Flecainide Aurobindo

Package leaflet: Information for the user

Flecainide Aurobindo 100 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 Flecainide Aurobindo is and what it is used for

Flecainide belongs to a group of medicines that act against cardiac arrhythmia (known as antiarrhythmics). It inhibits the conduction of electrical impulses in the heart and prolongs the period during which the heart is at rest, thereby restoring normal pumping function.
Flecainide Aurobindo is used:

• for certain serious heart arrhythmias, which often present as severe palpitations or tachycardia.
• for serious heart 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 to any of the excipients 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 unsure
or wish further information, consult your doctor or pharmacist.
if you are also taking certain antiarrhythmics (sodium channel blockers);
if you know you have a genetic disease (Brugada syndrome) characterized by an abnormal electrocardiogram (ECG).

Warnings and precautions
Talk to your doctor or pharmacist before taking Flecainide Aurobindo:
if you have impaired liver and/or kidney function, as the concentration of flecainide in the blood may
increase. In this case, your doctor will regularly monitor flecainide blood levels.
if you have a permanent pacemaker or temporary stimulating electrodes.
if you have experienced cardiac arrhythmias after heart surgery.
if you have had heart attacks.
if you suffer from severe bradycardia or marked hypotension. These conditions must be corrected
before using Flecainide Aurobindo.
A decrease or increase in blood potassium levels may affect the action of flecainide.
Diuretics, medicines that stimulate intestinal movement (laxatives), and corticoadrenal hormones (corticosteroids) may reduce blood potassium levels. In such cases, your doctor should monitor your blood potassium levels.

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 reduced milk intake, and in newborns who switched from powdered milk feeding to dextrose.

Other medicines and Flecainide Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you take other medicines together with flecainide, they may affect how it works and/or its side effects (i.e., interactions may occur).
Interactions may occur, for example, when taking 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 should be reduced in some patients,
calcium antagonists, such as verapamil (used to lower blood pressure),
diuretics, laxatives (medicines that stimulate intestinal movement), and adrenal cortex hormones (corticosteroids): your doctor may monitor your blood potassium levels,
mizolastine and terfenadine (medicines used for allergies),
ritonavir, lopinavir, and indinavir (medicines used to treat HIV infection),
fluoxetine, paroxetine, and certain other antidepressants known as "tricyclic antidepressants",
phenytoin, phenobarbital, and carbamazepine (medicines used for epilepsy): these substances may accelerate flecainide elimination,
clozapine (for the treatment of psychotic disorders),
quinine (a medicine used for malaria),
terbinafine (for treating fungal infections),
cimetidine (an antacid), which may increase the effect of Flecainide Aurobindo,
bupropion (a smoking cessation aid),
digoxin (a medicine to stimulate the heart); Flecainide Aurobindo may increase digoxin blood levels.

Flecainide Aurobindo with food and drinks
Dairy products (milk, formula milk, and possibly yogurt) may reduce flecainide absorption in children and newborns. 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 reduced milk intake, and in newborns who switched from powdered milk feeding 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Flecainide should not be used during pregnancy unless strictly necessary, as it has been shown that flecainide crosses the placenta in patients taking it during pregnancy. If flecainide is used during pregnancy, plasma levels of flecainide in the mother should be monitored. You should consult your doctor as soon as you suspect you are pregnant or if you plan to have children. Flecainide is excreted in breast milk. Mothers should not breastfeed during treatment with flecainide.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you experience side effects such as dizziness, double or blurred vision, or a sensation of lightheadedness, your reaction ability may be reduced. This may be dangerous in situations requiring concentration and attention, such as driving, operating dangerous machinery, or working at heights. If you are unsure whether flecainide is negatively affecting your ability to drive, consult your doctor.

3. How to take Flecainide Aurobindo

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Your doctor will prescribe a personalized dose suitable for your condition. Treatment with flecainide is normally started under medical supervision (if necessary, in hospital). Follow your doctor's advice carefully while taking flecainide. If you have any doubts, consult your doctor or pharmacist.
When and how should the tablets be taken?
Take the tablets with a sufficient amount of liquid (e.g. water). The daily dose is usually divided throughout the day and should be taken on an empty stomach or at least one hour before meals.
The following general dosage is only indicative:
The recommended starting dose ranges between 50 mg and 200 mg. This dose 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 daily).
Use in children
These tablets must not be taken by children under 12 years of age.
Patients with impaired renal or hepatic function
Your treating doctor may prescribe a lower dose.
Patients with a permanent pacemaker
The daily dose must not exceed 100 mg twice daily.
Patients treated concomitantly with cimetidine (a medicine for gastric disorders) or amiodarone (a medicine for cardiac arrhythmia)
Your doctor will monitor you regularly and, in 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 (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 when the dose is increased, an ECG should be performed every 2–4 days.
Patients treated with a lower than usual dose should undergo ECGs more frequently. Your doctor may adjust the dose at intervals of 6–8 days. These patients should undergo an ECG during the second and third weeks after starting treatment.
If you take more Flecainide Aurobindo than you should
If you take more Flecainide Aurobindo than prescribed, contact your doctor immediately or go to the nearest emergency department.
If you forget to take Flecainide Aurobindo
Take the missed dose as soon as you remember, unless you remember only when it is almost time for the next dose. In this case, do not take the missed dose in addition, but continue with your regular schedule. It is important to remember to take the tablets as prescribed. If in doubt, consult your doctor.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Flecainide Aurobindo
If you suddenly stop taking flecainide, you will not experience withdrawal symptoms. However, your cardiac arrhythmia will no longer be adequately controlled. Therefore, do not stop using this medicine without informing your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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):

• increased frequency 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):

• decrease in red blood cells, white blood cells and platelets
• irregular heartbeat with increased heart rate
• nausea
• vomiting
• constipation
• abdominal pain
• loss of appetite
• diarrhoea
• flatulence
• pain in the upper abdomen, fullness (dyspepsia)
• allergic skin reactions such as rash, urticaria and hair loss

Rare (may affect up to 1 in 1,000 people):

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

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

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

Not known (frequency cannot be estimated from the available data):
Changes in electrocardiogram (ECG)
Increased stimulation threshold in patients with pacemakers or temporary stimulation electrodes, impairment of conduction between the atria and ventricles of the heart (second- or third-degree atrioventricular block), cardiac standstill, slower or faster heartbeat, loss of the heart's ability to pump sufficient blood to body tissues, chest pain, low blood pressure, heart attack, awareness of heartbeat, pause in normal heart rhythm (sinus arrest), appearance of a certain pre-existing heart condition (Brugada syndrome) not previously experienced before treatment with Flecainide Aurobindo, lung scarring or lung disease (called interstitial lung disease causing breathing difficulties), liver disorders.

Reporting of side effects
If you experience any side effects, 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 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 stated on the packaging after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Flecainide Aurobindo contains

• The active substance 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 almost white, round, biconvex tablets, engraved with "1" and "2" separated by a score line on one side and "CC" on the other side. The tablet can be divided into two equal parts.
Flecainide Aurobindo tablets are available in transparent PVC/PVdC/Al blisters and in HDPE containers with polypropylene caps.
Blister packs: 20, 28, 30, 40, 50, 56, 60, 84, 90 and 100 tablets.
HDPE containers: 20, 500 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Germany Flecainid Aurobindo 50 mg/100 mg Tabletten
Italy Flecainide Aurobindo
Malta Flecainide Acetate 50 mg/100 mg Tablets
Netherlands Flecaïnideacetaat Aurobindo 50 mg/100 mg tabletten
Spain Flecainida Aurobindo 100 mg comprimidos
United Kingdom Flecainide Acetate 50mg/100 mg Tablets

This Patient Information Leaflet was last approved on