ALMARYTM <100 MG Таблетки

Содержание инструкции

1. ALMARYTM 100 mg tablets
   1. What is Almarytm and what is it used for
   2. What you need to know before taking Almarytm
   3. How to take Almarytm
   4. Possible side effects
   5. How to store Almarytm
   6. Contents of the pack and other information

ALMARYTM 100 mg tablets

flecainide acetate

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Almarytm is and what it is used for
• 2. What you need to know before you take Almarytm
• 3. How to take Almarytm
• 4. Possible side effects
• 5. How to store Almarytm
• 6. Contents of the pack and other information

1. What is Almarytm and what is it used for

Almarytm contains the active substance flecainide acetate, belonging to the class of
medicines called “antiarrhythmics”. It works by controlling the speed and rhythm of the heart
as it inhibits the conduction of the stimulus in the heart and prolongs the period in which the heart
is at rest, bringing it back to pumping normally.
Almarytm is used in adults and adolescents over the age of 12 yearsfor:

• some forms of cardiac arrhythmias (alterations of the heart rhythm, i.e. the number of heartbeats per minute), which may potentially be life-threatening
• tachycardia (very fast heartbeat)
• atrial fibrillation/flutter (disordered and very high frequency contractions of the atria, a part of the heart).

Treatment with Almarytm tablets in patients with sustained ventricular tachycardia
must be carried out in hospital and followed by a specialist doctor.

2. What you need to know before taking Almarytm

Do not take Almarytm

• if you are allergic to flecainide acetate or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs, leading to fluid buildup in the legs, lungs and other tissues) and if you have had a heart attack
• if you have cardiogenic shock (a decrease in blood pressure with severe reduction of heart function)
• if you have a heart block (the heart misses beats)
• if you suffer from or have suffered in the past from other heart rhythm disorders
• if you suffer from Brugada syndrome (a genetic heart disease characterized by an abnormal electrocardiogram)
• if you suffer from other heart disorders other than those for which this medicine will be given to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Almarytm.
Treatment with this medicine will begin in hospital or under the supervision of a
specialist doctor if you suffer from some heart rhythm disorders (see section 3).
The doctor will avoid prescribing Almarytm:

• if you suffer from heart disease or if your heart function is abnormal;
• if you suffer from chronic atrial fibrillation (chronic and very high frequency disordered contraction of the heart atria);
• if your liver function is severely impaired.

The doctor will be particularly careful when prescribing Almarytm:

• if you suffer from heart diseases (including atrioventricular block and heart failure);
• if you have suffered from atrial fibrillation after heart surgery;
• if you suffer from a heart disease (sinus node disease) that affects the area where the heartbeat originates;
• if you have a permanent pacemaker (a device capable of electrically stimulating the contraction of your heart) or temporary heart stimulation electrodes;
• if you suffer from disorders of the balance between water and salts dissolved in the body (for example, you have a decrease or increase in potassium levels in the blood). Before you are given Almarytm, the doctor will check your salt levels and institute appropriate therapy to return the values to normal;
• if you suffer from severe bradycardia (severe reduction in heart rate) or marked hypotension (low blood pressure). Before you are given Almarytm, the doctor will check your heart rate and blood pressure, and institute appropriate therapy to return the values to normal;
• if you suffer from reduced liver and/or kidney function, because the concentration of flecainide in the blood may increase. In this case, the doctor may decide to regularly check the concentration of flecainide in the blood;
• if you are elderly, because the concentration of flecainide in the blood may increase.

Children and adolescents
Avoid giving Almarytm to children under 12 years of age, because the safety and efficacy
of this medicine have not been demonstrated.

Other medicines and Almarytm
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking:

• other antiarrhythmic medicines(medicines used to treat arrhythmias, e.g. amiodarone, verapamil, diltiazem), because the doctor will decide whether to give you Almarytm or reduce the dose to be administered;
• antihistamines(medicines used to counteract allergic reactions, e.g. mizolastine and terfenadine);
• antivirals(medicines used to treat viral infections, e.g. ritonavir alone or in combination with lopinavir and indinavir);
• antidepressants(medicines used to treat depression, e.g. fluoxetine and other tricyclic antidepressants);
• antipsychotics(medicines used to treat mental disorders, e.g. clozapine);
• antiepileptics(medicines used to treat epilepsy, e.g. phenytoin, phenobarbital, carbamazepine);
• antimalarials(medicines used to treat malaria, e.g. quinine);
• antifungals(medicines used to treat fungal infections, e.g. terbinafine);
• propranolol(medicine used for hypertension, angina pectoris and other indications);
• diuretics(medicines that help the formation and elimination of urine), laxatives(medicines that stimulate bowel movement) and corticosteroids(adrenal cortex hormones), because they can cause serious side effects on the heart due to a decrease in potassium in the blood (see section “Warnings and precautions”);
• H2 antihistamines(medicines used to treat gastric ulcers, e.g. cimetidine);
• medicines for smoking cessation(e.g. bupropion);
• cardiac glycosides(medicines used to stimulate the heart).

