FREQUIL 50 mg Hard Capsules, Prolonged Release

Зміст інструкції

1. What is Frequil prolonged-release hard capsules and what is it used for
2. What you need to know before taking Frequil prolonged-release hard capsules
3. How to take Frequil prolonged-release hard capsules
4. Possible side effects
5. How to store Frequil prolonged-release hard capsules
6. Package Contents and Other Information

Frequil50 mg prolonged-release hard capsules

Frequil100 mg prolonged-release hard capsules

Frequil150 mg prolonged-release hard capsules
Frequil 200 mg prolonged-release hard capsules

flecainide acetate
Read this leaflet carefully before you start to use 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 their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Frequil prolonged-release hard capsules and what is it used for

Frequil 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 increases the time during which the heart
is at rest, bringing it back to pumping normally.
Frequil prolonged-release hard capsules is used in cases of:

• Some serious cardiac arrhythmias which often manifest with severe heart palpitations or tachycardia (accelerated heartbeat).
• Serious cardiac arrhythmias that do not respond adequately to treatment with other medicines, or when other treatments cannot be tolerated.

2. What you need to know before taking Frequil prolonged-release hard capsules

Do not take Frequil prolonged-release hard capsules:

• If you are allergicto flecainide acetateor to any of the other ingredientsof this medicine (listed in section 6).
• If you suffer from another heart condition, different from the one for which you are taking this medicine. If you have doubts, or want further information, contact your doctor or pharmacist.
• If you are taking other antiarrhythmic drugs (sodium channel blockers).
• If you suffer from Brugada syndrome (a genetic heart disease).

Warnings and precautions
Talk to your doctor before taking Frequil prolonged-release hard capsules:

• If you suffer from reduced liver and/or kidney function, as the concentration of flecainide acetate in the blood may increase. In this case, your doctor may regularly check the concentration of flecainide acetate in your blood.
• If you are elderly, as the concentration of flecainide acetate in the blood may increase.
• If you have a permanent pacemaker or temporary cardiac stimulation electrodes.
• If you have suffered from cardiac arrhythmias following heart surgery.
• If you suffer from severe bradycardia (slow heartbeat) or marked hypotension. These conditions must be corrected before using Frequil prolonged-release hard capsules.
• If you have had a heart attack.

A decrease or increase in potassium levels in the blood can affect
the effect of this medicine. Diuretics, medicines that stimulate bowel motility
(laxatives) and adrenal cortex hormones (corticosteroids) can
lower blood potassium levels. In this case, your doctor may want to check
the amount of potassium in your blood. .

Children under 12 years
Flecainide acetate is not approved for use in children under 12 years of age, but
its toxicity has been reported during treatment with flecainide acetate in children
who have reduced milk intake and in infants who have switched from formula
to dextrose feeding.
If your doctor has prescribed flecainide to your child, make sure that the intake of dairy
products (milk, formula, yogurt) by the child remains stable during the
treatment. Before changing your child's dairy intake, consult your
doctor.

Other medicines and Frequil prolonged-release hard capsules
Tell your doctor if you are taking, have recently taken or might take
any other medicine.
If you use other medicines together with Frequil prolonged-release hard capsules, the medicines
can sometimes affect how they work and/or their side effects (i.e.
there may be interactions).
For example, interactions can occur when using this medicine with:

• Digoxin (a medicine that stimulates the heart); flecainide acetate may increase the level of digoxin in the blood.
• Medicines that reduce the pumping function of the heart (including propranolol), such as those known as beta-blockers.
• Some medicines against epilepsy (e.g. phenytoin, phenobarbital and carbamazepine): the degradation of flecainide acetate may be accelerated by these substances.
• Cimetidine (an antacid); may increase the effect of flecainide acetate.
• Amiodarone (for heart diseases); the dose of flecainide acetate may need to be reduced in some patients.
• Medicines against depression (paroxetine, fluoxetine and other antidepressants such as those known as tricyclic antidepressants).
• Clozapine, haloperidol and risperidone (medicines used to treat schizophrenia); (also known as neuroleptics).
• Mizolastine, astemizole and terfenadine (medicines against allergies).
• Quinine and halofantrine (medicines against malaria).
• Calcium antagonists such as verapamil (which lower blood pressure).
• Diuretics (such as thiazide diuretics and loop diuretics), laxatives, adrenal cortex hormones (corticosteroids): it may be necessary to regularly check your potassium levels in the blood.
• Sodium channel blockers (class I antiarrhythmics), such as disopyramide and quinidine; see section “Do not use this medicine”.
• Medicines to treat HIV infections (ritonavir, lopinavir and indinavir).
• Terbinafine (to treat fungal infections).
• Bupropion (a drug that helps to quit smoking).

Frequil prolonged-release hard capsules with food and drink
This medicine must be taken with liquid.
In children and infants, dairy products (milk, formula and possibly yogurt) can
reduce the absorption of flecainide acetate.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
During pregnancy, this medicine should only be used if the benefits outweigh the
risks, as flecainide acetate has been shown to cross the placenta in
patients taking it during pregnancy. If this medicine is taken during
pregnancy, the plasma levels of flecainide acetate in the mother must be
monitored. If you suspect you are pregnant or wish to become pregnant, you should consult your
doctor as soon as possible.
Flecainide acetate is secreted into breast milk. During breastfeeding, this medicine must
be used only if the benefits outweigh the risks.

Driving and operating machinery
If you experience side effects such as dizziness, double or blurred vision, or a
feeling of emptiness in your head, your reaction ability may be reduced. This
state can be dangerous in situations that require concentration and attention,
such as driving, operating dangerous machinery or performing work at a certain height. If you
have doubts about whether this medicine is having a negative effect on your ability to
drive, consult your doctor.

3. How to take Frequil prolonged-release hard capsules

Take this medicine always exactly as your doctor or pharmacist has told you. If you have doubts, ask your doctor or pharmacist.
Your doctor will prescribe a personalised dose, adjusted to your needs. Treatment with this medicine will be started, as usual, under the supervision
of your doctor (if necessary, in hospital). Carefully follow your doctor's advice when
taking this medicine. If you have doubts, ask your doctor or pharmacist.
When and how should the capsules be taken?
Take the capsules swallowing them with sufficient liquid (e.g. water).
The daily dose is usually taken once a day at the same time.
The usual dosage is only indicative and is as follows:

For patients with supraventricular arrhythmias
The recommended dose is 100 mg per day. The doctor may increase the dose up to
a maximum of 300 mg per day.

For patients with cardiac arrhythmias
The recommended dose is 200 mg per day. The maximum daily dose is 400 mg. This
dose is generally prescribed to patients of more robust build or in cases where cardiac
arrhythmia needs to be treated quickly. The doctor will gradually reduce the dose over
3-5 days to reach the minimum effective dose. The doctor may also
reduce the dose during long-term treatment.

Elderly patients
In elderly patients, the excretion rate may be delayed. The doctor will take this into
account during treatment and may prescribe a lower dose. The dose in elderly patients
should not exceed 300 mg per day.

Patients with reduced kidney function
The initial maximum dose is 100 mg per day; the doctor will regularly check the levels
of flecainide acetate in the blood.

Patients with reduced liver function
The doctor may prescribe a lower dose.

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

Patients who are treated simultaneously with cimetidine (medicine for stomach disorders) or amiodarone (medicine for cardiac arrhythmia)

The doctor will perform regular checks and prescribe a lower dose to some patients.
During treatment, the doctor will regularly measure the level of flecainide acetate in the
blood and you will undergo an examination known as an electrocardiogram (ECG) of the heart.
A simple ECG should be performed once a month while a more detailed ECG
once every three months. At the beginning of treatment and when the dose is increased you will
undergo an ECG every 2-4 days.
The ECG will be performed more frequently in patients who are taking a dose lower
than normally prescribed. The doctor can adjust the doses at intervals of 6-8 days.
These patients will undergo an ECG in the second and third week after the start
of treatment.

Use in children
These capsules should not be taken by children under 12 years of age.

If you take more Frequil prolonged-release hard capsules than you should
If you fear an overdose, you should immediately inform your doctor.

If you forget to take Frequil prolonged-release hard capsules
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 to the regular dose, but continue with the dosage schedule. It is
important to take the capsules following the dosage schedule. For any doubts, please
consult your doctor. Do not take a double dose to make up for the forgotten capsule.

