Amarhiton

Leaflet attached to the packaging: patient information

Amarhyton, 50 mg, prolonged-release hard capsules

Amarhyton, 100 mg, prolonged-release hard capsules

Flecainide acetate

You should carefully read the contents of the leaflet before taking the medicine.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Amarhyton and what is it used for

Amarhyton, in the form of prolonged-release hard capsules, belongs to a group of medicines that counteract heart rhythm disorders (called anti-arrhythmic medicines). It slows down the conduction of stimuli in the heart and prolongs the resting time of the heart, causing the heart to pump blood properly again.
Amarhyton is used:

• for certain severe heart rhythm disorders that often manifest as severe palpitations or rapid heart rate (tachycardia);
• in cases of severe heart rhythm disorders (arrhythmia) that do not respond to treatment with other medicines or when other treatments are not tolerated;
• in cases of severe atrial heart rhythm disorders, if other treatments are not effective.

2. Important information before taking Amarhyton

When not to take Amarhyton

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

Warnings and precautions

Before starting to take Amarhyton, you should discuss it with your doctor:

• if you have liver or kidney function disorders, as the flecainide concentration in the blood may increase - in such cases, the doctor may recommend regular determination of the flecainide concentration in the blood;
• if you are elderly, as the flecainide concentration in the blood may increase;
• if you have a permanent pacemaker or temporary stimulating electrodes;
• if you have had heart rhythm disorders after heart surgery;
• if you have significant bradycardia (slow heart rate) or severe hypotension (low blood pressure) - these disorders should be corrected before taking Amarhyton;
• if you have had a heart attack.

Decreased or increased potassium levels in the blood may affect the action of Amarhyton.
Diuretics, laxatives, and adrenal cortex hormones (corticosteroids) may decrease potassium levels in the blood. In such cases, the doctor may recommend determining the potassium level in the blood.

Children under 12 years of age

Amarhyton is not intended for use in children under 12 years of age. Flecainide toxicity has been reported in children who have reduced milk intake, as well as in infants who have been switched from milk to dextrose feeding.

Amarhyton and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
When taking other medicines with Amarhyton, the medicines may interact with each other and (or) cause side effects (i.e., interactions may occur).
During treatment with this medicine, interactions may occur with such medicines as:

• digoxin (a heart-stimulating medicine) - Amarhyton may increase the digoxin concentration in the blood;
• medicines that weaken heart contractions, such as beta-adrenolytics;
• certain anti-epileptic medicines (e.g., phenytoin, phenobarbital, and carbamazepine) - these substances may accelerate the breakdown of flecainide;
• cimetidine (a medicine that neutralizes stomach acid) - may enhance the action of Amarhyton;
• amiodarone (used in heart diseases) - in some patients, the dose of Amarhyton may need to be reduced;
• antidepressants (paroxetine, fluoxetine, and some other antidepressants);
• clozapine (a medicine used in the treatment of schizophrenia);
• mizolastine, astemizole, and terfenadine (medicines used to treat allergies);
• quinine and halofantrine (medicines used to treat malaria);
• verapamil (a medicine that lowers blood pressure);
• quinidine (an anti-arrhythmic medicine);
• medicines used to treat HIV infections (ritonavir, lopinavir, and indinavir);
• diuretics, such as thiazides and loop diuretics;
• disopyramide (an anti-arrhythmic medicine) - do not take Amarhyton if you are also taking disopyramide;
• terbinafine (used to treat fungal infections);
• bupropion (used to treat nicotine addiction).

Amarhyton with food and drink

Amarhyton in the form of prolonged-release hard capsules should be taken on an empty stomach or at least one hour before a meal.
Dairy products (milk, infant formula, and possibly yogurt) may reduce the absorption of flecainide in children and infants. Amarhyton is not intended for use in children under 12 years of age.
Flecainide toxicity has been reported in children who have reduced milk intake, as well as in infants who have been switched from milk to dextrose feeding.

Pregnancy and breastfeeding

Amarhyton should be used during pregnancy only if the benefits outweigh the risks, as flecainide has been shown to cross the placenta in patients taking flecainide during pregnancy. If Amarhyton is used during pregnancy, the flecainide concentration in the blood should be monitored. You should immediately inform your doctor if you become pregnant, suspect you are pregnant, or plan to become pregnant.
Flecainide passes into breast milk. Amarhyton should be used during breastfeeding only if the potential benefits are greater than the potential risks.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience side effects such as dizziness, double vision, blurred vision, or a feeling of "emptiness" in the head, your ability to react may be impaired. This may be dangerous in situations that require concentration and attention, such as driving vehicles, operating machines, or working at heights. If you are unsure whether Amarhyton affects your ability to drive, you should consult a doctor.

