Flecainide Doc Generici

Package leaflet: Information for the patient

FLECAINIDE DOC Generici 100 mg 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 other people, even if their symptoms are the same as yours, as it could 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:

1. What FLECAINIDE DOC Generici is and what it is 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

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

FLECAINIDE DOC Generici contains flecainide acetate, which belongs to a class of medicines called antiarrhythmics. It works by controlling the rate and rhythm of the heartbeat, as it inhibits the conduction of electrical impulses in the heart and prolongs the resting phase of the heart, thereby restoring normal pumping function.

FLECAINIDE DOC Generici is used in adults and adolescents over the age of 12 years for:

• certain types of cardiac arrhythmias (abnormal heart rhythms, i.e. alterations in the number of heartbeats per minute), some of which may be potentially life-threatening
• tachycardia (very rapid heartbeat)
• atrial fibrillation/flutter (disorganized, very rapid contractions of the atria, chambers of the heart).

Treatment with FLECAINIDE DOC Generici tablets in patients with sustained ventricular tachycardia must be carried out in a hospital setting and monitored by a specialist physician.

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

Do not take FLECAINIDE DOC Generici

• if you are allergic to flecainide or to any of the other ingredients of this medicine (listed in section 6);
• if you have heart failure (a condition in which the heart is unable to pump sufficient blood to meet the body's needs, resulting in fluid accumulation in the legs, lungs, and other tissues) and if you have had a heart attack;
• if you have cardiogenic shock (low blood pressure with severe reduction in heart function);
• if you have cardiac block (the heart misses beats);
• if you currently suffer or have previously suffered from other heart conduction disorders;
• if you have Brugada syndrome (a genetic heart disease characterized by abnormal electrocardiogram);
• if you suffer from other heart conditions different from those for which this medicine is prescribed.

Warnings and precautions
Talk to 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 certain heart rhythm disorders (see section 3).
Your doctor will avoid prescribing FLECAINIDE DOC Generici:

• if you have heart disease or impaired heart function;
• if you suffer from chronic atrial fibrillation (chronic, disorganized, and very rapid contraction of the heart's atria);
• if liver function is severely reduced.

Your doctor will exercise particular caution when prescribing FLECAINIDE DOC Generici:

• if you have heart diseases (including atrioventricular block and heart failure);
• if you have experienced atrial fibrillation after heart surgery;
• if you have a heart condition affecting the sinus node (the area where the heartbeat originates);
• if you have a permanent pacemaker or temporary cardiac pacing electrodes;
• if you have imbalances in water and electrolyte levels in the body (for example, low or high blood potassium levels). Before administering FLECAINIDE DOC Generici, your doctor will check your blood electrolyte levels and initiate appropriate treatment to normalize them;
• if you suffer from severe bradycardia (severely reduced heart rate) or marked hypotension (low blood pressure). Before administering FLECAINIDE DOC Generici, your doctor will check your heart rate and blood pressure and initiate appropriate treatment to normalize them;
• if you have reduced liver and/or kidney function, as flecainide blood concentration may increase. In such cases, your doctor may decide to regularly monitor flecainide blood levels;
• if you are elderly, as flecainide blood concentration may increase.

Children and adolescents
Do not give FLECAINIDE DOC Generici to children under 12 years of age, as the safety and efficacy of this medicine have not been established.

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

• In particular, inform your doctor if you are taking: other antiarrhythmic medicines (medicines used to treat arrhythmias, e.g. amiodarone, verapamil, diltiazem), as your doctor will decide whether to administer FLECAINIDE DOC Generici or reduce the dose;
• antihistamines (medicines used to treat allergic symptoms, 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 (a medicine used for hypertension, angina pectoris, and other indications);
• diuretics (medicines that increase urine production and elimination), laxatives (medicines that stimulate intestinal movement), and corticosteroids (hormones of the adrenal cortex), as they may cause serious heart-related adverse effects due to decreased blood potassium levels (see section "Warnings and precautions");
• H2 antihistamines (medicines used to treat gastric ulcers, e.g. cimetidine);
• smoking cessation medicines (e.g. bupropion);
• cardiac glycosides (medicines used to stimulate the heart).

FLECAINIDE DOC Generici with food and drinks
Flecainide should be taken on an empty stomach, or at least one hour before meals.
Dairy products (milk, formula milk, and possibly yogurt) may reduce the absorption of FLECAINIDE DOC Generici in children and newborns. The use of FLECAINIDE DOC Generici is not authorized in children under 12 years of age. However, flecainide toxicity has been reported in children during treatment when milk intake was reduced, and in newborns switching from formula milk to dextrose feeding.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Avoid taking FLECAINIDE DOC Generici during pregnancy unless the benefits outweigh the risks.
Breastfeeding
If you are breastfeeding, your doctor will decide whether to discontinue breastfeeding or stop treatment with FLECAINIDE DOC Generici, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.

Driving and using machines
After taking FLECAINIDE DOC Generici, you may experience adverse effects such as dizziness or visual disturbances, which may impair your reaction ability and pose a risk in situations requiring concentration and alertness, such as driving, operating machinery, or working at heights.

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 exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Treatment with FLECAINIDE DOC Generici should be initiated under the supervision of a doctor, possibly in a hospital setting, if:

• you suffer from certain types of tachycardia (AV nodal reentrant tachycardia and sustained ventricular tachycardia)
• you have heart rhythm disorders and have been diagnosed with a disease caused by abnormal electrical conduction in the heart (Wolff-Parkinson-White syndrome).

Dosage
Supraventricular arrhythmia (a type of arrhythmia)
The initial dose is 50 mg every 12 hours, i.e. ½ tablet twice daily.
Your doctor may increase the dose by increments of 50 mg twice daily every 4 days, as considered necessary.
The maximum dose is 300 mg, i.e. 3 tablets per day.

Sustained ventricular tachycardia (a type of tachycardia)
The initial dose is 100 mg every 12 hours, i.e. 1 tablet twice daily.
Your doctor may increase the dose by increments of 50 mg, i.e. ½ tablet twice daily every 4 days.
The maximum dose is 400 mg, i.e. 4 tablets per day.

Paroxysmal atrial fibrillation (a type of fibrillation)
The initial dose is 50 mg, i.e. ½ tablet twice daily.
Your doctor may increase the dose to 100 mg, i.e. 1 tablet twice daily.
If your symptoms do not improve, your doctor may instruct you to take the tablets every 8 hours.

If you have reduced kidney function
Your doctor will determine the appropriate dose by monitoring flecainide blood levels.
The initial dose may be 100 mg once daily (or 50 mg twice daily) or 100 mg every 12 hours, i.e. twice daily.

If you are elderly
The initial dose is 100 mg twice daily and may be reduced after the first week of treatment.

Use in children and adolescents
FLECAINIDE DOC Generici is not recommended for 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 prescribed, consult your doctor immediately or go to the nearest hospital, as you may experience adverse effects, even serious ones:

• disturbances in heart conduction
• reduced heart rate and contractility
• decreased blood pressure
• rapid respiratory depression and cardiac arrest, which may lead to death.
  Your doctor will initiate appropriate treatment and provide necessary 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 questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone who is given it will experience them.
If you experience any of the following serious adverse effects while being treated with FLECAINIDE DOC Generici, inform your doctor immediately, who will assess whether treatment should be stopped:

• disturbance in the conduction of heartbeats if you have not undergone surgery to implant a "pacemaker";
• changes in the electrocardiogram (ECG) trace (a test to evaluate heart function) that may indicate Brugada syndrome;
• yellowish discoloration of the skin and whites of the eyes, apparently without cause, or signs of impaired liver function (e.g. increased liver enzymes, substances present in the liver);
• blood disorders (haematological dyscrasias).

The following adverse effects have been observed and reported during treatment with FLECAINIDE DOC Generici, according to the frequency listed below:
Very common (may affect more than 1 in 10 people):

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

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

• occurrence of a more severe type of arrhythmia or increased frequency or severity of a pre-existing arrhythmia (proarrhythmia)
• shortness of breath (dyspnoea)
• lack of strength (asthenia)
• tiredness (fatigue)
• fever
• fluid accumulation in tissues (oedema)
• malaise

Uncommon (affects less than 1 in 100 patients):

• decrease in red blood cells, white blood cells, and platelets
• inability to achieve an erection (impotence)
• personality changes (depersonalisation)
• reduced sexual desire (decreased libido)
• excessive feeling of well-being (euphoria)
• increased dreaming (increased dream activity)
• inability to participate or show 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 causing breathing difficulty (bronchospasm)
• nausea
• vomiting
• constipation
• stomach pain (abdominal pain)
• decreased appetite
• diarrhoea
• difficulty digesting (dyspepsia)
• excessive gas formation in the stomach or intestines (flatulence)
• dry mouth
• altered taste
• itching
• skin inflammation with shedding of superficial scales (exfoliative dermatitis)
• allergic skin inflammation (allergic dermatitis), including skin rash
• loss or thinning of hair (alopecia)
• joint pain (arthralgia)
• muscle pain (myalgia)
• increased urine production (polyuria)
• inability of the urinary bladder to empty completely (urinary retention)
• swelling of lips, tongue, and mouth

Rare (affects less than 1 in 1,000 patients):

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

Very rare (affects less than 1 in 10,000 patients):

• 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)
• skin reactions following exposure to light (photosensitivity reactions)

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

• changes in electrocardiogram
• changes in stimulation threshold in patients with pacemakers or temporary pacing electrodes, severe disturbance of the heart's electrical conduction system (second- and third-degree atrioventricular block)
• cessation of heartbeat
• slower heartbeat (bradycardia)
• loss of the heart's ability to pump sufficient blood to body tissues (heart failure/congestive heart failure)
• chest pain
• low blood pressure (hypotension)
• heart attack (myocardial infarction)
• awareness of heartbeat (palpitations)
• pause in normal heart rhythm (sinus arrest)
• rapid heartbeat (tachycardia)
• lack of coordination in the pulsations of the heart's ventricles (ventricular fibrillation)
• emergence of a pre-existing heart condition not previously diagnosed (unmasking of pre-existing Brugada syndrome)
• lung damage (pulmonary fibrosis)
• lung disease causing breathing difficulties (interstitial lung disease)
• liver dysfunction

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report adverse effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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 stated on the pack 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 FLECAINIDE DOC Generici contains

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

Description of the appearance of FLECAINIDE DOC Generici and pack contents
White or almost white, round, biconvex tablets, marked with “1” and “2” separated by a break line on one side and “CC” on the other side. The tablet can be divided into two equal parts.
FLECAINIDE DOC Generici tablets are available in transparent PVC/PVdC/Al blisters containing 20 or 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano, 43 - 24041 Brembate (BG) - Italy
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta