PROPAFENONE 150 mg Фильм-Coated Таблетки

Содержание инструкции

1. PROPAFENONE EG 150 mg film-coated tablets, 300 mg film-coated tablets
   1. What is PROPAFENONE EG and what is it used for
   2. What you need to know before you take PROPAFENONE EG
   3. How to take PROPAFENONE EG
   4. Possible side effects
   5. How to store PROPAFENONE EG
   6. Package Contents and Other Information

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

Generic medicine
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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you need to know before you take PROPAFENONE EG

Do not take PROPAFENONE EG if

• you are allergic to propafenone hydrochloride or other similar substances or to any of the other ingredients of this medicine (listed in section 6);
• your heart is not functioning well (manifest heart failure or congestive heart failure);
• you have had a heart attack in the last three months;
• you have a serious problem with blood circulation due to reduced activity of your heart (cardiogenic shock, except that caused by arrhythmia);
• you have Brugada syndrome, a defect or block in the heart's conduction system;
• 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 disturbances of excitation conduction at the sinoatrial, atrioventricular and intraventricular level, sick sinus syndrome, atrial conduction defects, second or third degree atrioventricular block, bundle branch block or distal block in the absence of an artificial pacemaker);
• you have an imbalance of salt levels in your body (for example, potassium);
• you are taking a medicine called ritonavir used to treat AIDS (see “Other medicines and PROPAFENONE EG”);
• you have serious breathing problems (severe obstructive pneumopathies);
• you have been diagnosed with a serious muscle disease known as myasthenia gravis;
• you are pregnant, unless specifically indicated by your doctor (see “Pregnancy and breastfeeding”);
• you are breastfeeding with breast milk (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 tests) to assess your response to this medicine.
Take this medicine with caution and tell your doctor if:

• you have a serious heart problem (significant structural heart disease), as you are more exposed to the side effects of this medicine;
• 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 have 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 the section “Use in people with liver or kidney problems”);
• you have problems with the respiratory tract (obstructive broncho-pneumopathy, asthma). During treatment with PROPAFENONE EG, the following conditions may occur (see also the section “Possible side effects”):
• worsening of the 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.

If you are going to have surgery (even dental surgery), it is important to tell the surgeon or dentist that
you are taking Propafenone EG because this medicine can affect the anesthetic (such as lidocaine) or other treatments used (see “Other medicines and PROPAFENONE EG”).

Other medicines and PROPAFENONE EG
Tell 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 anesthetics, medicines used to induce anesthesia during a surgical operation (such as 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 and paroxetine);
• cyclosporine (an immunosuppressant, used after transplantation or for the treatment of arthritis or psoriasis);
• theophylline (a drug used to treat asthma);
• drugs that affect heart activity, such as amiodarone, digoxin, quinidine;
• phenobarbital (a drug used for epilepsy);
• drugs used to prevent blood clots (for example, phenprocoumone, warfarin);
• ketoconazole (a antifungal drug);
• cimetidine (a drug for ulcers);
• antibiotics (for example, erythromycin or rifampicin);;

PROPAFENONE EG with drinks
Avoid taking Propafenone EG with grapefruit juice as this may interact with your treatment.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, this medicine should
be used under strict medical supervision.
If you are pregnant, do not take PROPAFENONE EG (see section “Do not take Propafenone
EG”) unless otherwise indicated by your doctor.
If you are breastfeeding, do not take PROPAFENONE EG.

Driving and using machines
PROPAFENONE EG can cause blurred vision, dizziness, fatigue and low blood pressure. If
you experience these symptoms, avoid driving vehicles or using machines or doing anything that
requires attention.

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 following exactly the instructions of your doctor. If you have any doubts, ask 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 slight local anesthetic effect.
Adults
The recommended daily dose is 450-600 mg, i.e. 1 tablet of PROPAFENONE EG 150 mg 3
times a day or 1 tablet of PROPAFENONE EG 300 mg 2 times a day.
After 3-4 days of treatment, your doctor may assess the need to increase the dose to the maximum
recommended dose of 900 mg, i.e. 2 tablets of PROPAFENONE EG 150 mg tablets 3 times a
day or 1 tablet of PROPAFENONE EG 300 mg coated tablets 3 times a day.
Your doctor will identify the most suitable maintenance dose for you by performing cardiological
checks (electrocardiographic evaluations and blood pressure measurements).
In some cases (significant widening of the QRS complex, prolongation of the corrected QT interval for
heart rate, AV block of second or third degree), it may be necessary to reduce the dose.

Use in the elderly and in people with serious heart problems
If you are elderly or if you have serious heart damage, the dose of PROPAFENONE EG must be increased
gradually and your doctor must monitor you closely, 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 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: heart rhythm or
electrocardiogram (ECG) alterations, lowering of blood pressure, even sudden, headache,
dizziness, blurred vision, altered sensitivity (paresthesia), tremors, nausea, difficulty evacuating
(constipation), dry mouth, drowsiness, convulsions 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 a missed tablet.

If you stop taking PROPAFENONE EG
It is important that you take this medicine for the entire duration of the therapy prescribed by your doctor. DO
NOT STOP TREATMENT just because you feel better, as your symptoms may
reappear or worsen.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking PROPAFENONE EG immediately and contact your doctor if any of the
following occur:

• allergic reactions manifesting with itching, more or less sudden appearance of skin lesions, for example changes in color in patches or widespread, swelling of the face, eyes, lips, tongue and throat, difficulty breathing, blood changes, increased heart rate with possible sudden drop in blood pressure (anaphylactic reactions);
• weight loss, yellowish discoloration 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;
• feeling of heart racing, changes in heart conduction.

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

• alteration of the heartbeat such as decrease (sinus bradycardia, bradycardia) or increase (tachycardia) or strong increase (flutter);
• anxiety, sleep disorders, headache, altered taste;
• blurred vision;
• chest pain, difficulty breathing;
• abdominal pain, vomiting, nausea, diarrhea, difficulty evacuating (constipation), dry mouth;
• abnormal liver function tests (example increase of transaminases, gamma-glutamyltransferase, alkaline phosphatase in the blood);
• feeling unwell (asthenia), fatigue, fever.

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

• decrease in platelets in the blood (thrombocytopenia);
• loss of appetite;
• nightmares, vertigo, fainting (syncope), problems with coordination (ataxia), altered sensation (paresthesia);
• increased heart rate (ventricular tachycardia)
• alterations of the heart rhythm (arrhythmia), low blood pressure (hypotension);
• skin rashes such as hives, redness (erythema), itching;
• abdominal distension, presence of gas in the intestine (flatulence);
• erectile dysfunction.

Other side effects

• ventricular fibrillation (a type of heart rhythm disturbance), reduction of heart function or frequency;
• reduction of white blood cells (leukopenia) or certain types of white blood cells (agranulocytosis, granulocytopenia) in the blood, with increased risk of infections;
• sudden drop in blood pressure following the sudden transition from a sitting or lying position to an upright position (orthostatic hypotension);
• confusional state, convulsions, absence or scarcity of movements with muscle rigidity (extrapyramidal symptoms), restlessness;
• urge to vomit, stomach or intestinal disorders;
• Lupus-like syndrome manifesting with rash on the face, joint pain, muscle disorders and fever;
• decrease in the number of sperm (which disappears after discontinuation of treatment).
• bitter taste and sensation of numbness or tingling in the mouth.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is 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 waste water 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 ingredient 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 Authorisation 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)