FLECAINIDE AUROVITAS 100 mg TABLETS

2. What you need to know before you take Flecainida Aurovitas

Do not take Flecainida Aurovitas

• If you are allergic to flecainide or any of the other ingredients of this medicine (listed in section 6).
• If you have any heart problem other than the problem for which you are taking this medicine. If you are not sure or need further information, consult your doctor or pharmacist.
• If you are taking other anti-arrhythmic agents (sodium channel blockers).
• If you know you have a genetic disease (Brugada syndrome) characterized by an abnormal electrocardiogram (ECG).

Warnings and precautions

Consult your doctor or pharmacist before taking 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 been implanted with a permanent pacemaker or have temporarily been fitted with cardiac electrodes,
• you have had cardiac arrhythmias after heart surgery,
• you have had a heart attack,
• you have severe bradycardia or pronounced hypotension. These diseases must be corrected before using Flecainida Aurovitas.

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

Treatment with oral flecainide should be carried out under direct hospital supervision or by a specialist in patients with:

• Certain rapid cardiac arrhythmias (AV nodal reentrant tachycardia); cardiac arrhythmias associated with WPW syndrome (Wolff-Parkinson-White syndrome) and other conduction disorders.
• Occasional irregular heartbeats (paroxysmal fibrillation) with disabling symptoms.
• Treatment of patients with other indications should continue to be initiated in the hospital.

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

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

Diuretics, laxatives (medicines that stimulate intestinal movements) and adrenal cortex hormones (corticosteroids) may reduce potassium levels in the blood. In this case, your doctor may determine your potassium blood 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 to dextrose-based foods.

Other medicines and Flecainida Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you use other medicines with flecainide, they may sometimes affect how they work and/or their side effects (e.g., interactions may occur).

Potentially fatal or fatal side effects may occur due to increased drug concentration in the blood due to interactions (see section 4 "Possible side effects").

"Consult a doctor or go immediately to the hospital emergency department".

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

• sodium channel blockers (class I anti-arrhythmics), such as disopyramide and quinidine, see the "Do not take Flecainida Aurovitas" section,
• beta-blockers such as propranolol (medicines that reduce heart pumping function),
• amiodarone (for heart diseases); the dose of Flecainida Aurovitas may need to be reduced in some patients,
• calcium channel blockers, such as verapamil (to reduce blood pressure),
• diuretics, laxatives (medicines that stimulate intestinal movements) and adrenal cortex hormones (corticosteroids): your doctor may perform tests to measure potassium levels in the blood,
• astemizole, mizolastine, and terfenadine (medicines for allergies),
• ritonavir, lopinavir, and indinavir (medicines for treating HIV infection),
• fluoxetine, paroxetine, reboxetine, and certain antidepressants called "tricyclic antidepressants",
• phenytoin, phenobarbital, and carbamazepine (medicines for epilepsy): flecainide metabolism may be accelerated by these substances,
• clozapine, haloperidol, and risperidone (for treating psychotic diseases),
• quinine, quinidine, and halofantrine (medicines for malaria),
• terbinafine (for treating fungal infections),
• cimetidine (an anti-acid); may increase the effect of Flecainida Aurovitas,
• bupropion (medicine for quitting smoking),
• digoxin (a medicine for stimulating 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 the absorption of flecainide 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 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 the absorption of flecainide from the intestine into 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

During pregnancy, you should not take flecainide unless it is 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 plan to become pregnant. Flecainide is excreted in breast milk. Therefore, breastfeeding mothers should not breastfeed their babies if they take flecainide.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you experience side effects such as dizziness, double vision, or blurred vision, or if you feel dizzy, your ability to react may be reduced. This may be dangerous in situations that require concentration and attention, such as driving cars, operating hazardous machinery, or performing work at heights. If you are not sure if flecainide has negative effects on your ability to drive, consult your doctor.

Flecainida Aurovitas contains sodium

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

3. How to take Flecainida Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dosage

Your doctor will prescribe a personalized dose adjusted to your needs. Treatment with flecainide will usually start under medical supervision (if necessary in the hospital). Follow your doctor's advice strictly when taking flecainide. If you are 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 (e.g., water). The daily dose is usually distributed throughout the day, taken on an empty stomach or at least one hour before meals.