Almarytm with food and drink
Dairy products (milk, infant formula and possibly yogurt) can reduce the absorption
of Almarytm in children and infants. The use of Almarytm is not authorized in children
under 12 years of age, however, flecainide toxicity has been reported during
treatment in children who have decreased milk intake and in infants who
have switched from powdered milk feeding to glucose feeding.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy
Avoid taking Almarytm during pregnancy unless the benefits of this medicine
outweigh the risks.

Breastfeeding
If you are breastfeeding, the doctor will decide whether to stop breastfeeding or stop
therapy with Almarytm, taking into account the benefit of breastfeeding for the
child and the benefit of therapy for you.

Driving and operating machinery
Following the intake of Almarytm, side effects such as
dizziness or visual disturbances may occur, which reduce your reaction capacity and may
pose a danger in situations requiring concentration and attention such as
driving or operating machinery or working safely.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially
“sodium-free”.

3. How to take Almarytm

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Treatment with Almarytm 100 mg tablets should be started under the supervision of a
doctor, if necessary in a hospital environment, if:

• you suffer from certain forms of tachycardia (AV nodal reentrant tachycardia and sustained ventricular tachycardia)
• you suffer from heart rhythm disorders and have been diagnosed with a disease due to abnormal electrical conduction of the heart (Wolff-Parkinson-White syndrome).

How much

Supraventricular arrhythmia (a form of arrhythmia)
The initial dose is 50 mg every 12 hours, i.e. ½ tablet 2 times a day.
The doctor may increase the dose in increments of 50 mg, 2 times a day every 4 days, until
they deem it necessary.
The maximum dose is 300 mg, i.e. 3 tablets, per day.

Sustained ventricular tachycardia (a form of tachycardia)
The initial dose is 100 mg every 12 hours, i.e. 1 tablet 2 times a day.
The doctor may increase the dose in increments of 50 mg, i.e. ½ tablet 2 times a
day every 4 days.
The maximum dose is 400 mg, i.e. 4 tablets per day.

Paroxysmal atrial fibrillation (a form of fibrillation)
The initial dose is 50 mg, i.e. ½ tablet 2 times a day.
The doctor may increase the dose to 100 mg, i.e. 1 tablet 2 times a day.
If your symptoms do not improve, your doctor may tell you to take the tablets
every 8 hours.

If you have reduced kidney function
The doctor will assess the appropriate dose for you by monitoring flecainide levels in the blood.
The initial dose may be 100 mg once a day (or 50 mg twice a day) or 100 mg
every 12 hours, i.e. twice a day.

If you are elderly
The initial dose is 100 mg twice a day and may be reduced after the first week of
treatment.

Use in children and adolescents
Almarytm is not recommended in children under 12 years of age, as there is
insufficient evidence of its use in this age group.
The tablet can be divided into equal parts.

If you take more Almarytm than you should
If you take more Almarytm than you should, consult your doctor immediately or go to the nearest
hospital, as you may experience even serious side effects:

• heart conduction disturbances
• reduction of heart rate and contraction
• decrease in blood pressure
• rapid reduction of respiratory function and cessation of heartbeat which can lead to death. The doctor will establish appropriate treatment and adopt the necessary support measures.

If you forget to take Almarytm
Do not take a double dose to make up for a missed dose.

If you stop taking Almarytm
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone who receives it will experience them.
If you experience the following serious side effects during treatment with Almarytm, inform your doctor immediatelywho will assess whether to discontinue treatment:

• alteration of the heart's rhythm if you have not had surgical operation where a "pacemaker" has been applied to your heart;
• alterations in the electrocardiogram (ECG) (a test to assess heart function) which may indicate Brugada syndrome;
• yellowing of the skin and whites of the eyes, apparently without reason, or signs of impaired liver function (e.g. increased liver enzymes, substances present in the liver);
• blood disorders (haematological dyscrasias).