3. How to take Amarhyton

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult a doctor or pharmacist.
The doctor will prescribe an individual dose for each patient, adjusted to the existing disorders.
Treatment with Amarhyton usually starts under the supervision of a doctor (if necessary, in a hospital). While taking Amarhyton, you should strictly follow the doctor's instructions.
If you are unsure, you should consult a doctor or pharmacist.
Method of administration
You should swallow the capsule, washing it down with a sufficient amount of liquid (e.g., water). The daily dose is usually taken in divided doses, on an empty stomach or at least one hour before meals.
The usual initial dose is 100 mg to 200 mg. The doctor may increase the dose to a maximum of 400 mg per day.
Elderly patients
The doctor may prescribe a lower dose. In elderly patients, the dose should not exceed 300 mg per day.
Patients with kidney or liver function disorders
The doctor may prescribe a lower dose.
Patients with a permanent pacemaker
The dose should not exceed 200 mg per day.
Patients treated with cimetidine (a medicine for stomach disorders) or amiodarone (a medicine for heart rhythm disorders)
The doctor will regularly examine the patient, and some patients may be prescribed a lower dose.
During treatment, the doctor will prescribe regular determination of the flecainide concentration in the blood and electrocardiographic examination (ECG) of the heart. A simplified ECG examination should be performed once a month, and a full examination once every three months. At the beginning of treatment and during dose increases, an ECG examination should be performed every 2 to 4 days.
ECG examinations should be performed more frequently in patients receiving lower doses than usual. The doctor may adjust the dose at intervals of 6 to 8 days. In these patients, an ECG examination will be performed in the 2nd and 3rd week after starting treatment.

Use in children

This medicine should not be used in children under 12 years of age.

Taking a higher dose of Amarhyton than recommended

If you suspect an overdose, you should immediately inform your doctor.

Missing a dose of Amarhyton

You should take the missed dose as soon as you remember, unless it is almost time for the next dose. In this case, you should skip the missed dose and take the next dose at the usual time. It is important to take the medicine as prescribed by your doctor. If you are unsure, you should consult a doctor.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Amarhyton

If you suddenly stop taking Amarhyton, you will not experience withdrawal symptoms. However, your heart rhythm disorders will no longer be controlled as intended. You should not stop taking the medicine without consulting your doctor.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Amarhyton can cause side effects, although not everybody gets them.
Some side effects may be serious. If you experience any of the following side effects, you should immediately contact your doctor:
Common (affecting at least 1 in 100 patients):

• heart rhythm disorders: palpitations, accelerated or slowed heart rate;
• chest pain;
• shortness of breath or other breathing or lung disorders;
• fever, flushing, or sweating;
• fainting or feeling faint.

Rare (affecting at least 1 in 10,000 patients):

• tinnitus;
• jaundice (yellowing of the skin and eyes);
• seizures (convulsions).

Other side effects (frequency not known):

• heart attack;
• heart failure/ cardiac arrest (respiratory arrest, loss of consciousness, and cardiac arrest).

Similarly to other anti-arrhythmic medicines, flecainide may cause heart rhythm disorders.
Existing arrhythmia may worsen or a new arrhythmia may occur. The risk of pro-arrhythmic action is highest in patients with organic heart disease and (or) significant heart function disorders.
Other side effects that may occur are:

Very common (affecting at least 1 in 10 patients):

• dizziness;
• feeling of "emptiness" in the head;
• vision disorders, such as double vision, blurred vision, and difficulty focusing.

Common (affecting at least 1 in 100, but less than 1 in 10 patients):

• shortness of breath;
• weakness;
• fatigue;
• fever;
• fluid accumulation in tissues (edema) and discomfort;
• low blood pressure (hypotension).

Uncommon (affecting at least 1 in 1,000, but less than 1 in 100 patients):

• nausea;
• vomiting;
• constipation;
• abdominal pain;
• anorexia;
• diarrhea;
• indigestion (upper abdominal pain, feeling of fullness);
• bloating;
• decreased red blood cell count (which may cause pale skin and weakness or shortness of breath);
• decreased white blood cell count (which may cause susceptibility to infections);
• decreased platelet count (which may cause bleeding or easy bruising);
• skin allergic reactions, such as rash and hair loss.

