Package Insert: Information for the User

Flecainida Aurovitas 100 mg Tablets EFG

flecainide acetate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Flecainida belongs to a group of medications that act against heart arrhythmias (designated antiarrhythmics). It inhibits the stimulation of conduction in the heart and prolongs the time during which the heart is at rest, causing the heart to beat normally again.

Flecainida Aurovitas is used:

• for some severe heart arrhythmias, which often appear as strong heart palpitations or tachycardia,
• for severe heart arrhythmias that have not responded well to treatment with other medications or when other treatments are not tolerated.

Do not take Flecainida Aurovitas

• If you are allergic to flecainide or any of the other components of this medication (listed in section 6).
• If you have any heart problems other than the condition for which you are taking this medication. If you are unsure or require additional information, consult your doctor or pharmacist.
• If you are taking other antiarrhythmic agents (sodium channel blockers).
• If you know that you have a genetic disorder (Brugada syndrome) characterized by an abnormal electrocardiogram (ECG).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flecainida Aurovitas if:

• You have reduced liver and/or kidney function, as flecainide concentrations in the blood may increase. In this case, your doctor may monitor your flecainide blood levels periodically.
• You have had a permanent pacemaker implanted or temporarily had cardiac electrodes placed.
• You have had heart arrhythmias after heart surgery.
• You have had a heart attack.
• You have severe bradycardia or pronounced hypotension.These conditions must be corrected before using Flecainida Aurovitas.

The plasma elimination rate of flecainide may be reduced in the elderly. This should be taken into account when making dose adjustments.

Oral flecainide treatment should be performed under direct hospital or specialist supervision in patients with:

• Certain rapid heart arrhythmias (AV node reciprocal tachycardia); heart arrhythmias associated with WPW syndrome (Wolff-Parkinson-White syndrome) and other conduction pathway disorders.
• Occasional irregular heartbeats (paroxysmal fibrillation) with incapacitating symptoms.
• Treatment of patients with other indications should be initiated in the hospital.

High or low potassium levels in the blood may influence the effect of flecainide.

Electrolyte disturbances (e.g., hypokalemia and hyperkalemia) should be corrected before using flecainide.

Diuretics, laxatives (medications that stimulate intestinal movement), and adrenal cortex hormones (corticosteroids) may reduce potassium levels in the blood. In this case, your doctor may perform blood tests to measure your potassium levels.

Children

Flecainida Aurovitas tablets are not recommended for use in children under 12 years of age; however, flecainide toxicity has been reported during treatment in children who reduced their milk intake and in infants who switched from formula milk to dextrose-based foods.

Other medicationsandFlecainida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you are taking other medications with flecainide, these medications may affect how both act and/or their side effects (e.g., may cause interactions).

Potentially fatal or even fatal secondary effects may occur due to increased drug concentrations in the blood caused by interactions (see section 4 “Possible side effects”).

“Consult a doctor or go immediately to the hospital emergency service.”

Interactions may occur when taking this medication with, for example:

• Sodium channel blockers (class I antiarrhythmics) such as disopyramide and quinidine, see the section “Do not take Flecainida Aurovitas”,
• Beta-blockers such as propranolol (medications that reduce heart pumping function),
• Amiodarone (for heart disease); the Flecainida Aurovitas dose may need to be reduced in some patients,
• Calcium channel blockers such as verapamil (to reduce blood pressure),
• Diuretics, laxatives (medications that stimulate intestinal movement), and adrenal cortex hormones (corticosteroids): your doctor may perform blood tests to measure your potassium levels,
• Astemizole, mizolastine, and terfenadine (allergy medications),
• Ritonavir, lopinavir, and indinavir (HIV infection medications),
• Fluoxetine, paroxetine, reboxetine, and certain tricyclic antidepressants,
• Phenobarbital, phenytoin, and carbamazepine (epilepsy medications): flecainide metabolism may be accelerated by these substances,
• Clozapine, haloperidol, and risperidone (for psychiatric disorders),
• Quinine, quinidine, and halofantrine (malaria medication),
• Terbinafine (for fungal infections),
• Cimetidine (an antacid); may increase the effect of Flecainida Aurovitas,
• Bupropion (a smoking cessation medication),
• Digoxin (a medication to stimulate the heart); Flecainida Aurovitas may increase digoxin levels in the blood.

Taking Flecainida Aurovitas with food, drinks, and alcohol

Dairy products (milk, infant formula, and possibly yogurt) may reduce flecainide absorption in children and infants. Flecainida is not authorized for use in children under 12 years of age; however, flecainide toxicity has been reported during treatment with flecainide in children who reduced their milk intake and in infants who switched from formula milk to dextrose-based foods.

Flecainida should be taken on an empty stomach or at least one hour before meals.

If flecainide and activated charcoal (e.g., charcoal tablets) are administered at the same time, this should only be done after consulting a doctor, as flecainide absorption from the intestine to the bloodstream is affected and, therefore, the efficacy of Flecainida Aurovitas.

Pregnancy, breastfeeding, and fertility

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

During pregnancy, flecainide should not be taken unless strictly necessary, as flecainide crosses the placenta in patients taking flecainide during pregnancy. If flecainide is used during pregnancy, flecainide blood levels should be monitored. You should consult your doctor as soon as you suspect you are pregnant or if you plan to become pregnant. Flecainide is excreted in breast milk. Therefore, mothers breastfeeding should not breastfeed their babies if they are taking flecainide.

Ask your doctor or pharmacist before taking medications.

Driving and operating machinery

If you experience adverse reactions such as dizziness, double vision, or blurred vision, or if you feel dizzy, your ability to react may be reduced.You may be at risk in situations that require concentration and attention, such as driving cars, operating hazardous machinery, or working at heights.If you are unsure whether flecainide has a negative effect on your ability to drive, consult your doctor.

Flecainida Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

Your doctor will prescribe a personalized dose adjusted to your needs. Flecainide treatment will usually start under medical supervision (if necessary in the hospital). Follow your doctor's instructions strictly when taking flecainide. If unsure, consult your doctor or pharmacist.

When and how to take the tablets

Take the tablets by swallowing them with a sufficient amount of liquid (for example, water). The usual daily dose is usually distributed throughout the day, taken with an empty stomach or at least one hour before eating.

The general dose is as follows:

The initial recommended dose usually ranges from 50 to 200 mg. Your doctor may increase it up to a maximum daily dose of 400 mg.

Older patients

Your doctor may prescribe a lower dose.The dose in older patients should not exceed 300 mg per day (or 150 mg twice a day).

Use in children

Children under 12 years old should not take these tablets.

Patients with reduced renal or hepatic function

Your doctor may prescribe a lower dose.

Patients with a permanent pacemaker

The daily dose should not exceed 100 mg twice a day.

Patients being treated simultaneously with cimetidine (stomach problem medication) or amiodarone (arrhythmia treatment medication)

Your doctor will monitor you regularly and in some cases may prescribe a lower dose.

During treatment, your doctor will regularly determine your flecainide blood levels and perform an electrocardiogram. They may perform a simple electrocardiogram once a month, and a more complete one every three months. You will have an electrocardiogram every 2 or 4 days at the beginning of treatment and if the dose is increased.

In patients receiving lower doses, they may perform an ECG more frequently. Your doctor may adjust the dose in intervals of 6 to 8 days. In these patients, an electrocardiogram will be performed in weeks 2 and 3 after starting treatment.

Switch from intravenous to tablet administration

Due to the almost complete oral bioavailability of flecainide, switching from IV flecainide to oral flecainide is possible without a new dose adjustment. As a general rule, an interval of 8 to 12 hours should elapse between the end of IV administration and the ingestion of the first tablet. Due to the narrow therapeutic margin of flecainide, close monitoring is required.

If you take more Flecainida Aurovitas than you should

If you take more flecainide than you should, consult your doctor or go to the hospital's emergency department immediately.

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 Flecainida Aurovitas

Take the dose as soon as you realize you have forgotten to take a dose, unless the next dose is very close. In this case, do not take the missed dose and follow your usual schedule. It is essential to take your medication according to the established schedule. Consult your doctor if you have any doubts.

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

If you interrupt treatment with Flecainida Aurovitas

If you suddenly stop taking flecainide, you will not experience withdrawal symptoms. However, the heart arrhythmia will not be adequately controlled. Therefore, never stop taking your medication without your doctor's knowledge.

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

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

Like other medicines for arrhythmia, flecainide may have the side effect of causing a heart rhythm disorder. Existing heart arrhythmia may worsen or a new heart arrhythmia may develop. The risk of these side effects is higher in patients with structural heart disease and/or significant reduction in cardiac function.

Regarding the heart, the most common side effects are a decrease or increase in heart rate (bradycardia, tachycardia), palpitations, cardiac arrest, heart failure, chest pain, myocardial infarction, and decreased blood pressure (hypotension).

The most frequently reported side effects are dizziness and visual disturbances, which occurred in approximately 15% of patients. These side effects usually disappear after a few days if treatment is continued or can be eliminated by reducing the dose. The side effects that may occur include the following:

Very common(may affect more than 1 in 10 people)

• dizziness,vertigo, and lightheadedness,
• visual disturbances, such as double vision, blurred vision, and difficulty focusing.

Common(may affect up to 1 in 10 people)

• appearance of pre-existing arrhythmias (irregular heartbeats) more frequently,
• difficulty breathing,
• weakness,
• fatigue,
• fever,
• fluid in the tissues (edema),
• unpleasantness.

Uncommon(may affect up to 1 in 100 people)

• decrease in red and white blood cells and platelets,
• decrease in libido,
• disorder of depersonalization/derealization,
• euphoric mood,
• increase in dream activity,
• apathy,
• stupor,
• erectile dysfunction,
• eye irritation,
• photophobia,
• rapid involuntary eye movements (nystagmus),
• hypertension,
• bronchospasm,
• irregular and more frequent heartbeats,
• nausea,
• vomiting,
• constipation,
• abdominal pain,
• decreased appetite,
• diarrhea,
• flatulence,
• dry mouth,
• alterations in taste,
• exfoliative dermatitis,
• upper abdominal pain, feeling of full stomach (dyspepsia),
• skin reactions such as skin rash, blisters, and alopecia,
• production of abnormally large volumes of urine (polyuria),
• urinary retention,
• swollen lips, tongue, and mouth.

Rare(may affect up to 1 in 1,000 people)

• seeing things that are not real (hallucinations),
• depression,
• confusion,
• anxiety,
• memory loss (amnesia),
• insomnia,
• tingling or numbness,
• difficulty controlling movements (ataxia),
• decreased sensitivity,
• increased sweating(hyperhidrosis),
• syncope (fainting),
• shaking,
• flushing,
• numbness,
• headache,
• nervous system disturbances, for example, in arms and legs,
• seizures,
• movement disorders (dyskinesia),
• noises in the ears,
• paralysis,
• speech disorder,
• sensation of things spinning around you (vertigo),
• lung inflammation (pneumonia),
• increased liver enzymes, reversible upon discontinuing treatment,
• yellowing of the skin or white of the eyes caused by liver or blood problems (jaundice),
• hives (urticaria).

Very rare(may affect up to 1 in 10,000 people)

• increased levels of some antibodies,
• small cloudy spots in the eyeball,
• sensitivity to sunlight.

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

• changes in the electrocardiogram (ECG).

Increased threshold of stimulation in patients with pacemakers or temporary electrodes, alterations in conduction between the atrium and ventricles of the heart (second- or third-degree atrioventricular block), cardiac arrest, slower or faster heart rate, loss of heart function to pump enough blood to the body's tissues, chest pain, low blood pressure, heart attack, sensation of feeling your heartbeats, pause in normal heart rhythm (sinus arrest), appearance of pre-existing heart disease (Brugada syndrome) that was not seen before treatment with flecainide, lung scarring or lung disease (called interstitial lung disease that causes difficulty breathing), liver disorders, anorexia, joint pain, and muscle pain.

Although a causal relationship has not been established, periodic monitoring of liver function tests should be carried out during treatment with flecainide. In patients who develop unexplained jaundice or signs of liver dysfunction, it is recommended to discontinue flecainide to eliminate the drug as a possible causal agent.

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 through the Spanish System for the Vigilance 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.

Do not use this medication after the expiration date that appears on the box, blister pack, and bottle label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at your pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Flecainida Aurovitas

• The active ingredient is flecainide acetate. Each tablet contains 100 mg of flecainide acetate.
• The other components (excipients) are: microcrystalline cellulose (E-460), sodium croscarmellose, pregelatinized starch (derived from corn, rice, and potato starch), hydrogenated vegetable oil, and magnesium stearate (E-572).

Appearance of the product and content of the container

Tablet.

Uncoated tablets, white to off-white, biconvex, rounded, scored, and marked with “1” and “2” separated by a deep score on one face of the tablet and “CC” on the other face. The tablet can be divided into equal doses.

Flecainida Aurovitas tablets are available in transparent PVC/PVdC-aluminum foil blisters and in high-density polyethylene (PEAD) bottles with polypropylene closures.

Container sizes:

Blister packs: 20, 28, 30, 40, 50, 56, 60, 84, 90, and 100 tablets.

PEAD bottles: 20, 500, and 1,000 tablets.

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036, Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Last review date of this leaflet: June 2022

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