Patient Information Leaflet: Information for the User

Propafenone Accord 150 mg film-coated tablets, 300 mg film-coated tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Propafenone Accord is and what it is used for
What you need to know before taking Propafenone Accord
How to take Propafenone Accord
Possible side effects
How to store Propafenone Accord
Contents of the pack and other information

1. What Propafenone Accord is and what it is used for

Propafenone Accord belongs to a group of medicines called antiarrhythmics. The active substance is
propafenone hydrochloride. Propafenone Accord slows down the heart rate and helps regulate the heartbeat.
Propafenone Accord is used to treat certain cardiac arrhythmias (abnormal heart rhythm):

Symptomatic supraventricular tachyarrhythmias requiring treatment.
Symptomatic, serious ventricular tachyarrhythmias, if considered life-threatening by the physician.

2. What you need to know before taking Propafenone Accord

Do not take Propafenone Accord:

if you are allergic to propafenone hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
if you have a heart condition called Brugada syndrome, which causes a potentially life-threatening abnormal heart rhythm.
if you have heart failure or certain heart problems other than those causing abnormal heart rhythm:
- if you have had a heart attack within the last 3 months
- if you have uncontrolled heart failure
- if you have cardiogenic shock, unless caused by arrhythmia
- if you have a very slow heart rate
if you have cardiac conduction disorders (sinoatrial node dysfunction, atrial conduction defects, second-degree or higher AV block, bundle branch block or distal block in the absence of an artificial pacemaker)
if you have low blood pressure
- if your doctor has told you that you have an imbalance of blood electrolytes (e.g. potassium)
- if you suffer from severe obstructive lung disease
- if you have been diagnosed with a condition known as myasthenia gravis
- if you are taking ritonavir (an antiviral medicine used in the treatment of HIV)

Warnings and precautions
Talk to your doctor or pharmacist before taking Propafenone Accord:

if you have respiratory problems, such as asthma (see section "Do not take Propafenone Accord" above)
if you have ever had heart problems
if you have a pacemaker (this may need adjustment)
if you have impaired liver and/or kidney function
if you are elderly
if you are pregnant, planning to become pregnant, or breastfeeding (see section "Pregnancy and breastfeeding" below)

Before and during treatment, your doctor should perform periodic ECG checks and blood pressure monitoring to assess your individual dose.
If you are due to undergo surgery, it is important to inform the surgeon or dentist that you are taking this medicine. Propafenone Accord may affect the anaesthetic or other treatments used.
Children
Propafenone Accord is not suitable for children weighing less than 45 kilograms.
Other medicines and Propafenone Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
It is very important that you inform your doctor if you are taking any of the following medicines:

other medicines used to treat heart conditions and high blood pressure, or medicines that may affect heart rate, including beta-blockers (e.g. propranolol, metoprolol, amiodarone, digoxin, quinidine)
medicines used to prevent blood clots (e.g. phenprocoumon, warfarin)
antibiotic and antifungal medicines (e.g. erythromycin, rifampicin, ketoconazole)
ciclosporin (an immunosuppressant used after organ transplant surgery or in the treatment of arthritis or psoriasis)
medicines used to treat depression and/or generalized anxiety disorder (e.g. so-called SSRIs [such as fluoxetine or paroxetine] or tricyclic antidepressants [such as desipramine], venlafaxine)
narcotic drugs or neuroleptics (medicines used to treat schizophrenia, e.g. thioridazine)
phenobarbital (a medicine used to treat epilepsy)
theophylline (a medicine used to treat asthma)
local anaesthetics, medicines used for example during pacemaker implantation, dental surgery, or other minor surgical procedures (e.g. lidocaine)
cimetidine (a medicine used to treat stomach ulcers)
muscle relaxants
ritonavir (an antiviral medicine used in the treatment of HIV) (see section "Do not take Propafenone Accord" above)

Propafenone Accord with food and drink
Propafenone Accord must not be taken with grapefruit juice, as concomitant use may lead to increased levels of propafenone.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy:
You must not take propafenone during pregnancy unless your doctor considers it essential.
Breastfeeding:
Inform your doctor if you are breastfeeding or intend to start breastfeeding. Propafenone should be used with caution in breastfeeding mothers, as propafenone may be excreted in human breast milk.
Driving and using machines
Before driving, operating machinery, or performing tasks requiring concentration, make sure you are aware of how this medicine affects you. Propafenone Accord may cause blurred vision, dizziness, fatigue, and low blood pressure in some people. This should be particularly considered at the beginning of treatment with propafenone, after changes in therapy, or when combined with alcohol.
Propafenone Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Propafenone Accord

