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RYTHMODAN 10MG/ML INJECTION

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RME 90130

Rythmodan® 10mg /mL
Injection

1. An initial direct intravenous injection
of 2mg/kg (but not exceeding 150mg
(15ml) irrespective of body weight)
should be given slowly over not less
than five minutes, ie, the rate of
injection must not exceed 30mg (3ml)
per minute in order to reduce or
avoid unwanted haemodynamic
effects. If conversion occurs during
this time the injection should be
stopped. If the arrhythmia is to
respond to Rythmodan it will usually
do so within 10–15 minutes after
completion of the injection.
If conversion is achieved by
intravenous Rythmodan but the
arrhythmia subsequently recurs, a
further slow direct intravenous
injection over not less than five
minutes may be administered
cautiously and preferably under ECG
control. The total administration by
the intravenous route should not
exceed 4mg/kg (maximum 300mg) in
the first hour, nor should the
combined administration by the
intravenous and oral routes exceed
800mg in 24 hours.

disopyramide
The following is extracted from the SPC.
Technical Information for the
preparation and administration of
Rythmodan
1. NAME OF THE MEDICINAL
PRODUCT
Rythmodan Injection
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each glass ampoule contains 12.88mg
disopyramide phosphate (equivalent to
10mg of disopyramide) per 1ml of
solution.
4.2 Posology and method of
administration
Route of Administration: Rythmodan
Injection is intended for intravenous
use only.
Adults
The recommended dosage can be given
by two different regimes:

2. An initial direct intravenous injection
as above, ie over not less than five
minutes, maintained by intravenous
infusion by drip of 20–30mg/hour
(or 0.4mg/kg/hour) up to a maximum
of 800mg daily. This regime should
be employed if the patient is unable
to take oral medication or in
particularly serious arrhythmias
being treated in coronary care units.
Children
Not applicable. Rythmodan Injection is
not intended for use in children.
Elderly
A dose reduction due to reduced renal
and hepatic function in the elderly
(especially elderly non-smokers) should
be considered (see section 4.4).

6.3 Shelf–life
60 months.
6.4 Special precautions for storage
Store below 25∞C
6.5 Nature and contents of container
Colourless neutral glass ampoules are
available as 5ml, 10ml or 15ml.
6.6 Instructions for use/handling
Not Applicable.
9. DATE OF FIRST
AUTHORISATION/RENEWAL OF
AUTHORISATION
15th June 1998
10. DATE OF (PARTIAL) REVISION OF
TEXT
November 2005

6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Benzyl Alcohol, Sorbitol, Water for
Injection.
6.2 Incompatibilities
Not applicable.

Ê

Ê

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rythmodan® 10mg /mL
Injection
disopyramide

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

Read all of this leaflet carefully before you start
having 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 Injection is and what it
is used for
2. Before you have Rythmodan Injection
3. How Rythmodan Injection is given
4. Possible side effects
5. How to store Rythmodan Injection
6. Further information
1. What Rythmodan Injection is and
what it is used for
The name of your medicine is Rythmodan 10mg/mL
Injection (called Rythmodan Injection in this leaflet).
Rythmodan Injection 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 when you cannot take a
capsule or tablet
• To keep your heart beating at a normal rhythm
• To stop unusual heartbeats (arrhythmias) happening
after a heart attack
2. Before you have Rythmodan Injection

i

Do not have Rythmodan Injection and tell
your doctor if:
You are allergic (hypersensitive) to disopyramide or
any of the other ingredients of Rythmodan Injection
(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 have this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or nurse
before having Rythmodan Injection.
Take special care with Rythmodan
Injection
Check with your doctor or pharmacist before having
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 any kidney or liver problems
You have a disease which causes muscle weakness
(myasthenia gravis)

The person having the medicine is a child.
Rythmodan Injection contains benzyl alcohol and is
not suitable for use in children (see section below
‘Important information about some of the
ingredients of Rythmodan Injection’)
If you are not sure if any of the above applies to you, talk
to your doctor or pharmacist before having Rythmodan
Injection.
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 Injection
can affect the way some other medicines work.
Also some medicines can affect the way Rythmodan
Injection 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 Injection:
• Medicines for depression such as amitriptyline,
mipramine 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 Injection 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 Injection 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 having 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 mother's milk.

