APOCARD 100 mg TABLETS

2. What you need to know before taking Apocard

Do not take Apocard

• If you are allergic to flecainide or any of the other ingredients of this medicine (listed in section 6).
• If you have heart failure, as flecainide may worsen it.
• If you have had a recent myocardial infarction, as flecainide may cause new arrhythmias or worsen existing ones.
• If you have alterations in heart rhythm (a type of block or long-standing atrial fibrillation) or suffer from heart valve disease, as flecainide may cause 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 sinus node dysfunction, atrioventricular conduction defects, second- or third-degree atrioventricular block, bundle branch block, or distal block.

Warnings and Precautions

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

• As flecainide may cause new arrhythmias or worsen existing ones.
• If you have heart failure, as flecainide may worsen it.
• If you have a pacemaker, as flecainide may interfere with its proper functioning.
• If you have renal or hepatic insufficiency, as they may increase blood levels of flecainide because it is eliminated more slowly.
• If you have coronary heart disease, as flecainide may slow down the 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 it may increase the toxicity of flecainide.
• When flecainide is administered with anti-arrhythmics, beta-blockers, tricyclic antidepressants, neuroleptics, the levels of both drugs may increase.
• In case of presenting alterations in the electrocardiogram that may suspect a Brugada syndrome.
• Dairy products (milk, infant formulas, and some yogurts) may reduce the absorption of flecainide.
• Flecainide, as a medication with a narrow therapeutic margin, requires caution and close monitoring when patients switch to a different formulation.

Pediatric Population

The use of flecainide is not recommended in children under 12 years of age.

Elderly Patients:

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

Taking Apocard with Other Medicines

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

• Digoxin (a medicine to treat heart failure and abnormal heart rate, arrhythmias), as flecainide may increase its blood levels.
• Quinidine and amiodarone (anti-arrhythmics), as they may increase flecainide blood levels.
• Propranolol and sotalol (anti-arrhythmics), as when taken with flecainide, they may decrease the heart's contractile force.
• The use of flecainide with verapamil and diltiazem (anti-arrhythmic medications) is not recommended.
• Certain antidepressants, as they may increase flecainide blood levels. The use of antidepressants (fluoxetine, paroxetine, reboxetine, etc.) increases the risk of arrhythmias.
• Phenytoin, phenobarbital, and carbamazepine (medicines 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 to treat allergies), as they increase the risk of heart rhythm alterations.
• Quinine (a medicine for malaria), as it increases flecainide blood levels.
• Ritonavir (a medicine for the treatment of AIDS), as it increases flecainide blood levels.
• Cimetidine (an antacid), as it increases flecainide blood levels.
• Bupropion (a medicine to help quit smoking), as it increases flecainide blood levels.
• Terbinafine (an antifungal medicine), as it may increase flecainide blood levels.

Interference with Analytical Tests

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

Taking Apocard with Food, Drinks, and Alcohol

The absorption of the tablets of this medicine is not modified by the presence of food.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Flecainide should only be used during pregnancy if the benefits outweigh the risks.

Breastfeeding

Flecainide is excreted in breast milk. Although the risk of the baby suffering from side effects is very low, this medicine should only be used during breastfeeding if the benefits outweigh the risks.

Driving and Using Machines

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

Apocard Contains Sodium

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

3. How to Take Apocard

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

Remember to take your medicine.

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

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

In elderly patients or patients with severe hepatic and renal insufficiency, your doctor may monitor flecainide blood levels.

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

If you think the action of Apocard is too strong or too weak, tell your doctor immediately.

Use in Children

Currently, there are limited data in children, and therefore, the use of Apocard should be supervised by a cardiologist accustomed to managing arrhythmias in the pediatric population.

If You Take More Apocard Than You Should

If you have taken more Apocard than you should, talk to your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology 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 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 Apocard

Do not stop treatment before, as arrhythmias may occur, sometimes very severe.

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

4. Possible Side Effects

Like all medicines, Apocard can cause side effects, although not everybody gets them.

Very Common Side Effects (may affect more than 1 in 10 patients)

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

Common Side Effects (may affect up to 1 in 10 patients)

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

Uncommon 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.

Rare Side Effects (may affect up to 1 in 1,000 patients)

• Hallucinations, depression, confusion, anxiety, memory loss, and sleep disturbances.
• Feeling of tingling, coordination disorders, decreased sensitivity, excessive sweating, syncope (sudden and brief loss of consciousness), tremors, flushing (redness of the face), somnolence, headache, peripheral neuropathy (pain, loss of sensitivity, and inability to control muscles), seizures, abnormal and involuntary movements.
• Tinnitus, vertigo.
• Pulmonary disease (inflammation of the lungs or pneumonitis).
• Increased liver enzymes, with or without jaundice (yellow color in 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 present with skin redness after a few minutes of sun exposure).

Frequency Not Known (cannot be estimated from the available data)

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

Reporting of Side Effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Apocard

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the label and carton after CAD or EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Apocard 100 mg Tablets

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

Appearance of the Product and Package Contents

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.

Packages of 30 and 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Rottapharm Ltd.

Damastown Industrial Park, Mulhuddart

Dublin 15

Ireland

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the Last Revision of this Leaflet:January 2024

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