Patient Information Leaflet: Product Characteristics

Flecard 100mg tablets EFG

(flecainide acetate)

Read this leaflet carefully before you start taking this medicine because 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 only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet.Seesection4.

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

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 it may worsen with flecainide,
• if you have had a recent heart attack or have had a cardiogenic shock (sudden heart failure) because flecainide may cause new arrhythmias or worsen existing ones,
• if you have heart rhythm disturbances (a type of blockage or have had atrial fibrillation for a long time) or have heart valve disease,because flecainide may cause new arrhythmias or worsen existing ones,
• if you have had a cardiogenic shock (sudden heart failure) in case 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 kidney or liver dysfunction (liver or kidney deterioration), your flecainide levels in the blood may increase because it is eliminated more slowly.
• If you have coronary artery disease, flecainide may slow down your heart rate or even cause a heart stop.
• If you have heart conduction disorders (a type of blockage), flecainide may increase the intensity of these blockages.
• If your potassium levels are altered, flecainide toxicity may increase.
• When flecainide is administered with antiarrhythmics, beta-blockers, tricyclic antidepressants, neuroleptics, the levels of bothmedicinesmay increase.

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

Taking Flecard with other medications

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

• Digoxin (a medication to treat heart failure and abnormal heart rate, arrhythmias), as flecainide may increase its levels in the blood.
• Quinidina and amiodarona (some antiarrhythmics), as they may increase flecainide levels in the blood.
• Propanolol and sotalol (some antiarrhythmics) as when taken with flecainide, they may decrease the heart's contraction force.
• Flecainide is not recommended to be used with verapamil and diltiazem (some antiarrhythmics).
• Some antidepressants as they may increase flecainide levels in the blood and the risk of arrhythmias. (flouxetina, reboxetina, etc.).
• Fenitoína, fenobarbital and carbamazepina (some medications to treat epilepsy) as they increase flecainide elimination.
• Clozapina (a medication for schizophrenia), as it increases the risk of arrhythmias.
• Mizolastina and terfenadina (some medications to treat allergy) as they increase the risk of heart rhythm disturbances.
• Quinina (a medication for malaria) as it increases flecainide levels in the blood.
• Ritonavir, lopinavir e indinavir (medications for HIV treatment), as they increase flecainide levels in the blood.
• Diuretics, as they may alter potassium levels in the blood and increase flecainide toxicity.
• Cimetidina (an antacid) as it increases flecainide levels in the blood.
• Bupropión (a medication to help quit smoking) as it increases flecainide levels in the blood.

Interference with diagnostic tests

If you are to undergo any diagnostic test, 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. You can take it well before, during, or after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacistbefore using this medication.

Driving and operating machinery

During treatment, adverse reactions may appear,(dizziness, drowsiness, blurred vision),so if you notice these symptoms, you should not drive cars 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”.

Follow exactly the administration instructions for this medication 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 400 mg (4 tablets) per day depending on your individual characteristics.

If you have severe liver and kidney failure, your doctor may monitor your flecainide blood levels.

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

Use in children and adolescents:

Currently, there are limited data available for children, and therefore the use of Flecard should be supervised by a cardiologist experienced in managing arrhythmias in the pediatric population. If you estimate that 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, contact the Toxicological 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 recommended by your doctor.

Do not take a double dose to make up for missed 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 interrupt treatment with Flecard

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

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

Like all medications, Flecard may produce adverse effects, although not everyone will experience them.

Body: Weakness or fatigue, discomfort, fatigue, fever, swelling (edemas).

Metabolism and nutrition: Anorexia

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

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

Immune system: In rare cases, the number of certain antibodies has increased.

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.

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

Neurological: Dizziness, vertigo, and headache. Difficulty performing voluntary movements. In rare cases, seizures, sensitivity changes, or tingling in feet and hands, instability while walking, may occur. Face redness, headache, ear noises, 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.

In extremely rare cases, corneal deposits have been described.

Respiratory: Pulmonary disease (inflammation of the lungs or pneumonitis) and sensation of lack of air. Difficulty breathing.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

No special storage conditions are required.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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, croscarmellose sodium, microcrystalline cellulose (E-460i) and magnesium stearate (E-572).

Appearance of the product and contents of the packaging

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 packaging of 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Generis Farmaceutica S.A.

Rua Joào de Deus, nº 19,

Venda Nova,

2700-487 Amadora,

Portugal

Last review date of this leaflet:May2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.