Flecainide Acetate 50mg/5ml Oral Solution

• Keep this leaflet. 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 leaflet. See section 4.

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

• if you are allergic to flecainide acetate or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from heart failure or some types of heart rhythm disorders
• if you suffer from heart valve disease
• if you have a history of heart attacks
• if you have low blood pressure or a slow beating heart
• if you have a serious heart condition called cardiogenic shock which causes rapid breathing, weakness, looking pale, confusion and can lead to a loss of consciousness
• if you have a heart condition called Brugada Syndrome, which causes you to have a potentially life-threatening heart rhythm disorder
• if you are already taking Disopyramide to regulate your heartbeat

Talk to your doctor or pharmacist before taking Flecainide:

• if you know you have high or low levels of salt (such as potassium) in your blood
• if you suffer from liver or kidney problems
• if you have a heart rhythm disorder called ‘sick sinus syndrome’
• if you have a pacemaker
• if you suffer from an enlarged heart, or some types of heart disease
• This medicine may cause temporary numbness in your mouth. Do not eat food or drink hot liquids until the effect has completely worn off

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or the following:

• diuretics (water tablets) e.g. furosemide
• corticosteroids for inflammatory conditions such as arthritis e.g. prednisolone
• laxatives to treat constipation
• other medicines used to regulate your heartbeat e.g. digoxin, quinidine, beta-blockers (e.g. atenolol, propranolol), amiodarone, verapamil
• anticonvulsants, for epilepsy e.g. phenytoin, phenobarbital, carbamazepine
• cimetidine, to treat stomach ulcers
• antivirals e.g. ritonavir, fixed-combination products containing ritonavir
• anti-malarials e.g. quinine
• antihistamine e.g. mizolastine, terfenadine
• antidepressants e.g. fluoxetine, paroxetine, reboxetine and tricyclic anti-depressants such as imipramine
• bupropion, used as an antidepressant and an antismoking aid
• antifungals e.g. terbinafine
• antipsychotics to treat some mental illnesses e.g. clozapine

Dairy products like milk, infant formula and possibly yoghurt have been shown to reduce the absorption of flecainide acetate in children and infants. It is not known if this may apply to adults. Talk to your pharmacist or doctor for advice.

Flecainide should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby. If your doctor does decide to give you Flecainide, you will be monitored closely during your pregnancy. 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 any medicine.

Do not drive or operate machinery if you feel dizzy or drowsy, or you have eyesight problems while taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Liquid Maltitol- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Contact your doctor or nearest hospital emergency department immediately. Take the medicine pack with you, even if there is no medicine left. This is so the doctor knows what you have taken.

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 dose.

If you suddenly stop taking Flecainide you may experience side effects. Speak to your doctor first before stopping this medicine.

Common side effects (may affect up to 1 in 10 people)

• fast or irregular heart beat.

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

• inflammation of the lungs which can cause weakness, breathlessness, cough and raised temperature (pneumonitis)
• changes in liver function with or without yellowing of the skin or whites of the eyes (jaundice), usually reversible on stopping treatment
• fits (convulsions).

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

• worsening of eyesight.

Not Known (frequency cannot be estimated from available data)

• heart block which can cause light-headedness, fainting and irregular heart rhythm
• slower heart rhythm, dangerously fast heart rhythm
• heart attack
• a heart disease called sinus arrest
• chest pain
• scarring of the lungs or lung disease which causes shortness of breath
• heart failure which can cause shortness of breath and swelling of the feet or legs due to fluid retention

The following side effects have also been reported:

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

• feeling giddy, dizzy or lightheaded
• blurred or double vision

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

• breathlessness, difficulty breathing
• weakness
• tiredness
• fever
• excessive fluid in the body (swelling)

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

• reduction in red blood cell count, which may make the skin pale and cause weakness or breathlessness
• reduction in white blood cell count, which makes you prone to infections
• reduction in platelet count, which can make you bleed or bruise more easily than normal
• feeling or being sick
• constipation
• stomach pain or discomfort
• reduced appetite
• diarrhoea
• indigestion
• wind (flatulence)
• inflammation of the skin due to allergies, including rash
• hair loss

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

• depression
• confusion or anxiety
• loss of memory
• difficulty sleeping or sleepiness
• seeing, hearing or feeling things that are not there (hallucinations)
• nervousness
• 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
• redness of the skin (flushing)
• headache
• ringing in the ears
• a nettle-like rash, hives

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

• dry mouth or taste changes
• sensitivity of the skin to light
• painful, swollen joints or muscle pain
• impotence
• raised levels of certain antibodies, which may cause inflammation.

Not Known (frequency cannot be estimated from available data):

• low blood pressure
• palpitations
• liver disease
• numbness in the mouth (temporary)

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is flecainide as flecainide acetate 50 mg per 5ml.

The other ingredients are citric acid monohydrate, sodium citrate, strawberry flavour, sucralose, liquid maltitol and purified water.

Flecainide is a clear colourless to straw coloured solution, supplied in an amber glass bottle, with a tamper evident, child resistant white plastic cap with a 30ml cup.

Flecainide oral solution is supplied in a bottle containing 150 ml oral solution.