RYTHMODAN 100MG CAPSULES
Active substance: DISOPYRAMIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
1. What Rythmodan Capsules are and what they are used for 2. Before you take Rythmodan Capsules 3. How to take Rythmodan Capsules 4. Possible side effects 5. How to store Rythmodan Capsules 6. Further information
In this leaflet: Do not take Rythmodan Capsules and tell your doctor if:
2.Before you take Rythmodan Capsules
Rythmodan 100mg Capsules disopyramide
1.What Rythmodan Capsules are and what they are used for
The name of your medicine is Rythmodan 100mg Capsules (called Rythmodan Capsules in this leaflet). Rythmodan Capsules contain a medicine called disopyramide. This belongs to a group of medicines called anti-arrhythmic agents. It works by controlling the uneven beating of your heart and returns it to the normal rhythm.
Is this leaflet hard to see or read? Phone 01483 505515 for help
i
Read all of this leaflet carefully before you start taking this medicine.
You are allergic (hypersensitive) to disopyramide or any of the other ingredients of Rythmodan (see Section 6: Further Information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. You have any other heart problems apart from unusual heartbeats (arrhythmias) You are taking other medicines to control your heart rhythm (see section below Taking other medicines) You are taking other medicines which could cause unusual heartbeats (see section below Taking other medicines) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rythmodan Capsules.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. It is used for controlling your heartbeat in the following situations: Arrhythmias - where your heartbeats are uneven, or unusually fast or slow To keep your heart beating at a normal rhythm To stop unusual heartbeats (arrhythmias) happening after a heart attack To stop unusual heartbeats (arrhythmias) during an operation
-1-
R766580
Take special care with Rythmodan Capsules Taking other medicines
Check with your doctor or pharmacist before taking your medicine if:
L You have low levels of potassium in
L You have low blood sugar levels. This
your blood (called hypokalaemia)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rythmodan Capsules can affect the way some other medicines work. Also some medicines can affect the way Rythmodan Capsules works.
Antibiotics such as erythromycin, clarithromycin, azithromycin or sparfloxacin Antihistamines such as astemizole or terfenadine Cisapride - used for heartburn Pentamidine - used for pneumonia Pimozide and thioridazine - used for schizophrenia
L
L L L
L
can happen if you have diabetes, a low body weight, a poor diet or if you are elderly You have glaucoma (raised pressure in the eye which causes painful eyes with blurred vision) You have an enlarged prostate You have any kidney or liver problems You have a disease which causes muscle weakness (myasthenia gravis) You are elderly and have problems with your memory or attention span, or sometimes have difficulty thinking clearly In particular, do not take this medicine, and tell your doctor: If you are taking any of the following medicines for uneven heartbeats (arrhythmias): Beta-blockers such as propranolol, oxprenolol or acebutolol Verapamil also used for chest pain or high blood pressure Digoxin also used for heart problems
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rythmodan Capsules. Medicines for depression such as amitriptyline, imipramine or maprotiline Medicines for male sexual problems such as sildenafil, tadalafil or vardenafil
-2-
If you are taking any of the following medicines that can increase the risk of unusual heartbeats (arrhythmias) when taken at the same time as Rythmodan Capsules:
The following medicines may affect the way Rythmodan Capsules works: Amphotericin B - used for fungal infections Tetracosactide - used to test some hormone problems Rifampicin - used for infections Atropine used in eye drops and in cough and cold medicines Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or incontinence Medicines used to calm emotional or mental problems or stop you feeling sick or being sick such as chlorpromazine or prochlorperazine Water tablets (diuretics) such as furosemide Corticosteroids such as hydrocortisone, betamethasone or prednisolone Laxatives such as bisacodyl or senna Medicines for epilepsy such as phenobarbital, primidone or phenytoin
Taking this medicine
Do not take a double dose to make up for a forgotten capsule.
If you forget to take Rythmodan Capsules
If you stop taking Rythmodan Capsules
Keep taking Rythmodan Capsules until your doctor tells you to stop.
Take this medicine by mouth Swallow the capsules with a drink of water If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
Rythmodan Capsules may affect the way the following medicines work: Medicines for HIV infections such as ritonavir, indinavir or saquinavir Theophylline - used for wheezing or difficulty in breathing Ciclosporin - used to help prevent rejection of transplants Warfarin - used to thin the blood
Adults
The usual starting dose is three to eight capsules (300 to 800mg) in divided doses daily.
?
If you have any further questions about this medicine, ask your doctor or pharmacist.
Pregnancy and breast-feeding Elderly
Your doctor may lower your dose if you have any kidney or liver problems.
4.Possible side effects
Like all medicines, Rythmodan Capsules can cause side effects, although not everybody gets them.
Children
Rythmodan Capsules are not suitable for use in children.
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine. This is because small amounts of this medicine may pass into the mothers milk.
Blood tests
Your doctor may ask you to have regular blood tests to check your blood sugar levels.
Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment
If you have an allergic reaction. The signs may include: a skin rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Driving and using machines
If you take more Rythmodan Capsules than you should
Rythmodan Capsules may affect your ability to concentrate and react quickly. You may have blurred vision or become dizzy or light-headed. If this happens, do not drive or use any tools or machines. If you take more capsules than you should, talk to a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: dizziness, feeling tired, uneven heartbeat (palpitations), dry mouth, difficulty in passing water (urinating), feeling or being sick, stomach pain or fits (seizures).
-3-
Tell your doctor as soon as possible if you have any of the following:
Feeling faint, dizzy or light-headed Palpitations or an uneven, fast or slow heartbeat that you have not had before or that gets worse
3.How to take Rythmodan Capsules
Always take Rythmodan Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com
Do not use Rythmodan Capsules if you notice your capsules are crumbling, broken or discoloured.
Marketing Authorisation Holder and Manufacturer
6.Further information What Rythmodan Capsules contain
- Each capsule contains 100mg of the active substance, disopyramide - The other ingredients are maize starch, magnesium stearate, STA-RX 1500 (pregelatinised starch), talc, gelatin, indigo carmine, iron oxide (E172) and titanium dioxide (E171) Manufacturer Sanofi Winthrop Industrie 56, route de Choisy-au-Bac 60205 Compiegne France
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What Rythmodan Capsules look like and contents of the pack
The capsules have a green cap and yellow body and are printed in black ink with RY on one part and RL on the other. The capsules are available in blister-packs of 84 capsules or bottles of 100 capsules. Not all pack sizes may be marketed.
This leaflet was last revised in 08/2012
Sanofi, 1972 - 2012
Feeling sick (nausea) or being sick (vomiting), dry mouth, indigestion, diarrhoea, constipation, stomach pain, loss of appetite Difficulty in passing urine, especially in men with prostate problems Difficulty in getting or maintaining an erection, or in ejaculating (impotence) Mood changes or mental problems Blurred or double vision Yellowing of your skin or eyes (jaundice) Worsening of myasthenia gravis (a disease which causes muscle weakness) You may get more infections than usual. This could be caused by a lowering in the number of white blood cells (called neutropenia) Low blood sugar levels (hypoglycaemia). Signs include sweating, paleness, headache, faintness or drowsiness Problems with memory or attention span, difficulty thinking clearly.
5.How to store Rythmodan Capsules
Keep out of the sight and reach of children. Store below 25C. Do not use Rythmodan Capsules after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
-4R766580
1. What Rythmodan Capsules are and what they are used for 2. Before you take Rythmodan Capsules 3. How to take Rythmodan Capsules 4. Possible side effects 5. How to store Rythmodan Capsules 6. Further information
In this leaflet: Do not take Rythmodan Capsules and tell your doctor if:
2.Before you take Rythmodan Capsules
Rythmodan 100mg Capsules disopyramide
1.What Rythmodan Capsules are and what they are used for
The name of your medicine is Rythmodan 100mg Capsules (called Rythmodan Capsules in this leaflet). Rythmodan Capsules contain a medicine called disopyramide. This belongs to a group of medicines called anti-arrhythmic agents. It works by controlling the uneven beating of your heart and returns it to the normal rhythm.
Is this leaflet hard to see or read? Phone 01483 505515 for help
i
Read all of this leaflet carefully before you start taking this medicine.
You are allergic (hypersensitive) to disopyramide or any of the other ingredients of Rythmodan (see Section 6: Further Information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. You have any other heart problems apart from unusual heartbeats (arrhythmias) You are taking other medicines to control your heart rhythm (see section below Taking other medicines) You are taking other medicines which could cause unusual heartbeats (see section below Taking other medicines) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rythmodan Capsules.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. It is used for controlling your heartbeat in the following situations: Arrhythmias - where your heartbeats are uneven, or unusually fast or slow To keep your heart beating at a normal rhythm To stop unusual heartbeats (arrhythmias) happening after a heart attack To stop unusual heartbeats (arrhythmias) during an operation
-1-
R766580
Take special care with Rythmodan Capsules Taking other medicines
Check with your doctor or pharmacist before taking your medicine if:
L You have low levels of potassium in
L You have low blood sugar levels. This
your blood (called hypokalaemia)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rythmodan Capsules can affect the way some other medicines work. Also some medicines can affect the way Rythmodan Capsules works.
