ARYTHMOL 150MG TABLETS

Active substance: PROPAFENONE HYDROCHLORIDE

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ARYTHMOL®
150 & 300 mg Tablets
Propafenone
Hydrochloride

IMPORTANT INFORMATION
Read all of this leaflet carefully
before you start taking
this medicine.
• Keep this leaflet as you may need
to read it again
• This leaflet provides a summary of
the information currently available
for Arythmol
• For further information or advice
ask your doctor or pharmacist
• This medicine is for you only and
should never be given to anyone
else, even if they appear to have
the same symptoms as you
• Tell your doctor or pharmacist if you
experience any side effects

Leaflet Contents:
1. What is Arythmol & what is it used for?
2. What should you know before taking Arythmol?
3. How should you take your Arythmol?
4. Possible side effects of Arythmol.
5. How should you store Arythmol?
6. Further information about Arythmol.
1. What is Arythmol & what is it used for?
Arythmol belongs to a group of medicines called
antiarrhythmic agents. Arythmol slows down the heart
rate and helps to regulate the heartbeat. Arythmol tablets
are used to treat and prevent arrhythmias (abnormal
heart rhythms).
2. What should you know before taking
Arythmol?
If the answer to any of these questions is
YES, tell your doctor or pharmacist BEFORE
you start to take Arythmol.
• Are you sensitive (allergic) to propafenone or any of the
other ingredients in the tablets (see section 6)?
• Have you had a heart attack in the previous 3 months?
• Are you pregnant or planning to become pregnant, or
are you breast feeding?
• Do you suffer from heart failure or any heart problems
other than your abnormal heart rhythm?
• Do you have a heart condition called Brugada
Syndrome, which causes you to have a potentially lifethreatening heart rhythm?
• Do you have an unusually slow heart rate or hypotension
(low blood pressure)?
• Do you suffer from any breathing problems, such as

asthma or chronic bronchitis or emphysema?
• Have you been diagnosed as having the condition
known as myasthenia gravis?
• Has your doctor told you that you have a disturbance
in the salts (e.g. sodium or potassium) in your blood?
• Are you going to be receiving an anaesthetic?
• Are you taking any of the following?
· medicines that affect the activity of the heart such as
amiodarone, digoxin, quinidine;
· tablets to prevent blood clots (e.g. warfarin);
· antibiotics (e.g. erythromycin or rifampicin);
· any of the group of medicines known as beta-blockers
(these are used to treat high blood pressure);
· any antiviral agents (e.g. ritonavir);
· any of the group of medicines known as major
tranquillisers, or an antidepressant of the tricyclic
or related group (e.g. amitriptyline, dothiepin,
desipramine);
· any other antidepressants, such as venlafaxine,
fluoxetine, paroxetine;
· cimetidine (an ulcer medicine), ciclosporin (an
immunosuppressant,
used
after
transplant
operations, or in the treatment of arthritis or psoriasis),
theophylline (used in the treatment of asthma),
ketoconazole (an antifungal agent), phenobarbitol
(for epilepsy) or grapefruit juice.
OTHER IMPORTANT INFORMATION
• If you need to have an operation it is important to
tell the surgeon or dentist, Arythmol may affect the
anaesthetic or other treatments used.
• If you have a pacemaker, it may need to be altered.
• Arythmol is NOT suitable for children.
• Your doctor may perform ECGs and blood pressure
monitoring prior to and during treatment to monitor
your individual dose.

DRIVING AND USING MACHINERY
It is NOT advisable to drive, operate machinery or do
anything that requires you to be alert until you know
how the tablets affect you. This is because Arythmol can
cause blurred vision, dizziness, tiredness and low blood
pressure in some people.
3. How should you take Arythmol?

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Follow your doctor’s directions about when and how to
take your tablets and look at the label on the carton. Your
pharmacist will also help if you are not sure. The number
of tablets that you will need to take will be decided by
your doctor.
This may be between one Arythmol 150 mg tablet three
times a day to one Arythmol 300 mg tablet three times
a day.
You may need a lower dose of Arythmol if you are elderly,
if you have problems with your kidneys or liver, or if you
have a low bodyweight.
Swallow your tablets without chewing them.
It is best to take them after food with some
water. Do not take with grapefruit juice.
IF YOU OR SOMEONE YOU KNOW TAKES MORE
ARYTHMOL THAN PRESCRIBED (AN OVERDOSE)
you should contact a doctor or go to the nearest hospital
casualty department IMMEDIATELY, taking your tablets
with you.
IF YOU FORGET TO TAKE YOUR ARYTHMOL
TABLETS take them as soon as you remember, unless it
is almost time for your next dose. If it is, do not take the

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missed dose at all. Never double up on a dose to make
up for the one you have missed.
IF YOU STOP TAKING ARYTHMOL, without your
doctor’s advice, your condition may get worse. It is
important that you keep taking these tablets until your
doctor tells you to stop. Do NOT stop just because you
feel better.

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4. Possible side effects of Arythmol.
As well as benefits, all medicines may sometimes have
unwanted effects in some people.
Tell your doctor IMMEDIATELY if you develop any of
the following conditions:
• a rash, itching or skin reddening or other signs of an
allergic reaction such as difficulty breathing. Although
these are rare, they can be serious.
• yellowing of the skin and/or eyes, as these may be a
sign of liver problems
• you start to bruise easily or if you develop a very sore
throat with a high fever, as in very rare cases, treatment
may affect the amount of white blood cells and platelets
in the blood.

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Other side effects with Arythmol may include:
Very Common side effects (occurring in more than 1 in
10 users):
- Dizziness
- Irregular (slow or fast) heart beat
- Heart palpitations (being aware of your heart beat)

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Common side effects (occurring in 1 to 10 users in 100):
- Anxiety
- Difficulty sleeping

-

Headache
Alteration of taste or a bitter taste
Blurred vision
Abnormal heart rhythm
Shortness of breath
Stomach pain
Feeling or being sick
Diarrhoea
Constipation
Dry mouth
Liver disorders
Chest pain
Feeling tired or weak
Fever

Uncommon side effects (occurring in 1 to 10 users in 1000):
- Reduction in blood platelets, which increases risk of
bleeding or bruising
- Loss of appetite
- Nightmares
- Fainting
- Ataxia (problems with or loss of coordination)
- Low blood pressure
- Vertigo (spinning sensation)
- A tingling or pricking sensation of the skin
- Numbness
- Bloating
- Flatulence (passing wind/gas)
- Redness of skin and itchy skin
- Impotence
The following are side effects with an unknown frequency:
- Severe reduction in the number of white blood cells
which makes infections more likely
- Confusion
- Seizures
- Tremor (feeling shaky)

-

Rigidity (stiffness)
Restlessness
Life threatening irregular heart beat
Heart problems which can cause shortness of breath
or ankle swelling
A fall in the blood pressure on standing up which may
cause dizziness, light headedness or fainting
Yellowing of the skin or whites of the eyes caused by
liver or blood problems
Retching
Lupus-like syndrome (an allergic condition which
causes joint pain, skin rashes and fever)

A reversible drop in sperm count has occasionally been
reported with high doses.
If you experience any other unusual symptoms whilst
taking your tablets, tell your doctor or pharmacist.
5. How should you store Arythmol?
Your tablets should be stored in a safe place out of the
reach and sight of children. They should be kept below
30 °C and in their original packaging.
Do NOT use Arythmol after the expiry date printed on the
packaging. The date refers to the last day of that month.
If your doctor decides to stop the treatment, return any
left over tablets to your pharmacist. Only keep the tablets
if your doctor tells you to. Do not dispose of the leftover
tablets carelessly (e.g. down the toilet or in with your
general rubbish).

6. Further information about Arythmol.
The active ingredient in Arythmol is propafenone
hydrochloride.
The tablets are white and are available in two strengths,
containing either 150 mg or 300 mg of propafenone
hydrochloride. Other ingredients include: microcrystalline
cellulose, maize starch, hypromellose, croscarmellose
sodium, purified water, macrogol, titanium dioxide (E171)
and magnesium stearate.
Each pack of Arythmol 150 mg tablets contains 90
tablets.
Each pack of Arythmol 300 mg tablets contains 60
tablets.
Marketing Authorisation Holder:
Abbott Laboratories Ltd., Abbott House,
Vanwall Business Park, Vanwall Road, Maidenhead,
Berkshire SL6 4XE, United Kingdom
Manufacturer: AbbVie Deutschland GmbH & Co. KG,
Knollstrasse, 67061 Ludwigshafen, Germany
The leaflet was last revised in January 2013.

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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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