If you stop taking Frequil prolonged-release hard capsules
If you suddenly stop treatment with this medicine, you will not experience
withdrawal symptoms. However, the cardiac arrhythmia will no longer be controlled as
expected. Therefore, never stop treatment 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, this medicine can cause side effects, although not everyone will experience them.
Like other antiarrhythmics, flecainide acetate may have the effect of inducing arrhythmia.
Pre-existing arrhythmia may worsen or a new arrhythmia may occur. The risk
of pro-arrhythmic effects is more likely in patients with structural heart disease and/or
significant impairment of heart function.
With regard to the heart, the most common side effects are decreased or
increased heart rate (bradycardia, tachycardia), palpitations, cardiac arrest, heart failure, chest pain, heart attack and low blood pressure (hypotension).
Other side effects that may occur include the following:

Very common( may affect more than 1 in 10 people):
dizziness, feeling of faintness, vision problems such as double vision, blurred
vision and difficulty focusing.

Common (may affect up to 1 in 10 people):
shortness of breath, weakness, fatigue, fever, fluid accumulation in the tissues
(edema) and malaise.

Uncommon (may affect up to 1 in 100 people):
nausea, vomiting, constipation, abdominal pain, loss of appetite, diarrhea, dyspepsia
(upper abdominal pain, feeling of fullness), flatulence, decreased
red blood cells, white blood cells and platelets, allergic skin reactions such as rash
and hair loss.

Rare (may affect up to 1 in 1,000 people):
lung inflammation (pneumonia), tingling skin (“as if ants
are walking on the skin”), coordination problems, difficulty in
movement (tics), decreased sensitivity, increased sweating, syncope,
ringing in the ears, tremor, feeling of dizziness (vertigo), hot flashes,
drowsiness, severe depression, anxiety, insomnia, headache, nervous system disorders,
for example in the arms and legs, convulsions, confusion, seeing things that
do not exist (hallucinations), amnesia, urticaria, high levels of liver enzymes with or
without jaundice (yellow eyes or skin).

Very rare (may affect up to 1 in 10,000 people):
high levels of certain antibodies, corneal deposits, light sensitivity.

Not known (frequency cannot be estimated from available data):
certain changes in the electrocardiogram (increase in PR and QRS intervals),
increased pacing threshold in patients with pacemakers or temporary cardiac pacing electrodes, impaired conduction between atria and
ventricles of the heart (second or third degree atrioventricular block), interrupted heartbeat, slowing or acceleration of the heartbeat, loss of
the heart's ability to pump enough blood to the body's tissues, chest pain,
low blood pressure, heart attack, feeling of feeling the heartbeat
, a pause in the normal heart rhythm (sinus arrest), life-threatening irregular heartbeat (atrial fibrillation and ventricular fibrillation),
the appearance of a pre-existing heart disease (Brugada syndrome)
that had not been diagnosed before treatment with this medicine, lung injury
or lung disease (pulmonary fibrosis and interstitial lung disease),
liver dysfunction, joint pain and muscle pain.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. 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 Frequil prolonged-release hard capsules

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 which is stated on the packaging after
“Do not use after” 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 dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Frequil prolonged-release hard capsules contain
The active ingredient is flecainide acetate.
Frequil 50 mg prolonged-release hard capsules: each capsule contains 50 mg of
flecainide acetate.
Frequil 100 mg prolonged-release hard capsules: each capsule contains 100 mg of
flecainide acetate.
Frequil 150 mg prolonged-release hard capsules: each capsule contains 150 mg of
flecainide acetate.
Frequil 200 mg prolonged-release hard capsules: each capsule contains 200 mg of
flecainide acetate.
The other ingredients are:

• povidone
• microcrystalline cellulose
• crospovidone
• colloidal silicon dioxide
• magnesium stearate
• methacrylic acid-methyl methacrylate copolymer (1:2)
• polyethylene glycol
• talc

The coatings of the different capsules contain 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 the appearance of Frequil prolonged-release hard capsules and contents
of the pack
Frequil 50 mg prolonged-release hard capsules are opaque gelatin capsules with a white body and a white cap containing round micro-tablets of
white or almost white color.
Frequil 100 mg prolonged-release hard capsules are opaque gelatin capsules with a grey body and a white cap containing round micro-tablets of
white or almost white color.
Frequil 150 mg prolonged-release hard capsules are opaque gelatin capsules with a grey body and a grey cap containing round micro-tablets of
white or almost white color.
Frequil 200 mg prolonged-release hard capsules are opaque gelatin capsules with a grey body and a pink cap containing round micro-tablets of
white or almost white color.
Pack sizes:
Blisters: 28, 30, 60 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milan

Manufacturer
Laboratorios Liconsa S.A.
Avda. Miralcampo n° 7 Poligono Industrial Miralcampo 19200 Azuqueca de Henares
(Guadalajara)
Spain

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations: