Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:

•    Feeling sick (nausea) or being sick (vomiting), dry mouth, indigestion, diarrhoea, constipation, stomach pain, loss of appetite

•    Difficulty in passing urine, especially in men with prostate problems

•    Difficulty in getting or maintaining an erection, or in ejaculating (impotence)

•    Mood changes or mental problems

•    Blurred or double vision

•    Yellowing of your skin or eyes (jaundice)

•    Worsening of myasthenia gravis (a disease which causes muscle weakness)

•    You may get more infections than usual. This could be caused by a lowering in the number of white blood cells (called neutropenia)

•    Low blood sugar levels (hypoglycaemia). Signs include sweating, paleness, headache, faintness or drowsiness

•    Problems with memory or attention span, difficulty thinking clearly

5.How to store Rythmodan Capsules

Keep out of the reach and sight of children.

Store below 25°C.

Do not use Rythmodan Capsules after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not use Rythmodan Capsules if you notice your capsules are crumbling, broken or discoloured.

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 Rythmodan Capsules contain

-    Each capsule contains 150mg of the active substance, disopyramide

-    The other ingredients are maize starch, magnesium stearate, STA-RX 1500 (pregelatinised starch), talc, gelatine, indigo carmine, iron oxide and titanium dioxide

What Rythmodan Capsules look like and contents of the pack

The capsules have a white cap and body and are printed with ‘RY' on one part and ‘150' on the other, in black ink.

The tablets are available in blister-packs of 84 capsules.

If you are taking any of the following medicines that can increase the risk of unusual heartbeats (arrhythmias) when taken at the same time as Rythmodan Capsules:

•    Medicines for depression such as amitriptyline, imipramine or maprotiline

•    Medicines for male sexual problems such as sildenafil, tadalafil or vardenafil

•    Antibiotics such as erythromycin, clarithromycin, azithromycin or sparfloxacin

•    Antihistamines such as astemizole or terfenadine

•    Cisapride - used for heartburn

•    Pentamidine - used for pneumonia

•    Pimozide and thioridazine - used for schizophrenia

The following medicines may affect the

way Rythmodan Capsules works:

•    Amphotericin B - used for fungal infections

•    Tetracosactide - used to test some hormone problems

•    Rifampicin - used for infections

•    Atropine - used in eye drops and in cough and cold medicines

•    Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or incontinence

•    Medicines used to calm emotional or mental problems or stop you feeling sick or being sick such as chlorpromazine or prochlorperazine

•    Water tablets (diuretics) such as furosemide

•    Corticosteroids such as hydrocortisone, betamethasone or prednisolone

•    Laxatives such as bisacodyl or senna

•    Medicines for epilepsy such as phenobarbital, primidone or phenytoin

Rythmodan Capsules may affect the way

the following medicines work:

•    Medicines for HIV infections such as ritonavir, indinavir or saquinavir

•    Theophylline - used for wheezing or difficulty in breathing

•    Ciclosporin - used to help prevent rejection of transplants

•    Warfarin - used to thin the blood

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Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine. This is because small amounts of this medicine may pass into the mothers' milk.

Driving and using machines

Rythmodan Capsules may affect your ability to concentrate and react quickly. You may have blurred vision or become dizzy or light-headed. If this happens, do not drive or use any tools or machines.

Turn

Over

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Rythmodan® 150mg Capsules

disopyramide

^sanofi aventjs

Is this leaflet hard to see or read?

Phone 01483 505515 for help

• 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 Rythmodan Capsules are and what they are used for

2.    Before you take Rythmodan Capsules

3. How to take Rythmodan Capsules

4. Possible side effects

5.    How to store Rythmodan Capsules

6.    Further information

1.What Rythmodan Capsules are and what they are used for

It is used for controlling your heartbeat in

the following situations:

•    Arrhythmias - where your heartbeats are uneven, or unusually fast or slow

•    To keep your heart beating at a normal rhythm

•    To stop unusual heartbeats (arrhythmias) happening after a heart attack

•    To stop unusual heartbeats (arrhythmias) during an operation

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.

The name of your medicine is Rythmodan 150mg Capsules (called Rythmodan Capsules in this leaflet). Rythmodan Capsules contain a medicine called disopyramide. This belongs to a group of medicines called anti-arrhythmic agents.

It works by controlling the uneven beating of your heart and returns it to the normal rhythm.

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2.Before you take Rythmodan Capsules

Do not take Rythmodan Capsules land tell your doctor if:

You are allergic (hypersensitive) to disopyramide or any of the other ingredients of Rythmodan Capsules (see Section 6: Further Information)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

You have any other heart problems -apart from unusual heartbeats (arrhythmias)

You are taking other medicines to control your heart rhythm (see section below ‘Taking other medicines')

You are taking other medicines which could cause unusual heartbeats (see section below ‘Taking other medicines')

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rythmodan Capsules.

0Take special care with Rythmodan Capsules

Check with your doctor or pharmacist before taking your medicine if:

▲ You have low levels of potassium in your blood (called hypokalaemia)

▲ You have low blood sugar levels. This can happen if you have diabetes, a low body weight, a poor diet or if you are elderly

▲ You have glaucoma (raised pressure in the eye which causes painful eyes with blurred vision)

▲ You have an enlarged prostate ▲ You have kidney and liver problems ▲ You have a disease which causes muscle weakness (myasthenia gravis)

▲ You are elderly and have problems with your memory or attention span, or sometimes have difficulty thinking clearly If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rythmodan Capsules.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rythmodan Capsules can affect the way some other medicines work.

Also some medicines can affect the way Rythmodan Capsules works.

In particular, do not take this medicine, and tell your doctor:

If you are taking any of the following medicines for uneven heartbeats (arrhythmias):

•    Beta-blockers such as propranolol, oxprenolol or acebutolol

•    Verapamil - also used for chest pain or high blood pressure

•    Digoxin - also used for heart problems

3.How to take Rythmodan Capsules

Always take Rythmodan Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth

•    Swallow the capsules with a drink of water

•    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

Adults

The usual dose is two to five capsules (300mg to 800mg) daily in divided doses.

Elderly

Your doctor may lower your dose if you have any kidney or liver problems.

Children

Rythmodan Capsules are not suitable for use in children.

If you take more Rythmodan Capsules than you should

If you take more capsules than you should, talk to a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: dizziness, feeling tired, uneven heartbeat (palpitations), dry mouth, difficulty in passing water (urinating), feeling or being sick, stomach pain or fits (seizures).

If you forget to take Rythmodan Capsules

Do not take a double dose to make up for a forgotten capsule.

If you stop taking Rythmodan Capsules

Keep taking Rythmodan Capsules until your doctor tells you to stop.

If you have any further questions about this medicine, ask your doctor or pharmacist.

4.Possible side effects

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

Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment

•    If you have an allergic reaction. The signs may include: a skin rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Tell your doctor as soon as possible if you have any of the following:

•    Feeling faint, dizzy or light-headed

•    Palpitations or an uneven, fast or slow heartbeat that you have not had before or that gets worse

Blood tests

Your doctor may ask you to have regular blood tests to check your blood sugar

levels.    _- 4 _-

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sanofi-aventis, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432

email: uk-medicalinformation@sanofi-

aventis.com

Manufacturer

Sanofi Winthrop Industrie 56, route de Choisy-au-Bac 60205 Compiegne France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in February 2010.

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