Flecard 100 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Flecard 100 mg tablets EFG

(flecainide acetate)

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Flecard is and what it is used for

Flecard belongs to a group of medicines called antiarrhythmics. It is indicated for the treatment of different types of arrhythmias (abnormalities in heart rhythm and rate).

2. What you need to know before taking Flecard

Do not take Flecard

• if you are allergic (hypersensitive) to flecainide or to any of the other components of this medicine (listed in section 6),
• if you have heart failure (inadequate pumping of blood to the rest of the body), as it may worsen with flecainide,
• if you have recently had a myocardial infarction (heart attack) or have experienced cardiogenic shock (acute heart failure), because flecainide may cause new arrhythmias or worsen existing ones,
• if you have heart rhythm disorders (certain types of blocks or long-standing atrial fibrillation) or suffer from heart valve disease, because flecainide may cause new arrhythmias or worsen existing ones,
• if you have had cardiogenic shock (acute heart failure) in the context of known hypersensitivity.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flecard

• Flecainide may cause new arrhythmias or worsen existing ones.
• If you have heart failure, flecainide may worsen it.
• If you have a pacemaker, flecainide may interfere with its proper functioning.
• If you have renal or hepatic impairment (impaired kidney or liver function), blood levels of flecainide may increase because it is eliminated more slowly.
• If you have sinoatrial node disease, flecainide may slow the heart rate or even cause cardiac arrest.
• If you have cardiac conduction disorders (certain types of blocks), flecainide may increase the severity of these blocks.
• If your potassium levels are abnormal, the toxicity of flecainide may increase.
• When flecainide is administered with antiarrhythmics, beta-blockers, tricyclic antidepressants, or neuroleptics, blood levels of both medications may increase.

Consult your doctor, even if the circumstance mentioned above occurred in the past.

Taking Flecard with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Digoxin (a medicine used to treat heart failure and abnormal heart rate, arrhythmias), as flecainide may increase its blood levels.
• Quinidine and amiodarone (antiarrhythmic medicines), as they may increase blood levels of flecainide.
• Propranolol and sotalol (antiarrhythmic medicines), as when taken with flecainide, they may reduce the heart's force of contraction.
• The use of flecainide with verapamil and diltiazem (antiarrhythmic medicines) is not recommended.
• Some antidepressants, as they may increase blood levels of flecainide and the risk of arrhythmias (fluoxetine, reboxetine, etc.).
• Phenytoin, phenobarbital, and carbamazepine (medicines used to treat epilepsy), as they increase the elimination of flecainide.
• Clozapine (a medicine for schizophrenia), as it increases the risk of arrhythmias.
• Mizolastine and terfenadine (medicines used to treat allergies), as they increase the risk of heart rhythm disturbances.
• Quinine (a medicine for malaria), as it increases blood levels of flecainide.
• Ritonavir, lopinavir, and indinavir (medicines for the treatment of AIDS), as they increase blood levels of flecainide.
• Diuretics, as they may alter blood potassium levels and increase flecainide toxicity.
• Cimetidine (an antacid), as it increases blood levels of flecainide.
• Bupropion (a medicine to help quit smoking), as it increases blood levels of flecainide.

Interference with diagnostic tests

If you are due to undergo any diagnostic tests, inform your doctor that you are taking this medicine, as it may alter test results.

Taking Flecard with food and drink

The absorption of Flecard tablets is not affected by food. They may be taken before, during, or after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

During treatment, adverse reactions may occur (such as dizziness, drowsiness, blurred vision); therefore, if you experience these symptoms, you should not drive vehicles or operate dangerous machinery.

Flecard contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Flecard

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Flecard is taken orally. It may be taken either before, during, or after meals.

The tablets should be swallowed whole with a sufficient amount of liquid – a glass of water. The usual dose is one tablet twice daily.

Your doctor may recommend up to a maximum total daily dose of 400 mg (4 tablets), depending on your individual characteristics.

If you have severe hepatic and renal impairment, your doctor may monitor your blood levels of flecainide.

Dosage in renal impairment: The maximum initial dose should not exceed 100 mg per day.

Use in children and adolescents:

Currently, limited data are available in children, and therefore the use of Flecard should be supervised by a cardiologist experienced in managing arrhythmias in the pediatric population. If you feel that the effect of Flecard is too strong or too weak, inform your doctor immediately.

The tablet may be divided into equal doses.

If you take more Flecard than you should

If you have taken more Flecard than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Flecard

If you forget to take a dose, take the next dose at the scheduled time and continue taking the tablets as prescribed by your doctor.

Do not take a double dose to make up for forgotten doses.

If you miss more than one dose, or if your irregular and rapid heartbeat seems to have worsened, contact your doctor immediately.

If you stop taking Flecard

Your doctor will advise you on the duration of your treatment with Flecard. Do not stop treatment prematurely, as this may trigger arrhythmias, sometimes very serious.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Flecard may cause adverse effects, although not everyone experiences them.

Body as a whole: Weakness or tiredness, malaise, fatigue, fever, swelling (edema).

Metabolism and nutrition: Anorexia.

Cardiovascular: Chest pain, hypotension, or disturbances in heart rhythm.

Skin and appendages: Flushing, allergic skin reactions (rash, urticaria). Some patients may become more sensitive to sunlight after taking these tablets and may develop skin redness after only a few minutes of sun exposure.

Immune system: Rarely, an increase in certain antibodies has been reported.

Blood: Decrease in the number of red blood cells, white blood cells, and platelets.

Psychiatric: Rarely, hallucinations, depression, confusion, memory loss, anxiety, and sleep disturbances.

Gastrointestinal: Nausea, vomiting, gas, constipation, diarrhea, abdominal pain, indigestion, flatulence, and loss of appetite.

Hepatic and biliary: Signs of jaundice (yellowing of the skin or eyes).

Neurological: Dizziness, vertigo, and headache. Difficulty performing voluntary movements. In rare cases, seizures, sensory disturbances, or tingling in the hands and feet, and unsteadiness while walking may occur. Facial flushing, headache, tinnitus, somnolence, increased sweating, syncope (sudden and brief loss of consciousness), and tremor.

Ophthalmological: Visual disturbances such as blurred or double vision, which are usually transient, may occur.

Very rarely, corneal deposits have been reported.

Respiratory: Lung disease (lung inflammation or pneumonitis) and shortness of breath. Difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Flecard

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Flecard

• The active substance is flecainide acetate. Each tablet contains 100 mg of flecainide (as acetate).
• The other components are: pregelatinized corn starch, corn starch, sodium croscarmellose, microcrystalline cellulose (E-460i), and magnesium stearate (E-572).

Appearance of the product and contents of the pack

Flecard 100 mg is presented as tablets for oral administration. The tablets are white, round, biconvex, and scored.

Flecard 100 mg is available in packs of 30 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Generis Farmaceutica S.A.

Rua Joào de Deus, nº 19,

Venda Nova,

2700-487 Amadora,

Portugal

Date of the most recent revision of this leaflet: May 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.