Patient Information Leaflet

PROPAFENONE EG 150 mg film-coated tablets, 300 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PROPAFENONE EG is and what it is used for

PROPAFENONE EG contains the active substance propafenone hydrochloride, which belongs to a group of
medicines called antiarrhythmics. These medicines slow down and help regulate the heartbeat.
Propafenone EG is used to treat and prevent disturbances in heart rhythm (ventricular and supraventricular tachycardias and tachyarrhythmias, including the W.P.W. syndrome, when associated with disabling symptoms).

2. What you should know before taking PROPAFENONE EG

Do not take PROPAFENONE EG if

you are allergic to propafenone hydrochloride or to similar substances or to any of the other ingredients of this medicine (listed in section 6);
your heart is not functioning properly (manifest heart failure or congestive heart failure);
you have had a heart attack within the last three months;
you have a serious circulation problem due to reduced heart activity (cardiogenic shock, except when caused by arrhythmia);
you have Brugada syndrome, a heart conduction defect or block;
you have an unusually slow heartbeat (severe symptomatic bradycardia) or very low blood pressure (marked hypotension);
you suffer from other heart problems (severe pre-existing conduction disorders at sinoatrial, atrioventricular, and intraventricular levels; sick sinus syndrome (bradycardia-tachycardia syndrome); atrial conduction defects; second- or higher-degree atrioventricular block; bundle branch block or distal block in the absence of an artificial pacemaker);
you have an imbalance in body electrolyte levels (e.g. potassium);
you are taking a medicine called ritonavir used to treat AIDS (see "Other medicines and Propafenone EG");
you have serious respiratory problems (severe obstructive lung disease);
you have been diagnosed with a severe muscle disease known as myasthenia gravis;
you are pregnant, unless specifically advised by your doctor (see "Pregnancy and breastfeeding");
you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking PROPAFENONE EG.
Before and during treatment with PROPAFENONE EG, your doctor must perform periodic checks (ECG, clinical examinations) to assess your response to this medicine.
Take this medicine with caution and inform your doctor if:

you have a serious heart condition (significant structural heart disease), as you may be more susceptible to adverse effects of this medicine;
you have previously had a heart attack. In this case, your doctor will prescribe this medicine only when absolutely necessary (life-threatening ventricular arrhythmias);
you have liver or kidney problems (impaired hepatic or renal function). In such cases, your doctor must reduce the dose and monitor you regularly via electrocardiogram (see section "Use in patients with liver or kidney problems");
you have respiratory problems (obstructive bronchopulmonary disease, asthma). During treatment with PROPAFENONE EG, the following conditions may occur (see also section "Possible side effects"):
worsening of symptoms of a muscle disease called myasthenia gravis or of your heart problems (conversion of paroxysmal atrial fibrillation into atrial flutter with resulting 2:1 or 1:1 conduction block);
disturbances in the functioning of your pacemaker. In this case, your doctor must carefully monitor and adjust the device settings.

If you are undergoing surgery (including dental procedures), it is important to inform the surgeon or dentist that you are taking Propafenone EG, as this medicine may interact with anaesthetics (such as lidocaine) or other treatments used (see "Other medicines and Propafenone EG").
Other medicines and PROPAFENONE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:

local anaesthetics, medicines used to induce anaesthesia during surgery (e.g. lidocaine);
beta-blockers, medicines used to treat high blood pressure or heart problems (propranolol, metoprolol);
tricyclic antidepressants, medicines used to treat depression (desipramine), or other antidepressants (venlafaxine, fluoxetine, paroxetine);
cyclosporine (an immunosuppressant, used after transplantation or to treat arthritis or psoriasis);
theophylline (a medicine used to treat asthma);
medicines affecting heart activity, such as amiodarone, digoxin, quinidine;
phenobarbital (a medicine used for epilepsy);
medicines used to prevent blood clotting (e.g. fenprocoumon, warfarin);
ketoconazole (an antifungal medicine);
cimetidine (a medicine for ulcers);
antibiotics (e.g. erythromycin or rifampicin).

