FLECAINIDE

Main information

  • Trade name:
  • FLECAINIDE
  • Dosage:
  • 100 Milligram
  • Pharmaceutical form:
  • Tablets
  • Prescription type:
  • Product subject to prescription which may be renewed (B)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLECAINIDE
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • flecainide

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Marketed
  • Authorization number:
  • PA1986/050/002
  • Authorization date:
  • 13-06-2006
  • Last update:
  • 12-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

27-06-17

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49704

Flecainide 50mg & 100mg

Tablets All (Mylan Direct) TEI

22-6-17

170x480mm

Leafl et

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Flecainide 50 mg Tablets

Flecainide 100 mg Tablets

fl ecainide acetate

PACKAGE LEAFLET: INFORMATION FOR

THE PATIENT

Read all of this leafl et carefully before you

start taking this medicine because it contains

important information for you.

Keep this leafl et. You may need to read it

again.

If you have any further questions, ask your

doctor or pharmacist.

This medicine has been prescribed for you

only. Do not pass it on to others. It may

harm them, even if their signs of illness are

the same as yours.

If you get any side effects, talk to your

doctor or pharmacist. This includes any

possible side effects not listed in this

leafl et. See section 4.

WHAT IS IN THIS LEAFLET

1. What Flecainide is and what it is used for

2. What you need to know before you take

Flecainide

3. How to take Flecainide

4. Possible side effects

5. How to store Flecainide

6. Contents of the pack and other

information

What Flecainide is and what it is

used for

Flecainide belongs to a group of medicines

called antiarrhythmics which can be used to

control the rate and rhythm of the heart.

Flecainide tablets are used to treat:

Arrhythmias (irregular heart beat)

Tachycardia (heart beat too fast)

Atrial fi brillation (rapid contractions of

muscles in the heart).

It is important for your doctor to treat these

conditions quickly and effectively in order to

prevent more serious heart problems from

developing.

What you need to know before

you take Flecainide

Do not take Flecainide:

if you are allergic to fl ecainide or any of the

other ingredients of this medicine (listed in

section 6).

if you suffer from heart failure, heart valve

disease or missed heart beats (heart block)

if you have had a heart attack in the past

if you have a continuous (longstanding)

rapid and irregular heart beat (atrial

fi brillation)

if you have any other condition that may

affect the rhythm of your heart

if you have a heart condition called

Brugada syndrome, which causes you to

have a potentially life-threatening heart

rhythm disorder

if you have an imbalance of salts in your

blood

if you are allergic to any medicines known

as amides e.g. sulfonamides

if you are already taking class 1

antiarrhythmic medicines e.g. quinidine.

Warnings and precautions

Tell your doctor or pharmacist before taking

Flecainide

if you have liver or kidney problems

if you have rapid and irregular heartbeats

following heart surgery

if you have slow heart beat or very low

blood pressure

if you have a problem related to the

structure of your heart

if you have a heart pacemaker

if you know you have high or low levels of

a salt (e.g. potassium) in your blood.

Children and adolescents

Flecainide is not recommended for children

under 18 years of age.

Other medicines and Flecainide

Tell your doctor or pharmacist if you are

taking, have recently taken or might take any

other medicines.

Tell your doctor or pharmacist if you are

already taking any of the following medicines:

other antiarrhythmics, used to treat a heart

condition, such as cardiac glycosides (e.g.

digoxin) beta-blockers (e.g. atenolol),

amiodarone, quinidine, lidocaine, calcium

channel blockers (e.g. verapamil)

diuretics (‘water’ tablets) e.g. furosemide

corticosteroids, normally used to treat

pain, e.g. dexamethasone

laxatives, used to treat constipation

antidepressants, normally used to treat

depression, e.g. fl uoxetine, paroxetine,

amitriptyline, reboxetine

antiepileptics, used to treat fi ts

(convulsions), e.g. phenytoin,

phenobarbital, carbamazepine

antipsychotics e.g. clozapine, to treat a

mental illness

antihistamines, normally used to treat

allergies, e.g. mizolastine, terfenadine

quinine, used to treat malaria

antiviral medicines, used to treat viral

infections, e.g. ritonavir, lopinavir, indinavir

cimetidine, used to treat ulcers or

heartburn

bupropion, used as an antidepressant and

an anti-smoking aids.

