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PROPAFENONE HYDROCHLORIDE 300MG TABLETS

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1846/1847

11.12.12[5]
Arythmol® 150 mg Tablets
Propafenone hydrochloride 150 mg
Tablets
Arythmol® 300 mg Tablets
Propafenone hydrochloride 300 mg
Tablets

(propafenone hydrochloride)
PATIENT INFORMATION LEAFLET
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
This medicine is available using any of the above names but
will be referred to as Arythmol throughout this leaflet.
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 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 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 life-threatening
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 affects 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), phenobarbital
(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?
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 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.

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.
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)
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?
As with all medicines, it is important to keep your Arythmol
tablets in a safe place.
Keep your medicine out of the sight and reach of children.
Do not store above 25oC. Store in the original package.
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).
If your tablets become discoloured or show any other signs
of deterioration, consult your doctor or pharmacist who will
tell you what to do.
6. FURTHER INFORMATION ABOUT ARYTHMOL.
The active ingredient in Arythmol tablets is propafenone
hydrochloride.
Each Arythmol 150mg film-coated tablet available as a white
round biconvex tablet, marked with ‘150’ on one side and
plain on the other side of the tablet, contains 150mg of the
active ingredient propafenone hydrochloride.
Each Arythmol 300mg film-coated tablet available as a white
round biconvex tablet, marked with ‘300’ on one side and
plain on the other side of the tablet, contains 300mg of the
active ingredient propafenone hydrochloride.
Each tablet also contains microcrystalline cellulose, maize
starch, croscarmellose sodium, macrogol, hypromellose,
magnesium stearate, titanium dioxide (E 171).
Each pack of Arythmol 150mg tablets contains blister strip
pack of 20 or 90 tablets.
Each pack of Arythmol 300mg tablets contains blister strip
pack of 20 or 60 tablets.
Who makes your medicine?
Arythmol tablets are manufactured by Abbott GmbH & Co.
KG, Knollstrasse 50, 67061 Ludwigshafen, Germany.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

Arythmol 150mg tablets PL No: 20636/1846
Arythmol 300mg tablets PL No: 20636/1847

Leaflet revision and issue date (Ref) 11.12.12[5]
Arythmol is a trademark of Gerd Petrik.

1846/1847
11.12.12[5]

Propafenone hydrochloride 150 mg
Tablets
Propafenone hydrochloride 300 mg
Tablets
PATIENT INFORMATION LEAFLET
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 Propafenone
- 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
This medicine is available using any of the above names but
will be referred to as Propafenone throughout this leaflet.
Leaflet Contents:
1. What is Propafenone & what is it used for?
2. What should you know before taking Propafenone?
3. How should you take your Propafenone?
4. Possible side effects of Propafenone?
5. How should you store Propafenone?
6. Further information about Propafenone.

- 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), phenobarbital
(for epilepsy) or grapefruit juice.
Other important information
- If you need to have an operation it is important to tell the
surgeon or dentist, Propafenone may affect the
anaesthetic or other treatments used.
- If you have a pacemaker, it may need to be altered.
- Propafenone 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 Propafenone can cause
blurred vision, dizziness, tiredness and low blood pressure
in some people.

1. WHAT IS PROPAFENONE & WHAT IS IT USED FOR?
Propafenone belongs to a group of medicines called anti
arrhythmic agents. Propafenone slows down the heart rate
and helps to regulate the heartbeat. Propafenone tablets are
used to treat and prevent arrhythmias (abnormal heart
rhythms).

3. HOW SHOULD YOU TAKE PROPAFENONE?
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.

2. WHAT SHOULD YOU KNOW BEFORE TAKING
PROPAFENONE?
If the answer to any of these questions is YES, tell your
doctor or pharmacist BEFORE you start to take
Propafenone.
- 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 life-threatening
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 affects the activity of the heart such as
amiodarone, digoxin, quinidine;
- tablets to prevent blood clots (e.g. warfarin);
- antibiotics (e.g. erythromycin or rifampicin);

This may be between one Propafenone hydrochloride
150 mg tablet three times a day to one Propafenone
hydrochloride 300 mg tablet three times a day.
You may need a lower dose of Propafenone 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 Propafenone
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 Propafenone tablets 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. Never
double up on a dose to make up for the one you have
missed.
If you stop taking Propafenone, 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.

4. POSSIBLE SIDE EFFECTS OF PROPAFENONE.
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.
Other side effects with Propafenone 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)
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 PROPAFENONE?
As with all medicines, it is important to keep your
Propafenone tablets in a safe place.
Keep your medicine out of the sight and reach of children.
Do not store above 25oC. Store in the original package.
Do NOT use Propafenone 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).
If your tablets become discoloured or show any other signs
of deterioration, consult your doctor or pharmacist who will
tell you what to do.
6. FURTHER INFORMATION ABOUT PROPAFENONE.
The active ingredient in Propafenone tablets is propafenone
hydrochloride.
Each Propafenone 150mg film-coated tablet available as a
white round biconvex tablet, marked with ‘150’ on one side
and plain on the other side of the tablet, contains 150mg of
the active ingredient propafenone hydrochloride.
Each Propafenone 300mg film-coated tablet available as a
white round biconvex tablet, marked with ‘300’ on one side
and plain on the other side of the tablet, contains 300mg of
the active ingredient propafenone hydrochloride.
Each tablet also contains microcrystalline cellulose, maize
starch, croscarmellose sodium, macrogol, hypromellose,
magnesium stearate, titanium dioxide (E 171).
Each pack of Propafenone 150mg tablets contains blister
strip pack of 20 or 90 tablets.
Each pack of Propafenone 300mg tablets contains blister
strip pack of 20 or 60 tablets.
Who makes your medicine?
Propafenone tablets are manufactured by Abbott GmbH &
Co. KG, Knollstrasse 50, 67061 Ludwigshafen, Germany.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

Propafenone hydrochloride150mg tablets
PL No: 20636/1846
Propafenone hydrochloride 300mg tablets
PL No: 20636/1847

Leaflet revision and issue date (Ref) 11.12.12[5]

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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