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RYTHMODAN RETARD 250 MG MODIFIED-RELEASE TABLETS

Active substance(s): DISOPYRAMIDE PHOSPHATE

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504162/PL1b

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Rythmodan Retard 250 mg
Modified-Release Tablets
(disopyramide phosphate)
The name of your medicine is Rythmodan Retard 250 mg
Modified-Release Tablets. Throughout this leaflet it will be
referred to as Rythmodan Retard.
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 is and what it is 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 IS AND WHAT IT IS
USED FOR
Rythmodan Retard contains 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.
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
Sucrose and anhydrous glucose: 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.
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.

Continued overleaf

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.
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.
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.
Do not store above 25°C.
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 Retard contains
- Each tablet contains 250 mg disopyramide base.
- The other ingredients are glyceryl monostearate,
sucrose, povidone and magnesium stearate. The film
coating contains hypromellose, propylene glycol and
anhydrous glucose.
What Rythmodan Retard look like and contents of the
pack
The tablets are white to off-white, biconvex, modified tablets.
One side has a break-line and is embossed 013 and E and
the other side is embossed with the Roussel logo.
The tablets are available in blister-packs of 60 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
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.
®

Rythmodan Retard 250 mg Modified-Release Tablets
PLPI 18067/0441
POM
®

Rythmodan Retard is a registered trademark of Aventis
Pharma S.A.
This leaflet was last revised on 2

nd

December 2014.

To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

504162/PL1b

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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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