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PROPAFENONE HYDROCHLORIDE 300MG FILM COATED TABLETS

Active substance(s): PROPAFENONE HYDROCHLORIDE

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Package leaflet: Information for the user
Propafenone Hydrochloride 150mg Film-coated Tablets
Propafenone Hydrochloride 300mg Film-coated Tablets
Propafenone Hydrochloride
Read all of this leaflet carefully before you start using
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.
What is in this leaflet
1. What Propafenone Hydrochloride tablets are and what
are they used for.
2. What you need to know before you take Propafenone
Hydrochloride tablets
3. How to take Propafenone Hydrochloride tablets
4. Possible side effects
5. How to store Propafenone Hydrochloride tablets
6. Contents of the pack and other information
1.

What Propafenone Hydrochloride tablets are
and what are they used for

Propafenone belongs to a group of medicines called
anti-arrhythmic agents.
Propafenone is used for the following:
 to slow down the heart rate and help to regulate the heartbeat
 to treat and prevent arrhythmias (abnormal heart rhythms).
2.

What you need to know before you take
propafenone hydrochloride tablets

Do not take propafenone hydrochloride tablets:
 if you are allergic (hypersensitive) to propafenone
hydrochloride or any of the other ingredients of this
medicine (see section 6).
 if you suffer from a heart rhythm disorder called
Brugada syndrome.
 if you have had a heart attack within the last 3 months.
 if you suffer from heart failure or any heart problems
other than abnormal heart rate/heart rhythm.
 if you have an unusually slow heart rate or low blood
pressure (hypotension).
 if you suffer from breathing problems, such as chronic
bronchitis or emphysema (sometimes known as COPD).
 if you have been told you that you have an imbalance of
potassium or sodium in your blood.
 if you suffer from myasthenia gravis which causes
muscle weakness
 if you are taking ritonavir
Propafenone Hydrochloride tablets are not suitable for children.
Warnings and precautions:
Talk to your doctor or pharmacist before using
Propafenone hydrochloride tablets. Especially if you:
 are pregnant or planning to become pregnant or breast
feeding.
 suffer from any breathing problems, such as asthma
 have been told that you have a disturbance in the salts (e.g.
sodium or potassium) in your blood
 have a heart pacemaker.
 suffer from liver or kidney disease
 Tell your surgeon or dentist that you are taking propafenone
hydrochloride tablets if surgery is planned. It may affect the
anaesthetic used.
Other medicines and Propafenone Hydrochloride tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription and herbal medicines.

Tell your doctor if you are using or have recently used:
 Any other medicines used to treat heart conditions,
angina and high blood pressure, or medicines that may
impact the heart rate including:
- beta blockers (e.g. propanolol, metoprolol)
- amiodarone,
- digoxin,
- quinidine
 Medicines used to treat depression (e.g. amitriptyline,
dothiepin, desipramine, venlafaxine, fluoxetine, paroxetine)
 Antibiotic and antifungal medicines (e. g. erythromycin
,rifampicin, ketoconazole)
 Medicines used to prevent organ transplant rejection
(cyclosporin)
 Local anaesthetic medicines for dental surgery, or other
minor surgical procedures (e.g. lidocaine)
 Medicines used for thinning blood (anticoagulant
medicines e.g. warfarin)
 Other medicines used to treat stomach ulcers (cimetidine)
 Medicines for asthma (e.g. theophylline)
 Medicines used for prevention and treatment of nausea
and vomiting ( e.g. tropisetron or dolasetron)
 Antihistamine to treat allergy (e.g.mizolastine)
 Medicines for epilepsy or seizures (e.g. phenobarbital )
 Cyclosporine (an immunosuppressant, used after transplant
operations, or in the treatment of arthritis or psoriasis)
 Ritonavir (an antivirus medicines used in the treatment of
HIV) – you must not use this medicine with Propafenone
hydrochloride tablets
Propafenone Hydrochloride tablets with food or drink
Propafenone hydrochloride tablets should not be taken
with grapefruit juice. They should be taken after food,
with some water.
Other important information
 If you need to have an operation it is important to tell
the surgeon or dentist, Propafenone hydrochloride may
affect the anaesthetic or other treatments used.
 If you have a pacemaker, it may need to be altered.
 Propafenone hydrochloride tablets are not suitable for
children.
 Your doctor may perform ECGs and blood pressure monitoring
prior to and during treatment to monitor your individual dose.
Pregnancy and breast-feeding
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. The
safety of propafenone for use during pregnancy has not
been established. Hence, it should be taken only if your
doctor advises to do so.
You should not take propafenone hydrochloride tablets if
you are breast-feeding
Driving and using machines
Propafenone hydrochloride tablets can cause blurred
vision, dizziness, tiredness and low blood pressure in
some people. Do not drive, operate machinery or do
anything that requires you to be alert until you know how
the tablets affect you.
3.

