APOCARD 10 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Apocard

Do not use 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 heart rhythm disorders (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 use 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 kidney or liver failure, as flecainide levels in the blood may increase 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 the toxicity of flecainide may increase.
• 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 medicine 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 this should be taken into account when adjusting the dose.

Using 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 rhythms), as flecainide may increase its levels in the blood.
• Quinidine and amiodarone (anti-arrhythmics), as they may increase flecainide levels in the blood.
• Propranolol and sotalol (anti-arrhythmics), as they may decrease the heart's contractile force when taken with flecainide.
• The use of flecainide with verapamil and diltiazem (anti-arrhythmic medicines) is not recommended.
• Some antidepressants, as they may increase flecainide levels in the blood. 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 disorders.
• Quinine (a medicine for malaria), as it increases flecainide levels in the blood.
• Ritonavir (a medicine for the treatment of AIDS), as it increases flecainide levels in the blood.
• Cimetidine (an antacid), as it increases flecainide levels in the blood.
• Bupropion (a medicine to help quit smoking), as it increases flecainide levels in the blood.
• Terbinafine (an antifungal medicine), may increase flecainide levels in the blood.

Interference with laboratory 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.

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 the infant suffering adverse 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 37.6 mg of sodium (a major component of table salt/cooking salt) in each ampoule. This is equivalent to 1.9% of the maximum recommended daily sodium intake for an adult.

3. How to use Apocard.

Apocard solution for injection is administered exclusively by intravenous route.

This injection will be administered by a doctor in the hospital. The doctor will decide the dose that best suits your conditions. The injection can be administered directly into your vein from the syringe or can be administered through a drip (infusion).

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

If administered through a drip in a vein, the maximum total dose in the first 24 hours should not exceed 600 mg, and in patients with renal impairment, this dose should be reduced by half.

Elderly people may need a lower dose.

The doctor will be in charge of controlling the intravenous administration of Apocard.

If you have severe liver and kidney failure, your doctor may monitor your flecainide blood levels.

Dosage in renal failure: 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 is 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 use more Apocard than you should

If you have used more Apocard than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult 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 forgotten doses.

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

If you have any other questions about 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 people)

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

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

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

Uncommon side effects (may affect up to 1 in 100 people)

• 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 people)

• Hallucinations, depression, confusion, anxiety, memory loss, and sleep disturbances
• Feeling of tingling, lack of coordination in body movements, decreased 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.
• 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 people)

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

Frequency not known (cannot be estimated from the available data)

• Cardiovascular disorders (cardiac arrest, decreased heart rate, chest pain, decreased blood pressure, infarction, palpitations, tachycardia)
• Pulmonary disorders
• Liver disorders
• Anorexia
• Ventricular fibrillation
• Pain in the joints 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 Medicines and Healthcare Products Agency (AEMPS) website: 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 which is stated on the label and on the carton after EXP. The expiry date refers to the last day of the month shown.

Do not use Apocard 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. Contents of the pack and other information.

Composition of Apocard 10 mg/ml Solution for Injection

• The active substance is flecainide acetate.

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

Appearance of the product and pack contents

Apocard 10 mg/ml is presented as a solution for injection for intravenous administration.

Each pack contains 5 ampoules of 15 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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.

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of last revision of this leaflet: July 2021

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

--------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Dosage and administration

Injectable

• Bolus: Intravenous injection without dilution in case of emergency or to obtain a particularly rapid effect. 2 mg/kg will be administered i.v. in no less than 10 minutes. It can also be administered as a mini-infusion diluted in 5% glucose. Never administer more than 150 mg of flecainide acetate in this way. Continuous ECG monitoring is recommended in all patients receiving the bolus, interrupting the administration of the drug when the arrhythmia is controlled.

In patients with persistent ventricular tachycardia or a history of heart failure, it should be injected even more slowly and under electrocardiographic control. 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, it is recommended to start therapy with 2 mg/kg in slow injection over 30 minutes, and continue with intravenous injection at the following doses:

First hour: 1.5 mg/kg per hour.

Second hour and subsequent hours: 0.1 - 0.25 mg/kg per hour. The switch to oral administration will be made by administering 100 mg of Apocard and decreasing the infusion by 20% every hour until it is suppressed at the fourth hour: a new dose of 100 mg will be administered 12 hours after the first. It is recommended to monitor plasma levels in patients receiving the highest recommended doses. The maximum accumulated dose administered in 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 reduced by half.

Treatment with Apocard injectable should be carried out under electrocardiographic monitoring.

Plasma levels

Basal plasma levels are between 0.2 and 1.0 µg/ml (200 to 1000 ng/ml). Basal levels above 0.7 - 1.0 µg/ml (700 - 1000 ng/ml) may favor the appearance of side effects, especially cardiac ones. It is recommended to monitor plasma levels in circumstances where a deterioration of the drug's elimination pathways is anticipated: severe liver and kidney failure, and in patients with a history or symptoms suggestive of heart failure.

Dosage in renal failure

In patients with renal failure (creatinine clearance less than 35 ml/min), the maximum initial dose will not exceed 100 mg per day (50 mg every 12 hours). In these patients, it is recommended to monitor plasma levels.

Patients treated with another anti-arrhythmic and switched to flecainide:

The pharmacokinetic characteristics of the anti-arrhythmic drug and its possible interaction with flecainide should be taken into account. The need for hospitalization of the patient will be assessed, especially in cases where withdrawal of the anti-arrhythmic may cause the appearance of severe arrhythmias.

Use in pediatric population:

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