PROPAFENONE EG with beverages
Avoid taking Propafenone EG with grapefruit juice, as this may interact with your treatment.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning pregnancy, this medicine should be used only under strict medical supervision.
Do not take PROPAFENONE EG if you are pregnant (see section "Do not take Propafenone EG") unless otherwise directed by your doctor.
Do not take PROPAFENONE EG if you are breastfeeding.
Driving and using machines
PROPAFENONE EG may cause blurred vision, dizziness, fatigue, and low blood pressure. If you experience these symptoms, avoid driving, operating machinery, or performing any activity requiring alertness.
Propafenone EG 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 EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Swallow the tablet whole with a glass of water, during meals. Do not divide the tablet as it has a
bitter taste and a slight local anaesthetic effect.
Adults
The recommended daily dose is 450–600 mg, i.e. 1 tablet of PROPAFENONE EG 150 mg 3
times daily or 1 tablet of PROPAFENONE EG 300 mg twice daily.
After 3–4 days of treatment, your doctor may assess whether it is necessary to increase the dose up to the maximum recommended dose of 900 mg, i.e. 2 tablets of PROPAFENONE EG 150 mg 3 times daily or 1 tablet of PROPAFENONE EG 300 mg 3 times daily.
Your doctor will determine the most appropriate maintenance dose for you by performing cardiac monitoring (electrocardiographic evaluations and blood pressure measurements).
In some cases (significant widening of the QRS complex, prolongation of the corrected QT interval, second- or third-degree AV block), it may be necessary to reduce the dose.
Use in elderly patients and patients with severe heart problems
If you are elderly or have severe heart disease, the dose of PROPAFENONE EG should be increased gradually, and your doctor must monitor you closely, especially at the beginning of treatment.
Use in patients with liver or kidney problems
If you suffer from liver or kidney problems (hepatic or renal insufficiency), your doctor must monitor you closely and reduce the dose of this medicine.
If you take more PROPAFENONE EG than you should
Contact your doctor IMMEDIATELY or go to the nearest hospital.
High doses of this medicine can cause: changes in heart rhythm or
electrocardiogram (ECG), lowering of blood pressure (even sudden), headache,
dizziness, blurred vision, sensory disturbances (paraesthesia), tremors, nausea, difficulty evacuating (constipation), dry mouth, drowsiness, seizures and, in severe cases, respiratory arrest, coma and even death.
If you forget to take PROPAFENONE EG
Do not take a double dose to make up for the forgotten tablet.
If you stop taking PROPAFENONE EG
It is important that you take this medicine for the entire duration of treatment prescribed by your doctor. DO NOT STOP TREATMENT just because you feel better, as your symptoms may recur or worsen.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking PROPAFENONE EG immediately and contact your doctor if you experience any of the
following conditions:

allergic reactions manifesting as itching, more or less sudden appearance of skin lesions, for example discolouration in spots or widespread areas, swelling of the face, eyes, lips, tongue and throat, breathing difficulties, blood abnormalities, increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions);
weight loss, yellowing of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of allergy, liver damage, cholestasis or liver inflammation (hepatitis).

Very common side effects (may affect more than 1 in 10 people)

dizziness;
sensation of palpitations, heart conduction disturbances.

Common side effects (may affect up to 1 in 10 people)

changes in heart rate such as slowing (sinus bradycardia, bradycardia) or speeding up (tachycardia) or marked increase (flutter);
anxiety, sleep disorders, headache, taste disturbances;
blurred vision;
chest pain, difficulty breathing;
abdominal pain, vomiting, nausea, diarrhoea, difficulty passing stools (constipation), dry mouth;
abnormal liver function tests (e.g. increased transaminases, gamma-glutamyl transferase, alkaline phosphatase in blood);
feeling of malaise (asthenia), fatigue, fever.

Uncommon side effects (may affect up to 1 in 100 people)

reduced platelet count in blood (thrombocytopenia);
decreased appetite;
nightmares, vertigo, fainting (syncope), coordination problems (ataxia), altered sensation (paraesthesiae);
increased heart rate (ventricular tachycardia);
heart rhythm disturbances (arrhythmia), low blood pressure (hypotension);
skin rashes such as urticaria, redness (erythema), itching;
abdominal bloating, intestinal gas (flatulence);
erectile dysfunction.

Other side effects

ventricular fibrillation (a type of heart rhythm disturbance), reduced heart function or heart rate;
reduced levels of white blood cells (leucopenia) or certain types of white blood cells (agranulocytosis, granulocytopenia) in blood, increasing the risk of infections;
sudden drop in blood pressure upon rapidly changing from a lying or sitting position to standing (orthostatic hypotension);
confusion, convulsions, absence or reduced movement with muscle rigidity (extrapyramidal symptoms), restlessness;
nausea, stomach or intestinal disturbances;
lupus-like syndrome presenting with facial rash, joint pain, muscle disorders and fever;
reduced sperm count (which resolves after discontinuation of treatment);
bitter taste and numbness or tingling sensation in the mouth.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store PROPAFENONE EG

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

6. Package contents and other information

What PROPAFENONE EG contains

The active substance is propafenone hydrochloride. Each tablet contains 150 mg or 300 mg of propafenone hydrochloride.
The other ingredients are: pregelatinized starch, sodium starch glycolate, copovidone, magnesium stearate, talc, macrogol 6000, titanium dioxide and hypromellose.

Description of the appearance of PROPAFENONE EG and package contents
PROPAFENONE EG 150 mg film-coated tablets
Pack containing 30 tablets.
PROPAFENONE EG 300 mg film-coated tablets
Pack containing 30 tablets.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan
Manufacturer
DOPPEL FARMACEUTICI S.r.l. - Via Volturno, 48 20089 – Quinto De’ Stampi – Rozzano (MI)