Amarhiton

Leaflet attached to the packaging: patient information

Amarhyton, 50 mg, prolonged-release hard capsules

Amarhyton, 100 mg, prolonged-release hard capsules

Flecainide acetate

Read the leaflet carefully before taking the medicine.

• 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 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 leaflet, please inform 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 pack 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:

• in 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 have not responded 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 for additional information, consult your 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, 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, your doctor may recommend regular determination of 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, your doctor may recommend determining potassium levels 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 with reduced milk intake, as well as in infants who were fed dextrose instead of milk.

Amarhyton and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
When taking other medicines with Amarhyton, they may interact with each other and (or) cause side effects (i.e., interactions may occur).
Interactions may occur with the following medicines:

• digoxin (a heart stimulant) - Amarhyton may increase digoxin levels in the blood;
• medicines that weaken heart contractions, such as beta-adrenergic blockers;
• certain anti-epileptic medicines (e.g., phenytoin, phenobarbital, and carbamazepine) - these substances may accelerate the breakdown of flecainide;
• cimetidine (a stomach acid neutralizer) - 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 other antidepressants);
• clozapine (a medicine used to treat schizophrenia);
• mizolastine, astemizole, and terfenadine (anti-allergic medicines);
• quinine and halofantrine (anti-malarial medicines);
• verapamil (a blood pressure lowering medicine);
• 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 (for 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 meals.
Dairy products (milk, infant formula, and possibly yogurt) may reduce flecainide absorption in children and infants. Amarhyton is not intended for use in children under 12 years of age.
Flecainide toxicity has been reported in children with reduced milk intake, as well as in infants who were fed dextrose instead of milk.

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, flecainide levels in the blood should be monitored. You should inform your doctor immediately 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, consult your 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 reaction ability may be impaired. This can be dangerous in situations that require concentration and attention, such as driving vehicles, operating machines, or working at heights. If in doubt whether Amarhyton affects your ability to drive, consult your doctor.

3. How to take Amarhyton

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will recommend an individual dose for you, tailored to your condition.
Treatment with Amarhyton usually starts under medical supervision (if necessary, in a hospital). While taking Amarhyton, follow your doctor's instructions carefully.
If in doubt, consult your doctor or pharmacist.
Method of administration
Swallow the capsule 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. Your doctor may increase the dose up to a maximum of 400 mg per day.
Elderly patients
Your doctor may recommend a lower dose. In elderly patients, do not use a dose higher than 300 mg per day.
Patients with kidney or liver function disorders
Your doctor may recommend a lower dose.
Patients with a permanent pacemaker
Do not use a dose higher than 200 mg per day.
Patients treated with cimetidine (a stomach acid neutralizer) or amiodarone (a heart rhythm disorder medicine)
Your doctor will regularly examine you, and some patients may be recommended a lower dose.
During treatment, your doctor will recommend regular determination of flecainide levels in the blood and electrocardiographic examination (ECG) of the heart. A simplified ECG should be performed once a month, and a full ECG once every three months. At the beginning of treatment and during dose increase, an ECG should be performed every 2 to 4 days.
ECG should be performed more frequently in patients receiving a lower dose than usual. Your doctor may adjust the dose at intervals of 6 to 8 days. In these patients, an ECG will be performed in the 2nd and 3rd week after starting treatment.

Use in children

Do not use this medicine in children under 12 years of age.

Taking a higher dose of Amarhyton than recommended

If you suspect an overdose, inform your doctor immediately.

Missing a dose of Amarhyton

Take the missed dose as soon as you remember, unless it is close to the time for the next dose. In this case, skip the missed dose and take the next dose at the usual time. It is important to take the medicine as recommended by your doctor. If in doubt, consult your doctor.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Amarhyton

If you stop taking Amarhyton suddenly, withdrawal symptoms will not occur. However, heart rhythm disorders will no longer be controlled as intended. Do not stop taking the 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, 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, contact your doctor immediately:
Common (affects at least 1 in 100 people):

• 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 (affects at least 1 in 10,000 people):

• 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).

As with 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 (affects at least 1 in 10 people):

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

Common (affects at least 1 in 100, but less than 1 in 10 people):

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

Uncommon (affects at least 1 in 1,000, but less than 1 in 100 people):

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

Rare (affects at least 1 in 10,000, but less than 1 in 1,000 people):

• pneumonia;
• tingling sensation on the skin ("pins and needles");
• coordination disorders;
• involuntary, repetitive movements (tics);
• reduced sensitivity;
• increased sweating;
• transient loss of consciousness;
• tremors;
• vertigo (dizziness 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 (affects less than 1 in 10,000 people):

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

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;
• perception of heart activity (palpitations);
• pause in normal heart rhythm (sinus arrest);
• life-threatening heart rhythm disorders (ventricular flutter);
• exposure of a previously existing heart disease (Brugada syndrome), which was not observed before treatment with this medicine;
• scarring of the lungs or lung diseases (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, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 storage.
Keep this medicine out of the 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. 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 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);
Silica, colloidal, anhydrous;
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 pack

Amarhyton 50 mg prolonged-release hard capsules are opaque, white, size 4 gelatin capsules with a white body and white cap, containing white or almost white, round mini-tablets.
Amarhyton 100 mg prolonged-release hard capsules are opaque, size 3 gelatin capsules 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: [email protected]

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: