Flecainide acetate Holsten

Package Leaflet: Information for the Patient

Flecainide Acetate Holsten, 50 mg, Tablets

Flecainide Acetate Holsten, 100 mg, Tablets

Flecainide Acetate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Flecainide Acetate Holsten and what is it used for
• 2. Important information before taking Flecainide Acetate Holsten
• 3. How to take Flecainide Acetate Holsten
• 4. Possible side effects
• 5. How to store Flecainide Acetate Holsten
• 6. Contents of the pack and other information

1. What is Flecainide Acetate Holsten and what is it used for

Flecainide belongs to a group of medicines that counteract heart rhythm disorders (known as anti-arrhythmic medicines). The medicine inhibits the conduction of impulses in the heart and prolongs the time during which the heart is at rest, causing the heart to pump blood properly again.

Flecainide Acetate Holsten is used:

• to treat certain severe heart rhythm disorders, which often manifest as strong heart palpitations or tachycardia (fast heart rate);
• to treat severe heart rhythm disorders, in cases where a good response to treatment with other medicines has not been achieved, or when other medicines are not tolerated.

2. Important information before taking Flecainide Acetate Holsten

When not to take Flecainide Acetate Holsten:

• if you are allergic to flecainide acetate or any of the other ingredients of this medicine (listed in section 6);
• if you have another heart disease other than the heart disease for which you are taking this medicine. In case of doubts or if you want to obtain more information, consult your doctor or pharmacist;
• if you are taking certain other anti-arrhythmic medicines (sodium channel blockers);
• if you have Brugada syndrome (a genetic heart disease).

Warnings and precautions

Before starting to take Flecainide Acetate Holsten, discuss it with your doctor or pharmacist.

• if you have liver or kidney function disorders, as the concentration of flecainide in the blood may increase. In this case, your doctor may regularly check the concentration of flecainide in your blood;
• if you are elderly, as the concentration of flecainide in the blood may increase;
• if you have a permanently implanted pacemaker or electrodes for temporary stimulation;
• if you have had arrhythmias after heart surgery;
• if you have had severe bradycardia (slow heart rate) or significantly low blood pressure. These conditions should be corrected before starting treatment with this medicine;
• if you have had a heart attack in the past.

An increased or decreased potassium level in the blood may affect the action of this medicine. Diuretics, laxatives, and adrenal cortex hormones (corticosteroids) may decrease potassium levels. In this case, your doctor should check your potassium level in the blood.

Children under 12 years of age

Flecainide is not approved for use in children under 12 years of age.

Flecainide Acetate Holsten and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• digoxin (a medicine that stimulates heart function); flecainide may increase the concentration of digoxin in the blood;
• medicines that reduce the strength of heart muscle contraction (e.g., propranolol), so-called beta-adrenolytics;
• certain medicines used to treat epilepsy (such as phenytoin, phenobarbital, and carbamazepine); the breakdown of flecainide may be accelerated by the use of these medicines;
• cimetidine (a medicine that inhibits stomach acid secretion); may enhance the effect of flecainide;
• amiodarone (used in heart diseases); in some patients, the dose of flecainide may need to be reduced;
• medicines used to treat depression (paroxetine, fluoxetine, and some other antidepressants, so-called "tricyclic antidepressants");
• clozapine, haloperidol, and risperidone (medicines used to treat schizophrenia, also known as neuroleptics);
• mizolastine, astemizole, and terfenadine (medicines used to treat allergies);
• quinine and halofantrine (medicines used to treat malaria);
• calcium channel blockers, such as verapamil (medicines used to lower blood pressure);
• diuretics, laxatives, and adrenal cortex hormones (corticosteroids): regular monitoring of potassium levels in the blood may be necessary;
• sodium channel blockers (anti-arrhythmic medicines of class I), such as disopyramide and quinidine; see "When not to take this medicine";
• medicines used to treat HIV infection (ritonavir, lopinavir, and indinavir);
• terbinafine (used to treat fungal infections);
• bupropion (a medicine that helps quit smoking).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

This medicine can be used during pregnancy only if the benefits outweigh the risks, as flecainide passes through the placenta. When using flecainide during pregnancy, the concentration of flecainide in the mother should be monitored. Consult your doctor as soon as you think you may be pregnant or plan to have a child.

Flecainide passes into breast milk. This medicine can be used during breastfeeding only if the benefits outweigh the risks.

Driving and using machines

If you experience side effects such as dizziness, double vision, or blurred vision, or if you have dizziness, it may prolong your reaction time.

This may be dangerous in situations that require concentration and attention, such as when driving or operating heavy machinery.

If you are unsure whether this medicine affects your ability to drive, consult your doctor.

Flecainide Acetate Holsten contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Flecainide Acetate Holsten

Take this medicine always as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.

Your doctor will prescribe an individual dose. Treatment with this medicine usually starts under medical supervision (if necessary, in a hospital setting). While taking this medicine, follow your doctor's instructions carefully.

Take the tablets with a sufficient amount of liquid (e.g., water). The daily dose should usually be divided throughout the day.

The general dosing schedule is for guidance only and is as follows:

For patients with ventricular arrhythmias, whose cause is located in the atria, the recommended dose is 50 mg twice a day. If necessary, your doctor may increase the dose to a maximum of 300 mg per day.

For patients with ventricular arrhythmias, the recommended dose is 100 mg twice a day.

The maximum daily dose is 400 mg. This dose is usually used in patients with a large body mass or in patients who require rapid control of arrhythmia. After 3-5 days, your doctor will usually gradually reduce the dose to the smallest effective dose. If necessary, your doctor may reduce the dose during long-term treatment.

For elderly patients

In elderly patients, the elimination rate may be lower. Your doctor will take this into account. The dose in elderly patients should not exceed 300 mg per day (or 150 mg twice a day).

Patients with renal impairment

In these patients, the maximum initial dose is 100 mg per day (or 50 mg twice a day), and your doctor should regularly monitor the flecainide concentration.

Patients with liver impairment

Your doctor may prescribe a lower dose.

Patients with a permanently implanted pacemaker

The daily dose should not exceed 200 mg per day (or 100 mg twice a day).

Patients treated with cimetidine (a medicine used to treat stomach and intestinal disorders) or amiodarone (a medicine used to treat arrhythmias)

Your doctor will regularly monitor your condition and may prescribe a lower dose for some patients.

During treatment, your doctor will regularly monitor the flecainide concentration in your blood and perform an electrocardiogram (ECG) of your heart. A basic ECG will be performed every month, and a more detailed ECG every three months. An ECG will be performed every 2-4 days at the beginning of treatment and during dose increase.

An ECG should be performed more frequently in patients who receive a dose lower than the usual recommended dose. Your doctor may adjust the dose at intervals of 6-8 days. In this case, an ECG should be performed in these patients in the 2nd and 3rd week after starting treatment.

Use in children

These tablets should not be used in children under 12 years of age.

Flecainide Acetate Holsten, 100 mg, tablets

The tablet can be divided into equal doses.

Taking a higher dose of Flecainide Acetate Holsten than recommended

In case of accidental ingestion of too many tablets, go immediately to the nearest hospital emergency department.

Missing a dose of Flecainide Acetate Holsten

Take the missed dose as soon as possible, unless it is time for the next dose. In this case, the patient may not take an additional dose, but must continue taking the medicine according to the dosing schedule. It is important to take the tablets according to the dosing schedule. In case of doubts, consult your doctor.

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

Stopping treatment with Flecainide Acetate Holsten

In case of sudden discontinuation of this medicine, there are no withdrawal symptoms. However, the heart action will no longer be controlled. Therefore, never stop taking this medicine without consulting your doctor.

If you have any further questions about 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.

As with other anti-arrhythmic medicines, flecainide may cause arrhythmia. Existing arrhythmia may worsen or new arrhythmia may occur. The pro-arrhythmic effect occurs mainly in patients with heart defects and (or) significant reduction of heart function.

