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ARYTHMOL 300MG TABLETS

Active substance(s): 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 because it contains
important information for you.
• 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 only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

MKP-00254-2016 GB_d8.indd 2

1. What Arythmol is and what is it used for
Arythmol contains the active substance propafenone
hydrochloride.
Arythmol belongs to a group of medicines called anti
arrhythmic 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 you need to know before you take
Arythmol
Do not take Arythmol:
• if you are allergic to propafenone hydrochloride or
any of the other ingredients of this medicine (listed
in section 6).
• if you have a heart condition called Brugada
Syndrome, which causes you to have a potentially
life-threatening heart rhythm.
• if you had a heart attack in the previous 3 months.
• if you suffer from heart failure or any heart problems
other than your abnormal heart rhythm.
• If you have a usually slow heart rate or hypotension
(low blood pressure).
• If you suffer from any breathing problems, such as
chronic bronchitis or emphysema.
• If your doctor has told you that you have a
disturbance in the salts (e.g. sodium or potassium)
in your blood.
• if you been diagnosed as having the condition
known as myasthenia gravis?
• if you are taking ritonavir (antiviral agents)

Warnings and precautions
Talk to your doctor or pharmacist before taking
Arythmol
• If you are pregnant or planning to become pregnant
• If you are breast feeding
• If you suffer from any breathing problems, such as
asthma
Take special care with Arythmol
• Tell your surgeon or dentist that you are taking
Arythmol if surgery is planned. It may affect the
anaesthetic used.
• If you have a pacemaker, it may need to be altered.
• Your doctor may perform ECGs and blood pressure
monitoring prior to and during treatment to monitor
your individual dose.
Children and adolescents
Arythmol is NOT suitable for children.
Other medicines and Arythmol
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• 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 betablockers (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)
• phenobarbital (for epilepsy)

Arythmol with food and drink
Arythmol should not be taken with grapefruit juice.
Arythmol should be taken after food, with some water.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
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 to take your Arythmol
Always take this medicine as your doctor or pharmacist
told you. Check with your doctor or pharmacist if you
are not sure. The number of tablets that you will need
to take will be decided by your doctor.
Adults
The recommended dose may be between one
Arythmol 150 mg tablet three times a day to one
Arythmol 300 mg tablet three times a day.
Elderly
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.
Use in children and adolescents
Arythmol is NOT suitable for children.
Swallow your tablets without chewing
them. It is best to take them after food
with some water. Do not take with
grapefruit juice.

MKP-00254-2016 · GB · 5203 · M096/M097 · XXX

Package leaflet: Information for the user

What is in this leaflet
1. What Arythmol is and what is it used for
2. What you need to know before you take Arythmol
3. How to take your Arythmol
4. Possible side effects
5. How to store Arythmol
6. Contents of the pack and other information

6.7.16 09:31

MKP-00254-2016 · GB · 5203 · M096/M097 · XXX

If you take more Arythmol than you should
If you or someone else takes more Arythmol than
prescribed, you should contact a doctor or go to the
nearest hospital casualty department IMMEDIATELY,
taking your tablets and box with you, as this will allow
easier identification of the tablets.

Other side effects with Arythmol may include:
Very Common side effects:
- Dizziness
- Heart palpitations (being aware of your heart beat)
- Heart rhythm disorders

If you forget to take Arythmol
If you forgot to take a dose, take them as soon as you
remember, unless it is almost time for your next dose.
If it is, do not take the missed dose at all. Do not take a
double dose to make up for a forgotten dose.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Common side effects:
- 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

Tell your doctor IMMEDIATELY if you develop any of
the following conditions:
• seizures
• life threatening irregular heart beat
• heart problems which can cause shortness of
breath or ankle swelling
• 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 the whites of the eyes,
as these may be a sign of liver problems (blockage
of flow from the liver (cholestatis), inflammation of
the liver (hepatitis)) or blood 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.

