Package Leaflet: Information for the User

FlecainideNormon100 mg Tablets EFG

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.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

Flecainida belongs to a group of medications known as antiarrhythmics.

Thismedicationis indicatedin the treatment of various types of arrhythmias (alterations in the rhythm and frequency of the heart).

Do not take Flecainida Normon

• 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 cause new arrhythmias or worsen existing ones.
• If you have heart rhythm disorders (a type of block or have had atrial fibrillation for a long time) or have heart valve disease, as flecainide may cause new arrhythmias or worsen existing ones.
• If you have had cardiac shock or in case of known hypersensitivity.
• If you have known Brugada syndrome.
• If you have sinoatrial node 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 Flecainida Normon:

• As flecainide may cause 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.
• If you present with electrocardiogram alterations that may suspect Brugada syndrome.

Children and adolescents

Flecainida is not recommended for use in children under 12 years old.

Older patients

In these patients, the elimination rate may be reduced, so this should be taken into account when adjusting doses.

Taking Flecainida Normon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Be cautious if you are using the following medications:

• 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.
• Propranolol and sotalol (some antiarrhythmics), as when taken with flecainide, they may decrease heart contraction force.
• Flecainida 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, 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 heart rhythm disorders.
• Quinina (a medication for malaria), as it increases flecainide levels in the blood.
• Ritonavir, lopinavir, and indinavir (medications for treating HIV/AIDS), as they increase flecainide levels in the blood.
• Diuretics, as they may alter potassium levels in the blood and increase flecainide toxicity.
• 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.
• The use of flecainida is compatible with the use of oral anticoagulants.

Interference with diagnostic tests

If you are to undergo any diagnostic test, inform your doctor that you are using this medication, as it may alter the results.

Taking Flecainida Normon with food and drinks

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

Pregnancyandlactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Flecainida should only be used during pregnancy if the benefits outweigh the risks.

Lactation
Flecainida is excreted in breast milk. Although the risk of adverse effects in the infant is very low, flecainida 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.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again. Remember to take your medication.

Your doctor will indicate the duration of your treatment withthismedication.

Thismedicationis taken orally. It can be taken well 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 400 mg (4 tablets) per day depending on your particular characteristics.

Thetabletcan be dividedintoequal halves.

If you have severe liver and kidney failure, it is possible that your doctor will monitor the flecainide levels in your blood.

Patients with kidney disease

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

If you estimate that the action offlecainideis 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 flecainide should be supervised by a cardiologist experienced in managing arrhythmias in the pediatric population.

If you take more FlecainidaNormonthan you should

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

If you forgot to take FlecainidaNormon

If you forgot 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 the missed doses.

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

If you interrupt treatment with FlecainidaNormon

Do not stop treatment beforehand, as arrhythmias, sometimes very severe, may occur.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

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

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.
• Tingling sensation, loss of coordination in body movements, decreased sensitivity, excessive sweating, sudden 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.
• Noises in the ears, 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 (affect less than 1 in 10,000 patients)

• Increased levels of certain antibodies.
• Corneal deposits.
• Phototoxicity (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.

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 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.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of FlecainidaNormon

• The active ingredient is flecainide acetate. Each tablet contains 100 mg of 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 container

White or almost white, round, biconvex tablets with a breaking bar and marked with “F” and “100” on one face. Each container contains 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this prospectus: December 2014.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Productshttp://www.aemps.gob.es