Flecainide acetate holsten

Package leaflet: Information for the patient

Flecainide acetate Holsten, 50 mg, tablets
Flecainide acetate Holsten, 100 mg, tablets
Flecainidi acetas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this 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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Flecainide acetate Holsten is and what it is used for
2. What you need to know 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 Flecainide acetate Holsten is and what it is used for

Flecainide belongs to a group of medicines that work against heart rhythm disorders (known as antiarrhythmic medicines). The medicine inhibits the conduction of electrical impulses in the heart and prolongs the resting time of the heart, thereby helping the heart to pump blood properly again.
Flecainide acetate Holsten is used:

• for the treatment of certain severe heart rhythm disorders, which often manifest as strong palpitations or tachycardia (rapid heartbeat);
• for the treatment of severe heart rhythm disorders when adequate response has not been achieved with other medicines, or when other medicines are not tolerated.

2. Important information before taking Flecainide acetate Holsten

When not to take Flecainide acetate Holsten:

• if the patient is allergic to flecainide acetate or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has another heart disease different from the heart condition for which the patient is taking this medicine. If in doubt or if the patient would like to obtain further information, consult a doctor or pharmacist;
• if the patient is taking certain other antiarrhythmic medicines (sodium channel blockers);
• if the patient has Brugada syndrome (a genetic heart disease).

Warnings and precautions
Before starting treatment with Flecainide acetate Holsten, discuss this with your doctor or pharmacist.

• if the patient has impaired liver function and/or impaired kidney function, as this may lead to increased blood levels of flecainide. In such cases, the doctor may regularly monitor flecainide blood levels;
• if the patient is elderly, as this may lead to increased blood levels of flecainide;
• if the patient has a permanently implanted cardiac pacemaker or temporary pacing electrodes;
• if the patient has previously experienced arrhythmias after heart surgery;
• if the patient has previously had severe bradycardia (slow heart rate) or markedly low blood pressure. These conditions should be corrected before starting treatment with this medicine;
• if the patient has previously had a heart attack.

Abnormal blood potassium levels (high or low) may affect the action of this medicine. Diuretics, prokinetic agents (laxatives), and corticosteroids may reduce blood potassium levels. In such cases, the doctor should check blood potassium levels.

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 if you are taking, have recently taken, or might take any other medicines.

Interactions may occur, for example, when this medicine is taken together with the following medicines:

• digoxin (a medicine that stimulates heart function); flecainide may increase digoxin blood levels;
• medicines that reduce the force of myocardial contraction (e.g. propranolol), so-called beta-blockers;
• certain medicines used to treat epilepsy (such as phenytoin, phenobarbital and carbamazepine); these medicines may increase the rate of flecainide metabolism;
• cimetidine (a medicine that inhibits gastric 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 certain 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 (water pills), laxatives (medicines stimulating peristalsis), and corticosteroids: regular monitoring of blood potassium levels may be necessary;
• sodium channel blockers (class I antiarrhythmic medicines), such as disopyramide and quinidine; see section "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 used to aid smoking cessation).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

This medicine should be used during pregnancy only if the benefits outweigh the risks, as flecainide crosses the placenta in pregnant women taking flecainide. When flecainide is used during pregnancy, flecainide blood levels in the mother should be monitored. Consult your doctor as soon as you suspect you are pregnant or if you are planning a pregnancy.

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

Driving and operating machinery
If the patient experiences adverse effects such as dizziness, double vision or blurred vision, or if the patient feels dizzy, this may prolong the patient's reaction time. This may be dangerous in situations requiring concentration and attention, such as when participating in road traffic, operating dangerous machinery, or working at heights.

If in doubt whether this medicine negatively affects the patient's ability to drive, discuss this with the doctor.

Flecainide acetate Holsten contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Flecainide acetate Holsten

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the individual dose. Treatment with this medicine usually begins under medical supervision (if necessary, in a hospital setting). While taking this medicine, you must strictly follow your doctor's instructions.
Take the tablets by swallowing them with sufficient fluid (e.g. water). The daily dose is usually divided throughout the day.
The general dosing regimen serves only as a guideline and is as follows:
For patients with ventricular rhythm disorders originating in the atria of the heart, the recommended dose is 50 mg twice daily. If necessary, your doctor may increase the dose up to the maximum of 300 mg per day.
For patients with ventricular rhythm disorders, the recommended dose is 100 mg twice daily. The maximum daily dose is 400 mg. This dose is usually prescribed for patients with a large body build or for patients in whom rapid control of arrhythmia is required. After 3–5 days, your doctor will usually gradually reduce the dose to the lowest effective dose possible. If necessary, your doctor may further reduce the dose during long-term treatment.

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

Patients with impaired kidney function
For these patients, the maximum initial dose is 100 mg per day (or 50 mg twice daily). Your doctor should regularly monitor flecainide blood levels.

Patients with impaired liver function
Your doctor may prescribe a lower dose.

Patients with a permanently implanted cardiac pacemaker
The daily dose should not exceed 200 mg per day (or 100 mg twice daily).

Patients receiving concomitant treatment with cimetidine (a medicine used to treat gastrointestinal disorders) or amiodarone (a medicine used to treat heart rhythm disorders)
Your doctor will regularly monitor your condition and may prescribe a lower dose for some patients.
During treatment, your doctor will regularly monitor flecainide blood levels and perform electrocardiographic (ECG) examinations of the heart. A basic ECG will be performed monthly, and a more detailed ECG every three months. ECG monitoring will be performed every 2–4 days at the beginning of treatment and during dose escalation.
ECG monitoring should be performed more frequently in patients receiving doses lower than usually recommended. Your doctor may adjust the dose at intervals of 6–8 days. In such cases, ECG should be performed in these patients during 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 may be divided into equal doses.

Taking more than the recommended dose of Flecainide acetate Holsten
If you accidentally take too many tablets, seek immediate medical attention at the nearest hospital emergency department.

Missing a dose of Flecainide acetate Holsten
Take the missed dose as soon as possible, unless it is almost time for the next dose. In the latter case, you may omit the missed dose but must continue taking the medicine according to the prescribed dosing schedule. It is important to take the tablets according to the dosing regimen. If in doubt, consult your doctor.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Flecainide acetate Holsten
No withdrawal symptoms occur if you suddenly stop taking this medicine. However, heart rhythm control will no longer be maintained. For this reason, you should never discontinue treatment with this medicine without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
As with other antiarrhythmic medicines, flecainide may cause heart rhythm disorders. Existing
heart arrhythmia may worsen, or a new heart arrhythmia may occur. The effect causing
disturbances in heart rhythm (proarrhythmic effect) occurs mainly in patients with structural
heart abnormalities and (or) significantly impaired heart function.
The most commonly occurring heart-related side effects include decreased or
increased heart rate (bradycardia, tachycardia), palpitations, cardiac arrest, heart failure, chest pain,
heart attack, and reduced blood pressure (hypotension).
Other side effects may also occur, including:
Very common (may affect more than 1 in 10 patients):
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 patients):
development of a more severe type of heart rhythm disorder or increased frequency or severity of
existing rhythm disorders (proarrhythmia), shortness of breath, weakness, fatigue, fever,
fluid retention in tissues (oedema), discomfort.
Uncommon (may affect up to 1 in 100 patients):
nausea, vomiting, constipation, abdominal pain, loss of appetite, diarrhoea, indigestion, bloating,
decreased number of red blood cells, white blood cells, and platelets, increased heart rate in patients
with atrial flutter, skin allergic reactions such as rashes, hair loss, dry mouth, taste disturbances.
Rare (may affect up to 1 in 1,000 patients):
lung inflammation, skin tingling, coordination problems, difficulty controlling movements (tics),
reduced sensitivity, excessive sweating, fainting, tinnitus, tremor, vertigo, skin redness, drowsiness,
severe depression, anxiety, insomnia, headache, nerve disorders such as in upper and lower limbs,
seizures, confusion, seeing things that are not there (hallucinations), memory loss, urticaria,
increased liver enzyme activity with or without yellowing of the whites of the eyes or skin (jaundice).
Very rare (may affect up to 1 in 10,000 patients):
increased levels of certain antibodies, deposits in the cornea (small, cloudy spots on the eyeball),
increased sensitivity to light.
Not known (frequency cannot be estimated from the available data):
certain changes in ECG findings (prolongation of PR interval and QRS complex), increased threshold values in patients with a cardiac pacemaker or temporary pacing electrodes, slowed conduction between the atria and ventricles (second- or third-degree atrioventricular block), cardiac arrest, slowed or accelerated heart rate, reduced ability of the heart to pump sufficient blood to body tissues, chest pain, low blood pressure, heart attack, sensation of heart beating, interruption of normal heart rhythm (sinoatrial block), ventricular fibrillation, occurrence of a pre-existing heart condition (Brugada syndrome) that was previously asymptomatic before starting flecainide treatment, lung fibrosis or lung disease (pulmonary fibrosis and interstitial lung disease), liver disease, joint pain, and muscle pain.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Flecainide acetate Holsten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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: pregelatinized starch, corn starch, sodium croscarmellose, 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 packed in blisters made of PVC/PVDC/Aluminium foil containing 20, 30, 50 or 100 tablets, in a cardboard carton.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Netherlands Flecainide Alkaloid-INT 50 mg tabletten
Flecainide Alkaloid-INT 100 mg tabletten
Bulgaria Felkarid 50 mg tablets
Felkarid 100 mg tablets
Germany Flecainid AAA-Pharma 50 mg Tabletten
Flecainid AAA-Pharma 100 mg Tabletten
Croatia Felkarid 50 mg tablete
Felkarid 100 mg tablete
Poland Flecainide acetate Holsten
Slovenia Felkarid 50 mg tablete
Felkarid 100 mg tablete