Flecainide acetate holsten

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Flecainide acetate Holsten (Felkarid), 50 mg, tablets
Flecainidi acetas
Flecainide acetate Holsten and Felkarid are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

Flecainide acetate Holsten belongs to a group of medicines that act against heart rhythm disorders
(known as antiarrhythmic agents). This medicine inhibits the conduction of electrical impulses in the heart and prolongs the time during which the heart remains at rest, thereby helping the heart to pump blood properly again.
Flecainide acetate Holsten is used:

• in the treatment of certain severe heart rhythm disorders, which often manifest as strong palpitations or tachycardia (rapid heartbeat);
• in the treatment of severe heart rhythm disorders which have not responded well to other medicines, or when other medicines are not tolerated.

2. 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 wishes to obtain more 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 concentration;
• 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 experienced arrhythmias after heart surgery;
• if the patient has previously had severe bradycardia (slow heartbeat) or markedly low blood pressure. These conditions should be corrected before starting treatment with this medicine;
• if the patient has previously had a myocardial infarction (heart attack).

Abnormal blood potassium levels (high or low) may affect the action of this medicine. Diuretics, drugs stimulating intestinal peristalsis (laxatives), and corticosteroids (adrenal cortex hormones) may reduce 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
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Drug interactions may occur, for example, when this medicine is taken together with the following:

• digoxin (a medicine that stimulates heart function); flecainide may increase digoxin blood levels;
• medicines that reduce the force of myocardial contraction (e.g. propranolol), known as beta-blockers;
• certain antiepileptic drugs (such as phenytoin, phenobarbital, and carbamazepine); these drugs may accelerate the metabolism of flecainide;
• 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, known as "tricyclic antidepressants");
• clozapine, haloperidol, and risperidone (medicines used to treat schizophrenia, also known as neuroleptics);
• mizolastine, astemizole, and terfenadine (medicines used to treat allergies);
• quinidine 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 (adrenal cortex hormones): regular monitoring of blood potassium levels may be necessary;
• sodium channel blockers (class I antiarrhythmic drugs), 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 support smoking cessation).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
This medicine may be used during pregnancy only if the benefits outweigh the risks, as flecainide crosses the placenta in patients taking flecainide during pregnancy. Flecainide blood levels should be monitored in the mother if used during pregnancy. Consult a doctor as soon as pregnancy is suspected or when planning a pregnancy.
Flecainide acetate Holsten passes into breast milk. This medicine may 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, reaction time may be prolonged. This may be dangerous in situations requiring concentration and attention, such as 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, meaning it is considered "sodium-free".

3. How to take Flecainide acetate Holsten

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Flecainide acetate Holsten is available in 50 mg and 100 mg strengths.
Your doctor will determine the individual dose. Treatment with this medicine is usually initiated
under medical supervision (if necessary, in a hospital setting). During treatment with this medicine,
you must strictly follow your doctor's instructions.
Take the tablets 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 arrhythmias originating in the atria,
the recommended dose is 50 mg twice daily. If necessary, your doctor may increase the dose up to
the maximum daily dose of 300 mg.
For patients with ventricular arrhythmias,
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 those 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. 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
In 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 concurrently treated 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 recommend a lower dose for some
patients.
During treatment, your doctor will regularly monitor flecainide blood levels and perform
electrocardiograms (ECG). A basic ECG should be performed monthly, and a more detailed ECG
every three months. During the initial treatment phase and dose escalation, ECGs should be
performed every 2–4 days.
More frequent ECG monitoring is required for patients receiving doses lower than usually
recommended. Your doctor may adjust the dose at intervals of 6–8 days. In such cases, ECGs
should be performed 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.
If you take more Flecainide acetate Holsten than recommended
If you accidentally take too many tablets, seek immediate medical attention at the nearest hospital
emergency department.
If you forget to take 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 skip the missed dose, but you must continue taking the medicine according to the
prescribed dosing schedule. It is important to take the tablets as directed. If in doubt, consult your
doctor.
Do not take a double dose to make up for a missed dose.
If you stop taking Flecainide acetate Holsten
There are no withdrawal symptoms if this medicine is stopped abruptly. However, heart rhythm
control will no longer be maintained. Therefore, you should never stop taking 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 gets them.
As with other antiarrhythmic medicines, flecainide may cause heart rhythm disorders. Existing
arrhythmias may worsen or new arrhythmias may occur. The proarrhythmic effect (a side effect that
induces disturbances in heart rhythm) occurs mainly in patients with structural heart abnormalities
and (or) significantly impaired heart function.

The most commonly occurring cardiac 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 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):
occurrence 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 people):
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 people):
lung inflammation, skin tingling, coordination problems, difficulty controlling movements (tics),
reduced sensitivity, excessive sweating, fainting, tinnitus, tremor, labyrinthine dizziness, skin
flushing, drowsiness, severe depression, anxiety, insomnia, headache, nerve disorders, for example
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 people):
increased levels of certain antibodies, deposition of deposits in the cornea (small, cloudy spots on
the eyeball), increased light sensitivity.

Unknown (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 cardiac pacemakers 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 the
body tissues, chest pain, low blood pressure, heart attack, sensation of heartbeats, interruption of
normal heart rhythm (sinus pause), ventricular fibrillation, emergence of a pre-existing heart
condition (Brugada syndrome) that was previously asymptomatic before starting flecainide therapy,
pulmonary fibrosis or lung disease (pulmonary fibrosis and interstitial lung disease), liver disease,
joint pain, and muscle pain.

Reporting of side effects
If you experience any side effects, including any possible side effects not listed in this leaflet,
please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of
the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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 packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 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
White or almost white, round, biconvex tablets with a diameter of 7 mm.
Flecainide acetate Holsten tablets are packed in blisters made of PVC/PVDC/Aluminium foil containing 20, 30, 50 or 100 tablets, in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Croatia, the country of export:
Alkaloid-INT d.o.o.
Šlandrova ulica 4, 1231 Ljubljana Črnuče, Slovenia
Manufacturer:
Alkaloid-INT d.o.o.
Šlandrova ulica 4, 1231 Ljubljana Črnuče, Slovenia
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Croatia, the country of export: HR-H-193649941-01
Parallel Import Authorisation number: 71/26
This medicinal product is authorised in the European Economic Area under the following names:
Netherlands: Flecainide Alkaloid-INT 50 mg tabletten
Bulgaria: Felkarid 50 mg tablets
Germany: Flecainid AAA-Pharma 50 mg Tabletten
Croatia: Felkarid 50 mg tablete
Poland: Flecainide acetate Holsten
Slovenia: Felkarid 50 mg tablete