The following side effects have been observed and reported during treatment with Almarytm, according to the following frequency:

Very common(may affect more than 1 in 10 people):

• dizziness, usually transient
• visual disturbances, such as double or blurred vision

Common(may affect up to 1 in 10 people):

• development of a more serious type of arrhythmia or an increase in the frequency or severity of a pre-existing arrhythmia (proarrhythmia)
• shortness of breath (dyspnea)
• lack of strength (asthenia)
• fatigue
• fever
• fluid retention in the tissues (edema)
• malaise

Uncommon(may affect less than 1 in 100 people):

• decrease in red blood cells, white blood cells or platelets
• inability to achieve an erection (impotence)
• changes in personality (depersonalization)
• decreased sexual desire (decreased libido)
• feeling of excessive well-being (euphoria)
• increased dreaming (increased dream activity)
• inability to participate or interest (apathy)
• stupor
• eye irritation
• discomfort caused by light (photophobia)
• rapid and repetitive eye movements (nystagmus)
• increased blood pressure (hypertension)
• irregular heartbeat with increased heart rate
• narrowing of the bronchi with difficulty breathing (bronchospasm)
• nausea
• vomiting
• constipation
• abdominal pain
• loss of appetite
• diarrhea
• difficulty digesting (dyspepsia)
• excessive gas formation in the stomach or intestines (flatulence)
• dry mouth
• altered taste
• itching
• skin inflammation with detachment of superficial scales (exfoliative dermatitis)
• skin inflammation due to allergy (allergic dermatitis), including skin rash
• hair loss or thinning (alopecia)
• joint pain (arthralgia)
• muscle pain (myalgia)
• increased urine production (polyuria)
• inability of the urinary bladder to empty completely (urinary retention)
• swollen lips, tongue, and mouth

Rare(may affect less than 1 in 1,000 people):

• seeing, hearing or perceiving things that are not there (hallucinations)
• depression
• confusion
• anxiety
• memory loss (amnesia)
• sleep disorders (insomnia)
• altered sensitivity of the limbs or other parts of the body (paresthesia)
• reduced motor coordination and gait (ataxia)
• decreased sensitivity (hypoesthesia)
• excessive sweating (hyperhidrosis)
• loss of consciousness due to circulatory and respiratory disorders (syncope)
• tremor
• sudden feeling of warmth (hot flushes)
• drowsiness
• headache
• peripheral nerve damage (peripheral neuropathy)
• involuntary body movements (convulsions)
• difficulty with movements (dyskinesia)
• inability to move (paresis)
• speech disorders
• involuntary contractions
• ringing or buzzing in the ears (tinnitus)
• vertigo
• lung inflammation (pneumonia)
• increased liver enzymes with or without jaundice (yellowing of the skin and whites of the eyes)
• severe urticaria

Very rare(may affect less than 1 in 10,000 people):

• increased levels of certain antibodies which may indicate an autoimmune disease, with or without systemic inflammation in the body
• deposits on the surface of the eye (corneal deposits)
• reactions following exposure of the skin to light (photosensitivity reactions)

Not known(frequency cannot be estimated from available data)

• changes in the electrocardiogram
• change in the stimulation threshold in patients with pacemakers or temporary stimulation electrodes
• severe alteration of the heart's electrical conduction system (second and third degree atrioventricular block)
• cardiac arrest
• slow heart rate (bradycardia)
• loss of the heart's ability to pump enough blood to the body's tissues (heart failure/congestive heart failure)
• chest pain
• low blood pressure (hypotension)
• heart attack (myocardial infarction)
• feeling of heartbeats (palpitations)
• pause in the normal heart rhythm (sinus arrest)
• fast heartbeat (tachycardia)
• lack of coordination of the ventricles of the heart (ventricular fibrillation)
• appearance of a certain heart disease pre-existing that had not been diagnosed before treatment (unmasking of a pre-existing Brugada syndrome)
• lung injury (pulmonary fibrosis)
• lung disease that causes difficulty breathing (interstitial lung disease)
• liver dysfunction

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Almarytm

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Almarytm contains

• The active ingredient is flecainide acetate. Each tablet contains 100 mg of flecainide acetate.
• The other ingredients are: pregelatinized starch, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate, sodium croscarmellose.

Description of the appearance of Almarytm and contents of the pack
It is presented as divisible tablets for oral use, white, round, biconvex with a fracture
line, packaged in blisters of 20, 30 or 60 tablets.
The tablet can be divided into equal doses.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN,
Ireland

Manufacturer
Mylan Hungary Kft, Mylan utca 1 - Komárom, H-2900, Hungary