin Syrup contains small amounts of alcohol (ethanol). It contains less than 100 mg per dose.
• Heminevrin 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 Heminevrin Syrup contains 350 mg of sorbitol. When taken as recommended, each dose contains up to 7 g of sorbitol. It can cause stomach upset and diarrhoea.
Always take Heminevrin Syrup 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 much syrup to take and how often. Do not take more than you have been told to.
Adults
The usual dose of Heminevrin Syrup depends on what you are taking it for.
• 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.
• To stop you feeling restless or agitated, the usual dose is one 5 ml spoonful 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 Heminevrin 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 Heminevrin 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.
Children
Heminevrin Syrup should not be taken by children.
If you take more Heminevrin Syrup than you should
If you take too much Heminevrin 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 unconscious).
If you forget to take Heminevrin 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.
• Keep out of the reach and sight of children.
• Store between 2 and 8°C in the fridge, but not frozen.
• Do not use Heminevrin 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.
[y Further information
Like all medicines, Heminevrin 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 Heminevrin 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 Heminevrin Syrup.
• 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.
What Heminevrin 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 levomenthol.
What Heminevrin Syrup looks like and contents of the pack
Heminevrin 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
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 Heminevrin Syrup
Reference number 27041/0002
This is a service provided by the Royal National Institute of the Blind.
This leaflet was last revised in June 2015.
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.
9000555/12