HEMINEVRIN 192MG CAPSULES

Active substance: CLOMETHIAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

HEMINEVRIN® 192 mg CAPSULES/
CLOMETHIAZOLE 192 mg CAPSULES
(Clomethiazole)
Patient Information Leaflet

27mm

Your medicine is known by either of the above names but will usually be referred to as Heminevrin Capsules
in this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

WARNING!

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.

DATE:

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.

UK PIL DATED FEBRUARY 2011

6464/2205D

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.

CODE:

PRODUCT:

Heminevrin 192mg caps

ARTWORKER:

DT

11/07/12

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’).

DATE OF PROOF:

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

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.

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

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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

PROOF HISTORY:
v.1 - waymade - 11/07/12

Leaflet Flat Size = 148 x 400

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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).

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.



6. Further information
Your medicine is called Heminevrin 192 mg Capsules/Clomethiazole 192 mg Capsules.
DATE:

Each Heminevrin 192mg capsule/Clomethiazole 192mg capsule contains 192 mg of the active ingredient,
Clomethiazole (as the edisilate) and fractionated coconut oil. The unmarked, soft capsules are
greyish-brown coloured.
Heminevrin 192 mg Capsules/Clomethiazole 192 mg Capsules themselves are made of the following:
gelatin, glycerin, sorbitol 70%, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and
titanium dioxide (E171).

POM

PL No: 6464/2205

DATE:

This product is manufactured by AstraZeneca Farmaceutica Spain SA, C/Serrano Galvache, 56, Edificio
Roble, 28033 Madrid, Spain and procured within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR

DT

11/07/12

ARTWORKER:

DATE OF PROOF:

Heminevrin 192mg caps

6464/2205D

PRODUCT:

CODE:

Heminevrin is a registered trademark of AstraZeneca AB.

UK PIL DATED FEBRUARY 2011

05-0269
PRE-PRESS NO.:

Leaflet revision and issue date (Ref.) 27.6.2012

CUSTOMER: Waymade

Q.A.
APPROVED:

Heminevrin 192 mg Capsules/Clomethiazole 192 mg Capsules are available as blister packs of 30 and 60
capsules, or packs of 1 x 30 or 2 x 30 capsules in glass containers.

Colour
Swatch

Black

000-0000D

WARNING!

CUSTOMER
APPROVED:



5. How to store Heminevrin Capsules
Do not use after the expiry date printed on the carton, bottle label or blister strip.
Heminevrin Capsules should not be stored above 25°C. Store in the original packaging.
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.
If the capsules become discoloured or show signs of any deterioration, you should seek the advice
of your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to
dispose of medicines that are no longer required. This will help to protect the environment.

WARNING!






WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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.

PROOF HISTORY:
v.1 - waymade - 11/07/12

Leaflet Flat Size = 148 x 400

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.

Expand view ⇕

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.

Hide
(web4)