Background pattern

Apocard 100 mg comprimidos

About the medicineAbout the medication

Introduction

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

1. What is Apocard and what is it used for

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).

2. What you need to know before starting to take Apocard

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".

3. How to Take Apocard

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.

4. Possible Adverse Effects

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.

5. Conservation of Apocard

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.

6. Content of the packaging and additional information

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/

Country of registration
Active substance
Prescription required
Yes
Manufacturer
Composition
Croscarmelosa sodica (10 mg mg)
This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.

Talk to a doctor online

Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.

5.01 review
Doctor

Anna Moret

Dermatology18 years of experience

Dr. Anna Moret is a board-certified dermatologist and dermatovenereologist. She specialises in adult and pediatric dermatology, venereology, aesthetic skin care, and general medicine. Her consultations are evidence-based and tailored to each patient’s dermatological needs.

Dr. Moret provides expert evaluation and treatment for: • Skin conditions such as eczema, acne, rosacea, dermatitis, and psoriasis • Hair and scalp issues including hair loss, dandruff, and seborrheic dermatitis • Pediatric skin problems — from newborns to adolescents • Sexually transmitted infections (STIs) and dermatovenereology • Aesthetic concerns: skin ageing, non-invasive cosmetic treatments • Skin allergies and hypersensitivity reactions • Mole checks, lesion evaluation, and skin cancer screening • Skincare advice and personalised cosmeceutical routines

Combining dermatology with general medical knowledge, Dr. Moret offers comprehensive care that addresses both skin health and underlying conditions. She also holds certification from the Canadian Board of Aesthetic Medicine, ensuring an internationally aligned approach to aesthetic dermatology.

CameraBook a video appointment
5.05 reviews
Doctor

Alina Tsurkan

Family medicine12 years of experience

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including: • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections • Chronic diseases: hypertension, diabetes, thyroid disorders, elevated cholesterol, weight management • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness • Women’s health: menstrual irregularities, perimenopausal symptoms, preventive screening • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance

She also provides: • IMT medical certificates for driving licence exchange in Portugal • Personalised preventive care and wellness consultations • Interpretation of test results and medical reports • Follow-up care and medication review • Support in managing multiple coexisting conditions • Remote prescription management and medical documentation

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

CameraBook a video appointment
5.04 reviews
Doctor

Andrei Popov

General medicine6 years of experience

Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

He specialises in diagnosing and treating pain conditions that affect quality of life, including: • Chronic pain lasting more than 3 months • Migraines and recurring headaches • Neck, back, lower back, and joint pain • Post-traumatic pain following injury or surgery • Nerve-related pain, fibromyalgia, and neuralgia In addition to pain management, Dr. Popov helps patients with: • Respiratory infections (colds, bronchitis, pneumonia) • High blood pressure and metabolic conditions such as diabetes • Preventive care and routine health check-ups

Online consultations last up to 30 minutes and include a detailed symptom review, personalised treatment planning, and medical follow-up when needed.

Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

CameraBook a video appointment
5.03 reviews
Doctor

Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevhenii Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise: • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan. • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions. • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies. • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries. • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required. • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up. • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data. • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications: • 12+ years of clinical experience in university hospitals in Germany and Spain • International education: Ukraine – Germany – Spain • Member of the German Society of Surgeons (BDC) • Certified in radiological diagnostics and robotic surgery • Active participant in international medical conferences and research

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

CameraBook a video appointment
See all doctors

Stay informed and save on care

Get health tips, platform updates, and exclusive promos for subscribers.

Follow us on social media
FacebookInstagramTikTok