FLECAINIDE NORMON 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

FlecainideNormon100 mg EFG Tablets

Flecainide acetate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Flecainide Normon and what is it used for
2. What you need to know before you take Flecainide Normon
3. How to take Flecainide Normon
4. Possible side effects
5. Storage of Flecainide Normon
6. Contents of the pack and further information

1. What is Flecainide Normon and what is it used for

Flecainide belongs to a group of medicines called anti-arrhythmics.

This medicine is indicated for the treatment of different types of arrhythmias (alterations of the heart rhythm and frequency).

2. What you need to know before you take Flecainide Normon

Do not take Flecainide Normon

• If you are allergic to flecainide or any of the other ingredients of this medicine (listed in section 6).
• If you have heart failure, because flecainide may worsen it.
• If you have had a recent myocardial infarction because flecainide may produce new arrhythmias or worsen existing ones.
• If you have rhythm disorders (a type of block or long-standing atrial fibrillation) or suffer from heart valve disease, because flecainide may produce new arrhythmias or worsen existing ones.
• If you have had a cardiogenic shock or in case of known hypersensitivity.
• If you have a known Brugada syndrome.
• If you have sinus node dysfunction, atrioventricular conduction defects, atrioventricular block of degree two or higher, bundle branch block or distal block.

Warnings and precautions

Consult your doctor or pharmacist before taking Flecainide Normon:

• Because flecainide may produce new arrhythmias or worsen existing ones.
• If you have heart failure because flecainide may worsen it.
• If you wear a pacemaker, because flecainide may interfere with its proper functioning.
• If you have renal or hepatic insufficiency, because they may increase blood levels of flecainide, as it is eliminated more slowly.
• If you have coronary heart disease, because 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, because it can increase the toxicity of flecainide.
• When flecainide is administered with anti-arrhythmics, beta-blockers, tricyclic antidepressants, neuroleptics, the levels of both drugs may increase.
• In case of presenting electrocardiogram alterations that may suspect a Brugada syndrome.

Children and Adolescents

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 it should be taken into account when making dose adjustments.

Taking Flecainide Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Be cautious if you are using the following medicines:

• Digoxin (a medicine to treat heart failure and abnormal heart rate, arrhythmias), because flecainide may increase its blood levels.
• Quinidine and amiodarone (anti-arrhythmics), because they may increase flecainide blood levels.
• Propranolol and sotalol (anti-arrhythmics), because when taken with flecainide, they may decrease the heart's contraction force.
• The use of flecainide with verapamil and diltiazem (anti-arrhythmic medicines) is not recommended.
• Certain antidepressants, because they may increase flecainide blood levels. The use of antidepressants (fluoxetine, reboxetine, etc.) increases the risk of arrhythmias.
• Phenytoin, phenobarbital, and carbamazepine (medicines to treat epilepsy), because they increase flecainide elimination.
• Clozapine (a medicine for schizophrenia), because it increases the risk of arrhythmias.
• Mizolastine and terfenadine (medicines to treat allergies), because they increase the risk of heart rhythm disorders.
• Quinine (a medicine for malaria), because it increases flecainide blood levels.
• Ritonavir, lopinavir, and indinavir (medicines for AIDS treatment), because they increase flecainide blood levels.
• Diuretics, because they may alter potassium blood levels and increase flecainide toxicity.
• Cimetidine (an anti-acid), because it increases flecainide blood levels.
• Bupropion (a medicine to help quit smoking), because it increases flecainide blood levels.
• Terbinafine (a medicine for fungi), may increase flecainide blood levels.
• The use of flecainide is compatible with the use of oral anticoagulants.

Interference with laboratory tests

If you are going to have any diagnostic tests, inform your doctor that you are using this medicine, because it may alter the results.

Taking Flecainide Normon with food and drinks

The absorption of flecainide tablets is not modified in the presence of food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Flecainide should only be used during pregnancy if the benefits outweigh the risks.BreastfeedingFlecainide is excreted in breast milk. Although the risk of the baby suffering adverse effects is very low, flecainide 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 occur, so if you notice these symptoms, you should not drive or operate machinery.

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

3. How to take Flecainide Normon

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with this medicine.

This medicine is taken orally. It can be taken before, during, or after meals. The tablets should be taken whole 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 up to 400 mg (4 tablets) per day, depending on your particular characteristics.

The tablet can be divided into two equal halves.

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

Patients with kidney disease

The maximum initial dose will not exceed 100 mg per day.

If you think the action of flecainide is too strong or too weak, tell your doctor immediately.

Use in Children

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

If you take more Flecainide Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Flecainide Normon

If you forget to take a dose, take the next dose when it is due and continue taking the tablets as your doctor has recommended.

Do not take a double dose to make up for forgotten doses.

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

If you stop taking Flecainide Normon

Do not stop treatment, as this may cause arrhythmias, sometimes very severe.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Common side effects (affect more than 1 in 100 patients)

• Alteration of heart rhythm.
• Breathing difficulties.
• Physical and mental weakness, fatigue, fever, edema (swelling), and malaise.

Uncommon side effects (affect less than 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 side effects (affect less than 1 in 1,000 patients)

• 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), convulsions, abnormal and involuntary movements.
• Tinnitus, vertigo.
• Pulmonary disease (inflammation of the lungs or pneumonitis).
• Increased liver enzymes, with and without jaundice (yellow color in skin or eyes).
• Severe urticaria.

Very rare side effects (affect less than 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 redness of the skin after a few minutes of sun exposure).

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

• Cardiovascular disorders (cardiac arrest, decreased heart rate, chest pain, decreased tension, infarction, palpitations, tachycardia).
• Pulmonary disorders.
• Liver disorders.
• Anorexia.

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's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flecainide Normon

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

Do not use this medicine 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 further information

Composition of Flecainide Normon

• The active ingredient is flecainide acetate. Each tablet contains 100 mg of flecainide acetate.
• The other ingredients are: pregelatinized corn starch, sodium croscarmellose, microcrystalline cellulose, hydrogenated vegetable oil, and magnesium stearate.

Appearance of the product and pack contents

White or almost white, round, biconvex tablets, with a break line and marked with "F" and "100" on one side. Each pack contains 30 or 60 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet: December 2014.

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