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RYTHMODAN RETARD 250MG MODIFIED RELEASE TABLETS

Active substance(s): DISOPYRAMIDE PHOSPHATE / DISOPYRAMIDE PHOSPHATE / DISOPYRAMIDE PHOSPHATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Rythmodan Retard® 250mg
Modified Release Tablets
disopyramide

Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help
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 is
and what it is used for
The name of your medicine is Rythmodan
Retard 250mg Modified Release tablets
(called Rythmodan Retard in this leaflet).
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
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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:
L You have low levels of potassium in
your blood (called hypokalaemia)

L 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
L You have glaucoma (an eye condition
often caused by an abnormally high
pressure in the eye) or if you or someone
in your family have ever had glaucoma.
Your doctor may perform an eye pressure
test before prescribing Rythmodan
L You have an enlarged prostate
L You have a disease which causes muscle
weakness (myasthenia gravis)
L You are elderly and have problems with
your memory or attention span, or
sometimes have difficulty thinking clearly
L You have constipation or take any
medication that causes constipation
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

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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.

passing water (urinating), feeling or being
sick, stomach pain or fits (seizures).

Adults
The usual starting dose is one to one and a
half tablets (250mg to 375mg) twice a day.

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.

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
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If you forget to take Rythmodan Retard
Do not take a double dose to make up for
a forgotten tablet.

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 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
• In certain situations the blockage of bowel
can take place when on Rythmodan
especially in the elderly, when taken with
other medicines that may cause constipation
or when blood level of Rythmodan is
raised due to kidney or liver problems
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. Store in the
original package.
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 250mg of the active
substance, disopyramide base.
- The other ingredients are glyceryl
monostearate, sucrose, povidone and
magnesium stearate. The film coating
contains hydroxypropylmethylcellulose,
propylene glycol and anhydrous glucose.
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What Rythmodan Retard look like and
contents of the pack
The tablets are biconvex and white in
colour. One side has a break-line and is
embossed 013 and E. The other side is
embossed with the Roussel logo.
The tablets are available in blister-packs of
56, 60 or 100 tablets and in glass bottles of
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie,
56 route de Choisy au Bac,
60205 Compiegne Cedex,
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 09/2016
© sanofi, 1980 - 2016

Expand Transcript

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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