Frequil

Patient Information Leaflet

Frequil 50 mg prolonged-release hard capsules, 100 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules, 200 mg prolonged-release hard capsules

flecainide acetate
Please read this leaflet carefully before using 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 for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Frequil prolonged-release hard capsules are and what they are 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. Contents of the pack and other information

1. What Frequil prolonged-release hard capsules are and what they are used for

Frequil prolonged-release hard capsules belong to a group of medicines
that act against cardiac arrhythmia (known as antiarrhythmics).
It inhibits the conduction of electrical impulses in the heart and increases the time during which the heart
is at rest, allowing it to pump again in a normal manner.
Frequil prolonged-release hard capsules are used in the following cases:

• Certain severe cardiac arrhythmias that often present with severe palpitations or tachycardia (rapid heartbeat).
• Severe 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 allergic to flecainide acetate or to any of the other ingredients of this medicine (listed in section 6).
• If you have another heart condition different from the one for which you are taking this medicine. If you have any doubts or need further information, contact your doctor or pharmacist.
• If you are taking certain other antiarrhythmics (sodium channel blockers).
• If you have Brugada syndrome (a genetic heart disease).

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

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

Low or high levels of potassium in the blood may affect the action of this medicine. Diuretics, medicines that stimulate intestinal motility (laxatives), and adrenal cortex hormones (corticosteroids) may lower potassium levels in the blood. In such cases, your doctor may wish to monitor your blood potassium levels.

Children under 12 years of age
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 reduced milk intake and in newborns who switched from formula milk to dextrose feeding.
If your doctor has prescribed flecainide for your child, ensure that the child's intake of dairy products (milk, formula milk, yogurt) remains stable during treatment. Before changing your child’s dairy intake, consult your doctor.

Other medicines and Frequil prolonged-release hard capsules
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
If you take other medicines together with Frequil prolonged-release hard capsules, they may sometimes affect how each medicine works and/or their side effects (i.e., interactions may occur).
For example, interactions may occur when this medicine is used with:

• Digoxin (a medicine that stimulates the heart); flecainide acetate may increase digoxin blood levels.
• Medicines that reduce the heart's pumping function (including propranolol), such as beta-blockers.
• Certain antiepileptic drugs (e.g., phenytoin, phenobarbital, and carbamazepine): these substances may accelerate the breakdown of flecainide acetate.
• Cimetidine (an antacid); may increase the effect of flecainide acetate.
• Amiodarone (for heart conditions); the dose of flecainide acetate should be reduced in some patients.
• Medicines for depression (paroxetine, fluoxetine, and other antidepressants such as tricyclic antidepressants).
• Clozapine, haloperidol, and risperidone (medicines used to treat schizophrenia); also known as neuroleptics.
• Mizolastine, astemizole, and terfenadine (medicines for allergies).
• Quinine and halofantrine (medicines for malaria).
• Calcium antagonists such as verapamil (which lower blood pressure).
• Diuretics (such as thiazide diuretics and loop diuretics), laxatives, adrenal cortex hormones (corticosteroids): regular monitoring of your blood potassium levels may be necessary.
• 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 (for treating fungal infections).
• Bupropion (a medicine to help stop smoking).

Frequil prolonged-release hard capsules with food and drinks
This medicine should be taken with liquid.
In children and newborns, dairy products (milk, formula milk, and possibly also yogurt) may reduce the absorption of flecainide acetate.

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

Driving and using machines
If you experience side effects such as dizziness, double or blurred vision, or a sensation of emptiness in the head, your reaction ability may be reduced. This condition may be dangerous in situations requiring concentration and attention, such as driving, operating dangerous machinery, or working at heights. If you have any doubts about whether this medicine is negatively affecting your ability to drive, consult your doctor.

3. How to take Frequil prolonged-release hard capsules

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will prescribe a personalized dose adjusted according to your individual needs. Treatment with this medicine is usually started under medical supervision (if necessary, in hospital). Follow your doctor's advice carefully when taking this medicine. If you have any doubts, consult your doctor or pharmacist.

When and how should the capsules be taken?
Take the capsules with a sufficient amount of liquid (for example, water).
The daily dose is usually taken once daily at the same time each day.

The usual dosage is only indicative and is as follows:

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

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

Elderly patients
In elderly patients, the elimination rate may be delayed. Your doctor will take this into account during treatment and may prescribe a lower dose. The daily dose in elderly patients must not exceed 300 mg.

Patients with impaired renal function
The maximum initial dose is 100 mg daily. Your doctor will regularly monitor blood levels of flecainide acetate.

Patients with impaired hepatic function
Your doctor may prescribe a lower dose.

Patients with a permanent pacemaker
The daily dose must not exceed 200 mg.

Patients being treated concomitantly with cimetidine (a medicine for gastric disorders) or amiodarone (a medicine for cardiac arrhythmia)
Your doctor will perform regular checks and may prescribe a lower dose for some patients.
During treatment, your doctor will regularly monitor the blood level of flecainide acetate, and you will undergo a test known as an electrocardiogram (ECG) of the heart.
A simple ECG should be performed once a month, while a more detailed ECG should be performed every three months. At the beginning of treatment and when the dose is increased, you will undergo an ECG every 2–4 days.
ECG monitoring will be performed more frequently in patients receiving a lower dose than normally prescribed. Your doctor may adjust the dose at intervals of 6–8 days. These patients will undergo an ECG during the second and third weeks after starting treatment.

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

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

If you forget to take Frequil prolonged-release hard capsules
Take the missed dose as soon as you remember, unless you remember when it is almost time for the next dose. In this case, do not take the missed dose in addition to the regular dose, but continue with your usual dosing schedule. It is important to take the capsules according to the prescribed dosing schedule. For any doubts, consult your doctor.
Do not take a double dose to make up for a 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, your cardiac arrhythmia will no longer be controlled as expected. Therefore, never stop treatment without first consulting your doctor.

If you have any further questions about the use of this medicine, consult 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 higher in patients with structural heart disease and/or
significant impairment of heart function.
Regarding 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 lightheaded, 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 tissues
(edema), and malaise.
Uncommon (may affect up to 1 in 100 people):
nausea, vomiting, constipation, abdominal pain, loss of appetite, diarrhoea, dyspepsia
(upper abdominal pain, feeling of fullness), flatulence, decreased red blood cells, white blood cells, and platelets, skin allergic reactions such as rash, and hair loss.
Rare (may affect up to 1 in 1,000 people):
inflammation of the lungs (pneumonitis), skin tingling (“as if ants were crawling on the skin”), coordination problems, movement difficulties (tics), decreased sensation, increased sweating, syncope, ringing in the ears, tremor, sensation of dizziness (vertigo), hot flushes, somnolence, severe depression, anxiety, insomnia, headache, nerve disorders, for example in arms and legs, seizures, confusion, seeing things that are not there (hallucinations), amnesia, urticaria, elevated liver enzymes with or without jaundice (yellowing of eyes or skin).
Very rare (may affect up to 1 in 10,000 people):
elevated levels of certain antibodies, corneal deposits, light sensitivity.
Not known (frequency cannot be estimated from the available data):
some changes in the electrocardiogram (prolongation of PR and QRS intervals),
increased cardiac stimulation threshold in patients with pacemakers or temporary cardiac pacing electrodes, impaired conduction between the 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 sufficient blood to the body's tissues, chest pain, low blood pressure, heart attack, awareness of heartbeat (palpitations), a pause in the normal heart rhythm (sinus arrest), life-threatening irregular heartbeat (atrial fibrillation and ventricular fibrillation), emergence of a specific pre-existing heart condition (Brugada syndrome) not previously diagnosed before treatment with this medicine, lung injury or lung diseases (pulmonary fibrosis and interstitial lung disease), hepatic dysfunction, joint pain, and muscle pain.
Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, talk to your doctor or pharmacist. You can also report side effects
directly via the national reporting system at the following website:
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 above 30°C.
Do not use this medicine after the expiry date stated on the pack after "Do not use after" or "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 substance 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 components are:

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

The capsule coatings contain the following components:
50 mg: gelatin, titanium dioxide.
100 mg: gelatin, titanium dioxide, iron oxide black.
150 mg: gelatin, titanium dioxide, iron oxide black.
200 mg: gelatin, titanium dioxide, iron oxide black and iron oxide red.

Description of the appearance of Frequil prolonged-release hard capsules and pack contents
Frequil 50 mg prolonged-release hard capsules are opaque gelatin capsules with a white body and white cap, containing white or almost white round micro-tablets.
Frequil 100 mg prolonged-release hard capsules are opaque gelatin capsules with a grey body and white cap, containing white or almost white round micro-tablets.
Frequil 150 mg prolonged-release hard capsules are opaque gelatin capsules with a grey body and grey cap, containing white or almost white round micro-tablets.
Frequil 200 mg prolonged-release hard capsules are opaque gelatin capsules with a grey body and pink cap, containing white or almost white round micro-tablets.

Pack sizes:
Blister packs: 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 Milano, Italy

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 European Economic Area Member States under the following names: