FLEIDERINA 50 mg Твердые Капсулы, Пролонгированного Действия

Содержание инструкции

1. What is FLEIDERINA and what is it used for
2. What you need to know before taking FLEIDERINA
3. How to take Fleiderina
4. Possible side effects
5. How to store Fleiderina
6. Package Contents and Other Information

FLEIDERINA 50 mg prolonged-release hard capsules
FLEIDERINA 100 mg prolonged-release hard capsules
FLEIDERINA 150 mg, prolonged-release hard capsules
FLEIDERINA 200 mg, prolonged-release hard capsules
Flecainide acetate

Read this leaflet carefully before taking this medicine because 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 only for you. Do not give it to other people, even if
their symptoms are the same as yours, as it could be dangerous
If any side effects occur, including those not listed in this
leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is FLEIDERINA and what is it used for

Fleiderina prolonged-release hard capsules belongs to a group of medicines that act
against cardiac arrhythmia (known as antiarrhythmics). 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 pump normally.
Fleiderina prolonged-release hard capsules is used:

• for some serious cardiac arrhythmias, which often manifest with severe heart palpitations or tachycardia.
• for serious cardiac arrhythmias that have not responded well to treatment with other medicines, or when other treatments cannot be tolerated.

2. What you need to know before taking FLEIDERINA

Do not take Fleiderina:
If you are allergicto flecainideor to any of the other ingredientsof this medicine (listed in
section 6)
If you suffer from other heart conditions, different from the one for which you are taking this medicine. If you are not
sure or if you want more information, contact your doctor or pharmacist
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If you are taking certain other antiarrhythmic drugs (sodium channel blockers) at the same time
If you suffer from Brugada syndrome (a genetic heart disease).

Warnings and precautions
Talk to your doctor before taking Fleiderina:

• If you suffer from reduced liver and/or kidney function, as the concentration of flecainide in the blood may increase. In this case, your doctor will need to regularly check the concentration of flecainide in your blood,
• If you are elderly, as the concentration of flecainide in the blood may increase,
• If you have a permanent pacemaker or temporary stimulating electrodes,
• If you have experienced heart arrhythmias after heart surgery,
• If you suffer from severe bradycardia or pronounced hypotension. These conditions must be corrected before using Fleiderina,
• If you have had heart attacks.

A decrease or increase in blood potassium levels can affect the effect of
flecainide. Diuretics, medicines that stimulate bowel movements (laxatives) and adrenal corticosteroids (corticosteroids) can reduce blood potassium levels. In this case, the
doctor will need to monitor blood potassium levels.

Children under 12 years of age
Flecainide, the active substance of this medicinal product, is not approved for use in
children under 12 years of age. Nevertheless, signs of toxicity have been observed during
treatment with flecainide in children who had reduced their intake of dairy products. If your doctor
has prescribed flecainide to your child, make sure that the child's consumption of dairy products (e.g. milk, infant formula, yogurt) remains stable during treatment. Consult your doctor before
making any changes in your child's dairy consumption.

Other medicines and Fleiderina
If you are taking other medicines together with Fleiderina, it is possible that they will influence the way it works and/or its
side effects (i.e. interactions may occur).
Interactions may occur when using this medicine with, for example:

• digoxin (a medicine that stimulates the heart); Fleiderina may increase the level of digoxin in the blood,
• medicines that reduce the pumping function of the heart, such as those known as beta-blockers (e.g. propranolol)
• some medicines against epilepsy (e.g. phenytoin, phenobarbital and carbamazepine): the degradation of flecainide may be accelerated by these substances;
• cimetidine (an antacid); may increase the effect of Fleiderina,
• amiodarone (for heart conditions); the dose of flecainide may need to be reduced in some patients,

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• medicines against depression (paroxetine, fluoxetine and some other antidepressants),
• clozapine (a medicine used to treat schizophrenia),
• mizolastine, astemizole and terfenadine (medicines against allergies),
• quinine and halofantrine (medicines against malaria),
• verapamil (to reduce blood pressure),
• quinidine,
• medicines for the treatment of HIV infections (ritonavir, lopinavir and indinavir),
• thiazides and loop diuretics,
• disopyramide (an antiarrhythmic); do not use Fleiderina if you are also taking disopyramide.
• terbinafine (for the treatment of fungal infections),
• bupropion (smoking cessation medication).

