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RYTHMODAN RETARD 250MG MODIFIED RELEASE TABLETS

Active substance: DISOPYRAMIDE PHOSPHATE

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Version N°

2

20/05/2014
E Wasczczyk
21/05/2014
E Wasczczyk
Nom du produit
Référence article
Dosage
Quantité

Type Article

Rythmodan
R772390
250 mg
cprs

Notice double

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères

Bleu Reflex Blue U

NA
CRGB - V1 - 05/2012
1-606062
606062-1d
150 x 210 mm
10 pts

-1-

1

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.

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

Couleur
Nbre/Réf.

Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help

1. What Rythmodan Retard is
and what it is used for

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.

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disopyramide

2. Before you take Rythmodan Retard

Sanofi
Grande-Bretagne

Rythmodan Retard® 250mg
Modified Release Tablets

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

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

R772390

Code sécurité
772390

Numéro de Pages
1/4

2

20/05/2014
E Wasczczyk
21/05/2014
E Wasczczyk
Nom du produit
Référence article
Dosage
Quantité

Type Article

Rythmodan
R772390
250 mg
cprs

Notice double

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères
NA
CRGB - V1 - 05/2012
1-606062
606062-1d
150 x 210 mm
10 pts

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

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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

1

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

Couleur
Nbre/Réf.

Code sécurité
772390

Numéro de Pages
2/4

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.

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

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

Sanofi
Grande-Bretagne

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 (raised pressure in
the eye which causes painful eyes with
blurred vision)
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
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist
before taking Rythmodan Retard.

Also some medicines can affect the way
Rythmodan Retard works.

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Take special care with
Rythmodan Retard

Version N°

2
Type Article

Rythmodan
R772390
250 mg
cprs

Notice double

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères
NA
CRGB - V1 - 05/2012
1-606062
606062-1d
150 x 210 mm
10 pts

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.

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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

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

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

4. Possible side effects

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

Children
Rythmodan Retard is not suitable for use
in children.

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.

1

3. How to take Rythmodan Retard

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

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

Couleur
Nbre/Réf.

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.

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

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

Sanofi
Grande-Bretagne

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.

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.

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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.

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.

Code sécurité
772390

Numéro de Pages
3/4

Version N°

2

Nom du produit
Référence article
Dosage
Quantité

Type Article

Rythmodan
R772390
250 mg
cprs

Notice double

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères
NA
CRGB - V1 - 05/2012
1-606062
606062-1d
150 x 210 mm
10 pts
Code sécurité
772390

R772390

This leaflet was last revised in 05/2014
© sanofi, 1980 - 2014
Numéro de Pages
4/4

-4-

20/05/2014
E Wasczczyk
21/05/2014
E Wasczczyk

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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6. Further information

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.

1

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.

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5. How to store Rythmodan Retard

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.

Couleur
Nbre/Réf.

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.

Sanofi
Grande-Bretagne

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

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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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