The usual dose is as follows:

The initial recommended dose is usually between 50 and 200 mg. It may be increased by your doctor up to a maximum daily dose of 400 mg.

Elderly patients

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

Use in children

Children under 12 years of age should not take these tablets.

Patient with reduced renal or hepatic function

Your doctor may prescribe a lower dose.

Patient with a permanent pacemaker

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

Patient treated simultaneously with cimetidine (medicine for stomach problems) or amiodarone (medicine for arrhythmia treatment)

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

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. An electrocardiogram will be performed every 2 or 4 days at the start of treatment and if the dose is increased.

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

Switching from intravenous to oral 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 rule, an interval of 8 to 12 hours should pass between the end of IV administration and the intake of the first tablet. Since flecainide has a narrow therapeutic range, 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 emergency department immediately.

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 Flecainida Aurovitas

Take the dose as soon as you remember, unless the next dose is very close. In this case, do not take the missed dose and continue with your usual schedule. It is important that you take your medicine according to the established schedule. Consult your doctor if you have any doubts.

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

If you stop taking Flecainida Aurovitas

If you suddenly stop taking flecainide, you will not have withdrawal symptoms. However, the cardiac arrhythmia will not be properly controlled. Therefore, never stop taking your medicine without your doctor knowing.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Like other medicines for arrhythmia, flecainide may have the side effect of causing a cardiac rhythm disorder. Existing cardiac arrhythmia may worsen or a new cardiac arrhythmia may develop. The risk of these effects is greater in patients with structural heart disease and/or significantly reduced 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 fainting,
• 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) with greater frequency,
• breathing difficulties,
• weakness,
• fatigue,
• fever,
• fluid in the tissues (edema),
• discomfort.

Uncommon(may affect up to 1 in 100 people)

• decrease in red and white blood cells and platelets,
• decreased libido,
• depersonalization/derealization disorder,
• euphoric mood,
• increased 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,
• taste disturbances,
• exfoliative dermatitis,
• pain in the upper abdomen, feeling of full stomach (dyspepsia),
• allergic skin reactions such as rash, blisters, and hair loss,
• production of abnormally large volumes of urine (polyuria),
• urinary retention,
• swelling of the lips, tongue, and mouth.

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

• seeing objects that are not real (hallucinations),
• depression,
• confusion,
• anxiety,
• memory loss (amnesia),
• insomnia,
• tingling or numbness,
• difficulty controlling movements (ataxia),
• decreased sensitivity,
• increased sweating (hyperhidrosis),
• fainting (syncope),
• tremors,
• flushing,
• numbness,
• headache,
• nervous disorders, for example, in arms and legs,
• seizures,
• movement disorders (dyskinesia),
• noises in the ears,
• paresis,
• speech disorder,
• feeling that things around are spinning (vertigo),
• inflammation of the lungs (pneumonia),
• elevated liver enzymes, reversible upon discontinuation of treatment,
• yellowish color of the skin or whites 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(frequency cannot be estimated from available data)

• changes in the electrocardiogram (ECG).

Increased stimulation threshold in patients with pacemakers or temporary electrodes, alterations in conduction between the atria and ventricles of the heart (second- or third-degree atrioventricular block), cardiac rhythm stop, slower or faster heart rate, loss of the heart's ability to pump enough blood to the body's tissues, chest pain, low blood pressure, heart attack, feeling of heartbeats, pause in normal cardiac rhythm (sinus arrest), appearance of pre-existing heart disease (Brugada syndrome) that had not been seen before treatment with flecainide, lung scarring or lung disease (called interstitial lung disease that causes breathing difficulties), 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 rule out the drug as a possible causal agent.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Flecainide Aurovitas

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Flecainide 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 Package Contents

Tablet.

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

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

Package Sizes:

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

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036, Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Date of Last Revision of this Prospectus: June 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (www.aemps.gob.es)