Package leaflet: Information for the patient. Flecainide 50 mg Tablets Flecainide 100 mg Tablets. flecainide acetate

Transcription

1 Package leaflet: Information for the patient Flecainide 50 mg Tablets Flecainide 100 mg Tablets flecainide acetate 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 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. 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 1. 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. 2. What you need to know before you take Flecainide Do not take Flecainide: - if you are allergic to flecainide 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 rapid and irregular heart beat (atrial fibrillation) - 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. Page 2 of 7

2 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. fluoxetine, paroxetine, amitriptyline, reboxetine - antiepileptics, used to treat fits (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. terbinafine - anticoagulants, used to thin the blood, e.g. warfarin Flecainide with food and drink Dairy products may affect the intake of flecainide 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 benefits 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. 3. 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 flecainide levels. Adults The recommended starting dose is 100 mg of Flecainide twice a day. 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 can be controlled on 50 mg twice daily. Page 3 of 7

3 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 difficulty 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 first. 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. 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 heat 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) fits (convulsions) inflammation 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 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 Page 4 of 7

4 heart condition, heart block or changes in the generation of electrical impulses in the heart which can cause light-headedness, 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 fluid 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 fibrosis, 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) difficulty breathing weakness tiredness fever excessive fluid 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 (flatulence) inflammation 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 difficulty 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 (flushing) headache Page 5 of 7

5 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 leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ;Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. 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. 6. Contents of the pack and other information What Flecainide contains - The active substance is flecainide acetate. Each tablet contains either 50 mg or 100 mg of flecainide 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. Page 6 of 7

6 Product Authorisation Holder McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. 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. This leaflet was last revised in 02/2015. Page 7 of 7