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RYTHMODAN 100MG CAPSULES

Active substance(s): DISOPYRAMIDE / DISOPYRAMIDE / DISOPYRAMIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Rythmodan® 100mg Capsules
disopyramide

Is this leaflet hard to
see or read?
Phone 01483 505515
for help
Read all of this leaflet carefully before
you start taking this medicine.

• K
 eep 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. W
 hat 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

2. Before you take Rythmodan Capsules
Do not take Rythmodan Capsules
and tell your doctor if:



1. What Rythmodan Capsules are
and what they are used for
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.
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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R778260







Y ou 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 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.

Take special care with Rythmodan
Capsules
Check with your doctor or pharmacist
before taking your medicine if:














Y ou 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 (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
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
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 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

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
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• 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:
• M
 edicines 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 breastfeed, 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.

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

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.

Blood tests

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

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).
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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
• I f 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

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:

• F eeling 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,
faintness or drowsiness
• 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 Capsules
Keep out of the sight and reach 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.

carmine, iron oxide (E172) and titanium
dioxide (E171)

What Rythmodan Capsules look like and
contents of the pack
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.
The capsules are available in blister-packs of 84
capsules or bottles of 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer

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

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

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.

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

6. Further information
What Rythmodan Capsules contain

- E ach capsule contains 100mg of the active
substance, disopyramide
- The other ingredients are maize starch,
magnesium stearate, STA-RX 1500
(pregelatinised starch), talc, gelatin, indigo
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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, 1972 - 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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