Tell your doctor or pharmacist if you are taking, have recently taken, or may take
any other medicines.
Fleiderina with food and drink
Fleiderina should be taken on an empty stomach, or at least one hour before meals.
Dairy products (milk, infant formula and probably also yogurt) can reduce the absorption of
flecainide in children and infants. The use of flecainide, the active ingredient of this medicinal
product, is not approved in children under 12 years of age. Nevertheless, signs of toxicity have been
observed during treatment with flecainide in children who had reduced their
intake of dairy products. If your doctor has prescribed flecainide to your child, make sure that the
child's consumption of dairy products (e.g. milk, infant formula, yogurt) remains stable during
treatment. Consult your doctor before making any changes in your child's dairy
consumption.

Pregnancy and breastfeeding
During pregnancy Fleiderina should only be used if the benefits outweigh the risks as flecainide has been shown to cross the placenta in patients who take it during pregnancy.
If Fleiderina is used during pregnancy, the levels of flecainide in the mother's plasma should
be monitored. Consult your doctor as soon as you suspect you are pregnant, or if you are planning
to become pregnant.
Flecainide is excreted in breast milk. Fleiderina should only be used during breastfeeding if the
benefits outweigh the risks.
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning
a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
If you experience side effects such as dizziness, double vision or blurred vision, or if you feel
lightheaded, your reaction time may be reduced. This can be
dangerous in situations requiring concentration and attention, such as driving, using dangerous machinery or performing work at a certain height. If you have doubts about whether Fleiderina has a negative effect on your ability to drive, consult your doctor.
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3. How to take Fleiderina

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take this medicine following exactly the instructions of your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The doctor will prescribe a personalised dose, appropriate to your condition. Treatment with
Fleiderina is normally started under medical supervision (if necessary, in hospital). Follow
carefully the doctor's recommendations for taking Fleiderina. If you have any doubts, consult your doctor or the
pharmacist.
When and how to take the capsules?
Take the capsules by swallowing them with a sufficient amount of liquid (e.g. water). The daily
dose is normally divided throughout the day and must be taken on an empty stomach, or
at least one hour before meals.
The common dose is only indicative and is as follows:
The normal initial dose ranges from 100 to 200 mg. The dose may be increased by the doctor up to a
maximum of 400 mg per day.

Elderly patients
The doctor may prescribe a lower dose. The dose for elderly patients should not exceed 300
mg per day

Patients with reduced kidney or liver function
The doctor may prescribe a lower dose for you.

Patients with a permanent pacemaker
The daily dose should not exceed 200 mg per day.

Patients treated simultaneously with cimetidine (medicine for stomach disorders) or

amiodarone (medicine for cardiac arrhythmia)
The doctor will monitor you regularly, and, for some patients, a lower dose will be prescribed.
During treatment, the doctor will regularly determine the level of flecainide in the blood and
perform what is known as an electrocardiogram (ECG) of the heart. Once a month a simple ECG must be
performed, while every three months a more
detailed ECG must be performed. At the beginning of treatment and in case of an increase in the dose, an
ECG must be performed every 2-4 days.
Patients treated with a lower dose than normally used must undergo ECGs more
frequently. The doctor may adjust the doses at intervals of 6-8 days. These patients must be
subjected to an ECG in the second and third week from the start of treatment.
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Use in children
These capsules should not be taken by children under 12 years of age.

If you take more Fleiderina than you should
If you suspect an overdose, inform a doctor immediately.

If you forget to take Fleiderina
Take the dose as soon as you remember you have forgotten it, unless it is almost time to take the next dose. In this case, do not take the forgotten dose in addition,
but continue to follow the dosage schedule. It is important to remember to take the capsules following
the dosage schedule. If you have any doubts, consult your doctor.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Fleiderina
If you suddenly stop taking Fleiderina, there is no risk of withdrawal symptoms.
However, the cardiac arrhythmia will no longer be under control as expected. Therefore, do not stop
treatment without informing your doctor.
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 will experience them.
Like other antiarrhythmics, flecainide can have the effect of inducing arrhythmia. An existing arrhythmia may
worsen or a new arrhythmia may develop. The risk of proarrhythmic effects is more frequent in
patients with structural heart disease and/or significant impairment of cardiac function.
With regard to the heart, the most common side effects are an increase or a decrease
in heart rate (tachycardia, bradycardia), palpitations, cardiac arrest, heart failure,
chest pain, heart attack, and decreased blood pressure (hypotension).
Other side effects that may occur include:

Very common(in more than 1 in 10 people):
dizziness, feeling lightheaded, vision problems such as double vision, blurred vision, and
difficulty focusing

