FLECAINIDE DOK JENERIKI 100 MG Коированная таблетка

Содержание инструкции

1. FLECAINIDE DOC Generici 100 mg tablets
   1. What is FLECAINIDE DOC Generici and what is it used for
   2. What you need to know before taking FLECAINIDE DOC Generici
   3. How to take FLECAINIDE DOC Generici
   4. Possible side effects
   5. How to store FLECAINIDE DOC Generici
   6. Contents of the pack and other information

FLECAINIDE DOC Generici 100 mg 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 FLECAINIDE DOC Generici is and what it is used for
• 2. What you need to know before you take FLECAINIDE DOC Generici
• 3. How to take FLECAINIDE DOC Generici
• 4. Possible side effects
• 5. How to store FLECAINIDE DOC Generici
• 6. Contents of the pack and other information

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

FLECAINIDE DOC Generici contains flecainide acetate belonging to the class of medicines
called antiarrhythmics. It works by controlling the speed and rhythm of the heart as it inhibits the
conduction of the stimulus in the heart and prolongs the period in which the heart is at rest, bringing it back to
pump normally.
FLECAINIDE DOC Generici is used in adults and adolescents over the age of 12 for:

• some forms of cardiac arrhythmias (alterations of the heart rhythm, i.e. the number of heartbeats per minute), which may potentially be life-threatening
• tachycardia (very fast heartbeat)
• atrial fibrillation/flutter (disordered and very high frequency contractions of the atria, a part of the heart). Treatment with FLECAINIDE DOC Generici tablets in patients with sustained ventricular tachycardia must be carried out in hospital and followed by a specialist doctor.

2. What you need to know before taking FLECAINIDE DOC Generici

Do not take FLECAINIDE DOC Generici

• if you are allergic to flecainide or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs, causing fluid to build up in the legs, lungs and other tissues) and if you have had a heart attack
• if you have cardiogenic shock (a decrease in blood pressure with severe reduction of heart function)
• if you have heart block (the heart misses beats)
• if you suffer from or have previously suffered from other heart rhythm disorders
• if you suffer from Brugada Syndrome, a genetic heart disease characterized by an abnormal electrocardiogram
• if you suffer from other heart disorders other than those for which this medicine will be administered to you

Warnings and precautions
Consult your doctor or pharmacist before taking FLECAINIDE DOC Generici
Treatment with this medicine will begin in hospital or under the supervision of a specialist doctor if you suffer from some heart rhythm disorders (see section 3).
The doctor will avoid prescribing FLECAINIDE DOC Generici:

• if you suffer from heart disease or if your heart function is abnormal;
• if you suffer from chronic atrial fibrillation (chronic, disordered and very high frequency contraction of the heart atria);
• if your liver function is severely impaired.

The doctor will be particularly careful when prescribing FLECAINIDE DOC Generici:

• if you suffer from heart disease (including atrioventricular block and heart failure);
• if you have suffered from atrial fibrillation after heart surgery;
• if you suffer from a heart disease (sinus node disease) that affects the area where the heartbeat originates;
• if you have a permanent pacemaker (a device capable of electrically stimulating the contraction of your heart) or temporary heart stimulation electrodes;
• if you suffer from imbalances in water and salts dissolved in the body (for example, you have a decrease or increase in potassium levels in the blood). Before you are given FLECAINIDE DOC Generici, the doctor will check your salt levels and institute appropriate therapy to return the values to normal;
• if you suffer from severe bradycardia (severe slowing of the heart rate) or marked hypotension (low blood pressure). Before you are given FLECAINIDE DOC Generici, the doctor will check your heart rate and blood pressure, and institute appropriate therapy to return the values to normal;
• suffer from impaired liver and/or kidney function, because the concentration of flecainide in the blood may increase. In this case, the doctor may decide to regularly check the concentration of flecainide in the blood;
• if you are elderly, because the concentration of flecainide in the blood may increase.

Children and adolescents
Avoid giving FLECAINIDE DOC Generici to children under the age of 12, because the safety
and efficacy of this medicine have not been demonstrated.

Other medicines and FLECAINIDE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• In particular, tell your doctor if you are taking: other antiarrhythmic medicines (medicines used to treat arrhythmias, e.g. amiodarone, verapamil, diltiazem), because the doctor will decide whether to administer FLECAINIDE DOC Generici to you or to reduce the dose to be administered;
• antihistamines (medicines used to counteract allergic reactions, e.g. mizolastine and terfenadine);
• antivirals (medicines used to treat viral infections, e.g. ritonavir alone or in combination with lopinavir and indinavir);
• antidepressants (medicines used to treat depression, e.g. fluoxetine and other tricyclic antidepressants);
• antipsychotics (medicines used to treat mental disorders, e.g. clozapine);
• antiepileptics (medicines used to treat epilepsy, e.g. phenytoin, phenobarbital, carbamazepine);
• antimalarials (medicines used to treat malaria, e.g. quinine);
• antifungals (medicines used to treat fungal infections, e.g. terbinafine);
• propranolol (medicine used for hypertension, angina pectoris and other indications);
• diuretics (medicines that help the formation and elimination of urine), laxatives (medicines that stimulate bowel movement) and corticosteroids (adrenal cortex hormones), because they can cause serious side effects on the heart due to a decrease in potassium in the blood (see section “Warnings and precautions”);
• H2 antihistamines (medicines used to treat gastric ulcers, e.g. cimetidine);
• medicines for smoking cessation (e.g. bupropion);
• cardiac glycosides (medicines used to stimulate the heart).