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
Between 1 tablet of Propafenone Accord 150 mg three times daily and 1 tablet of
Propafenone Accord 300 mg three times daily.
Your doctor will determine the appropriate dose for you personally.
You may require a lower dose of Propafenone Accord if you are elderly, if you have kidney
or liver problems, or if you have a low body weight.
Use in children and adolescents
The dose will be determined by the doctor on an individual basis.
The recommended daily dose is 10–20 mg of propafenone per kilogram of body weight,
administered in three to four divided doses.
The Propafenone Accord formulation is not suitable for children weighing less than 45
kilograms.
How to take Propafenone Accord
Swallow the film-coated tablets whole (without chewing or sucking) with liquid (e.g., a
glass of water) after a meal. Do not take with grapefruit juice.
The 300 mg tablet may be divided into two equal doses.
If you take more Propafenone Accord than you should
If you take more Propafenone Accord than prescribed by your doctor, contact your
doctor IMMEDIATELY or go to the nearest hospital. Take the Propafenone Accord tablets
in their original packaging and this leaflet with you.
Signs of overdose include rapid heartbeat, abnormal heart rhythm, cardiac arrest, and low
blood pressure, which in severe cases may lead to cardiovascular shock.
In cases of overdose, metabolic acidosis, headache, dizziness, blurred vision, tingling or
itching of the skin (paresthesia), tremor, malaise, constipation, dry mouth, and seizures have
been reported. Death has also been reported.
In severe cases of poisoning, seizures, paresthesia, drowsiness, coma, and respiratory arrest may occur.
If you forget to take Propafenone Accord
Do not take a double dose to make up for the missed dose. If you forget to take a dose, take it as soon as
you remember, unless it is almost time for your next dose; in this case, take the next dose as usual.
If you stop taking Propafenone Accord
It is important that you continue taking Propafenone Accord for as long as your doctor
instructs you to do so. Do not stop treatment just because you feel better. If you stop taking
the tablets without consulting your doctor, your condition may worsen.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking Propafenone Accord IMMEDIATELY and contact your doctor if you experience any of the following:

you start bruising easily or develop a sore throat with high fever. The treatment may affect your white blood cells and blood platelets.
you develop skin rashes or notice yellowing of the skin and/or eyes, as these may be signs of liver problems.
signs of allergic reactions such as:
- skin rash or redness
- difficulty breathing
- swelling of the face, lips, tongue, or throat
- difficulty swallowing

Other adverse effects with Propafenone Accord may include:
Very common (may affect more than 1 in 10 people)

Dizziness
Irregular heartbeat (slow or fast) (conduction disturbances)
Palpitations (awareness of your heartbeat)

Common (may affect up to 1 in 10 people)

Anxiety
Sleep disorders
Headache
Taste disturbances or bitter taste
Blurred vision
Slow heart rate or increased heart rate (bradycardia, tachycardia)
Abnormal heart rhythm
Shortness of breath
Stomach pain
Feeling unwell, malaise (vomiting, nausea)
Diarrhoea
Constipation
Dry mouth
Liver disorders
Chest pain
Feeling tired or weak (asthenia, fatigue)
Fever

Uncommon (may affect up to 1 in 100 people)

Decrease in blood platelets, increasing the risk of bleeding or bruising
Loss of appetite
Nightmares
Fainting
Ataxia (problems or loss of coordination of muscle movements)
Numbness or tingling or itching of the skin (paraesthesia)
Dizziness
Heart rhythm disorders (ventricular tachycardia, arrhythmia)
Low blood pressure
Swelling
Flatulence (passing gas)
Skin redness and itching
Impotence

The following side effects have unknown frequency (frequency cannot be estimated from the available data):

Severe reduction in white blood cells with increased risk of infections (agranulocytosis, granulocytopenia, leucopenia)
Confusion
Seizures
Tremor or stiffness
Restlessness
Life-threatening irregular heartbeat (ventricular fibrillation)
Heart problems that may cause shortness of breath or swelling of the ankles (heart failure)
Drop in blood pressure when standing up, which may cause dizziness, confusion, or fainting (orthostatic hypotension)
Nausea, gastrointestinal disorders
Yellowing of the skin or whites of the eyes due to liver or blood problems (hepatocellular injury, cholestasis, hepatitis, jaundice)
Lupus-like syndrome (an allergic condition causing joint pain, skin rashes, and fever)
Decreased sperm count

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Propafenone Accord

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the label and on the carton after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Propafenone Accord contains

The active substance is propafenone hydrochloride.

Propafenone Accord 150 mg film-coated tablets:
Each film-coated tablet contains 150 mg of propafenone hydrochloride.
Propafenone Accord 300 mg film-coated tablets:
Each film-coated tablet contains 300 mg of propafenone hydrochloride.

The other components are

Core: Corn starch, hypromellose E5, microcrystalline cellulose, sodium croscarmellose, magnesium stearate
Tablet coating: Talc, hypromellose E5, titanium dioxide, macrogol 6000

Description of the appearance of Propafenone Accord and contents of the pack
Propafenone Accord 150 mg are film-coated tablets, biconvex, round-shaped, white to off-white, approximately 9.05 mm x 3.75 mm in size, smooth on both sides.
Propafenone Accord 300 mg are film-coated tablets, biconvex, round-shaped, white to off-white, approximately 11.15 mm x 5.05 mm in size, with a score line on one side and smooth on the other. The tablet can be divided into two equal doses.
Propafenone Accord is available in aluminum-PVC/PVdC blisters containing 20, 30, 60, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,
95-200 Pabianice,
Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, 32009,
Greece