Antibiotics such as erythromycin, clarithromycin, azithromycin or sparfloxacin Antihistamines such as astemizole or terfenadine Cisapride - used for heartburn Pentamidine - used for pneumonia Pimozide and thioridazine - used for schizophrenia
L
L L L
L
can happen if you have diabetes, a low body weight, a poor diet or if you are elderly You have glaucoma (raised pressure in the eye which causes painful eyes with blurred vision) You have an enlarged prostate You have any kidney or liver problems You have a disease which causes muscle weakness (myasthenia gravis) You are elderly and have problems with your memory or attention span, or sometimes have difficulty thinking clearly In particular, do not take this medicine, and tell your doctor: If you are taking any of the following medicines for uneven heartbeats (arrhythmias): Beta-blockers such as propranolol, oxprenolol or acebutolol Verapamil also used for chest pain or high blood pressure Digoxin also used for heart problems
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rythmodan Capsules. Medicines for depression such as amitriptyline, imipramine or maprotiline Medicines for male sexual problems such as sildenafil, tadalafil or vardenafil
-2-
If you are taking any of the following medicines that can increase the risk of unusual heartbeats (arrhythmias) when taken at the same time as Rythmodan Capsules:
The following medicines may affect the way Rythmodan Capsules works: Amphotericin B - used for fungal infections Tetracosactide - used to test some hormone problems Rifampicin - used for infections Atropine used in eye drops and in cough and cold medicines Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or incontinence Medicines used to calm emotional or mental problems or stop you feeling sick or being sick such as chlorpromazine or prochlorperazine Water tablets (diuretics) such as furosemide Corticosteroids such as hydrocortisone, betamethasone or prednisolone Laxatives such as bisacodyl or senna Medicines for epilepsy such as phenobarbital, primidone or phenytoin
Taking this medicine
Do not take a double dose to make up for a forgotten capsule.
If you forget to take Rythmodan Capsules
If you stop taking Rythmodan Capsules
Keep taking Rythmodan Capsules until your doctor tells you to stop.
Take this medicine by mouth Swallow the capsules with a drink of water If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
Rythmodan Capsules may affect the way the following medicines work: Medicines for HIV infections such as ritonavir, indinavir or saquinavir Theophylline - used for wheezing or difficulty in breathing Ciclosporin - used to help prevent rejection of transplants Warfarin - used to thin the blood
Adults
The usual starting dose is three to eight capsules (300 to 800mg) in divided doses daily.
?
If you have any further questions about this medicine, ask your doctor or pharmacist.
Pregnancy and breast-feeding Elderly
Your doctor may lower your dose if you have any kidney or liver problems.
4.Possible side effects
Like all medicines, Rythmodan Capsules can cause side effects, although not everybody gets them.
Children
Rythmodan Capsules are not suitable for use in children.
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine. This is because small amounts of this medicine may pass into the mothers milk.
Blood tests
Your doctor may ask you to have regular blood tests to check your blood sugar levels.
Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment
If you have an allergic reaction. The signs may include: a skin rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Driving and using machines
If you take more Rythmodan Capsules than you should
Rythmodan Capsules may affect your ability to concentrate and react quickly. You may have blurred vision or become dizzy or light-headed. If this happens, do not drive or use any tools or machines. If you take more capsules than you should, talk to a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: dizziness, feeling tired, uneven heartbeat (palpitations), dry mouth, difficulty in passing water (urinating), feeling or being sick, stomach pain or fits (seizures).
-3-
Tell your doctor as soon as possible if you have any of the following:
Feeling faint, dizzy or light-headed Palpitations or an uneven, fast or slow heartbeat that you have not had before or that gets worse
3.How to take Rythmodan Capsules
Always take Rythmodan Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com
Do not use Rythmodan Capsules if you notice your capsules are crumbling, broken or discoloured.
Marketing Authorisation Holder and Manufacturer
6.Further information What Rythmodan Capsules contain
- Each capsule contains 100mg of the active substance, disopyramide - The other ingredients are maize starch, magnesium stearate, STA-RX 1500 (pregelatinised starch), talc, gelatin, indigo carmine, iron oxide (E172) and titanium dioxide (E171) Manufacturer Sanofi Winthrop Industrie 56, route de Choisy-au-Bac 60205 Compiegne France
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What Rythmodan Capsules look like and contents of the pack
The capsules have a green cap and yellow body and are printed in black ink with RY on one part and RL on the other. The capsules are available in blister-packs of 84 capsules or bottles of 100 capsules. Not all pack sizes may be marketed.
This leaflet was last revised in 08/2012
Sanofi, 1972 - 2012
Feeling sick (nausea) or being sick (vomiting), dry mouth, indigestion, diarrhoea, constipation, stomach pain, loss of appetite Difficulty in passing urine, especially in men with prostate problems Difficulty in getting or maintaining an erection, or in ejaculating (impotence) Mood changes or mental problems Blurred or double vision Yellowing of your skin or eyes (jaundice) Worsening of myasthenia gravis (a disease which causes muscle weakness) You may get more infections than usual. This could be caused by a lowering in the number of white blood cells (called neutropenia) Low blood sugar levels (hypoglycaemia). Signs include sweating, paleness, headache, faintness or drowsiness Problems with memory or attention span, difficulty thinking clearly.
5.How to store Rythmodan Capsules
Keep out of the sight and reach of children. Store below 25C. Do not use Rythmodan Capsules after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
-4R766580
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.
