Leaflet: information for the user

Apocard 100 mg tablets

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.
• 1. If you have any questions, ask yourdoctororpharmacist.

-This medicine has been prescribed for you onlyand you must 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. See section 4.

1.What Apocard is and what it is used for

2.What you need to know before you start taking Apocard

3.How to take Apocard

4.Possible side effects

5.Storage of Apocard

6.Contents of the pack and additional information

Apocard tablets belong to a group of medicines called antiarrhythmics.

It is indicated for the treatment of different types of arrhythmias (alterations in the rhythm and frequency of the heart).

Do not take Apocard

• If you are allergic to flecainide or any of the other components of this medication (listed in section 6).
• If you have heart failure, as it may worsen with flecainide.
• If you have had a recent myocardial infarction, as flecainide may produce new arrhythmias or worsen existing ones.
• If you have rhythm disturbances (a type of block or have had atrial fibrillation for a long time) or have heart valve disease, as flecainide may produce new arrhythmias or worsen existing ones.
• If you have had a cardiogenic shock or in case of known hypersensitivity.
• Known Brugada syndrome.
• If you have sinoatrial dysfunction, atrioventricular conduction defects, second-degree or higher atrioventricular block, branch block, or distal block.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• As flecainide may produce new arrhythmias or worsen existing ones.
• If you have heart failure, as flecainide may worsen it.
• If you are wearing a pacemaker, as flecainide may interfere with its proper functioning.
• If you have renal or hepatic insufficiency, as it may increase flecainide levels in the blood, as it is eliminated more slowly.
• If you have coronary sinus disease, as flecainide may slow down heart rate or even cause cardiac arrest.
• If you have cardiac conduction disorders (a type of block), flecainide may increase the intensity of these blocks.
• If you have altered potassium levels, as flecainide toxicity may increase.
• When flecainide is administered with antiarrhythmics, beta-blockers, tricyclic antidepressants, neuroleptics, the levels of both medications may increase.
• In case of presenting ECG alterations that may suspect a Brugada syndrome
• Dairy products (milk, infant formulas, and some yogurts) may reduce flecainide absorption
• Flecainide, as a narrow therapeutic margin medication, requires caution and close monitoring when patients change to a different formulation.

Pediatric population

Flecainide is not recommended for use in children under 12 years old.

Geriatric patients:

In these patients, the elimination rate may be reduced, so this should be taken into account when making dose adjustments.

Taking Apocard 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 for treating 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 heart contraction force.
• Flecainide should not be used with verapamilo and diltiazem (some antiarrhythmics).
• Some antidepressants, as they may increase flecainide levels in the blood. The use of antidepressants (fluoxetina, paroxetina, reboxetina, etc) increases the risk of arrhythmias.
• Fenitoína, fenobarbital, and carbamazepina (some medications for treating epilepsy), as they increase flecainide elimination.
• Clozapina (a medication for schizophrenia), as it increases the risk of arrhythmias.
• Mizolastina and terfenadina (some medications for treating allergies), as they increase the risk of cardiac rhythm disturbances.
• Quinina (a medication for malaria), as it increases flecainide levels in the blood.
• Ritonavir (a medication for treating HIV/AIDS), as it increases flecainide levels in the blood.
• Cimetidina (an antacid), as it increases flecainide levels in the blood.
• Bupropión (a medication for helping to quit smoking), as it increases flecainide levels in the blood.
• Terbinafina (a medication for treating fungal infections), may increase flecainide levels in the blood.

Interference with diagnostic tests

Inform your doctor if you are undergoing any diagnostic tests, as this medication may alter the results.

Taking Apocard with food, drinks, and alcohol

The absorption of this medication's tablets is not modified in the presence of food.

Pregnancy, lactation, and fertility

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Flecainide should only be used during pregnancy if the benefits outweigh the risks.

Lactation

Flecainide is excreted in breast milk. Although the risk of adverse effects in the infant is very low, this medication should only be used during breastfeeding if the benefits outweigh the risks.

