Patient Information Leaflet

PROPAFENONE PENSA 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

PROPAFENONE PENSA contains the active substance propafenone hydrochloride, which belongs to a group of medicines called antiarrhythmics, used to treat irregular heart rhythms.
This medicine is indicated for the treatment of disorders of the heartbeat (tachyarrhythmias) resulting from cardiovascular conditions: ventricular extrasystoles, tachycardia, and ventricular and supraventricular tachyarrhythmias, including Wolff-Parkinson-White syndrome.

2. What you need to know before taking PROPAFENONE PENSA

Do not take PROPAFENONE PENSA if:

you are allergic (hypersensitive) to propafenone, to chemically similar medicines, or to any of the other ingredients of this medicine (listed in section 6);
your heart function is reduced compared to normal (manifest heart failure);
you have a serious blood circulation problem due to reduced heart function (cardiogenic shock, except when caused by arrhythmia);
you experience a severe reduction in heart rate (severe bradycardia);
you suffer from certain heart conditions, such as severe pre-existing conduction disorders at the sinoatrial, atrioventricular, or intraventricular level, sinoatrial node disease (bradycardia-tachycardia syndrome), atrial conduction defects, second-degree or higher atrioventricular block, or bundle branch or distal block in the absence of artificial pacemakers;
you have very low blood pressure (marked hypotension);
you have disturbances in the body's water and mineral levels (manifest electrolyte imbalance);
you have serious lung problems (severe obstructive pulmonary diseases);
you suffer from a serious muscle disease (myasthenia gravis);
you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking PROPAFENONE PENSA.
Before and during treatment with PROPAFENONE PENSA, your doctor will perform periodic checks (electrocardiogram (ECG), clinical examinations) to determine whether your response to the medicine justifies continued use.
Take this medicine with caution and inform your doctor if:

you have a heart condition called structural heart disease, as serious adverse events may occur more easily;
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 will reduce the dose of the medicine and ask you to undergo regular electrocardiograms (see section "Use in patients with liver or kidney problems");
you suffer from a respiratory condition called obstructive bronchopulmonary disease. During treatment with PROPAFENONE PENSA, the following may occur (see also section "Possible side effects"):
worsening of symptoms of a muscle disorder 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 rate and sensitivity threshold of your pacemaker. Therefore, the function of this device must be properly checked and adjusted accordingly.

Other medicines and PROPAFENONE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine together with doses of 800–1200 mg daily 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 (e.g., during pacemaker use, surgical or dental procedures); 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 PENSA;
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 problems. PROPAFENONE PENSA increases blood levels of these medicines, so it may be necessary to reduce their doses;
phenobarbital, a medicine used to treat epilepsy; in this case, careful monitoring of the response to PROPAFENONE PENSA therapy is recommended;
rifampicin, a medicine used to treat certain bacterial infections, as it may reduce the antiarrhythmic efficacy of PROPAFENONE PENSA by lowering its blood levels;
oral anticoagulants (e.g., phenprocoumon, warfarin), medicines used to thin the blood. PROPAFENONE PENSA increases the anticoagulant effect of these medicines (increased prothrombin time). Therefore, periodic blood tests should be performed (to monitor coagulation parameters);
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 blood levels of PROPAFENONE PENSA; in patients where this occurs, the dose must be adjusted accordingly;
venlafaxine, a medicine used to treat depression. PROPAFENONE PENSA may increase blood levels of this medicine;
paroxetine and fluoxetine, medicines used to treat depression. These medicines may increase levels of PROPAFENONE PENSA, so it may be necessary to reduce the dose of PROPAFENONE PENSA;
lidocaine, a medicine used to induce local anesthesia and to treat certain heart rhythm problems when administered by infusion (intravenous infusion), as it may increase the risk of adverse effects on the central nervous system;
amiodarone, a medicine used to treat certain heart rhythm problems. In this case, it may be necessary to adjust the doses of both medicines.

PROPAFENONE PENSA with food and drinks
Grapefruit juice may increase propafenone blood levels; therefore, it is advisable to avoid consuming 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, PROPAFENONE PENSA will be prescribed only when absolutely necessary and under direct medical supervision.
Due to potential serious adverse effects on the newborn, do not take this medicine if you are breastfeeding (see section "Do not take PROPAFENONE PENSA"). Your doctor will assess the importance of the therapy for you and decide whether you should discontinue breastfeeding or the use of the medicine.
Driving and using machines
In some patients, PROPAFENONE PENSA may cause blurred vision, dizziness, fatigue, and a sudden drop in blood pressure when moving from a sitting or lying position to standing (orthostatic hypotension). These symptoms may affect the patient's reaction speed.
Therefore, avoid driving or operating machinery if you experience these symptoms.
Propafenone Pensa 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 PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The tablet must be swallowed whole with a glass of water, during a meal. Do not split 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 PENSA 150 mg coated tablets taken 3 times a day or 1 tablet of
PROPAFENONE PENSA 300 mg coated tablets taken 2 times a day.
Your doctor may then gradually increase the dose up to the maximum recommended dose of
900 mg, i.e. 2 tablets of PROPAFENONE PENSA 150 mg coated tablets taken 3 times a
day or 1 tablet of PROPAFENONE PENSA 300 mg coated tablets taken 3 times a day.
This dose may be further increased only in cases of absolute necessity and under strict
medical supervision (specialist cardiological monitoring). These doses refer to a person
weighing approximately 70 kg. Therefore, for individuals with lower body weight, the dose should be reduced.
Your doctor will determine the most appropriate maintenance dose for you by performing cardiological checks (electrocardiographic evaluations and blood pressure monitoring).
In some cases (significant widening of the QRS complex, prolongation of the heart rate-corrected QT interval, second- or third-degree AV block), it may be necessary to reduce the dose.

Use in the elderly and in patients with heart, liver or kidney problems
If you are elderly or have severe heart damage, the dose of PROPAFENONE PENSA should be
gradually increased, and your doctor must monitor you closely, especially at the beginning of
treatment.
If you have kidney problems (renal impairment), this medicine should be taken with caution and the dose of PROPAFENONE PENSA should be reduced.
If you have liver problems (hepatic impairment), the dose of PROPAFENONE PENSA should be reduced.

If you take more PROPAFENONE PENSA than you should
An overdose of this medicine may cause disturbances in heart rhythm (impulse generation and conduction disorders such as prolongation of the PQ interval, widening of the QRS complex, sinoatrial block, atrioventricular block, ventricular tachycardia, ventricular flutter and ventricular fibrillation). In addition, low blood pressure (hypotension), drowsiness, seizures and death may occur.
If you or someone else has accidentally taken an excessive dose of PROPAFENONE PENSA, contact your doctor immediately or go to the nearest hospital.

If you forget to take PROPAFENONE PENSA
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 will experience 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), disturbances in the heart's electrical conduction (sinoatrial block, atrioventricular block, intraventricular block);
irregular 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) and loss of coordination (ataxia), tingling sensation in the extremities (paraesthesia), dizziness;
allergic reactions;
reduced number of certain types of white blood cells in the blood (leukopenia, granulocytopenia), reduced number of platelets in the blood. These side effects disappear when treatment is stopped.

Frequency not known (frequency cannot be estimated from the available data):

vision disorders (blurred vision);
dizziness;
heart problems (heart failure);
elderly patients: dizziness when standing up due to circulatory disturbances (postural hypotension) or a drop in 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), redness and skin irritation (rash), symptoms resembling a serious skin disease (lupus-like syndrome). These side effects improve when treatment is stopped;
irregular heart rhythm (ventricular tachycardia);
sexual problems in men (decreased sexual potency and sperm count). These side effects disappear when treatment is stopped. Do not stop taking this medicine if you notice any of these side effects, unless your doctor advises you to do so;
severe reduction in 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, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 PENSA

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 medicines 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 PENSA contains
PROPAFENONE PENSA 150 mg film-coated tablets

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

PROPAFENONE PENSA 300 mg film-coated tablets

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

Description of the appearance of PROPAFENONE PENSA and package contents
PROPAFENONE PENSA 150 mg film-coated tablets
Pack containing 30 tablets.
PROPAFENONE PENSA 300 mg film-coated tablets
Pack containing 30 tablets.
Marketing Authorization Holder
PENSA PHARMA S.P.A.
Via Ippolito Rosellini, 12
20124 Milano
Manufacturer
DOPPEL Farmaceutici S.r.l.
Via Volturno, 48
Quinto de’ Stampi – Rozzano (MI)