TAMBOCOR XL 200MG CAPSULES
Active substance: FLECAINIDE ACETATE
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Tambocor XL 200 mg Capsules
Flecainide acetate
Read all of this leaflet carefully before you take this medicine. Keep this leaflet. You may need to read it again. f you have any further questions, ask your doctor or I nurse. his medicine has been prescribed for you. Do not T pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What Tambocor XL capsules are for 2. Before you take Tambocor XL capsules 3. How to take Tambocor XL capsules 4. Possible side effects 5. How to store Tambocor XL capsules 6. Further information. 1. What Tambocor XL capsules are for Tambocor XL capsules belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart. Tambocor XL capsules are used to treat: rregular heart beat (arrhythmias) I eart beat too fast (tachycardia) H apid contractions of muscles in the heart (atrial R fibrillation). Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control. 2. Before you take Tambocor XL capsules Do not take Tambocor XL capsules and tell your doctor or nurse if: ou are allergic to active substance flecainide acetate Y or any of the other ingredients of Tambocor XL c apsules (See section 6) ou have heart failure Y ou have had a heart attack (myocardial infarction) Y our heart misses beats (have heart block) Y ou have long-standing rapid contractions of muscles Y in the heart (atrial fibrillation) ou have or have ever had any heart problems Y i ncluding problems with the valves in your heart or conduction problems ou have a specific condition where your heart beats Y abnormally (sinus node dysfunction) ou are pregnant or breast-feeding. Y Tambocor XL capsules are not recommended for use in children under 12 years of age. If any of the above applies to you tell your doctor or nurse. Before you take Tambocor XL capsules your doctor or nurse may check: our fluid levels are correct Y our liver and kidney functions. Y This is to check that Tambocor XL capsules are right for you and to help the doctor calculate the dose you need. Check with your doctor or nurse before taking Tambocor XL capsules if: ou have high blood pressure Y ou have chest pains (angina) Y ou have heart disease Y ou have kidney disease or kidney problems Y ou have liver disease or liver problems Y ou wear a pacemaker. Y Tell your doctor or nurse if you are taking any of the following medicines: ny other medicine used to treat irregular heart A beat (heart arrhythmias) or heart problems. Examples of such medicines include cardiac glycosides, b eta-blockers, verapamil or amiodarone edicines to treat high blood pressure M edicines used to treat depression (antidepressants), M such as tricyclic antidepressants, Prozac, fluoxetine or reboxetine edicines used to prevent epileptic fits M (anticonvulsants) such as phenytoin, phenobarbital or carbama epine z edicines to treat mental illness (antipsychotics) such M as clozapine edicines to treat allergic reactions (antihistamines) M such as mizolastine or terfenadine edicine to treat malaria (quinine) M edicine to treat HIV such as ritonavir, lopinavir or M indinavir ater tablets (diuretics) W edicine to treat stomach ulcers (cimetidine) M edicine to help stop you smoking (bupropion) M ny other medicine, including medicines obtained A without a prescription. These medicines may interfere with your treatment. Pregnancy and breast-feeding Do not take Tambocor XL capsules if you are pregnant, are trying to become pregnant, or are breast-feeding. If you are uncertain about anything, ask your nurse or doctor for advice. 3. How to take Tambocor XL capsules Always take Tambocor XL capsules exactly as your doctor has told you. Important: Your doctor will choose the dose that is right for your condition. Usually your treatment with T ambocor XL capsules will be started under hospital supervision. Remember: Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control. Tambocor XL capsules should be swallowed whole with some water. They should not be broken open or chewed.