How to take Propafenone Hydrochloride tablets

Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow your tablets with some water without chewing
them. It is best to take them after food.
The number of tablets that you will need to take will be
decided by your doctor. 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 hydrochloride
tablets if you are elderly, if you have problems with your
kidneys or liver, or if you have a low bodyweight.

• Impotence
• Heart rhythm disorders such as irregular
heart beat

Use in children
Propafenone hydrochloride tablets are not recommended
for children.

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
• Liver cell damage, blockage of the flow of bile from the
liver (cholestasis), inflammation of the liver (hepatitis),
yellowing of the skin or whites of the eyes (jaundice)
• Retching
• Lupus-like syndrome (an allergic condition which
causes joint pain, skin rashes and fever)
A reversible drop in the sperm count has occasionally
been reported with high doses.

If you take more Propafenone Hydrochloride tablets
than you should
It is important to stick to the dose on the label of the
medicine. If you or someone else swallows several of
these tablets all together, contact your doctor or nearest
hospital emergency department immediately. Always take
any tablets left over with you and also the box, as this will
allow easier identification of the tablets.
If you forget to take Propafenone Hydrochloride tablets
If you forget to take a dose, take it as soon as you remember.
If it is almost time for your next dose do not take a double
dose to make up for a forgotten dose, just carry on as before.
If you stop taking Propafenone Hydrochloride tablets
It is important that you keep taking these tablets until
your doctor tells you to stop. Don’t stop just because you
feel better. If you stop taking the tablets without your
doctor’s advice, your condition may get worse.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor or pharmacist immediately if you
experience any of the following:
• 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 hydrochloride
tablets 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

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.
For United Kingdom:
You can also report side effects directly via the Yellow
Card Scheme, at: www.mhra.gov.uk/yellowcard.
For Ireland:
You can also report side effects directly via
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more
information on the safety of this medicine.
5.

How to store Propafenone Hydrochloride tablets

 Keep this medicine out of the sight and reach of children.
 Do not use this medicine after the expiry date, which is
stated on the blister and carton. The expiry date refers
to the last day of the month.
 Do not store above 25°C. Store in the original carton to
protect from moisture.
 Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6.

Contents of the pack and other information

What Propafenone Hydrochloride tablets contains
The active substance is propafenone hydrochloride.
Each film-coated tablet contains 150mg, or 300mg of
propafenone hydrochloride.
Other ingredients are maize starch, hypromellose E5,
microcrystalline cellulose, Croscarmellose sodium, magnesium
stearate, talc, titanium dioxide and macrogol 6000.
What Propafenone Hydrochloride tablets looks like
and contents of the pack
Propafenone hydrochloride 150mg film-coated tablets are
white, round shaped, biconvex, film coated tablets plain
on both sides.
Propafenone hydrochloride 300mg film-coated tablets are
white to off white, round shaped, biconvex, film-coated
tablets with a score line on one side and plain on the
other side. The tablet can be divided into equal halves.
Propafenone hydrochloride 150mg film-coated tablets are
supplied in Aluminium//PVC/PVdC blisters containing 20,
50, 90 and 100 tablets. Propafenone hydrochloride 300mg
film-coated tablets are supplied in Aluminium//PVC/PVdC
blisters containing 20, 50, 60 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
This leaflet was last revised in 01/2016.

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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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