Flecainide Aurovitas 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flecainide Aurovitas 100 mg tablets EFG

flecainide acetate

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Flecainide Aurovitas is and what it is used for
2. What you need to know before taking Flecainide Aurovitas
3. How to take Flecainide Aurovitas
4. Possible adverse effects
5. How to store Flecainide Aurovitas
6. Contents of the pack and other information

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

Flecainide belongs to a group of medicines that work against heart arrhythmias (known as antiarrhythmics). It inhibits the electrical conduction impulse in the heart and prolongs the time during which the heart is at rest, helping the heart to resume a normal rhythm.

Flecainide Aurovitas is used:

• for certain serious heart arrhythmias, which often present as strong palpitations or tachycardia,
• for serious heart arrhythmias that have not responded well to treatment with other medicines or when other treatments are not tolerated.

2. What you need to know before taking Flecainide Aurovitas

Do not take Flecainide 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 condition different from the one for which you are taking this medicine. If you are unsure or require further information, consult your doctor or pharmacist.
• If you are taking other antiarrhythmic agents (sodium channel blockers).
• If you know 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 Flecainide Aurovitas if:

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

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

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

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

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

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

Diuretics, medicines that stimulate intestinal movement (laxatives), and adrenal cortex hormones (corticosteroids) may reduce blood potassium levels. In such cases, your doctor may measure your blood potassium levels.

Children

Flecainide 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 switching from formula milk to dextrose-based foods.

Other medicines and Flecainide Aurovitas

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

If you take other medicines together with flecainide, these medicines may sometimes affect how both work and/or their adverse effects (e.g., interactions may occur).

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

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

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

• Sodium channel blockers (class I antiarrhythmics), such as disopyramide and quinidine—see section “Do not take Flecainide Aurovitas”;
• Beta-blockers such as propranolol (medicines that reduce the heart's pumping function);
• Amiodarone (for heart conditions); the dose of Flecainide 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 movement), and adrenal cortex hormones (corticosteroids): your doctor may perform blood tests to measure potassium levels;
• Astemizole, mizolastine, and terfenadine (medicines for allergies);
• Ritonavir, lopinavir, and indinavir (medicines to treat HIV infection);
• Fluoxetine, paroxetine, reboxetine, and certain antidepressants known as “tricyclic antidepressants”;
• Phenytoin, phenobarbital, and carbamazepine (medicines for epilepsy): the metabolism of flecainide may be accelerated by these substances;
• Clozapine, haloperidol, and risperidone (for treating psychotic disorders);
• Quinine, quinidine, and halofantrine (medicines for malaria);
• Terbinafine (for treating fungal infections);
• Cimetidine (an antacid); may increase the effect of Flecainide Aurovitas;
• Bupropion (a medicine to help stop smoking);
• Digoxin (a medicine to stimulate the heart); Flecainide Aurovitas may increase digoxin blood levels.

Taking Flecainide Aurovitas with food, drinks, and alcohol

Dairy products (milk, infant formulas, and possibly yoghurt) may reduce the absorption of flecainide in children and infants. Flecainide 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 switching from formula milk to dextrose-based foods.

Flecainide should be taken on an empty stomach or at least one hour before a meal.

If flecainide and activated charcoal (e.g., charcoal tablets) are administered simultaneously, this should only be done after consulting with your doctor, as the absorption of flecainide from the intestine into the bloodstream may be affected, thereby reducing the efficacy of Flecainide 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 medicine.

You should not take flecainide during pregnancy unless strictly necessary, as flecainide crosses the placenta in patients taking it 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 are considering becoming pregnant. Flecainide is excreted in breast milk. Therefore, breastfeeding mothers should not breastfeed their babies while taking flecainide.

Ask your doctor or pharmacist before taking any medicines.

Driving and using machines

If you experience adverse reactions such as dizziness, double vision, blurred vision, or feel lightheaded, your reaction ability may be reduced. This could be dangerous in situations requiring concentration and attention, such as driving vehicles, operating dangerous machinery, or working at heights. If you are unsure whether flecainide affects your ability to drive, consult your doctor.

