Flecainide acetate holsten

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Flecainide acetate Holsten (Felkarid), 100 mg, tablets
Flecainidi acetas
Flecainide acetate Holsten and Felkarid are different brand names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 used to treat abnormal heart rhythms
(known as antiarrhythmics). This medicine slows down the conduction of electrical impulses in the heart and prolongs the resting phase of the heart, helping the heart to pump blood properly again.
Flecainide acetate Holsten is used:

• to treat certain serious heart rhythm disorders, often experienced as strong palpitations or tachycardia (rapid heartbeat);
• to treat serious 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 wishes 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 to take Flecainide acetate Holsten, discuss this with a 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 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, drugs stimulating peristalsis (laxatives), and corticosteroids (adrenal cortex hormones) may reduce potassium levels. In such cases, the doctor should check the blood potassium level.
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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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 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, so-called "tricyclic antidepressants");
• clozapine, haloperidol and risperidone (medicines used to treat schizophrenia, also called 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 (adrenal cortex hormones): 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
child, she should consult a 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 patients taking flecainide during pregnancy. When flecainide is used during pregnancy, flecainide levels in the mother should be monitored. 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, or if the patient has dizziness, this may prolong the patient's reaction time.
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 a doctor.
Flecainide acetate Holsten contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine 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 usually begins under
medical supervision (if necessary, in a hospital setting). While taking this medicine, it is essential to
follow your doctor's instructions precisely.
Take the tablets by swallowing them with a sufficient amount of liquid (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 of the heart, 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 used in patients with a large body build or
in 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. If necessary, your doctor may reduce the
dose during long-term treatment.
In 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 renal impairment
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 hepatic impairment
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 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 will be performed monthly, and a more detailed ECG every
three months. ECGs will be performed every 2–4 days at the beginning of treatment and during dose
escalation.
ECGs should be performed more frequently in patients receiving doses lower than usually
recommended. Your doctor may adjust the dose every 6–8 days. In such cases, ECGs should be
performed during the 2nd and 3rd weeks 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 Flecainide acetate Holsten than prescribed
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 you must continue taking the medicine according to the
prescribed 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.
Stopping Flecainide acetate Holsten
There are no withdrawal symptoms if you stop taking this medicine suddenly. However, heart
rhythm will no longer be controlled. Therefore, you should never stop taking this medicine without
consulting your doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Similarly to other antiarrhythmic medicines, flecainide may cause heart arrhythmia. 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) significant impairment of 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 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):
development of a more severe type of heart rhythm disorder or increased frequency or severity of
existing heart 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 skin 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, vestibular dizziness, skin
flushing, drowsiness, severe depression, anxiety, insomnia, headache, nerve disorders such as in
the upper and lower limbs, seizures, confusion, seeing things that are not there (hallucinations),
memory loss, urticaria, increased activity of liver enzymes 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 sensitivity to light.
Not known (frequency cannot be estimated from the available data):
certain changes in ECG examination (prolongation of PR interval and QRS complex), increased
threshold values in patients with cardiac pacemakers or temporary pacing electrodes, slowing of
conduction between the atria and ventricles of the heart (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
pounding heartbeat, interruption in normal heart rhythm (sinus pause), ventricular fibrillation,
emergence of a pre-existing heart condition (Brugada syndrome) that was asymptomatic before
starting treatment with flecainide, pulmonary fibrosis or lung disease (interstitial lung disease),
liver disease, joint pain and muscle pain.
Reporting of side effects
If any adverse effects occur, including any possible side effects not listed in this leaflet, 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 the 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 packaging. The expiry date refers to the last day of the stated month.
No special storage conditions 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 100 mg of flecainide acetate.
• The other ingredients are: pregelatinized starch (corn), 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 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 of PVC/PVDC/Aluminium 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 in:
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-144132696-01
Parallel import licence number: 70/26
This medicinal product is authorised for sale in the European Economic Area under the following names:
Netherlands Flecainide Alkaloid-INT 100 mg tabletten
Bulgaria Felkarid 100 mg tablets
Germany Flecainid AAA-Pharma 100 mg Tabletten
Croatia Felkarid 100 mg tablete
Poland Flecainide acetate Holsten
Slovenia Felkarid 100 mg tablete