Rare (affecting at least 1 in 10,000, but less than 1 in 1,000 patients):

• pneumonia;
• tingling sensation on the skin ("pins and needles");
• coordination disorders;
• involuntary, repetitive movements (tics);
• decreased sensitivity;
• increased sweating;
• transient loss of consciousness;
• tremors;
• feeling of spinning (vertigo of labyrinthine origin);
• sudden flushing of the skin (especially face and neck);
• drowsiness;
• severe depression;
• anxiety;
• insomnia (difficulty sleeping);
• headache;
• nerve disorders, e.g., in arms and legs;
• seizures;
• confusion;
• hallucinations;
• memory loss (amnesia);
• hives;
• increased liver enzyme activity with or without jaundice (yellowing of the eyes and skin).

Very rare (affecting less than 1 in 10,000 patients):

• increased levels of certain antibodies (detected in blood tests);
• presence of deposits in the cornea;
• increased sensitivity to light.

Unknown (frequency cannot be estimated from available data):

• certain changes in the electrocardiogram (prolongation of the PR and QRS intervals);
• increased stimulation threshold in patients with a pacemaker or temporary stimulating electrodes;
• disorders of conduction between the atria and ventricles (second- and third-degree atrioventricular block);
• cardiac arrest;
• feeling of heartbeats (palpitations);
• pause in normal heart rhythm (sinus arrest);
• life-threatening heart rhythm disorders (ventricular fibrillation);
• revelation of a pre-existing heart disease (Brugada syndrome), which was not observed before treatment with this medicine;
• scarring of the lungs or lung disease (pulmonary fibrosis and interstitial lung disease);
• liver function disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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 181C, 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 Amarhyton

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amarhyton contains

The active substance is flecainide acetate.

• Amarhyton 50 mg, prolonged-release hard capsules: each capsule contains 50 mg of flecainide acetate.
• Amarhyton 100 mg, prolonged-release hard capsules: each capsule contains 100 mg of flecainide acetate.

Other ingredients:
Mini-tablet core:
Povidone K-25;
Microcrystalline cellulose;
Crospovidone (type A);
Colloidal anhydrous silica;
Magnesium stearate,
Mini-tablet coating:
Methacrylic acid and methyl methacrylate copolymer (1:2);
Macrogol 400;
Talc.
The coatings of different capsules contain the following ingredients:
50 mg: gelatin, titanium dioxide (E171)
100 mg: gelatin, titanium dioxide (E171), and iron oxide black (E172).

What Amarhyton looks like and contents of the packaging

Amarhyton 50 mg prolonged-release hard capsules are opaque gelatin capsules, size 4, with a white body and white cap, containing white or almost white round mini-tablets.
Amarhyton 100 mg prolonged-release hard capsules are opaque gelatin capsules, size 3, with a gray body and white cap, containing white or almost white round mini-tablets.
Blisters of PVC/PVDC/Aluminum with 28 or 30 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Swyssi AG
14 Lyoner Strasse,
60528 Frankfurt am Main,
Germany
Tel. +49 69 66554 162
Email: info@swyssi.com

The medicinal product has been authorized in the Member States of the European Economic Area (EEA) under the following names:

Portugal
Amarhyton 50 mg, cápsula de libertação prolongada, duras
Amarhyton 100 mg, cápsula de libertação prolongada, duras
Austria
Amarhyton 50 mg, Hartkapseln, retardiert
Amarhyton 100 mg, Hartkapseln, retardiert
Czech Republic
Amarhyton 50 mg, tobolky s prodlouženým uvolňováním, tvrdé
Amarhyton 100 mg, tobolky s prodlouženým uvolňováním, tvrdé
Greece
Amarhyton 50 mg, καψάκιο παρατεταμένης αποδέσμευσης, σκληρά
Amarhyton 100 mg, καψάκιο παρατεταμένης αποδέσμευσης, σκληρά
Poland
Amarhyton 50 mg, kapsułki o przedłużonym uwalnianiu, twarde
Amarhyton 100 mg, kapsułki o przedłużonym uwalnianiu, twarde
Romania
Amarhyton 50 mg capsule cu eliberare prelungită, greu
Amarhyton 100 mg capsule cu eliberare prelungită, greu
Slovakia
Amarhyton 50 mg kapsuly s predĺženým uvoľňovaním, tvrdé
Amarhyton 100 mg kapsuly s predĺženým uvoľňovaním, tvrdé

Date of last revision of the leaflet: