ApoCard 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apocard 10 mg/ml solution for injection

flecainide acetate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed only for you; do not give it to others, 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.

Contents of the leaflet

1. What Apocard is and what it is used for
2. What you need to know before using Apocard
3. How to use 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 injectable solution belongs to the group of medicines called antiarrhythmics.

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

2. What you need to know before using Apocard

Do not use Apocard

• If you are allergic to flecainide or any of the other components 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 rhythm disturbances (certain types of heart blocks or long-standing 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 use 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 renal or hepatic 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 the toxicity of flecainide.
• 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, elimination rate may be reduced, which should be taken into account when adjusting doses.

Using 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 their combination with flecainide may reduce the heart's contractile force.
• The use of flecainide with verapamil and diltiazem (antiarrhythmic medicines) is not recommended.
• Some antidepressants, as they may increase blood levels of flecainide. 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 blood levels of flecainide.
• Ritonavir (a medicine used to treat HIV/AIDS), as it increases blood levels of flecainide.
• Cimetidine (an antacid), as it increases blood levels of flecainide.
• Bupropion (a medicine to help stop smoking), as it increases blood levels of flecainide.
• Terbinafine (an antifungal medicine), which may increase blood levels of flecainide.

Interference with diagnostic tests

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 use of 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 37.6 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 1.9% of the maximum daily recommended sodium intake for an adult.

3. How to use Apocard

Apocard injectable solution is administered exclusively by intravenous route.

This injection will be given to you by a doctor in a hospital. The doctor will decide the dose best suited to your condition. The injection may be administered directly into your vein from a syringe or may be given via a drip (infusion).

Flecainide may be administered by slow injection into your vein at a dose of 2 mg/kg over no less than 10 minutes; in patients with a history of heart failure, flecainide should be administered over 30 minutes, with a maximum dose of 150 mg.

If administered via intravenous drip, the maximum total dose within the first 24 hours should not exceed 600 mg; in patients with renal impairment, this dose should be reduced by half.

Elderly patients may require a lower dose.

Your doctor will monitor the intravenous administration of Apocard.

If you have severe hepatic and renal insufficiency, your doctor may monitor the levels of flecainide in your blood.

Dosing in renal insufficiency: The maximum initial dose should not exceed 100 mg per day.

If you think 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 use more Apocard than you should

If you have used 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 use Apocard

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

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

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 experiences 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
• Difficulty breathing (dyspnea)
• Physical and mental weakness, fatigue, fever, edema (swelling), and malaise

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, flatulence
• 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, decreased sensitivity, excessive sweating, syncope (sudden and brief loss of consciousness), tremor, flushing (reddening 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 urticaria

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, myocardial infarction, palpitations, tachycardia)
• Pulmonary disorders
• Liver disorders, 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 via the Spanish Pharmacovigilance System for Human Medicines: 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 above 30°C.

Do not use this medicine after the expiry date stated on the label and on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Do not use Apocard if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apocard 10 mg/ml injectable solution

• The active substance is flecainide acetate.

• The other components are: sodium acetate, glacial acetic acid and water for injection.

Appearance of the product and contents of the pack

Apocard 10 mg/ml is presented as an injectable solution for intravenous administration.

Each pack contains 5 vials of 15 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

CENEXI
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

For further information about this medicinal product, please contact 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: July 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Posology and method of administration

Injectable

• Bolus: Intravenous injection without dilution in emergency situations or when a particularly rapid effect is required. Administer 2 mg/kg i.v. over no less than 10 minutes. It may also be administered as a mini-infusion diluted in 5% glucose. In this case, no more than 150 mg of flecainide acetate should be administered. Continuous ECG monitoring is recommended in all patients receiving bolus administration, and administration should be interrupted once the arrhythmia is controlled.

In patients with persistent ventricular tachycardia or a history of heart failure, the injection should be performed even more slowly and under continuous electrocardiographic monitoring. In these patients, it is recommended to administer the initial dose over a period of less than 30 minutes.

• Intravenous infusion: When prolonged parenteral administration is required, therapy should be initiated with 2 mg/kg administered as a slow injection over 30 minutes, followed by intravenous infusion at the following doses:

First hour: 1.5 mg/kg/hour.
Second hour and thereafter: 0.1–0.25 mg/kg/hour. Transition to oral therapy should be performed by administering 100 mg of Apocard and reducing the infusion rate by 20% each hour until complete discontinuation after the fourth hour. A new dose of 100 mg should be administered 12 hours after the first. Plasma level monitoring is recommended in patients receiving the highest recommended doses. The maximum cumulative dose administered within the first 24 hours should not exceed 600 mg. In patients with renal impairment (creatinine clearance less than 35 ml/min), the recommended doses should be halved.

Parenteral treatment with Apocard injectable solution must be carried out under electrocardiographic monitoring.

Plasma levels

Baseline plasma levels range between 0.2 and 1.0 µg/ml (200 to 1000 ng/ml). Baseline levels above 0.7–1.0 µg/ml (700–1000 ng/ml) may increase the risk of adverse effects, particularly cardiac effects. Plasma level monitoring is recommended in circumstances where impaired drug elimination is expected: severe hepatic or renal impairment, and in patients with a history or symptoms suggestive of heart failure.

Dosing in renal impairment

In patients with renal impairment (creatinine clearance less than 35 ml/min), the maximum initial dose should not exceed 100 mg per day (50 mg every 12 hours). Plasma level monitoring is recommended in these patients.

Patients treated with another antiarrhythmic and switched to flecainide:

The pharmacokinetic characteristics of the antiarrhythmic drug and its potential interaction with flecainide should be taken into account. The need for hospitalization should be assessed, especially in cases where discontinuation of the antiarrhythmic may lead to the occurrence of serious arrhythmias.

Use in the paediatric population:

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