Apocard 100 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apocard 100 mg tablets

flecainide acetate

Read the entire 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 your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, 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 Apocard is and what it is used for
2. What you need to know before taking Apocard
3. How to take Apocard
4. Possible side effects
5. How to store Apocard
6. Contents of the pack and other information

1. What Apocard is and what it is used for

Apocard tablets belong to a group of medicines called antiarrhythmics.

It is indicated for the treatment of different types of arrhythmias (abnormalities in the heart's rhythm and rate).

2. What you need to know before taking Apocard

Do not take Apocard

• If you are allergic to flecainide or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart failure, as it may worsen with flecainide.
• If you have recently had a myocardial infarction, because flecainide may cause new arrhythmias or worsen existing ones.
• If you have disturbances in your heart rhythm (certain types of heart blocks or longstanding atrial fibrillation) or suffer from heart valve disease, because flecainide may cause new arrhythmias or worsen existing ones.
• If you have experienced cardiogenic shock or have 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:

• Because 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 kidney or liver impairment, as these may increase blood levels of flecainide due to slower elimination.
• If you have coronary sinus disease, as 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, as this may increase flecainide toxicity.
• When flecainide is administered with antiarrhythmics, beta-blockers, tricyclic antidepressants, or neuroleptics, blood levels of both drugs may increase.
• If you have electrocardiogram abnormalities suggestive of Brugada syndrome.
• Dairy products (milk, infant formulas, and some yoghurts) may reduce the absorption of flecainide.
• Flecainide, being a drug with a narrow therapeutic index, requires caution and close monitoring when patients switch to a different formulation.

Paediatric population

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

Elderly patients:

In these patients, the rate of elimination may be reduced, and this should be taken into account when adjusting the dose.

Taking Apocard 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 rhythms, 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 flecainide blood levels. The use of antidepressants (fluoxetine, paroxetine, reboxetine, etc.) increases the risk of arrhythmias.
• 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 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 stop smoking), as it increases flecainide blood levels.
• Terbinafine (an antifungal medicine) may increase flecainide blood levels.

Interference with diagnostic tests

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

Taking Apocard with food, drinks, and alcohol

The absorption of this medicine's tablets is not affected by food.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 adverse effects in the infant is very low, this medicine should only be used during breastfeeding if the benefits outweigh the risks.

Driving and using machines

During treatment, adverse effects such as dizziness and visual disturbances may occur. If you experience these symptoms, you should not drive or operate dangerous machinery.

Apocard contains sodium

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

3. How to take Apocard

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

Remember to take your medicine.

Your doctor will determine the duration and dose of your treatment with Apocard based on your condition.

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

The tablets may 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 daily.

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

In elderly patients or in patients with severe hepatic or renal impairment, your doctor may monitor your blood levels of flecainide.

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

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

Use in children

Currently, data in children are limited; therefore, the use of Apocard should be supervised by a cardiologist experienced in managing arrhythmias in the pediatric population.

If you take more Apocard than you should

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

If you forget to take Apocard

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

Do not take a double dose to make up for a missed dose.

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

If you stop taking Apocard

Do not stop treatment prematurely, as arrhythmias may occur, 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, Apocard may cause adverse effects, although not everyone will experience them.

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

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

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

• Heart rhythm disturbances.
• Breathing difficulty (dyspnea).
• Physical and mental weakness, fatigue, fever, and edema (swelling).

Uncommon adverse 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 adverse effects (may affect up to 1 in 1,000 patients)

• Hallucinations, depression, confusion, anxiety, memory loss, and sleep disturbances.
• Tingling sensation, lack of coordination in body movements, reduced sensitivity, excessive sweating, syncope (sudden and brief loss of consciousness), tremor, flushing (redness of the face), somnolence, headache, peripheral neuropathy (pain, loss of sensitivity, and inability to control muscles), seizures, abnormal and involuntary movements.
• Ringing in the ears, dizziness.
• Lung disease (inflammation of the lungs or pneumonitis).
• Increased liver enzymes, with or without jaundice (yellowing of the skin or eyes).
• Severe hives.

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

• Increase in certain antibodies.
• Corneal deposits.
• Photosensitivity (sensitivity to the effects of sunlight after taking these tablets, which may result in skin redness within minutes of sun exposure).

Frequency not known (cannot be estimated from available data)

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

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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 at temperatures above 30°C.

Do not use this medicine after the expiry date stated on the label and on the packaging following CAD or EXP. The expiry date refers to 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apocard 100 mg tablets

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

Appearance of the medicinal product and contents of the pack

Apocard is presented as tablets for oral administration. The tablets are white, circular/round, biconvex, and scored.

The tablet can be divided into equal doses.

Pack sizes 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

Date of the most recent review 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/