Important information about some of the
ingredients of Rythmodan Injection
• Sorbitol. If you have been told by your doctor that
you cannot tolerate some sugars, talk to your
doctor before taking this medicine
• Benzyl alcohol. Rythmodan Injection contains 10
mg/ml of benzyl alcohol. Rythmodan Injection
must not be given to premature babies or
neonates. It may cause toxic reactions and allergic
reactions in infants and children up to 3 years old.
3. How Rythmodan Injection is given
Having this medicine
• This medicine will be given to you by injection into
a vein or using a drip
• Your doctor may monitor your heart beat using a
machine called an electrocardiogram (ECG) and
may adjust your dose depending on your condition
• If you feel the effect of your medicine is too weak or
too strong, tell your doctor
Adults
The usual dose can be given in two different ways
depending on your condition:
1. You should be given an initial dose depending on
your body weight (2mg/kg). The maximum dose is
150mg (15ml). The initial dose will be given slowly
over five minutes (the rate of injection must not go
over 30mg per minute).
The total dose you can have by injection in the first
hour should not be larger than 4mg/kg of your
body weight or 300mg, which ever comes first. If
you are also taking this medicine by mouth such as
Rythmodan tablets or capsules, you should not
have more than a total combined dose of 800mg in
24 hours
or
2. If you are unable to take medicine by mouth
to treat your unusual heart beat, such as tablets or
capsules, or if you have serious heartbeat
problems ;
You should be given an initial injection slowly over
five minutes. Following this you will be given the
medicine using a drip at a rate of 20-30mg/hour.
The maximum dose is 800mg daily.
Elderly
Your doctor may lower your dose if you have any
kidney or liver problems.
Children
Rythmodan Injection 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 have more Rythmodan Injection than you
should
It is unlikely that your doctor or nurse will give you too
much medicine. Your doctor will be monitoring your
progress, and checking the medicine that you are
given. Always ask if you are not sure why you are
getting a dose of medicine. 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 miss a dose of Rythmodan Injection
Your doctor or nurse will have instructions on when to
give you this medicine. It is unlikely that you will not
be given the medicine as it has been prescribed.
However if you do think you have missed a dose, tell
your doctor or nurse.
If you stop having Rythmodan Injection
Keep having Rythmodan Injection until your doctor
tells you to stop. Do not stop having Rythmodan
Injection just because you feel better. If you stop, your
illness may get worse.
If you have any further questions about this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Rythmodan Injection 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:
• Feeling faint, dizzy or light-headed
• Palpitations or an uneven, fast or slow heartbeat
that you have not had before or 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
• 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
• Excessive sweating
5. How to store Rythmodan Injection
This medicine will be kept by your doctor or
pharmacist in a safe place where children cannot see
or reach it.
Rythmodan Injection should be stored below 25∞C.
Rythmodan Injection should not be used after the
expiry date which is stated on the label or carton after
EXP. The expiry date refers to the last day of that
month.
Your doctor should examine the injection for any
visible particles or discolouration.
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 Injection contains
- Each 1ml of injection contains 12.88mg of the
active substance disyopyramide phosphate
(equivalent to 10mg of disopyramide)
- The other ingredients are benzyl alcohol, sorbitol
and water for injection.
What Rythmodan Injection looks like and contents
of the pack
The injection is a colourless liquid available in glass
ampoules containing either 5 ml, 10ml or 15ml
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi-aventis, One Onslow Street, Guildford
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi-aventis.com
Manufacturer
Patheon UK Limited, Covingham, Swindon
Wiltshire, SN3 5BZ
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.

Driving and using machines
Rythmodan Injection 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.

This leaflet was last revised in September 2007.

RME 90130
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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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