Common (in more than 1 in 100 people, but less than 1 in 10 people):
shortness of breath, weakness, fatigue, fever, fluid buildup in the tissues (edema), and
general feeling of discomfort

Uncommon (in more than 1 in 1,000 people, but less than 1 in 100 people):
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nausea, vomiting, constipation, abdominal pain, anorexia, diarrhea, dyspepsia (upper abdominal pain,
fullness), flatulence, decreased red blood cells, leukocytes, and platelets, allergic skin
reactions such as rash or hair loss

Rare (in more than 1 in 10,000 people, but less than 1 in 1,000 people):
lung inflammation (pneumonia), tingling of the skin (“as if ants are
walking on the skin”), problems with coordination, difficulty with movements (tics), decreased
sensitivity, increased sweating, temporary loss of consciousness, ringing in the ears, tremor,
feeling of vertigo, flushing, drowsiness, severe depression, anxiety, insomnia, headache, nervous system
diseases for example in the arms or legs, convulsions, confusion, seeing things that are not there
(hallucinations), amnesia, urticaria, elevated liver enzymes with or without jaundice (yellow eyes and skin)

Very rare (in less than 1 in 10,000 people):
high levels of certain antibodies, corneal deposits, sensitivity to light

Frequency not known (frequency cannot be estimated based on available data):
certain changes in the electrocardiogram (increase in PR and QRS intervals), increased pacing threshold in patients with pacemakers or with temporary pacing electrodes,
impaired conduction between the atria and ventricles of the heart (second and third degree atrioventricular block), cessation of heartbeat, slower or faster heartbeat, loss
of the heart's ability to pump enough blood to the body's tissues, chest pain,
low blood pressure, heart attack, feeling your heartbeat, a pause in
the normal heart rhythm (sinus arrest), irregular heartbeat with life-threatening risk
(ventricular fibrillation), the appearance of a certain pre-existing heart condition (Brugada syndrome) that had not been observed before treatment with Fleiderina, scarring of
the lungs or lung diseases (pulmonary fibrosis and interstitial lung disease), liver dysfunction

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
"www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Fleiderina

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30ºC.
Do not use this medicine after the expiry date indicated on the packaging after “Do not use
beyond” or “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 eliminate medicines that you no longer use. These measures help to protect the environment.
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6. Package Contents and Other Information

What Fleiderina contains
The active ingredient is flecainide acetate.

• Fleiderina 50 mg prolonged-release hard capsules: each capsule contains 50 mg flecainide acetate
• Fleiderina 100 mg prolonged-release hard capsules: each capsule contains 100 mg flecainide acetate
• Fleiderina 150 mg prolonged-release hard capsules: each capsule contains 150 mg flecainide acetate
• Fleiderina 200 mg prolonged-release hard capsules: each capsule contains 200 mg flecainide acetate
• The other ingredients are: povidone, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and methacrylate copolymer (1:2), polyethylene glycol, talc.
• The outer coating of the various capsules contains the following components: 50 mg: gelatin, titanium dioxide. 100 mg: gelatin, titanium dioxide, black iron oxide. 150 mg: gelatin, titanium dioxide, black iron oxide. 200 mg: gelatin, titanium dioxide, black iron oxide and red iron oxide.

Description of Fleiderina and package contents
Flecainide 50 mg prolonged-release capsules are opaque gelatin capsules with a white body
and a white cap containing round, white or almost white micro-tablets.
Flecainide 100 mg prolonged-release capsules are opaque gelatin capsules with a grey body
and a white cap containing round, white or almost white micro-tablets.
Flecainide 150 mg prolonged-release capsules are opaque gelatin capsules with a grey body
and a grey cap containing round, white or almost white micro-tablets.
Flecainide 200 mg prolonged-release capsules are opaque gelatin capsules with a grey body
and a pink cap containing round, white or almost white micro-tablets.
Package size:
Blisters: 28 and 30 capsules.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder
Bruno Farmaceutici S.p.A
Via delle Ande, 15
00144 Rome

Manufacturer responsible for batch release
Laboratorios Liconsa, S.A.
Avda. Miralcampo, nº 7,
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

Netherlands
Lifleiderina 50 mg, hard capsules with prolonged release
Lifleiderina 100 mg, hard capsules with prolonged release
Lifleiderina 150 mg, hard capsules with prolonged release
Lifleiderina 200 mg, hard capsules with prolonged release

This leaflet was last updated on
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