Flecainide Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Flecainide Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Your doctor will prescribe a personalized dose adjusted to your individual needs. Treatment with flecainide will usually begin under medical supervision (if necessary, in hospital). Strictly follow your doctor's advice 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 divided throughout the day and should be taken on an empty stomach or at least one hour before meals.

The usual dosage is as follows:

The recommended initial dose is typically between 50 and 200 mg. Your doctor may increase this dose 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 daily).

Use in children

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

Patients with impaired renal or hepatic function

Your doctor may prescribe a lower dose.

Patients with a permanent pacemaker

The daily dose must not exceed 100 mg twice daily.

Patients being treated simultaneously with cimetidine (a medicine for stomach problems) or amiodarone (a medicine for the treatment of arrhythmias)

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

During treatment, your doctor will regularly determine the blood levels of flecainide and perform electrocardiograms (ECGs). A simple ECG may be performed once a month, and a more complete one every three months. An ECG will be performed every 2 to 4 days at the beginning of treatment and when the dose is increased.

In patients receiving lower doses, ECGs 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 starting treatment.

Switching from intravenous to oral administration

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

If you take more Flecainide Aurovitas than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Flecainide Aurovitas

Take the missed dose as soon as you remember, unless the next dose is due soon. In that case, do not take the missed dose and continue with your regular dosing schedule. It is important that you take your medicine according to the prescribed regimen. Consult your doctor if you have any doubts.

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

If you stop taking Flecainide Aurovitas

If you suddenly stop taking flecainide, you will not experience withdrawal symptoms. However, your cardiac arrhythmia will no longer be adequately controlled. Therefore, never stop taking this medicine without first consulting your doctor.

If you have any further questions about 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 everyone experiences them.

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

Regarding the heart, the most common side effects are decreased or increased 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 they may be resolved by reducing the dose. 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)

• increased frequency of pre-existing arrhythmias (irregular heartbeats),
• difficulty breathing,
• weakness,
• fatigue,
• fever,
• fluid accumulation in tissues (edema),
• malaise.

Uncommon (may affect up to 1 in 100 people)

• decreased red blood cells, white blood cells, and platelets,
• decreased libido,
• depersonalization/derealization disorder,
• euphoric mood,
• increased dream activity,
• apathy,
• stupor,
• erectile dysfunction,
• eye irritation,
• photophobia,
• involuntary rapid 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,
• upper abdominal pain, feeling of fullness in the stomach (dyspepsia),
• skin allergic reactions such as rash, blisters, and hair loss,
• 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 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),
• tremor,
• flushing,
• numbness,
• headache,
• nerve disturbances, for example in arms and legs,
• seizures,
• movement disorders (dyskinesia),
• ringing in the ears,
• paresis,
• speech disorder,
• sensation that surroundings are spinning (vertigo),
• lung inflammation (pneumonitis),
• elevated liver enzymes, reversible upon discontinuation of treatment,
• yellowish discoloration of the skin or whites of the eyes due to liver or blood problems (jaundice),
• hives (urticaria).

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

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

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

• changes in electrocardiogram (ECG).

Increased stimulation threshold in patients with pacemakers or temporary electrodes, disturbances in conduction between the atria and ventricles of the heart (second- or third-degree atrioventricular block), cardiac arrest, slower or faster heartbeat, loss of the heart's ability to pump sufficient blood to body tissues, chest pain, low blood pressure, heart attack, awareness of heartbeat (palpitations), pause in normal heart rhythm (sinus arrest), emergence of a pre-existing heart condition (Brugada syndrome) not previously detected before treatment with flecainide, lung scarring or lung disease (called interstitial lung disease causing 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 performed during treatment with flecainide. In patients who develop unexplained jaundice or signs of liver dysfunction, discontinuation of flecainide is recommended to exclude the drug as a possible causative 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Flecainide Aurovitas Storage

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

Do not use this medicine after the expiry date stated on the carton, blister pack, and label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Flecainide Aurovitas

• The active substance 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 contents of the pack

Tablet.

Film-coated 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 in high-density polyethylene (HDPE) bottles with polypropylene caps.

Pack sizes:

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

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

Only some pack 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 the most recent revision of this leaflet: June 2022

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