Used for the treatment and prevention of certain forms of severe heart rhythm disorders.
What are Flecardia® prolonged-release capsules and what are they used for?
Pharmacotherapeutic group: Flecardia® is an antiarrhythmic agent. Flecardia® is used for the treatment and prevention of certain forms of severe heart rhythm disorders, as well as for the prevention of heart defibrillation (electric shock) in some patients with an implanted cardioverter-defibrillator.
Active substance: Each 100 mg prolonged-release capsule contains 100 mg of flecainide (as flecainide acetate).
Other ingredients: Capsule content: povidone (Kollidon 25), microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate. Coating: Eudragit S-100, polyethylene glycol 400, talc.
Empty capsule composition: Flecardia® 100 mg (gray/white): titanium dioxide, black iron oxide, gelatin
It is necessary to strictly follow the instructions given by your doctor.
Do not use Flecardia® prolonged-release capsules:
If you are allergic (hypersensitive) to flecainide (flecainide acetate) or any of the other ingredients of Flecardia®.
In case of myocardial infarction (recent or past), except in life-threatening arrhythmia.
In case of heart failure.
In case of cardiac conduction disorders on electrocardiogram (ECG), unless you have a pacemaker.
In case of shock.
In case of Brugada syndrome (a genetic heart disease).
This product is generally not used in the following cases:
• In combination with Class I antiarrhythmic drugs.
• During pregnancy and breastfeeding.
Before taking Flecardia® prolonged-release capsules, consult your doctor or pharmacist.
Special warnings:
Regular monitoring during treatment is required.
As with many other antiarrhythmic agents, Flecardia® prolonged-release capsules may cause severe heart rhythm disturbances if used improperly.
This medicine alters ECG parameters.
Taking Flecardia® prolonged-release capsules may reveal Brugada syndrome (a genetic heart disease).
This medicine is not recommended for use in children under 12 years of age.
Special precautions for use:
Keep out of the sight and reach of children.
In case of unusual shortness of breath, unexplained cough, or cough associated with general deterioration of health, prolonged or unexplained fatigue, or fever, consult your doctor. These symptoms may be associated with pulmonary fibrosis (damage to lung tissue).
Children and adolescents: Not recommended.
Other medicines and Flecardia® prolonged-release capsules:
The use of this medicine is contraindicated with antiarrhythmic drugs that may cause ventricular tachycardia and is not recommended with antiarrhythmic drugs of the same group, Class I (quinidine, hydroquinidine, disopyramide, mexiletine, lidocaine, propafenone, cibenzoline).
Serious side effects, which may be life-threatening, may occur when this medicine is taken together with medicines that inhibit the CYP2D6 enzyme (a liver enzyme that affects the metabolism of this medicine).
Renal failure is likely to increase the level of the medicine in the blood.
It is important to inform your doctor if you are taking any other medicines that may alter blood electrolyte levels (especially potassium, e.g., diuretics, corticosteroids, or laxatives).
Medicines requiring special caution:
• Medicines that slow the heart rate: anticholinesterase agents (donepezil, rivastigmine, tacrine, pyridostigmine, neostigmine, ambenonium, and galantamine), as there is a risk of significant slowing of heart rhythm.
• Medicines that reduce myocardial contractility or slow heart rate, or reduce cardiac conduction (beta-blockers, amiodarone, digitalis, verapamil, diltiazem, mefloquine, guanfacine, and clonidine).
• Medicines that may increase the concentration of flecainide in the blood with a risk of overdose: cinacalcet, darifenacin, duloxetine.
• Medicines that may increase the side effects of flecainide: abiraterone, bupropion, and terbinafine.
Pregnancy: Do not use during pregnancy unless the clinical condition requires treatment with flecainide. Stop taking Flecardia® and immediately consult your doctor if you become pregnant during treatment with this medicine.
Breastfeeding: Since the medicine is excreted in breast milk, breastfeeding is contraindicated during treatment with Flecardia® prolonged-release capsules. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines:
The use of Flecardia® prolonged-release capsules may cause dizziness, tremor, and visual disturbances (or very rarely heart rhythm disturbances). Consult your doctor for advice and do not drive or operate machinery if you have experienced or are currently experiencing these side effects.
Additionally, despite taking Flecardia® prolonged-release capsules, heart rhythm disturbances may still occur. Do not drive, use tools, or operate machinery before consulting your doctor.
Method of administration: Always take Flecardia® prolonged-release capsules exactly as prescribed by your doctor. If you are unsure about anything, consult your doctor or pharmacist.
- The medicine is taken orally.
- The medicine is taken once daily.
- Try to take Flecardia® prolonged-release capsules at the same time every day.
Recommended dose: 100–200 mg per day. The dose should be gradually adjusted according to clinical and ECG monitoring.
In elderly patients (over 65 years) and in patients with a history of heart failure or severe renal failure, the initial dose should not exceed 100 mg per day.
In any case, strictly follow your doctor’s prescription.
If you think that the effect of Flecardia® prolonged-release capsules is too strong or too weak, consult your doctor or pharmacist.
Taking Flecardia® with food and drink: Flecardia® may be taken before, during, or after meals.
If you take more Flecardia® prolonged-release capsules than you should: Immediately consult your doctor, pharmacist, or the nearest emergency service or hospital. Overdose requires clinical and ECG monitoring by a doctor.
If you forget to take Flecardia® prolonged-release capsules: Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.
Possible side effects:
• There have been reports of severe heart failure and cardiogenic shock in some patients with existing cardiac disorders.
• Flecardia® prolonged-release capsules may worsen cardiac conduction disorders or slow cardiac conduction, especially in elderly patients.
• As with other Class I antiarrhythmic agents, Flecardia® prolonged-release capsules may worsen pre-existing heart rhythm disorders or cause new heart rhythm disorders.
• Electrocardiographic changes, hypotension.
• Signs of nervous system disorders have been reported at high doses: dizziness, loss of sensation, tremor, feeling of instability, headache, flushing, drowsiness. These side effects are reversible with dose reduction.
• Edema, fatigue.
• Visual disturbances.
• Nausea and digestive disorders.
• Increased liver enzymes.
• Eczema.
• Changes in complete blood count, increased antibodies.
• Hallucinations, depression, confusion, anxiety, amnesia, insomnia.
• Respiratory problems (dyspnea, fever, cough) have also been observed during long-term treatment with flecainide.
• Muscle and joint pain.
Storage conditions:
Keep out of the reach of children.
Do not use Flecardia® prolonged-release capsules after the expiry date stated on the carton. The expiry date refers to the last day of the indicated month.
This medicine does not require special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Dispensing conditions: Pharmaceutical product group – II, dispensed with prescription form №3.
Marketing authorization holder
Win Medica SA
1-3 Oidipodos str., & Attiki Odos Turnoff 33-35
152 38 Chalandri
Tel: 210 74 88 821
Manufacturer
LABORATORIOS LICONSA, S.A.
Guadalajara, Spain
