FLECAINIDE 50 mg Tablet

Зміст інструкції

1. Flecainide EG 50 mg and 100 mg tablets
   1. What is Flecainide EG and what is it used for
   2. What you need to know before taking Flecainide EG
   3. How to take Flecainide EG
   4. Possible side effects
   5. How to store Flecainide EG
   6. Package contents and other information

Flecainide EG 50 mg and 100 mg tablets

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, pharmacist or nurse.
• 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 could be harmful.
• 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 Flecainide EG is and what it is used for
• 2.What you need to know before you take Flecainide EG
• 3.How to take Flecainide EG
• 4.Possible side effects
• 5.How to store Flecainide EG
• 6.Contents of the pack and other information

1. What is Flecainide EG and what is it used for

Flecainide EG belongs to a group of medicines known as antiarrhythmics. Antiarrhythmics work by controlling the speed and rhythm of the heart.
Flecainide EG is used to treat:

• Arrhythmias (irregular heartbeat)
• Tachycardia (heartbeat that is too fast)
• Atrial fibrillation (rapid contractions of the heart muscles). It is important for the doctor to treat these conditions quickly and effectively to prevent the development of more serious heart problems. The tablets are available in two dosages: 50 mg and 100 mg.

2. What you need to know before taking Flecainide EG

Do not take Flecainide EG:

• if you are allergic to flecainide acetate or any of the other ingredients of Flecainide EG (see section 6).
• if you suffer from heart failure
• if you suffer from cardiogenic shock (the heart is unable to pump all the blood the body needs)
• if you suffer from atrioventricular block (failure of some beats to be transmitted to the ventricles)
• if you suffer from long-standing atrial fibrillation (rapid contractions of the heart muscles)
• if you suffer from or have suffered from heart disorders, including problems with the heart valves or conduction problems
• if you suffer from sinus node dysfunction (a specific condition in which the heartbeat is irregular)
• if you have suffered a myocardial infarction (heart attack)
• if you suffer from Brugada syndrome, a genetic condition that causes severe heart rhythm disturbances and can lead to sudden death in apparently healthy individuals.
• if you are pregnant or breastfeeding. Flecainide EG is not recommended for use in children under the age of 12 years, however, dairy products such as milk, infant formula and possibly yogurt may reduce the amount of flecainide acetate absorbed in children and infants. If you have any of the above conditions, inform your doctor or nurse.

Before taking Flecainide EG, your doctor or nurse may check:

• that your fluid levels are correct
• liver and kidney function. This is to check that Flecainide EG is suitable for you and to help your doctor calculate the dose you need.

Talk to your doctor or nurse before taking Flecainide EG if:

• you have high blood pressure
• you suffer from angina (chest pain)
• you suffer from cardiovascular disease
• you suffer from kidney disease or have kidney problems
• you suffer from liver disease or have liver problems
• you have a pacemaker. Warnings and precautionsTell your doctor or nurse if you are using any of the following treatments:
• other medicines used to treat heart arrhythmias or heart problems, such as cardiac glycosides, beta-blockers, verapamil, propranolol or amiodarone
• medicines to lower blood pressure
• antidepressants (medicines for depression) such as tricyclic antidepressants, Prozac, fluoxetine, paroxetine or reboxetine
• anticonvulsants (medicines used to prevent seizures) such as phenytoin, phenobarbital or carbamazepine
• antipsychotics (medicines used to treat mental disorders) such as clozapine
• antihistamines (medicines for the treatment of allergic reactions) such as mizolastine or terfenadine
• quinine (medicine for malaria)
• medicines for the treatment of HIV such as ritonavir, lopinavir or indinavir
• diuretics (water tablets)
• cimetidine (medicine for stomach disorders)
• bupropion (smoking cessation medicine)
• other medicines, including over-the-counter medicines These medicines may interfere with your treatment.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
Flecainide EG.

Driving and using machines
The ability to drive, operate machinery and perform work on unstable supports
may be affected by the onset of adverse reactions such as dizziness and visual disturbances
(if present).

3. How to take Flecainide EG

Take Flecainide EG following your doctor’s instructions exactly. If you have any doubts
consult your doctor or pharmacist.

Important:
The doctor will determine the correct dose for your condition. Treatment with
Flecainide EG will be initiated in hospital. If you have switched from a
different formulation (e.g. from a Flecainide injection), the doctor must perform
this operation with caution and must subject you to careful monitoring.
Adults:
Supraventricular arrhythmias (irregular heartbeat originating in the upper chambers
of the heart)

• Flecainide EG 50 mg tablets: the usual dose is one tablet to be taken twice a day.
• Flecainide EG 100 mg tablets: the usual dose is half a tablet to be taken twice a day. The doctor may prescribe a maximum dose of 300 mg per day (3 tablets of 100 mg or 6 tablets of 50 mg).

Ventricular arrhythmias (irregular heartbeat originating in the lower chambers
of the heart)

• Flecainide EG 50 mg tablets: the usual dose is two tablets to be taken twice a day.
• Flecainide EG 100 mg tablets: the usual dose is one tablet to be taken twice a day. The doctor may prescribe a maximum dose of 400 mg per day (4 tablets of 100 mg or 8 tablets of 50 mg).

Elderly patients and patients with kidney problems or heart disorders:

• The doctor may ask elderly patients and patients with kidney problems or heart disorders to take a lower dose. During the intake of this medicine, the doctor may ask you to undergo checks to verify that the medicine is working correctly and that the dose you are taking is suitable for you.

Children:

• Flecainide EG is not recommended in children under 12 years of age, however, dairy products such as milk, infant formula and possibly yogurt may reduce the amount of flecainide acetate absorbed in children and infants.

If you take more Flecainide EG than you should
If you accidentally take an overdose, go to the nearest hospital emergency room.

If you forget to take Flecainide EG
Do not take a double dose to make up for missed doses. It is sufficient
to take the next dose as scheduled.

If you stop taking Flecainide EG
Do not stop treatment with Flecainide EG without first discussing it with
your doctor.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Some side effects can be serious. If you experience any of the side effects listed below, contact your doctor immediately:

• change in heart rate; very strong, or fast orslow heartbeat
• chest pain
• shortness of breath or breathing problems
• fever, redness or increased sweating
• fainting or feeling faint

Rare (affecting 1 in 10,000 people):

• ringing in the ears
• yellowing of the skin and eyes (jaundice)
• seizures (convulsions)

Other side effects (frequency not known):

• heart attack
• cardiac arrest/heart failure (shortness of breath, loss ofconsciousness and loss of cardiac function)

Other side effects include those listed below; if they worsen, tell your doctor.
Very common (affecting more than 1 in 10 people):

• dizziness
• blurred or double vision

Common (affecting 1 in 100 people):

• feeling of weakness or fatigue
• lack of energy and strength
• swelling (fluid retention)

Uncommon (affecting 1 in 1,000 people):

• blood disorders (decreased red blood cell count, decreased white blood cell count, decreased platelet count)
• feeling or state of unwellness
• constipation
• stomach pain or indigestion
• loss of appetite
• diarrhoea
• flatulence
• bloating
• reddish, itchy or swollen skin rash
• hair loss

Rare (affecting 1 in 10,000 people):

• vertigo (a sensation of spinning)
• confusion and hallucinations
• depression
• feeling of anxiety (worry)
• forgetfulness
• sleep disorders
• numbness, tingling, itching, prickling or burning sensation on the skin
• unsteady gait, jerky movements or lack of coordination, difficulty speaking
• reduced sense of touch
• excessive sweating and flushing of the skin
• tremors
• strong desire to sleep or sleep for prolonged periods
• headache

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

• small dark spots on the eyeball
• skin sensitivity to sunlight

Other side effects (frequency not known):

• lung disease and scarring of the lungs
• liver disorders

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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flecainide EG

Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 Flecainide EG contains

• The active ingredient is flecainide acetate. Each 50 mg tablet contains 50 mg of flecainide acetate. Each 100 mg tablet contains 100 mg of flecainide acetate.
• The other ingredients are: microcrystalline cellulose (pH 101 and pH 102), sodium croscarmellose and magnesium stearate.

Description of the appearance of Flecainide EG and package contents
The 50 mg tablets are round, biconvex tablets of white to off-white colour,
with a diameter of approximately 6.5 mm and have the inscription “HP” on one
side and “183” on the other.
The 100 mg tablets are round, biconvex tablets of white to off-white colour,
with a diameter of approximately 8.5 mm and have a fracture line with the
inscription “H” and “P” on one side and “184” on the other. The tablet can be divided into equal
doses.
The 50 mg tablets are available in packs of 20, 30, 60 and 100 tablets in
blisters.
The 100 mg tablets are available in packs of 20, 60 and 100 tablets in
blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A.
Via Pavia 6
20136 Milan
Italy

Manufacturer
Tillomed Laboratories Ltd
220 Butterfield
Great Marlings
Luton, LU2 8DL
United Kingdom
Emcure Pharma UK Limited
Basepoint Business Centre
110 Butterfield
Great Marlings
Luton
LU2 8DL
United Kingdom
Tillomed Pharma GmbH
Manhagener Allee 36
22926 Ahrensburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area
with the following denomination:
United Kingdom Flecainide acetate 50 mg and 100 mg tablets
Germany Flecainid Tillomed 50 mg and 100 mg tabletten
Italy Flecainide EG
This leaflet was last updated on <{MM/AAAA}>