Patient Information Leaflet
Adults he usual dose is one 200 mg capsule per day. T ccasionally your doctor may decide you need a higher O or lower dose than this. If this is the case your doctor may prescribe Tambocor tablets. The elderly and patients with kidney or heart p roblems or elderly patients, and patients with kidney or heart F problems, the doctor may tell you to take a lower dose. While you are taking this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you. Children ambocor XL capsules are not recommended for T children under 12 years of age. If you take more Tambocor XL capsules than you should If you accidentally take too much, immediately go to the nearest hospital casualty department. If you forget to take Tambocor XL capsules Do not take a double dose to make up for a missed dose. Simply take the next dose as planned. If you stop taking Tambocor XL capsules Do not stop taking Tambocor XL capsules without first talking to your doctor. If you have any further questions about the use of this medicine, ask your doctor or nurse. 4. Possible side effects Like all medicines Tambocor XL capsules can cause side effects, although not everybody gets them. Seek immediate medical help if you have any of the following symptoms: our heartbeat changes; it starts to pound, or it Y gets faster or slower Y ou have chest pain ou become breathless or have other breathing or Y lung problems ou faint or you feel faint Y ou have ringing in your ears Y our skin and eyes begin to go yellow (jaundice) Y ou have a fever, become flushed or sweat Y ou have fits (convulsions). Y Other side effects: eeling or being sick F onstipation C eeling bloated F ind W iarrhoea D tomach pain or indigestion S oss of appetite L onfusion and hallucinations C orgetfulness F ifficulty sleeping D eeling anxious (worried) F epression D ed, itchy or swollen skin rash R ensitivity of the skin to sunlight S air loss H eeling weak or tired F
eadache H ouble or blurred vision D mall cloudy spots on the eyeball S eeling giddy or lightheaded F izziness or feeling that the room is spinning (vertigo) D haking (tremors) S nsteady walking, uncontrolled movements or poor U coordination umb or tingling hands or feet N welling. S If any of these side effects get serious, or you notice any side effects not listed in this leaflet, tell your doctor or nurse. 5. How to store Tambocor XL capsules Keep out of the reach and sight of children. Do not store above 25 C. Keep the container in the outer carton to protect the capsules from light and moisture. Do not use Tambocor XL capsules after the expiry date on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist. 6. Further information What Tambocor XL capsules contain he active substance in Tambocor XL capsules is T flecainide acetate. Each 200 mg capsule contains 200 mg flecainide acetate. he other ingredients are microcrystalline cellulose T (E 460i), methacrylic acid methyl methacrylate copolymer, macrogol 400, talc (E 553b), gelatin, titanium dioxide (E 171), iron oxide black (E 172), and erythrosine (E 127), shellac (E 904) and propylene glycol (E 152). What Tambocor XL capsules look like Tambocor XL 200 mg capsules are light grey and pink with 3M 200 printed in black ink. Tambocor XL 200mg capsules come in packs containing 15, 30 or 60 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder: Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford, CM22 6PU, UK. Manufacturer: 3M Health Care Limited, 1 Morley Street, Loughborough, Leicester, LE11 1EP, UK. This leaflet was last updated
If this leaflet is difficult to see or read and you would like it in a different format, please contact Meda harmaceuticals Ltd, P Skyway House, Parsonage Road, Takeley, Bishops Stortford, CM22 6PU, UK.
Tambocor is a trademark of MEDA AB. The Triangle Logo on the packaging is a trademark of 3M and is used under license.
Flecainide acetate
Read all of this leaflet carefully before you take this medicine. Keep this leaflet. You may need to read it again. f you have any further questions, ask your doctor or I nurse. his medicine has been prescribed for you. Do not T pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What Tambocor XL capsules are for 2. Before you take Tambocor XL capsules 3. How to take Tambocor XL capsules 4. Possible side effects 5. How to store Tambocor XL capsules 6. Further information. 1. What Tambocor XL capsules are for Tambocor XL capsules belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart. Tambocor XL capsules are used to treat: rregular heart beat (arrhythmias) I eart beat too fast (tachycardia) H apid contractions of muscles in the heart (atrial R fibrillation). Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control. 2. Before you take Tambocor XL capsules Do not take Tambocor XL capsules and tell your doctor or nurse if: ou are allergic to active substance flecainide acetate Y or any of the other ingredients of Tambocor XL c apsules (See section 6) ou have heart failure Y ou have had a heart attack (myocardial infarction) Y our heart misses beats (have heart block) Y ou have long-standing rapid contractions of muscles Y in the heart (atrial fibrillation) ou have or have ever had any heart problems Y i ncluding problems with the valves in your heart or conduction problems ou have a specific condition where your heart beats Y abnormally (sinus node dysfunction) ou are pregnant or breast-feeding. Y Tambocor XL capsules are not recommended for use in children under 12 years of age. If any of the above applies to you tell your doctor or nurse. Before you take Tambocor XL capsules your doctor or nurse may check: our fluid levels are correct Y our liver and kidney functions. Y This is to check that Tambocor XL capsules are right for you and to help the doctor calculate the dose you need. Check with your doctor or nurse before taking Tambocor XL capsules if: ou have high blood pressure Y ou have chest pains (angina) Y ou have heart disease Y ou have kidney disease or kidney problems Y ou have liver disease or liver problems Y ou wear a pacemaker. Y Tell your doctor or nurse if you are taking any of the following medicines: ny other medicine used to treat irregular heart A beat (heart arrhythmias) or heart problems. Examples of such medicines include cardiac glycosides, b eta-blockers, verapamil or amiodarone edicines to treat high blood pressure M edicines used to treat depression (antidepressants), M such as tricyclic antidepressants, Prozac, fluoxetine or reboxetine edicines used to prevent epileptic fits M (anticonvulsants) such as phenytoin, phenobarbital or carbama epine z edicines to treat mental illness (antipsychotics) such M as clozapine edicines to treat allergic reactions (antihistamines) M such as mizolastine or terfenadine edicine to treat malaria (quinine) M edicine to treat HIV such as ritonavir, lopinavir or M indinavir ater tablets (diuretics) W edicine to treat stomach ulcers (cimetidine) M edicine to help stop you smoking (bupropion) M ny other medicine, including medicines obtained A without a prescription. These medicines may interfere with your treatment. Pregnancy and breast-feeding Do not take Tambocor XL capsules if you are pregnant, are trying to become pregnant, or are breast-feeding. If you are uncertain about anything, ask your nurse or doctor for advice. 3. How to take Tambocor XL capsules Always take Tambocor XL capsules exactly as your doctor has told you. Important: Your doctor will choose the dose that is right for your condition. Usually your treatment with T ambocor XL capsules will be started under hospital supervision. Remember: Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control. Tambocor XL capsules should be swallowed whole with some water. They should not be broken open or chewed.
Patient Information Leaflet
Adults he usual dose is one 200 mg capsule per day. T ccasionally your doctor may decide you need a higher O or lower dose than this. If this is the case your doctor may prescribe Tambocor tablets. The elderly and patients with kidney or heart p roblems or elderly patients, and patients with kidney or heart F problems, the doctor may tell you to take a lower dose. While you are taking this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you. Children ambocor XL capsules are not recommended for T children under 12 years of age. If you take more Tambocor XL capsules than you should If you accidentally take too much, immediately go to the nearest hospital casualty department. If you forget to take Tambocor XL capsules Do not take a double dose to make up for a missed dose. Simply take the next dose as planned. If you stop taking Tambocor XL capsules Do not stop taking Tambocor XL capsules without first talking to your doctor. If you have any further questions about the use of this medicine, ask your doctor or nurse. 4. Possible side effects Like all medicines Tambocor XL capsules can cause side effects, although not everybody gets them. Seek immediate medical help if you have any of the following symptoms: our heartbeat changes; it starts to pound, or it Y gets faster or slower Y ou have chest pain ou become breathless or have other breathing or Y lung problems ou faint or you feel faint Y ou have ringing in your ears Y our skin and eyes begin to go yellow (jaundice) Y ou have a fever, become flushed or sweat Y ou have fits (convulsions). Y Other side effects: eeling or being sick F onstipation C eeling bloated F ind W iarrhoea D tomach pain or indigestion S oss of appetite L onfusion and hallucinations C orgetfulness F ifficulty sleeping D eeling anxious (worried) F epression D ed, itchy or swollen skin rash R ensitivity of the skin to sunlight S air loss H eeling weak or tired F
eadache H ouble or blurred vision D mall cloudy spots on the eyeball S eeling giddy or lightheaded F izziness or feeling that the room is spinning (vertigo) D haking (tremors) S nsteady walking, uncontrolled movements or poor U coordination umb or tingling hands or feet N welling. S If any of these side effects get serious, or you notice any side effects not listed in this leaflet, tell your doctor or nurse. 5. How to store Tambocor XL capsules Keep out of the reach and sight of children. Do not store above 25 C. Keep the container in the outer carton to protect the capsules from light and moisture. Do not use Tambocor XL capsules after the expiry date on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist. 6. Further information What Tambocor XL capsules contain he active substance in Tambocor XL capsules is T flecainide acetate. Each 200 mg capsule contains 200 mg flecainide acetate. he other ingredients are microcrystalline cellulose T (E 460i), methacrylic acid methyl methacrylate copolymer, macrogol 400, talc (E 553b), gelatin, titanium dioxide (E 171), iron oxide black (E 172), and erythrosine (E 127), shellac (E 904) and propylene glycol (E 152). What Tambocor XL capsules look like Tambocor XL 200 mg capsules are light grey and pink with 3M 200 printed in black ink. Tambocor XL 200mg capsules come in packs containing 15, 30 or 60 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder: Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford, CM22 6PU, UK. Manufacturer: 3M Health Care Limited, 1 Morley Street, Loughborough, Leicester, LE11 1EP, UK. This leaflet was last updated
If this leaflet is difficult to see or read and you would like it in a different format, please contact Meda harmaceuticals Ltd, P Skyway House, Parsonage Road, Takeley, Bishops Stortford, CM22 6PU, UK.
Tambocor is a trademark of MEDA AB. The Triangle Logo on the packaging is a trademark of 3M and is used under license.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
