FLECARD 100 mg TABLETS

Introduction

Leaflet: Information for the patient

Flecard 100 mg tablets EFG

(flecainide acetate)

Read this leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Flecard and what is it used for.
2. What you need to know before taking Flecard.
3. How to take Flecard.
4. Possible side effects.
5. Storage of Flecard.
6. Package contents and additional information

1. What is Flecard and what is it used for

Flecard belongs to the group of medications called antiarrhythmics. It is indicated for the treatment of different types of arrhythmias (alterations in heart rhythm and frequency).

2. What you need to know before taking Flecard

Do not take Flecard

• if you are allergic (hypersensitive) to flecainide or any of the other components of this medication (listed in section 6),
• if you have heart failure (insufficient blood pumping to the rest of the body), as flecainide may worsen it,
• if you have had a recent myocardial infarction (heart attack) or have had cardiogenic shock (acute heart failure), as flecainide may produce new arrhythmias or worsen existing ones,
• if you have rhythm disorders (a type of block or long-standing atrial fibrillation) or suffer from heart valve disease, as flecainide may produce new arrhythmias or worsen existing ones,
• if you have had cardiogenic shock (acute heart failure) in case of known hypersensitivity.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flecard

• Flecainide may produce 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 insufficiency (liver or kidney dysfunction), flecainide levels in the blood may increase because it is eliminated more slowly.
• If you have coronary artery disease, flecainide may slow down the heart rate or even cause cardiac arrest.
• If you have conduction disorders (a type of block), flecainide may increase the intensity of these blocks.
• If you have altered potassium levels, flecainide toxicity may increase.
• When flecainide is administered with antiarrhythmics, beta-blockers, tricyclic antidepressants, neuroleptics, the levels of both medications may increase.

Consult your doctor, even if the aforementioned circumstance has occurred to you at some point.

Taking Flecard with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

Interference with analytical tests

If you are going to undergo any diagnostic tests, inform your doctor that you are using this medication, as it may alter the results.

Taking Flecard with food and drinks

The absorption of Flecard tablets is not modified in the presence of food. It can be taken before, during, or after meals.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

During treatment, adverse reactions may appear (dizziness, drowsiness, blurred vision), so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

Flecard contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Flecard

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

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

If you have severe hepatic and renal insufficiency, your doctor may monitor your flecainide levels in the blood.

Dosage in renal insufficiency: The maximum initial dose will not exceed 100 mg per day.

Use in children and adolescents:

Currently, there is limited data available in children, and therefore, the use of Flecard should be supervised by a cardiologist experienced in the management of arrhythmias in the pediatric population. If you think the action of Flecard is too strong or too weak, inform your doctor immediately.

The tablet can be divided into equal doses.

If you take more Flecard than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Flecard

If you forget to take a dose, take the next dose when it is due and continue taking the tablets as your doctor has recommended.

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

If you forget to take more than one dose, or your irregular and rapid heartbeat seems to have worsened, consult your doctor immediately.

If you stop taking Flecard

Your doctor will indicate the duration of your treatment with Flecard. Do not stop treatment before, as this may induce arrhythmias, sometimes very severe.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Flecard can cause side effects, although not everyone will experience them.

Bodily: Weakness or fatigue, discomfort, fatigue, fever, swelling (edema).

Metabolism and nutrition: Anorexia

Cardiovascular: Chest pain, hypotension, or heart rhythm disorders.

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

Immune system: In rare cases, an increase in certain antibodies has been observed.

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

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

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

Liver and biliary system: Signs of jaundice (yellow color in skin or eyes).

Neurological: Dizziness, dizziness, and headache. Difficulty performing voluntary movements. In rare cases, seizures, sensory disturbances, or numbness of hands and feet, instability when walking. Flushing of the face, headache, ringing in the ears, drowsiness, increased sweating, syncope (sudden and brief loss of consciousness), and tremors.

Ophthalmological: Visual problems such as blurred or double vision, which are usually transient, often appear.

In very rare cases, corneal deposits have been described.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Flecard

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Flecard

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

Appearance of the product and package contents

Flecard 100 mg is presented in the form of oral tablets. The tablets are white, round, biconvex, and scored.

Flecard 100 mg is presented in packages 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 last revision of this leaflet: May 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.