Uncommon side effects:
- 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
- Irregular (slow or fast) heart beat

If you stop taking Arythmol
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.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects

MKP-00254-2016 GB_d8.indd 3

The following are side effects with an unknown
frequency:
- Severe reduction in the number of white blood
cells which makes infections more likely
- Confusion
- Tremor (feeling shaky)
- Rigidity (stiffness)
- Restlessness
- A fall in the blood pressure on standing up which
may cause dizziness, lightheadedness or fainting
- Retching, stomach problems
- 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.
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 Arythmol
Keep this medicine out of the sight and reach of
children.
Do NOT use Arythmol after the expiry date printed
on the packaging. The date refers to the last day of
that month.

6. Contents of the pack and other information
What Arythmol contains
• The active substance is propafenone hydrochloride.
Each tablet contains either 150mg or 300mg of
propafenone hydrochloride.
• The other ingredients are microcrystalline
cellulose, maize starch, hypromellose (Type 2910),
sodium croscarmellose, purified water, macrogol
6000, titanium dioxide (E171), macrogol 400 and
magnesium stearate.
What Arythmol looks like and contents of the pack
White to off white film coated, biconvex tablets. The
inscription on the tablets is 150 or 300 on one side.
The tablets are available in two strengths containing
either 150mg or 300mg of propafenone hydrochloride.
Each pack of Arythmol 150 mg tablets contains 90
tablets.
Each pack of Arythmol 300 mg tablets contains 60
tablets.
Marketing Authorisation Holder:
BGP Products Ltd., Abbott House, Vanwall
Business Park, Vanwall Road, Maidenhead,
Berkshire SL6 4XE, United Kingdom
Manufacturer:
AbbVie Deutschland GmbH & Co. KG,
Knollstrasse, 67061 Ludwigshafen, Germany
This leaflet was last revised in June 2016.

Do not store above 30⁰C.
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 throw away
any medicines via wastewater or household waste
(e.g. down the toilet or in with your general rubbish).
These measures will help protect the environment.

6.7.16 09:31

ARYTHMOL

150 & 300 mg Tablets
Propafenone
Hydrochloride

IMPORTANT INFORMATION
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same
as yours.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See
section 4.

If you forget to take propafenone hydrochloride
tablets
If you forgot to take a dose, take them as soon as
you remember, unless it is almost time for your next
dose. If it is, do not take the missed dose at all. Do
not take a double dose to make up for a forgotten
dose.
If you stop taking Arythmol
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.

1. What Arythmol is and what is it used for
Arythmol contains the active substance
propafenone hydrochloride.
Arythmol belongs to a group of medicines called
anti arrhythmic agents.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Arythmol slows down the heart rate and helps to
regulate the heartbeat. Arythmol tablets are used
to treat and prevent arrhythmias (abnormal heart
rhythms).

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

2. What you need to know before you take
Arythmol










Do not take Arythmol:
• if you are allergic to propafenone
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6).
if you have a heart condition called Brugada
Syndrome, which causes you to have a
potentially life-threatening heart rhythm.
if you had a heart attack in the previous 3
months.
if you suffer from heart failure or any heart
problems other than your abnormal heart
rhythm.
If you have a usually slow heart rate or
hypotension (low blood pressure).
If you suffer from any breathing problems, such
as chronic bronchitis or emphysema.
If your doctor has told you that you have
a disturbance in the salts (e.g. sodium or
potassium) in your blood.
if you have been diagnosed as having the
condition known as myasthenia gravis?
if you are taking ritonavir (antiviral agents)

Tell your doctor IMMEDIATELY if you develop any
of the following conditions:
• Seizures
• life threatening irregular heart beat
• heart problems which can cause shortness of
breath or ankle swelling
• 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 the whites of the
eyes, as these may be a sign of liver problems
(blockage of flow from the liver (cholestatis),
inflammation of the liver (hepatitis)) or blood
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.
MKP-00252-2016