Antifungals, used to treat fungal infections,

e.g. terbinafi ne

anticoagulants, used to thin the blood,

e.g. warfarin

Flecainide with food and drink

Dairy products may affect the intake of

fl ecainide in children and newborns. It is not

known if this may apply to adults. Talk to your

pharmacist or doctor for advice.

Pregnancy and breast-feeding

Flecainide should not be given to pregnant or

breast-feeding mothers unless the benefi ts to

the mother outweigh the risks to the baby.

If you are pregnant or breast-feeding, think

you may be pregnant or are planning to have

a baby, ask your doctor or pharmacist for

advice before taking this medicine.

Driving and using machines

Flecainide may cause side effects such as

feeling dizzy, drowsy or eyesight problems.

Do not drive or operate machinery if you

experience any of the side effects mentioned

above.

How to take Flecainide

Always take this medicine exactly as your

doctor has told you. Check with your doctor

or pharmacist if you are not sure.

Your doctor will monitor you regularly.

Your doctor has decided which dose is best

for you. Follow your doctor’s instructions and

do not change the dose yourself.

Treatment usually starts in hospital as the

doctor will perform an ECG (electrical tracing

of the heart) and monitor your blood

fl ecainide levels.

If you have switched from a different

formulation (fl ecainide injection) your doctor

should do so with caution and monitor you

closely.

Adults

The recommended starting dose is 50 mg or

100 mg of Flecainide twice a day, depending

on your condition. Your doctor may increase

the dose by 50 mg every 4 days to a

maximum dose of 400 mg daily. Your doctor

will then reduce your dose after 3-5 days to

the lowest dose that controls your heart

rhythm. Some patients, particularly those

with supra-ventricular tachycardia will be

adequately controlled on 50 mg twice daily.

Older people can be more sensitive to the

effects of Flecainide and may be given lower

doses.

Use in children and adolescents

Flecainide is not recommended for children

and adolescents under 18 years.

Patients with kidney or liver problems

Patients with kidney or liver problems or who

are taking other medicines, will be monitored

more often. The recommended starting dose

for a patient with kidney problems is 100 mg

once daily or 50 mg twice daily.

How to take

Swallow the tablets with a glass of water.

The score line is only there to help you break

the tablet if you have diffi culty swallowing it

whole (100 mg only).

If you take more Flecainide than you should

Contact your doctor or nearest hospital

casualty department immediately. Take the

container and any remaining tablets with you.

If you forget to take Flecainide

Take the next dose as soon as you remember

unless it is almost time for your next dose.

Do not take a double dose to make up for a

forgotten tablet.

If you stop taking Flecainide

Do not suddenly stop taking your medicine as

you may experience side effects. Speak to

your doctor fi rst.

If you have any further questions on the use

of this medicine, ask your doctor or

pharmacist.

Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

If any of the following happen to you, stop

taking Flecainide and tell your doctor

immediately or go to your nearest hospital

emergency department:

Common (may affect up to 1 in 10 people)

this medicine, like all other antiarrhythmic

medicines can cause the worsening of your

condition arrhythmia. You may experience

an unusually and dangerously fast heart

beat.

Uncommon (may affect up to 1 in 100 people)

signs of frequent infections such as fever,

severe chills, sore throat or mouth ulcers

due to a decrease in white blood cell count

(leucopenia).

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

fi ts (convulsions)

infl ammation of the lungs which can cause

weakness, breathlessness, cough and

raised temperature (pneumonitis).