The most common side effects from the heart are decreased or increased heart rate (bradycardia, tachycardia), heart palpitations, cardiac arrest, heart failure, chest pain, heart attack, and decreased blood pressure (hypotension).

Other side effects may occur, including:

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

dizziness, feeling of emptiness in the head, vision problems, such as double vision and blurred vision, and difficulty concentrating.

Common(may affect up to 1 in 10 people):

the occurrence of a more severe type of arrhythmia or an increase in the frequency or severity of existing arrhythmias (pro-arrhythmia), shortness of breath, weakness, fatigue, fever, and fluid retention (edema), discomfort.

Uncommon(may affect up to 1 in 100 people):

nausea, vomiting, constipation, abdominal pain, loss of appetite, diarrhea, indigestion, bloating, decreased red and white blood cell and platelet count, increased heart rate in patients with atrial fibrillation, skin allergic reactions such as rash, hair loss, dry mouth, taste disorders.

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

pneumonia, tingling sensation, coordination problems, difficulty controlling movements (tics), decreased sensitivity, increased sweating, fainting, tinnitus, tremors, vertigo, flushing, drowsiness, severe depression, anxiety, insomnia, headache, nerve disorders, e.g., of the arms and legs, seizures, confusion, hallucinations, memory loss, hives, increased liver enzyme activity with or without jaundice.

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

increased levels of certain antibodies, deposition of deposits in the cornea (small, cloudy spots on the eyeball) with increased sensitivity to light.

Unknown(frequency cannot be estimated from the available data):

certain changes in the ECG (prolongation of the PR and QRS intervals), increased threshold in patients with a pacemaker or electrodes for temporary stimulation, slowing of conduction between the atria and ventricles (second- or third-degree atrioventricular block), cardiac arrest, slowing or acceleration of heart rate, decreased ability of the heart to pump enough blood to the body, chest pain, low blood pressure, heart attack, feeling of heart palpitations, interruption of normal heart action (sinoatrial block), atrial fibrillation, occurrence of a certain existing heart disease (Brugada syndrome) that did not show symptoms before starting treatment with flecainide, pulmonary fibrosis or lung disease (pulmonary fibrosis and interstitial lung disease), liver disease, joint pain, and muscle pain.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181 C, 02-222 Warsaw

Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flecainide Acetate Holsten

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Flecainide Acetate Holsten contains

• The active substance is flecainide acetate. Each tablet contains 50 mg or 100 mg of flecainide acetate.
• The other ingredients are: maize starch, croscarmellose sodium, microcrystalline cellulose, hydrogenated vegetable oil, and magnesium stearate.

What Flecainide Acetate Holsten looks like and contents of the pack

Flecainide Acetate Holsten, 50 mg, tablets

White or almost white, round, biconvex tablets with a diameter of 7 mm.

Flecainide Acetate Holsten, 100 mg, tablets

White or almost white, round, biconvex tablets with a diameter of 9 mm and a score line on one side.

The tablet can be divided into equal doses.

Flecainide Acetate Holsten tablets are packaged in PVC/PVDC/Aluminum blisters containing 20, 30, 50, or 100 tablets, in a cardboard box.

Marketing authorization holder

Holsten Pharma GmbH

Hahnstraße 31-35

60528 Frankfurt am Main

Germany

Manufacturer/Importer

Alkaloid-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands

Flecainide Alkaloid-INT 50 mg tablets

Flecainide Alkaloid-INT 100 mg tablets

Bulgaria

Felkarid 50 mg tablets

Felkarid 100 mg tablets

Germany

Flecainid AAA-Pharma 50 mg tablets

Flecainid AAA-Pharma 100 mg tablets

Croatia

Felkarid 50 mg tablets

Felkarid 100 mg tablets

Poland

Flecainide Acetate Holsten

Slovenia

Felkarid 50 mg tablets

Felkarid 100 mg tablets

Date of last revision of the package leaflet:04/2022