Document: leaflet MAH BRAND_PLPI 18799-2517 change

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• leaflet MAH BRAND_PLPI 33532-0562
• leaflet MAH BRAND_PLPI 33902-0563

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Manufactured by: CHEPLAPHARM Arzneimittel GmbH, Bahnhofstrasse

1a, D-17498 Mesekenhagen, Germany.

Package Leaflet: Information For The User

Heminevrin® 192mg 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 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

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.

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.

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 Heminevrin 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 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.

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 Heminevrin 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 treat low blood pressure or low blood sugar), do not take Heminevrin Capsules.

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).

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 10mg of sorbitol. When taken as recommended, each dose contains up to 40mg of sorbitol.

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 Heminevrin 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 shaking (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

Like all medicines, Heminevrin 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 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.

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 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. 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.

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.

5. How to store Heminevrin Capsules

•    Do not use your tablet after the expiry date which is stated on the carton and bottle label after ‘Exp'. The expiry date refers to the last day of the month.

•    Do not store above 25°C. Store in original in Pack.

•    Keep out of the sight and reach of children.

•    if your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

•    If your capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

•    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 capsules contains:

The active ingredient in Heminevrin capsules is clomethiazole.

Each capsule contains 192mg clomethiazole

The other ingredients are Medium chain triglycerides, gelatin, glycerin (85%) sorbitol, manitol, oligosaccharides (31:3:66), brown iron oxide (E172) and titanium dioxide (E171).

The Heminevrin Capsules are unmarked, soft capsules are greyish-brown coloured.

Heminevrin Capsules are available as packs of 1 x 30 or 2 x 30 capsules in glass containers.

Package Leaflet: Information For The User

Clomethiazole 192mg 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

1. 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.

2. Before you take Clomethiazole Capsules

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 10mg of sorbitol. When taken as recommended, each dose contains up to 40mg of sorbitol.

3. How to take Clomethiazole Capsules

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.

4. Possible side effects

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. 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.

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.

5. How to store Clomethiazole Capsules

•    Do not use your tablet after the expiry date which is stated on the carton and bottle label after ‘Exp'. The expiry date refers to the last day of the month.

•    Do not store above 25°C. Store in original in Pack.

•    Keep out of the sight and reach of children.

•    if your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

•    If your capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

•    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 Clomethiazole capsules contains:

The active ingredient in Clomethiazole capsules is clomethiazole.

Each capsule contains 192mg clomethiazole

The other ingredients are medium chain triglycerides, gelatin, glycerin (85%) sorbitol, manitol, oligosaccharides (31:3:66), brown iron oxide (E172) and titanium dioxide (E171).

The Clomethiazole Capsules are unmarked, soft capsules are greyish-brown coloured.

Clomethiazole Capsules are available as packs of 1 x 30 or 2 x 30 capsules in glass containers.