Driving and operating machinery

During treatment, you may experience adverse effects (dizziness, and visual disturbances), so if you notice these symptoms, you should not drive or operate hazardous machinery.

Apocard contains sodium

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

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

Remember to take your medication.

Your doctor will indicate the duration and dosage of your treatment with Apocard based on your condition.

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

The tablets can be divided into equal doses and should be taken with a sufficient amount of liquid – a glass of water.

The recommended 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.

In elderly patients or in patients with severe liver and kidney failure, your doctor may monitor your flecainide blood levels.

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

If you estimate that the action of Apocard is too strong or too weak, inform your doctor immediately.

Use in children

Currently, there are limited data available for children, and therefore the use of Apocard should be supervised by a cardiologist experienced in managing arrhythmias in pediatric populations.

If you take more Apocard than you should

If you have taken more Apocard 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 product and the amount administered.

If you forget to take Apocard

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 compensate for missed doses.

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

If you interrupt treatment with Apocard

Do not discontinue treatment prematurely, as this may lead to arrhythmias, sometimes very severe.

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

Like all medicines, Apocard can cause side effects, although not everyone will experience them.

Very common side effects (may affect more than 1 in 10 patients)

• Dizziness (usually transient).
• Visual disturbances such as blurred vision or double vision.

Common side effects (may affect up to 1 in 10 patients)

• Alteration of heart rhythm.
• Dyspnea (difficulty breathing).
• Physical and mental weakness, fatigue, fever, and edema (swelling).

Rare side effects (may affect up to 1 in 100 patients)

• Decrease in the number of red blood cells, white blood cells, and platelets.
• Increased heart rate.
• Nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhea, indigestion, gas.
• Allergic dermatitis, including skin rash and hair loss.

Very rare side effects (may affect up to 1 in 1,000 patients)

• Hallucinations, depression, confusion, anxiety, memory loss, and sleep disturbances.
• Tingling sensation, loss of coordination in body movements, decreased sensitivity, excessive sweating, syncope (sudden and brief loss of consciousness), tremor, flushing (redness of the face), drowsiness, headache, peripheral neuropathy (pain, loss of sensation, and inability to control muscles), seizures, abnormal and involuntary movements.
• Ear noises, vertigo.
• Pulmonary disease (inflammation of the lungs or pneumonitis).
• Increased liver enzymes, with and without jaundice (yellow color of the skin or eyes).
• Severe urticaria.

Very rare side effects (may affect up to 1 in 10,000 patients)

• Increased levels of certain antibodies.
• Corneal deposits.
• Photosensitivity (sensitivity to the effects of sunlight after taking these tablets, which may cause skin redness after a few minutes of exposure to the sun).

Unknown frequency (cannot be estimated from available data)

• Cardiovascular alterations (cardiac arrest, decreased heart rate, chest pain, decreased blood pressure, myocardial infarction, palpitations, tachycardia).
• Pulmonary disorders.
• Liver alterations.
• Anorexia.
• Ventricular fibrillation.
• Joint pain and muscle pain.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30°C.

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

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

Medicationsshouldnotbedisposedofthroughdrainsortrash.Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Apocard 100 mg tablets

• The active ingredient is flecainide acetate.
• The other components are: pregelatinized cornstarch, sodium croscarmellose, microcrystalline cellulose, hydrogenated vegetable oil, and magnesium stearate.

Appearance of the product and content of the packaging

Apocard is presented in the form of oral tablets. The tablets are white, circular/rounded, biconvex, and scored.

The tablet can be divided into equal doses.

Packaging of 30 and 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Meda Pharma SL

C/General Aranaz, 86

28027Madrid

Spain

Responsible for manufacturing:

Rottapharm Ltd.

Damastown Industrial Park, Mulhuddart

Dublín 15

Ireland

For more information about this medication, please contact the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this prospectus:January 2024

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