FLECAINIDE DOC Generici with food and drink
Flecainide should be taken on an empty stomach, or at least one hour before meals.
Dairy products (milk, infant formula and possibly yogurt) can reduce the absorption of
FLECAINIDE DOC Generici in children and infants. The use of FLECAINIDE
DOC Generici is not authorized in children under the age of 12, however, flecainide toxicity has been
reported during treatment in children who have decreased milk intake and in infants
who have switched from powdered milk feeding to dextrose feeding.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Avoid taking FLECAINIDE DOC Generici during pregnancy, unless the benefits of this
medicine outweigh the risks.
Breastfeeding
If you are breastfeeding, your doctor will decide whether to stop breastfeeding or stop therapy
with FLECAINIDE DOC Generici, taking into account the benefit of breastfeeding for the
child and the benefit of therapy for you

Driving and operating machinery
Following the intake of FLECAINIDE DOC Generici, side effects may occur
such as dizziness or visual disturbances, which reduce your reaction ability and may represent
a danger in situations requiring concentration and attention such as driving or using
machinery or working safely.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take FLECAINIDE DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Treatment with FLECAINIDE DOC Generici should be started under the supervision of a doctor, if
necessary in a hospital setting, if:

• you suffer from certain forms of tachycardia (AV nodal reciprocating tachycardia and sustained ventricular tachycardia)
• you suffer from heart rhythm disorders and have been diagnosed with a disease due to abnormal electrical conduction of the heart (Wolff-Parkinson-White syndrome).

As regards
Supraventricular arrhythmia (a form of arrhythmia)
The initial dose is 50 mg every 12 hours, i.e. ½ tablet 2 times a day.
The doctor may increase the dose in increments of 50 mg, 2 times a day every 4 days, until
when he/she deems necessary.
The maximum dose is 300 mg, i.e. 3 tablets, per day.
Sustained ventricular tachycardia (a form of tachycardia)
The initial dose is 100 mg every 12 hours, i.e. 1 tablet 2 times a day.
The doctor may increase the dose in increments of 50 mg, i.e. ½ tablet 2 times a day every 4
days.
The maximum dose is 400 mg, i.e. 4 tablets per day.
Paroxysmal atrial fibrillation (a form of fibrillation)
The initial dose is 50 mg, i.e. ½ tablet 2 times a day.
The doctor may increase the dose to 100 mg, i.e. 1 tablet 2 times a day.
If your symptoms do not improve, your doctor may tell you to take the tablets every 8
hours.
If you have reduced kidney function
The doctor will assess the appropriate dose for you by monitoring flecainide levels in your blood.
The initial dose may be 100 mg once a day (or 50 mg twice a day) or 100 mg every
12 hours, i.e. twice a day.
If you are elderly
The initial dose is 100 mg twice a day and may be reduced after the first week of
treatment.

Use in children and adolescents
FLECAINIDE DOC Generici is not recommended in children under 12 years of age, as
there is insufficient evidence of its use in this age group.

If you take more FLECAINIDE DOC Generici than you should
If you take more FLECAINIDE DOC Generici than you should, consult your doctor immediately or
go to the nearest hospital, as you may experience even serious side effects:

• heart conduction disturbances
• reduction of heart rate and contraction
• decrease in blood pressure
• rapid decrease in breathing function and cardiac arrest which may lead to death. The doctor will establish appropriate treatment and adopt appropriate supportive measures.

If you forget to take FLECAINIDE DOC Generici
Do not take a double dose to make up for the missed tablet.

If you stop taking FLECAINIDE DOC Generici
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 everyone gets them.
If you experience the following serious side effects during treatment with FLECAINIDE DOC Generici, tell your doctor immediately, who will assess whether to stop treatment:

• alteration of the heart's electrical conduction if you have not had surgery to fit a "pacemaker" to your heart;
• changes in the electrocardiogram (ECG) (a test to assess heart function) that may indicate Brugada syndrome;
• yellowing of the skin and whites of the eyes, apparently without reason, or signs of impaired liver function (e.g., increased liver enzymes, substances present in the liver);
• blood disorders (blood dyscrasias).

The following side effects have been observed and reported during treatment with FLECAINIDE DOC Generici, according to the following frequency:

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

• dizziness, usually transient
• vision disturbances, such as double or blurred vision

Common(may affect up to 1 in 10 people):

• development of a more severe type of arrhythmia or an increase in the frequency or severity of a pre-existing arrhythmia (proarrhythmia)
• shortness of breath (dyspnea)
• lack of strength (asthenia)
• tiredness (fatigue)
• fever
• fluid retention in the tissues (edema).
• malaise

Uncommon(may affect less than 1 in 100 people):

• decrease in red blood cells, white blood cells and platelets
• inability to get an erection (impotence)
• changes in personality (depersonalization)
• decreased sexual desire (decreased libido)
• feeling of excessive well-being (euphoria)
• increased dreaming (increased dream activity)
• inability to participate or interest (apathy)
• stupor
• eye irritation
• discomfort caused by light (photophobia)
• rapid and repetitive eye movements (nystagmus)
• increased blood pressure (hypertension)
• irregular heartbeat with increased heart rate
• narrowing of the bronchi with difficulty breathing (bronchospasm)
• nausea
• vomiting
• constipation
• abdominal pain (abdominal pain)
• loss of appetite
• diarrhea
• difficulty digesting (dyspepsia)
• excessive gas formation in the stomach or intestines (flatulence)
• dry mouth
• altered taste
• itching
• skin inflammation with detachment of superficial scales (exfoliative dermatitis)
• skin inflammation due to allergy (allergic dermatitis), including skin rash
• hair loss or thinning (alopecia)
• joint pain (arthralgia)
• muscle pain (myalgia)
• increased urine production (polyuria)
• inability of the urinary bladder to empty completely (urinary retention)
• swollen lips, tongue, and mouth

Rare(may affect less than 1 in 1,000 people):

• seeing, hearing or perceiving things that are not there (hallucinations)
• depression
• confusion
• anxiety
• memory loss (amnesia)
• sleep disorders (insomnia)
• altered sensitivity of the limbs or other parts of the body (paresthesia)
• reduced motor and gait coordination (ataxia)
• decreased sensitivity (hypoesthesia)
• excessive sweating (hyperhidrosis)
• loss of consciousness due to circulatory and respiratory problems (syncope)
• tremor
• sudden feeling of warmth (hot flushes)
• drowsiness
• headache
• peripheral nerve suffering (peripheral neuropathy)
• involuntary body movements (convulsions)
• difficulty with movements (dyskinesia)
• inability to move (paresis)
• speech disorders
• involuntary contractions
• ringing or buzzing in the ears (tinnitus)
• vertigo
• lung inflammation (pneumonia)
• increased liver enzymes with or without jaundice (yellowing of the skin and whites of the eyes)
• severe hives

Very rare(may affect less than 1 in 10,000 people):

• increased levels of certain antibodies which may indicate an autoimmune disease, with or without systemic inflammation in the body
• deposits on the surface of the eye (corneal deposits
• reactions following exposure of the skin to light (photosensitivity reactions)

Not known(frequency cannot be estimated from available data):

• changes in the electrocardiogram
• change in the stimulation threshold in patients with pacemakers or temporary stimulation electrodes, severe alteration of the heart's electrical conduction system (second and third degree atrioventricular block)
• cardiac arrest
• slow heartbeat (bradycardia)
• loss of the heart's ability to pump enough blood to the body's tissues (heart failure/congestive heart failure)
• chest pain
• low blood pressure (hypotension)
• heart attack (myocardial infarction)
• feeling of heartbeats (palpitations)
• pause in the normal heart rhythm (sinus arrest)
• fast heartbeat (tachycardia)
• lack of coordination of the pulsations of the ventricles of the heart (ventricular fibrillation)
• appearance of a certain heart disease that had not been diagnosed before treatment (unmasking of a pre-existing Brugada syndrome)
• lung injury (pulmonary fibrosis)
• lung disease (causing difficulty breathing (interstitial lung disease)
• liver dysfunction.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. 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 FLECAINIDE DOC Generici

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. Contents of the pack and other information

What FLECAINIDE DOC Generici contains

• The active ingredient is flecainide acetate. Each tablet contains 100 mg of flecainide acetate.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, pregelatinized corn starch, hydrogenated vegetable oil, magnesium stearate.

Description of the appearance of FLECAINIDE DOC Generici and contents of the pack
White or off-white, round, biconvex tablets, with “1” and “2” engraved separated by a fracture line on one side and “CC” on the other side. The tablet can be divided into two equal parts.
FLECAINIDE DOC Generici tablets is available in transparent PVC/PVdC/Al blisters of 20
or 30 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano, 43 - 24041 Brembate (BG) - Italia
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG
3000, Malta