Package Leaflet: Information for the User

Apocard 10 mg/ml injectable solution

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 only.Do not pass it on to others even if their symptoms are the same as yours.It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist.Even if they do not appear 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 use Apocard

4.Possible side effects

5.Storage of Apocard

6. Contents of the pack and additional information

Apocard injectable solution belongs 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).

Do not use 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 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 use 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 due to slower elimination.
• 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 it may increase flecainide toxicity.
• When flecainide is administered with antiarrhythmics, beta-blockers, tricyclic antidepressants, neuroleptics, the levels of both medications may increase.
• In case of presenting electrocardiogram alterations that may suspect 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 switch 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 adjusting doses.

Use of 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 fungal infections), as it 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.

Pregnancy, lactation, and fertility

Pregnancy

If you are pregnant or breastfeeding, or if you 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 lactation 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 37.6 mg of sodium (main component of table salt/for cooking) in each ampoule. This is equivalent to 1.9% of the maximum daily sodium intake recommended for an adult.

Apocard injectable solution is administered exclusively by intravenous route.

This injection will be administered by a doctor in the hospital. The doctor will decide on the dose that best suits your condition. 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 over 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 into a vein, the maximum total dose in the first 24 hours should not exceed 600 mg, and in patients with renal deterioration, this dose should be reduced to half.

Older people may require a lower dose.

The doctor will be responsible for 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 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 is limited data available for children, and 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, 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 forgot to use Apocard

Do not use a double dose to compensate for missed doses.

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Apocard may 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, edema (swelling), and discomfort

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 discoloration 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 within minutes of sun exposure)

Unknown frequency (cannot be estimated from available data)

• Cardiovascular changes (cardiac arrest, decreased heart rate, chest pain, decreased blood pressure, myocardial infarction, palpitations, tachycardia)
• Pulmonary disorders
• Liver changesAnorexia
• Fibrillation of the ventricle
• 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 to the Spanish System for 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 medication.

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 on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Do not use Apocard if you observe visible signs of deterioration.

Medicamentsshouldnotbedisposedofthroughdrainsorgarbage.In case of doubt, ask your pharmacist how to dispose of the packaging andthemedicamentsthatarenolongerneeded.This will help protect the environment.

Composition of Apocard 10 mg/ml injectable solution

• The active ingredient is flecainide acetate.

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

Aspect of the product and content of the package

Apocard 10 mg/ml is presented in the form of an intravenous injectable solution.

Each package contains 5 ampoules of 15 ml.

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:

CENEXI

52, rue Marcel et Jacques Gaucher

94120 Fontenay-sous-Bois

France.

You can request more information about this medication by contacting 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 leaflet: July 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Dosage and administration

Injectable

a) Bolus: Intravenous injection without dilution in case of emergency or to achieve a particularly rapid effect. Administer 2 mg/kg i.v. in no less than 10 minutes. It can also be administered in the form of a mini-infusion by diluting in glucose 5%. Never administer more than 150 mg of flecainide acetate in this form. Continuous ECG monitoring is recommended for all patients receiving the bolus, interrupting the administration of the drug when arrhythmia control is achieved.

In patients with persistent ventricular tachycardia or a history of heart failure, it is recommended to inject even more slowly and under electrocardiographic control. In these patients, it is recommended to administer the initial dose over a period of time less than 30 minutes.

b) Intravenous infusion: When prolonged parenteral administration is required, it is recommended to initiate therapy with 2 mg/kg in slow injection over 30 minutes, and continue with the following intravenous injections:

First hour: 1.5 mg/kg per hour.

Second hour and subsequent hours: 0.1 - 0.25 mg/kg per hour. Proceed to oral administration by administering 100 mg of Apocard and reducing the infusion by 20% each hour until it is suppressed at the fourth hour: administer a new dose of 100 mg at 12 hours from the first. Continuous monitoring of plasma levels is recommended for patients receiving the recommended high 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 to half.

Parenteral treatment with Apocard injectable should be performed under electrocardiographic monitoring.

Plasma levels

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

Dosage in renal insufficiency

In patients with renal insufficiency (creatinine clearance less than 35 ml/min), the maximum initial dose should 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 antiarrhythmic and switched to flecainide:

Consider the pharmacokinetic characteristics of the antiarrhythmic drug and its possible interaction with flecainide. Evaluate the need for hospitalization of the patient, especially in cases where the withdrawal of the antiarrhythmic may cause the appearance of severe arrhythmias.

Use in pediatric population:

Currently, there are limited data available for children, and therefore the use of Apocard should be supervised by a cardiologist experienced in the management of arrhythmias in the pediatric population.