Package leaflet: Information for the patient

PROPAFENONE DOC Generici 150 mg film-coated tablets, 300 mg film-coated tablets

Generic Medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PROPAFENONE DOC Generici is and what it is used for

PROPAFENONE DOC Generici contains the active substance propafenone hydrochloride, which belongs to a group of medicines called antiarrhythmics that work by restoring normal heart rhythm.
This medicine is indicated for the prevention and treatment of heart rhythm disorders (ventricular and supraventricular tachycardias and tachyarrhythmias, including Wolff-Parkinson-White syndrome).

2. What you should know before taking PROPAFENONE DOC Generici

Do not take PROPAFENONE DOC Generici

if you are allergic to propafenone, to medicines similar to it, or to any of the other ingredients of this medicine (listed in section 6);
if your heart function is reduced compared to normal (overt heart failure);
if you have a serious circulation problem due to reduced heart activity (cardiogenic shock, except when caused by arrhythmia);
if you experience a marked slowing of the heartbeat (severe bradycardia);
if you have other heart problems (severe pre-existing conduction disorders at sinoatrial, atrioventricular, or intraventricular level; sick sinus syndrome (bradycardia-tachycardia syndrome); atrial conduction defects; second-degree or higher atrioventricular block; bundle branch block or distal block in the absence of an artificial pacemaker);
if you have very low blood pressure (marked hypotension);
if you have an imbalance in body fluids and electrolytes (electrolyte imbalance);
if you have serious lung diseases (severe obstructive pulmonary disorders);
if you suffer from a serious muscle disease (myasthenia gravis);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
if you are taking a medicine called ritonavir used to treat AIDS (see section “Other medicines and PROPAFENONE DOC Generici”).

Warnings and precautions
Talk to your doctor or pharmacist before taking PROPAFENONE DOC Generici.
Before and during treatment with PROPAFENONE DOC Generici, 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 previously had a heart attack. In this case, your doctor will prescribe this medicine only if absolutely necessary (life-threatening ventricular arrhythmias);
you suffer from liver or kidney problems (impaired hepatic or renal function). In these cases, your doctor must reduce the dose and monitor you regularly with an electrocardiogram (see section “Use in patients with liver or kidney problems”);
you have serious respiratory tract disorders (obstructive bronchopulmonary disease);
you have significant structural heart disease, as you may be more susceptible to adverse effects of this medicine.

During treatment with PROPAFENONE DOC Generici, the following conditions may occur (also see 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);
changes in the functioning of your pacemaker. In this case, your doctor must carefully monitor and adjust the device settings.

Other medicines and PROPAFENONE DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine together with daily doses of 800–1200 mg of ritonavir, a medicine used to treat AIDS.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

local anesthetics, medicines used to induce anesthesia during surgery; beta-blockers, medicines used to treat high blood pressure or heart problems; tricyclic antidepressants, medicines used to treat depression. These medicines may increase the effect of PROPAFENONE DOC Generici;
cyclosporine, a medicine used after organ transplantation; theophylline, a medicine used to treat asthma; desipramine, a medicine used to treat depression; propranolol and metoprolol, medicines used to treat high blood pressure; digoxin, a medicine used to treat certain heart conditions. PROPAFENONE DOC Generici increases blood levels of these medicines, so it may be necessary to reduce their doses;
phenobarbital, a medicine used to treat epilepsy; rifampicin, a medicine used to treat certain bacterial infections. These medicines may reduce the effectiveness of PROPAFENONE DOC Generici;
oral anticoagulants (e.g., phenprocoumon, warfarin), medicines used to treat certain blood circulation disorders. PROPAFENONE DOC Generici enhances the anticoagulant effect of these medicines (increased prothrombin time). In this case, your doctor should perform periodic blood tests (coagulation parameters), as it may be necessary to adjust the doses of these medicines;
ketoconazole, a medicine used to treat fungal infections; cimetidine, a medicine used to treat stomach disorders; quinidine, a medicine used to treat heart rhythm problems; erythromycin, a medicine used to treat bacterial infections. These medicines may increase the effect of PROPAFENONE DOC Generici;
venlafaxine, a medicine used to treat depression. PROPAFENONE DOC Generici increases blood levels of this medicine;
paroxetine and fluoxetine, medicines used to treat depression. These medicines increase the effect of PROPAFENONE DOC Generici, so it may be necessary to reduce the dose of PROPAFENONE DOC Generici;
lidocaine administered by infusion (intravenous infusion), a medicine used to induce local anesthesia and to treat certain heart rhythm disorders;
amiodarone, another medicine used to treat certain heart rhythm disorders. In this case, it may be necessary to adjust the dose of both medicines.

PROPAFENONE DOC Generici with food and drinks
Avoid drinking grapefruit juice while taking this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, take PROPAFENONE DOC Generici only when strictly necessary and under direct medical supervision (see section “Do not take PROPAFENONE DOC Generici”).
Do not take this medicine if you are breastfeeding (see section “Do not take PROPAFENONE DOC Generici”).
Driving and using machines
PROPAFENONE DOC Generici may cause blurred vision, dizziness, fatigue, or a sensation of dizziness upon standing due to low blood pressure (orthostatic hypotension). Therefore, avoid driving or operating machinery if you experience these symptoms.

3. How to take PROPAFENONE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Swallow the tablet whole with a glass of water, with food. Do not divide the tablet, as it has a bitter taste and a slight local anaesthetic effect.
The recommended dose (initial and maintenance dose) is 450–600 mg, i.e. 1 tablet of PROPAFENONE DOC Generici 150 mg coated tablets three times daily, or 1 tablet of PROPAFENONE DOC Generici 300 mg coated tablets twice daily. This dose refers to a person weighing approximately 70 kg; therefore, for individuals with a lower body weight, the dose should be reduced.
Your doctor may subsequently increase the dose gradually up to the maximum recommended dose of 900 mg, i.e. 2 tablets of PROPAFENONE DOC Generici 150 mg coated tablets three times daily, or 1 tablet of PROPAFENONE DOC Generici 300 mg coated tablets three times daily. This dose may be increased further only in cases of absolute necessity and under strict medical supervision (specialist cardiological monitoring).
In some cases (significant widening of the QRS complex, prolongation of the heart rate-corrected QT interval), it may be necessary to reduce the dose or temporarily discontinue treatment.

Use in elderly patients and patients with severe heart problems
If you are elderly or have severe heart disease, the dose of PROPAFENONE DOC Generici 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 have 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 DOC Generici than you should
If you take an excessive dose of this medicine, the following symptoms may occur: heart problems (disturbances in impulse generation and conduction such as prolongation of the PQ interval, widening of the QRS complex, sinoatrial block, atrioventricular block, ventricular tachycardia, ventricular flutter, and ventricular fibrillation), low blood pressure (hypotension), drowsiness, seizures, and death.
In case of accidental ingestion or overdose of PROPAFENONE DOC Generici, contact your doctor immediately or go to the nearest hospital.

If you forget to take PROPAFENONE DOC Generici
Do not take a double dose to make up for the missed tablet.
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 everybody gets them.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 people):

decreased or loss of appetite (anorexia), abdominal swelling, nausea, vomiting, constipation, dry mouth, altered taste (bitter taste), abdominal pain, sensation of numbness or tingling in the mouth;
slow heart rate (bradycardia), heart conduction disorders (sinoatrial block, atrioventricular block, intraventricular block);
severe liver problems (cholestasis). This side effect resolves upon discontinuation of treatment;
changes in heart rhythm (atrial flutter, ventricular fibrillation).

Very rare (may affect up to 1 in 10,000 people):

fatigue, headache;
chest pain, reduced muscle strength (asthenia);
restlessness, nightmares, sleep disturbances;
anxiety, confusion, temporary loss of consciousness (syncope), seizures, movement difficulties (extrapyramidal symptoms), loss of coordination (ataxia), tingling sensation in the extremities (paresthesia), dizziness;
allergic reactions;
reduced number of certain types of white blood cells in the blood (leukocytes, granulocytes), reduced platelet count. These side effects resolve upon discontinuation of treatment.

Other possible side effects:

vision disturbances (blurred vision);
dizziness;
heart problems (ventricular fibrillation, worsening of heart failure);
elderly patients: dizziness upon standing due to circulatory disturbances (postural hypotension) or low blood pressure (orthostatic hypotension). These side effects diminish by reducing the dose or discontinuing treatment;
severe liver problems (hepatocellular damage, cholestasis, hepatitis, jaundice, increased levels of liver enzymes such as transaminases and phosphatases);
itching, skin irritation (urticaria, skin rash, erythema), redness and irritation of the skin (exanthema), symptoms resembling a serious skin disease (lupus-like syndrome). These side effects improve upon discontinuation of treatment;
changes in heart rhythm (ventricular tachycardia);
sexual problems in men (reduced sexual potency and sperm count). These side effects disappear upon discontinuation of treatment. Do not stop taking this medicine if you experience any of these side effects unless your doctor advises you to do so;
severe reduction in the number of certain types of white blood cells in the blood (agranulocytosis);
worsening of symptoms in patients with breathing difficulties (bronchial asthma or bronchospasm).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PROPAFENONE DOC Generici

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 DOC Generici contains
PROPAFENONE DOC Generici 150 mg film-coated tablets

The active substance is propafenone hydrochloride. Each film-coated tablet contains 150 mg of propafenone hydrochloride.
The other components are: pregelatinized starch, sodium starch glycolate, copovidone, magnesium stearate, talc, macrogol 6000, titanium dioxide, hypromellose.

PROPAFENONE DOC Generici 300 mg film-coated tablets

The active substance is propafenone hydrochloride. Each film-coated tablet contains 300 mg of propafenone hydrochloride.
The other components are: pregelatinized starch, sodium starch glycolate, copovidone, magnesium stearate, talc, macrogol 6000, titanium dioxide, hypromellose.

Description of the appearance of PROPAFENONE DOC Generici and pack contents
PROPAFENONE DOC Generici 150 mg film-coated tablets
Pack containing 30 film-coated tablets in blister.
PROPAFENONE DOC Generici 300 mg film-coated tablets
Pack containing 30 film-coated tablets in blister.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan - Italy
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno 48 – Quinto De’ Stampi - 20089 Rozzano (MI) - Italy