RYTHMODAN RETARD 250MG TABLETS

Active substance: DISOPYRAMIDE PHOSPHATE

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Rythmodan® Retard 250mg Tablets

0126
06.01.14[13]

(disopyramide phosphate)
PATIENT INFORMATION LEAFLET
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.
In this leaflet:
1. What Rythmodan Retard are and what they are used for
2. Before you take Rythmodan Retard
3. How to take Rythmodan Retard
4. Possible side effects
5. How to store Rythmodan Retard
6. Further information
1. WHAT RYTHMODAN RETARD ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Rythmodan Retard 250mg Tablets (called
Rythmodan Retard in this leaflet). Rythmodan Retard contains a medicine
called disopyramide. This belongs to a group of medicines called antiarrhythmic agents.
It works by controlling the uneven beating of your heart and returns it to the
normal rhythm.
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
2. BEFORE YOU TAKE RYTHMODAN RETARD
Do not take Rythmodan Retard if:
- You are allergic (hypersensitive) to disopyramide or any of the other
ingredients of Rythmodan Retard (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’)
- You have any kidney or liver problems
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 Retard.
Take special care with Rythmodan Retard
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 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 Retard.
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
Retard can affect the way some other medicines work.
Also some medicines can affect the way Rythmodan Retard works.
In particular, do not take this medicine, and tell your doctor if:
If you are taking any of the following medicines for uneven
heartbeats (arrhythmias):
- Beta-blockers such as propranolol, oxprenolol or acebutolol
- Verapamil –used for chest pain or high blood pressure
- Digoxin – also used for heart problems

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 Retard:
- 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 Retard
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 Retard 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
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 Retard 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.
Important information about some of the ingredients of Rythmodan
Retard
You r medicine contains anhydrous glucose and sucrose. If you have been
told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE RYTHMODAN RETARD
Always take Rythmodan Retard 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 tablets with a drink of water
- Do not break, crush or chew your tablets
- If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor
- If you are being changed over from treatment with Rythmodan Injection,
your doctor may also give you Rythmodan Capsules. You will have these
for 24 hours before you have Rythmodan Retard tablets.
Adults
The usual starting dose is one to one and a half tablets (250mg to 375mg)
twice a day.
Elderly
Your doctor may lower your dose if you have any kidney or liver problems.
Children
Rythmodan Retard is not suitable for use in children.
Blood tests
Your doctor may ask you to have regular blood tests to check your blood
sugar levels.

If you take more Rythmodan Retard than you should
If you take more tablets 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 Retard
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Rythmodan Retard
Keep taking Rythmodan Retard 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 Retard can cause side effects, although not
everybody gets them.

6. FURTHER INFORMATION
What Rythmodan Retard contains
- Each tablet contains 250mg of the active ingredient disopyramide as
disopyramide phosphate in a modified release formulation.
- The other ingredients are glyceryl stearate, anhydrous glucose, povidone,
magnesium stearate, hypromellose, propylene glycol and sucrose.
What Rythmodan Retard looks like and contents of the pack
Rythmodan Retard are white, round, biconvex tablets. One side has a
break-line and is embossed '013' and ‘E’; the other side is embossed with
the Roussel logo.
Rythmodan Retard are available in blister packs of 40 and 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Sanofi Winthrop Industrie, Route du Choisy au Bac 56,
F-60205 Compiegne, France. Procured from within the EU and repackaged
by the Product Licence holder P.I.E. Pharma Ltd, 207 Kenton Road,
Harrow, Middlesex HA3 0HD.
POM

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
side effects:
- Feeling faint, dizzy or light-headed
- Palpitations or an uneven, fast or slow heartbeat that you have not had
before or that gets worse
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, feeling faint or drowsy
- Problems with memory or attention span, difficulty thinking clearly
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 RYTHMODAN RETARD
Keep out of the sight and reach of children.
o

Do not store above 25 C. Protect from light.
Do not use Rythmodan Retard 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 Retard if you notice your tablets 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.

PL 15361/0126

Leaflet revision and issue date (Ref.) 06.01.14[13]
Rythmodan Retard is a trademark of Aventis Pharma SA.

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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.

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