FLECAINIDE 100 mg Tablet

Зміст інструкції

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

Flecainide Aurobindo 100 mg tablets

Generic medicine

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 their symptoms are the same as yours, as it could 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 Flecainide Aurobindo is and what it is used for
• 2. What you need to know before you take Flecainide Aurobindo
• 3. How to take Flecainide Aurobindo
• 4. Possible side effects
• 5. How to store Flecainide Aurobindo
• 6. Contents of the pack and other information

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

Flecainide 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.
Flecainide Aurobindo is used:

• for some serious cardiac arrhythmias, which often manifest as 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 Flecainide Aurobindo

Do not take Flecainide Aurobindo
if you are allergic to flecainide or any of the other ingredients of this medicine (listed in section 6).
if you suffer from other heart conditions, different from those for which you are taking this medicine. If you are not sure
or if you want further information, consult your doctor or pharmacist.
if you are also taking certain antiarrhythmics (sodium channel blockers);
if you know you have a genetic condition (Brugada Syndrome) characterized by an abnormal electrocardiogram
(ECG).

Warnings and precautions
Talk to your doctor or pharmacist before taking Flecainide Aurobindo:
if you have reduced liver and/or kidney function, as the concentration of flecainide in the blood may
increase. In this case, your doctor will regularly check the concentrations of
flecainide in the blood.
if you have a permanent pacemaker or temporary stimulating electrodes.
if you have suffered from heart arrhythmias after heart surgery.
if you have had a heart attack
if you suffer from severe bradycardia or pronounced hypotension. These conditions must be corrected
before using Flecainide Aurobindo.
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 the level of potassium in the blood. In this case, your doctor will need to keep
potassium levels in the blood under control.

Children
The use of Flecainide Aurobindo is not recommended in children under 12 years of age, however
flecainide toxicity has been reported during treatment with flecainide in children who have reduced
milk intake, and in newborns who have switched from powdered milk feeding to dextrose.

Other medicines and Flecainide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
If you use other medicines together with flecainide, it is possible that these may affect the way it works and/or its
side effects (i.e. interactions may occur).
Interactions can occur, for example, when using the following medicines:
sodium channel blockers (Class I antiarrhythmics), such as disopyramide and quinidine: see
section “Do not use Flecainide Aurobindo”,
beta-blockers such as propranolol (medicines that reduce the heart's pumping function),
amiodarone (for heart problems); the dose of Flecainide Aurobindo may need to be reduced for some
patients,
calcium antagonists, such as verapamil (used to lower blood pressure),
diuretics, laxatives (medicines that stimulate bowel movement) and adrenal cortex hormones (corticosteroids): your doctor may have checked the amount of potassium in your blood.
mizolastine and terfenadine (medicines used against allergies),
ritonavir, lopinavir and indinavir (medicines used to treat HIV infection),
fluoxetine, paroxetine and certain other antidepressants called “tricyclic antidepressants”,
phenytoin, phenobarbital and carbamazepine (medicines used against epilepsy): the breakdown of
flecainide may be accelerated by these substances,
clozapine (for the treatment of psychotic disorders),
quinine (medicine used against malaria),
terbinafine (to treat fungal infections),
cimetidine (an antacid), this may increase the effect of Flecainide Aurobindo,
bupropion (smoking cessation medicine),
digoxin (a medicine to stimulate the heart); Flecainide Aurobindo may increase the level of
digoxin in the blood

Flecainide Aurobindo with food and drink
Dairy products (milk, infant formula and possibly yogurt) can reduce the absorption of
flecainide in children and infants. The use of flecainide is not recommended in children under 12
years of age, however, flecainide toxicity has been reported during treatment in children who have
reduced milk intake, and in newborns who have switched from powdered milk to
dextrose.
Flecainide should be taken on an empty stomach, or at least one hour before meals.

Pregnancy, breastfeeding and fertility
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.
Flecainide should not be used during pregnancy unless it is strictly necessary, as
flecainide has been shown to cross the placenta in patients taking it during
pregnancy. If flecainide is used during pregnancy, the levels of flecainide in the mother’s plasma
must be monitored. You should consult your doctor as soon as you suspect you are pregnant or if you intend
to become pregnant. Flecainide is secreted into breast milk. Mothers should not breastfeed during
treatment with flecainide.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
If you experience side effects such as dizziness, double or blurred vision, or feel lightheaded, your reaction time may be reduced. This can be dangerous in situations that
require concentration and attention, such as driving, operating dangerous machinery, or working at
height. If you are not sure whether flecainide is affecting your ability to drive, consult your doctor.

3. How to take Flecainide Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Dosage
Your doctor will prescribe a personalised dose, appropriate for your condition. Treatment with flecainide
will normally be started under medical supervision (if necessary, in hospital). Carefully follow your
doctor’s advice while taking flecainide. If you have any doubts, ask your doctor or pharmacist.
When and how should the tablets be taken?
Take the tablets by swallowing them with a sufficient amount of liquid (e.g. water). The daily dose
is normally divided throughout the day and should be taken on an empty stomach or at least one hour before
meals.
The general dose is only indicative and is as follows:
the recommended initial dose varies between 50 and 200 mg. This may be increased by your doctor up to a
maximum of 400 mg per day.

Elderly patients
Your doctor may prescribe a lower dose. The dose for elderly patients should not exceed 300 mg per
day (or 150 mg twice a day).

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

Patients with reduced kidney or liver function
Your doctor may prescribe a lower dose.

Patients with a permanent pacemaker
The daily dose should not exceed 100 mg twice a day.

Patients treated simultaneously with cimetidine (medicine for stomach problems) or amiodarone

(medicine for heart rhythm disorders)
Your doctor will check you regularly and, for some patients, a lower dose will be prescribed.
During treatment, your doctor will regularly determine the level of flecainide in your blood and perform what
is known as an electrocardiogram of the heart (ECG). A simple ECG should be performed once a month, while a more detailed ECG should be performed once every three months. At the beginning of
treatment and in case of dose increase, an ECG should be performed every 2-4 days.
Patients treated with a lower dose than normally used should undergo ECGs more
frequently. Your doctor may adjust the doses at intervals of 6-8 days. These patients should be
subjected to an ECG on the second and third week from the start of treatment.

If you take more Flecainide Aurobindo than you should
If you take more Flecainide Aurobindo than you should, contact your doctor immediately or go
immediately to the emergency room.

If you forget to take Flecainide Aurobindo
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 your schedule. It is important to remember to take the tablets as scheduled. If you have
any doubts, ask your doctor.
Do not take a double dose to make up for a missed tablet.

If you stop taking Flecainide Aurobindo
If you suddenly stop taking flecainide you will not have any withdrawal symptoms. However, the heart
rhythm disorder will no longer be controlled as desired. Therefore, do not stop using the medicine without
informing your doctor.
If you have any further questions on 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 everybody gets them.
manifest.

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

• dizziness
• visual disturbances, such as double vision, blurred vision and difficulty focusing.

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

• a more frequent occurrence of pre-existing arrhythmia (irregular heartbeat)
• shortness of breath
• weakness
• fatigue
• fever
• fluid in the tissues (edema)

Uncommon(may affect up to 1 in 100 people):

• decreased red blood cells, white blood cells and platelets
• irregular heartbeat with increased heartbeat
• nausea
• vomiting
• constipation
• abdominal pain
• decreased appetite
• diarrhea
• flatulence
• pain in the upper abdomen, fullness (dyspepsia)
• allergic skin reactions such as rash, hives and hair loss

Rare(may affect up to 1 in 1000 people):

• seeing things that are not there (hallucinations)
• depression
• confusion
• anxiety
• memory loss (amnesia)
• insomnia
• tingling or numbness
• difficulty controlling movements (ataxia)
• decreased sensitivity
• increased sweating
• fainting (syncope)
• tremor
• hot flushes
• drowsiness
• headache
• nervous disorders e.g. in the arms and legs
• convulsions
• movement disorders (dyskinesia)
• ringing in the ears
• sensation of spinning (vertigo)
• lung inflammation (pneumonia)
• increase in liver enzymes reversible upon discontinuation of treatment
• yellowing of the skin or whites of the eyes, caused by problems with the liver or blood (jaundice)
• urticaria

Very rare(may affect up to 1 in 10,000 people):

• high levels of specific antibodies
• small dark spots on the eyeball
• sensitivity to sunlight,

Not known(the frequency cannot be estimated from the available data):
Changes in the electrocardiogram (ECG)
Increased pacing threshold in patients with pacemakers or temporary pacing electrodes
compromised conduction between the atria and ventricles of the heart (second or third degree atrioventricular block), stopped heartbeat, slower or faster heartbeat, loss of the heart's ability to pump enough blood to the body tissues, chest pain, low blood pressure, heart attack, feeling your heartbeat, a pause in the normal heart rhythm (sinus arrest), appearance of a pre-existing heart disease (Brugada syndrome) that had never occurred before treatment with Flecainide Aurobindo, scarring of the lungs or lung disease (called interstitial lung disease causing difficulty breathing), liver disorders.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://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 Flecainide Aurobindo

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 packaging after EXP. The expiry date
refers to the last day of the month.
This medicine does not require any particular 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 Aurobindo contains

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

Description of the appearance of Flecainide Aurobindo and package contents
Tablets

Flecainide Aurobindo 100 mg tablets:
White or off-white, round, biconvex tablets, with “1” and “2” engraved separated by a fracture line on one side and “CC” on the other side. The tablet can be divided into two equal halves.
Flecainide Aurobindo tablets are available in transparent PVC/PVdC/Al blisters and in
HDPE containers with a polypropylene closure.
Blisters: 20, 28, 30, 40, 50, 56, 60, 84, 90 and 100 tablets.
HDPE: 20, 500 and 1000 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Germany Flecainid Aurobindo 50 mg/100 mg Tablets
Italy Flecainide Aurobindo
Malta Flecainide Acetate 50 mg/100 mg Tablets
Netherlands Flecaïnideacetaat Aurobindo 50 mg/100 mg tablets
Spain Flecainida Aurobindo 100 mg comprimidos
United Kingdom Flecainide Acetate 50mg/100 mg Tablets