Not known (cannot be estimated from the

available data)

liver problems which may cause you to

feel or be sick, loss of appetite, feeling

generally unwell, fever, itchy skin,

yellowing of the skin or whites of the eyes,

dark urine, pale stools

1204066

H49704

sudden signs of allergy such as rash,

itching or hives on the skin, swelling of the

face, lips, tongue or other parts of the

body, shortness of breath, wheezing or

trouble breathing

heart condition, heart block or changes in

the generation of electrical impulses in the

heart which can cause lightheadedness,

fainting and irregular heart rhythm (second

or third degree atrioventricular block,

Brugada syndrome, sinus arrest)

heart attack

heart failure which can cause shortness of

breath and swelling of the feet or legs due

to fl uid retention

faster heart rhythm (ventricular

tachycardia)

change in the electrical activity of the

heart, which may need to be taken into

account if you use a pacemaker (see also

section 2, “Warnings and precautions”)

thickening and scarring of the lungs or

lung disease which causes shortness of

breath, cough and raised temperature

(pulmonary fi brosis, interstitial lung

disease).

Other possible side effects

Very common (may affect more than 1 in

10 people)

feeling giddy, dizzy or lightheaded

blurred or double vision.

Common (may affect up to 1 in 10 people)

diffi culty breathing

weakness

tiredness

fever

excessive fl uid in the body (swelling).

Uncommon (may affect up to 1 in 100 people)

signs of reduced number of different blood

cells which may cause unusual bruising or

bleeding of the skin (reduced number of

platelets), tiredness, headaches, dizziness,

being short of breath when exercising and

looking pale (reduced number of red blood

cells)

feeling or being sick

constipation

stomach pain or discomfort

reduced appetite

diarrhoea

indigestion

wind (fl atulence)

infl ammation of the skin due to allergies,

including rash

hair loss.

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

depression

confusion or anxiety

loss of memory

diffi culty sleeping

sleepiness

seeing, hearing or feeling things that are

not there (hallucinations)

numbness or weakness of the arms and

legs

tingling, pins and needles

sudden uncontrollable or abnormal body

movements, shaking

decreased feeling or sensitivity, especially

in the skin

increased sweating

fainting

spinning sensation (vertigo)

redness of the skin (fl ushing)

headache

ringing in the ears

changes in liver enzymes which can be

seen in a blood test

a nettle-like rash, hives.

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

worsening of eyesight, deposits on the eye

causing spots in vision (corneal deposits)

sensitivity of the skin to light

increased levels of antibodies which can be

seen in a blood test.

Not known (frequency cannot be estimated

from the available data)

slower heart rhythm

chest pain

low blood pressure

fast or irregular heart beat (palpitations).

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any

possible side effects not listed in this leafl et.

You can also report side effects directly via

HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie. By reporting side

effects you can help provide more

information on the safety of this medicine.

How to store Flecainide

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 carton and blister or

container after ‘Expiry date:’.

The expiry date refers to the last day of that

month.

This medicinal product does not require any

special storage conditions.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines

you no longer use. These measures will help

to protect the environment.

Contents of the pack and other

information

What Flecainide contains

The active substance is fl ecainide acetate.

Each tablet contains either 50 mg or

100 mg of fl ecainide acetate.

The other ingredients are magnesium

stearate, croscarmellose sodium and

microcrystalline cellulose.

What Flecainide looks like and contents of

the pack

The tablets are white and convex. The 50 mg

tablets are marked ‘FC’ over ‘50’ and the

100 mg tablets are marked ‘FC’ scoreline

‘100’, on one side. On the other side the

tablets are marked ‘G’.

Flecainide 50 mg tablets are available in

plastic containers and blister packs of 20, 30,

50, 60 and 100 tablets.

Flecainide 100 mg tablets are available in

plastic containers and blister packs of 20, 30,

40, 50, 60 and 100 tablets.

Not all pack sizes may be marketed.

Product Authorisation Holder

Teva B.V., Swensweg 5, 2031GA Haarlem,

Netherlands

Manufacturers

McDermott Laboratories Ltd. t/a Gerard

Laboratories, 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13, Ireland.

Generics [UK] Ltd, Station Close, Potters Bar,

Herts EN6 1TL, UK.

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

This leafl et was last revised in 07/2017.