PROPAFENONE 150 mg Coated Tablet

Зміст інструкції

1. PROPAFENONE DOC Generici 150 mg coated tablets, 300 mg coated tablets
   1. What is PROPAFENONE DOC Generici and what is it used for?
   2. What you need to know before you take PROPAFENONE DOC Generici
   3. How to take PROPAFENONE DOC Generici
   4. Possible side effects
   5. How to store PROPAFENONE DOC Generici
   6. Contents of the pack and other information

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

Equivalent Medicinal Product
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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PROPAFENONE DOC Generici is and what it is used for
• 2. What you need to know before you take PROPAFENONE DOC Generici
• 3. How to take PROPAFENONE DOC Generici
• 4. Possible side effects
• 5. How to store PROPAFENONE DOC Generici
• 6. Contents of the pack and other information

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

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

2. What you need to know before you take PROPAFENONE DOC Generici

Do not take PROPAFENONE DOC Generici

• if you are allergic to propafenone, similar medicines or any of the other ingredients of this medicine (listed in section 6);
• if your heart is functioning less than normal (manifest heart failure);
• if you have a serious problem with blood circulation due to reduced activity of your heart (cardiogenic shock, except that caused by arrhythmia);
• if you experience a severe slowing of the heartbeat (severe bradycardia);
• if you suffer from other heart problems (serious pre-existing disturbances of excitation conduction at the sinoatrial, atrioventricular and intraventricular level, sinoatrial node disease (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 of water and salt levels in the body (electrolyte imbalance);
• if you have severe lung problems (severe obstructive pneumopathies);
• if you suffer from a severe 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 tests) to assess your response to this medicine.
Take this medicine with caution and tell your doctor if:

• you have had a heart attack in the past. In this case, the doctor will prescribe this medicine only in cases of absolute necessity (ventricular arrhythmias that endanger the patient's life);
• you suffer from liver or kidney problems (impaired hepatic or renal function). In these cases, the doctor needs to reduce the dose of medicine to be taken and monitor it constantly via an electrocardiogram (see section “Use in people with liver or kidney problems”);
• you have severe respiratory problems (broncho-obstructive pneumopathy);
• you have a serious heart problem (significant structural heart disease), as you are more exposed to the side effects of this medicine.

During treatment with PROPAFENONE DOC Generici, the following conditions may occur
(see also section “Possible side effects”):

• worsening of symptoms of a muscle disease called myasthenia gravis or your heart problems (conversion of paroxysmal atrial fibrillation to atrial flutter with resulting 2:1 or 1:1 conduction block);
• changes in the functioning of your pacemaker. In this case, the doctor must carefully check and modify the operation of this device.

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

• local anesthetics, medicines used to induce anesthesia during a surgical operation; beta-blockers, medicines used to treat high blood pressure or heart problems; tricyclic antidepressants, medicines used to treat depression. These medicines can increase the effectiveness of PROPAFENONE DOC Generici;
• cyclosporine, a medicine used after an organ transplant; 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 some heart problems. PROPAFENONE DOC Generici increases the levels of these medicines in the blood, so it may be necessary to reduce the doses of these medicines;
• phenobarbital, a medicine used to treat epilepsy; rifampicin, a medicine used to treat some bacterial infections. These medicines can reduce the effectiveness of PROPAFENONE DOC Generici;
• oral anticoagulants (e.g. phenprocoumon, warfarin), medicines used to treat some blood circulation problems. PROPAFENONE DOC Generici increases the anticoagulant effect of these medicines (increased prothrombin time). In this case, the doctor should perform periodic blood tests (coagulation parameters) as it may be necessary to change 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 can increase the effectiveness of PROPAFENONE DOC Generici;
• venlafaxine, a medicine used to treat depression. PROPAFENONE DOC Generici increases the levels of this medicine in the blood;
• paroxetine and fluoxetine, medicines used to treat depression. These medicines increase the effectiveness of PROPAFENONE DOC Generici, so it may be necessary to reduce the dose of PROPAFENONE DOC Generici;
• lidocaine administered intravenously (infusion), a medicine used to induce local anesthesia and to treat some heart rhythm problems;
• amiodarone, another medicine used to treat some heart rhythm problems. In this case, it may be necessary to change the dose to be taken of both medicines.

PROPAFENONE DOC Generici with food and drink
Avoid taking grapefruit juice if you are taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking this medicine.
If you are pregnant, take PROPAFENONE DOC Generici only if absolutely
necessary and under the direct supervision of your doctor (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 operating machinery
PROPAFENONE DOC Generici can cause blurred vision, dizziness, fatigue or a feeling
of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension). Therefore, avoid driving vehicles or operating machinery if you experience these symptoms.

3. How to take PROPAFENONE DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Take the tablet whole with a sip of water, on a full stomach. Do not divide the tablet as
it has a bitter taste and a mild local anesthetic effect.
The recommended dose (initial and maintenance dose) is 450-600 mg, i.e. 1 tablet of
PROPAFENONE DOC Generici 150 mg coated tablets 3 times a day or 1 tablet
of PROPAFENONE DOC Generici 300 mg coated tablets 2 times a day. This dose refers to a person weighing approximately 70 Kg, therefore, for people with a lower weight, the dose
must be reduced.
The doctor may subsequently gradually increase the dose up to the maximum recommended dose
of 900 mg, i.e. 2 tablets of PROPAFENONE DOC Generici 150 mg
coated tablets 3 times a day or 1 tablet of PROPAFENONE DOC Generici 300
mg coated tablets 3 times a day. This dose can be further increased only in cases
of absolute necessity and under strict medical supervision (specialist cardiology control).
In some cases (significant widening of the QRS complex, prolongation of the corrected QT
interval for the frequency), it may be necessary to reduce the dose or temporarily suspend the
treatment.

Use in the elderly and in people with severe heart problems
If you are elderly or if you have severe heart damage, the dose of PROPAFENONE DOC Generici must
be increased gradually and your doctor must keep you under strict control, especially
at the beginning of treatment.

Use in people with liver or kidney problems
If you suffer from liver or kidney problems (hepatic/renal insufficiency), your doctor must keep you under
strict control and reduce the dose of this medicine.

If you take more PROPAFENONE DOC Generici than you should
In case of taking an excessive dose of this medicine, the following symptoms may occur:
heart disorders (disorders of impulse generation and conduction such as
prolongation of the PQ interval, widening of the QRS complex, sinoatrial block, block
atrioventricular, ventricular tachycardia, ventricular flutter and ventricular fibrillation),
lowering of blood pressure (hypotension), drowsiness, convulsions and death.
In case of accidental ingestion/taking of an excessive dose of PROPAFENONE DOC
Generici, immediately inform your doctor 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 the use of 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 bloating, nausea, vomiting, constipation, dry mouth, altered taste (bitter taste), abdominal pain, sensation of numbness or tingling in the mouth;
• slow heartbeat (bradycardia), heart conduction disorders (sinoatrial block, atrioventricular block, intraventricular block);
• serious liver problems (cholestasis). This side effect disappears upon stopping treatment;
• heart rhythm disturbances (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, confused state, temporary loss of consciousness (syncope), convulsions, movement difficulties (extrapyramidal symptoms) and loss of coordination (ataxia), sensation of tingling in the extremities (paresthesia), dizziness;
• allergic reactions;
• reduction in the number of certain types of white blood cells in the blood (leukocytes, granulocytes), reduction in the number of platelets in the blood. These side effects disappear upon stopping treatment.

Other possible side effects:

• vision disturbances (blurred vision);
• dizziness;
• heart problems (ventricular fibrillation, worsening of heart failure);
• elderly patients: feeling of dizziness when standing up due to blood circulation disorders (postural hypotension) or a decrease in blood pressure (orthostatic hypotension). These side effects are reduced by reducing the dose or stopping treatment;
• serious 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 (exanthem), symptoms similar to a severe skin disease (lupus-like syndrome). These side effects are reduced by stopping treatment;
• heart rhythm disturbances (ventricular tachycardia);
• sexual problems in men (decreased potency and number of spermatozoa). These side effects disappear upon stopping treatment. Do not stop taking this medicine if you notice the onset 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 who have difficulty breathing (bronchial asthma or bronchospasm).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
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 particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• The active ingredient is propafenone hydrochloride. Each film-coated tablet contains 150 mg of propafenone hydrochloride.
• The other ingredients 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 ingredient is propafenone hydrochloride. Each film-coated tablet contains 300 mg of propafenone hydrochloride.
• The other ingredients are: pregelatinized starch, sodium starch glycolate, copovidone, magnesium stearate, talc, macrogol 6000, titanium dioxide, hypromellose.

Description of the appearance of PROPAFENONE DOC Generici and contents of the pack
PROPAFENONE DOC Generici 150 mg film-coated tablets
Pack of 30 film-coated tablets in blisters.

PROPAFENONE DOC Generici 300 mg film-coated tablets
Pack of 30 film-coated tablets in blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano - Italy

Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno 48 – Quinto De’ Stampi - 20089 Rozzano (MI) - Italy