RYTHMODAN 100MG CAPSULES

Active substance: DISOPYRAMIDE

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R769530

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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.

1

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

Couleur
Nbre/Réf.

Rythmodan
R769530
100 mg
gelules

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

Sanofi
Grande-Bretagne

Notice double

• 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.

Laboratoires
Pays

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Read all of this leaflet carefully before
you start taking this medicine.

Type Article

The name of your medicine is Rythmodan
100mg 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.

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

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You are allergic (hypersensitive) to
disopyramide or any of the other ingredients
of Rythmodan (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 Rythmodan Capsules
and tell your doctor if:

2. Before you take Rythmodan Capsules

2

Is this leaflet hard to see
or read?
Phone 01483 505515 for
help

disopyramide

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

In this leaflet:

Version N°

Rythmodan® 100mg Capsules

PACKAGE LEAFLET:
INFORMATION FOR THE USER

COMPIÈGNE

NA
NA
1-606062
606062-1d
150 x 210 mm
9 pts
Code sécurité
R769530

Bleu Reflex Blue U
Numéro de Pages
1/4

If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking Rythmodan Capsules.

-2-

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• Medicines for depression such as
amitriptyline, imipramine or maprotiline
• Medicines for male sexual problems such
as sildenafil, tadalafil or vardenafil

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:

Rythmodan
R769530
100 mg
gelules

• Beta-blockers such as propranolol,
oxprenolol or acebutolol
• Verapamil – also used for chest pain or
high blood pressure
• Digoxin – also used for heart problems

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

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L
L
L

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• 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

1

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

Couleur
Nbre/Réf.

The following medicines may affect the
way Rythmodan Capsules works:

Sanofi
Grande-Bretagne

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 any kidney or 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

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blood (called hypokalaemia)

Type Article

L You have low blood sugar levels. This can

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L You have low levels of potassium in your

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

Taking other medicines

2

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.

• 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

Version N°

Take special care with Rythmodan
Capsules

COMPIÈGNE

NA
NA
1-606062
606062-1d
150 x 210 mm
9 pts
Code sécurité
R769530

Bleu Reflex Blue U
Numéro de Pages
2/4

Driving and using machines

Always take Rythmodan Capsules exactly as
your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
-3-

• 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 as soon as possible if
you have any of the following:

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3. How to take Rythmodan Capsules

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 take more Rythmodan Capsules
than you should

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

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

Rythmodan
R769530
100 mg
gelules

Blood tests

Rythmodan Capsules are not suitable for use in
children.

Notice double

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.

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

4. Possible side effects

1

Children

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

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Elderly

Type Article

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.

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

Sanofi
Grande-Bretagne

The usual starting dose is three to eight
capsules (300 to 800mg) in divided doses daily.

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

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Adults

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If you stop taking Rythmodan Capsules

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

If you forget to take Rythmodan
Capsules

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Pregnancy and breast-feeding

• 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

• 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

Taking this medicine

Version N°

Rythmodan Capsules may affect the way
the following medicines work:

COMPIÈGNE

NA
NA
1-606062
606062-1d
150 x 210 mm
9 pts
Code sécurité
R769530

Bleu Reflex Blue U
Numéro de Pages
3/4

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.

Bleu Reflex Blue U

R769530

NA
NA
1-606062
606062-1d
150 x 210 mm
9 pts

-4-

© Sanofi, 1972 - 2013

This leaflet was last revised in 07/2013

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.

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N° version Country Ex.
N° plan Dimensionnel
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Reporting of side effects

- Each capsule contains 100mg of the active
substance, disopyramide
- The other ingredients are maize starch,
magnesium stearate, STA-RX 1500
(pregelatinised starch), talc, gelatin, indigo
carmine, iron oxide (E172) and titanium
dioxide (E171)

What Rythmodan Capsules contain

Rythmodan
R769530
100 mg
gelules

6. Further information

Notice double

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

1

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.

Couleur
Nbre/Réf.

Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com

Sanofi
Grande-Bretagne

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Marketing Authorisation Holder and
Manufacturer

Type Article

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

Laboratoires
Pays

The capsules are available in blister-packs of 84
capsules or bottles of 100 capsules.
Not all pack sizes may be marketed.

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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.

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• 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.

The capsules have a green cap and yellow body
and are printed in black ink with ‘RY’ on one
part and ‘RL’ on the other.

What Rythmodan Capsules look like and
contents of the pack

2

Store below 25°C.

Keep out of the sight and reach of children.

5.How to store Rythmodan Capsules

Version N°

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:

COMPIÈGNE

Code sécurité
R769530

Numéro de Pages
4/4

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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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