Package leaflet:
Information for the user

What is in this leaflet
1. What Arythmol is and what is it used for
2. What you need to know before you take
Arythmol
3. How to take your Arythmol
4. Possible side effects
5. How to store Arythmol
6. Contents of the pack and other information

Other side effects with Arythmol may include:
Very Common side effects:
- Dizziness
- Heart palpitations (being aware of your heart
beat)
- Heart rhythm disorders

Common side effects:
- 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:
- 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
- Irregular (slow or fast) heart beat
The following are side effects with an unknown
frequency:
- Severe reduction in the number of white blood
cells which makes infections more likely
- Confusion
- Tremor (feeling shaky)
- Rigidity (stiffness)
- Restlessness
- A fall in the blood pressure on standing up which
may cause dizziness, lightheadedness or fainting
- Retching, stomach problems
- 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.

1

MKP-00252-2016_d6

PAGE 1

3

PAGE 3

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.

The tablets are available in two strengths
containing either 150mg or 300mg of propafenone
hydrochloride.
Each pack of Arythmol 150 mg tablets contains
90 tablets.
Each pack of Arythmol 300 mg tablets contains
60 tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Arythmol
• If you are pregnant or planning to become
pregnant
• If you are breastfeeding
• If you suffer from any breathing problems, such
as asthma.

Marketing Authorisation Holder:
BGP Products Ltd., Abbott House, Vanwall
Business Park, Vanwall Road, Maidenhead,
Berkshire SL6 4XE, United Kingdom

Take special care with Arythmol
• Tell your surgeon or dentist that you are taking
Arythmol if surgery is planned. It may affect the
anaesthetic used.
• If you have a pacemaker, it may need to be altered.
• Your doctor may perform ECG and blood pressure
monitoring prior to and during treatment to monitor
your individual dose.

5. How to store Arythmol
Keep this medicine out of the sight and reach of
children.
Do NOT use Arythmol after the expiry date printed
on the packaging. The date refers to the last day
of that month.

Manufacturer:
Famar Lyon, 29, avenue Charles de Gaulle,
69230 Saint-Genis-Laval, France
This leaflet was last revised in June 2016.

Children and adolescents
Arythmol is NOT suitable for children.

Do not store above 30⁰C.
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 throw
away any medicines via wastewater or household
waste (e.g. down the toilet or in with your general
rubbish). These measures will help protect the
environment.
6. Contents of the pack and other information

MKP-00252-2016

What Arythmol contains
• The active substance is propafenone
hydrochloride. Each tablet contains either
150mg or 300mg of propafenone hydrochloride.
• The other ingredients are microcrystalline
cellulose, maize starch, hypromellose (Type
2910), sodium croscarmellose, purified water,
macrogol 6000, titanium dioxide (E171),
macrogol 400 and magnesium stearate.
What Arythmol looks like and contents of the
pack
White to off white film coated, biconvex tablets.
The inscription on the tablets is 150 or 300 on one
side.

Other medicines and Arythmol
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• 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 betablockers (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)
• phenobarbital (for epilepsy)
Arythmol with food and drink
Arythmol should not be taken with grapefruit juice.
Arythmol should be taken after food, with some water.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
Driving and using machines
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 to take your Arythmol
Always take this medicine as your doctor or
pharmacist told you. Check with your doctor or
pharmacist if you are not sure. The number of
tablets that you will need to take will be decided by
your doctor.
Adults
The recommended dose may be between one
Arythmol 150 mg tablet three times a day to one
Arythmol 300 mg tablet three times a day.
Elderly
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.
Use in children and adolescents
Arythmol is NOT suitable for children.
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 take more Arythmol than you should
If you or someone else takes more Arythmol
than prescribed, you should contact a doctor or
go to the nearest hospital casualty department
IMMEDIATELY, taking your tablets and box with
you, as this will allow easier identification of the
tablets.

4

MKP-00252-2016_d6

PAGE 4

2

PAGE 2

Expand view ⇕

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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