SOTALOL 80 MG TABLETS
Active substance: SOTALOL HYDROCHLORIDE
View full screen / Print PDF » Download PDF ⇩
Transcript
PAGE 1: FRONT FACE (INSIDE OF REEL) Top of page cut-off to middle of registration mark: 44 mm.
PAGE 2: REAR FACE (OUTSIDE OF REEL)
SOTALOL 80 mg AND 160 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
are also receiving injections of erythromycin (an antibiotic) or vincamine (which may be used to treat some forms of brain disease, notably dementia), or if you are taking bepridil (used to treat angina), cisapride (used to treat certain gastrointestinal problems), diphenamil (which may be used to treat a slow heart beat), mizolastine (used to treat hayfever), moxifloxacin (an antibiotic) or floctafenine (used to treat pain). If you are elderly, it is especially important for you not to take Sotalol if any of the above applies to you. Take special care with Sotalol: Sotalol may sometimes make an abnormal heart beat worse or cause new heart rhythm problems. Tell your doctor before you start to take this medicine if you have: heart failure which is being treated or a heart rhythm disorder called first degree atrioventricular (AV) block, or you have recently had a heart attack an electrolyte imbalance (low levels of potassium and magnesium in your blood) severe or prolonged diarrhoea frequent allergic reactions an over-active thyroid gland psoriasis (patches of thickened and sore skin) diabetes, treated with insulin or sulphonylureas, as warning signs of low blood sugar may be less obvious than usual kidney disease. Other precautions you should take: Tell the hospital staff or dentist you are taking Sotalol if you are to have an operation requiring an anaesthetic or need X-rays. Never stop taking Sotalol abruptly (see 3. How to take Sotalol). Athletes should note that sotalol can cause positive results in drug tests. Taking other medicines: Some medicines must not be taken at the same time as sotalol. These are listed above, under the heading Do not take Sotalol if you. Talk to your doctor if you are taking any of the medicines listed below. Sotalol should not generally be taken at the same time as the following medicines because of the risk of further heart problems: halofantrine (used to treat malaria) pentamidine (used to treat pneumonia) sparfloxacin (an antibiotic) methadone (which may be used to treat cough, pain and heroin addiction) diltiazem or verapamil (called calcium channel blockers or antagonists, used to treat abnormal heart beats) medicines that can cause high blood pressure such as monoamine oxidase inhibitors (MAOIs) e.g. moclobemide, phenelzine, isocarboxazid. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice. Your doctor may prescribe Sotalol during pregnancy if it is clearly necessary. Do not take Sotalol unless your doctor tells you to and always take it exactly as prescribed. Breast-feeding is not recommended during treatment with Sotalol.
Driving and using machines Sotalol may affect your eyesight or make you feel dizzy. Do not drive or operate any tools or machines if you are affected. Important information about some of the ingredients of Sotalol Sotalol tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3
HOW TO TAKE SOTALOL
chest pain, palpitations, ankle swelling, ECG (cardiogram) abnormalities, low blood pressure, worsened irregular heartbeat, fainting, heart failure skin rashes, itching, sweating, sensitivity to light nausea, vomiting, diarrhoea, indigestion, abdominal pain and flatulence cramp, muscle or joint pain sexual problems including impotence fatigue, dizziness, light-headedness, vertigo, lethargy, headaches, depression, sleeping difficulties, pins-and-needles, numbness, anxiety.
Pharma code 236 (Main)
Always take Sotalol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is: Adults (including the elderly): The initial dose is 80 mg of Sotalol taken once daily or in two divided doses at 12 hour intervals. Your doctor will then gradually increase this according to your needs.
In exceptional cases, there have been reports of inflammation of the joints and connective tissue (e.g. tendons) with skin rashes. These symptoms usually disappear once treatment is stopped. If you have psoriasis, or intermittent claudication (cramp-like leg pain brought on by walking), your symptoms may become worse.
1. What Sotalol is and what it is used for 2. Before you take Sotalol 3. How to take Sotalol 4. Possible side effects 5. How to store Sotalol 6. Further information
1
WHAT SOTALOL IS AND WHAT IT IS USED FOR
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, The usual dose is between 160 mg and 320 mg please tell your doctor or pharmacist. of Sotalol taken in two or three divided doses each day. HOW TO STORE SOTALOL
5
Sotalol belongs to a group of medicines called beta-blockers, which slow the heart beat, so the heart beats more efficiently. Sotalol is used to prevent a recurrence of serious heart beat problems.
2
BEFORE YOU TAKE SOTALOL
DO NOT take Sotalol if you: are allergic (hypersensitive) to sotalol or any of the other ingredients of this medicine are sensitive to sulphonamides e.g. co-trimoxazole, sulfadiazine have any heart problems, other than those for which your medicine has been prescribed, in particular: abnormal heart rhythms called long QT syndrome torsades de pointes atrioventricular (AV) block sick sinus syndrome (without a pacemaker) if your heart beats less than 50 times per minute if you suffer from uncontrolled heart failure if you are in shock due to heart problems (a condition which may be associated with low blood pressure, cold skin, a weak pulse, mental confusion and anxiety) suffer from any of the following conditions: asthma or any other breathing difficulties Prinzmetals angina (chest pain and palpitations at rest, usually during sleep) problems with your circulation (e.g. Raynauds phenomenon or pain in the calf muscles on walking) phaeochromocytoma (a benign adrenal tumour) which is not being treated low blood pressure (which is not due to an irregular heartbeat) severe kidney problems metabolic acidosis (acidification of the blood) are due to have a general anaesthetic are also taking other medicines to correct an abnormal heart rhythm, e.g. quinidine, hydroquinidine or disopyramide (called class Ia antiarrhythmic agents) or amiodarone, dofetilide or ibutilide (called class III antiarrhythmic agents) are also taking medicines used to treat schizophrenia and other serious mental disorders e.g. sulpiride, sultopride, amisulpride, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, tiapride, pimozide, haloperidol, droperidol (called neuroleptics)
For certain patients who have a life-threatening Keep out of the reach and sight of children. Do irregular heart beat, the dose can be increased not use Sotalol after the expiry date that is up to 480 mg or 640 mg of Sotalol daily. stated on the outer packaging. Store in the original package and protect from light. Patients with kidney problems may require a Medicines should not be disposed of via lower dose. wastewater or household waste. Ask your pharmacist how to dispose of medicines no Children: longer required. These measures will help to Due to a lack of data Sotalol is not recommended protect the environment. for use in children. Please check with your doctor. Method of administration You should swallow Sotalol whole with a full glass of water.
6
FURTHER INFORMATION
If you take more Sotalol than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, What Sotalol looks like and contents of the any remaining tablets and the container with pack: you to the hospital or doctor so that they know Sotalol 80 mg Tablets are light blue, oval which tablets were consumed. shaped tablets, scored on one side and debossed with the number 93 and 61 If you forget to take Sotalol on each side of the score, plain on the other If you forget to take a dose, take one as soon as side. you remember, unless it is nearly time to take Sotalol 160 mg Tablets are light blue, oval the next one. Never take two doses together. shaped tablets, scored on one side and Take the remaining doses at the correct time. debossed with the number 93 and 62 on each side of the score, plain on the other If you stop taking Sotalol side. You must not stop taking Sotalol suddenly, as The tablets can be divided into equal halves. this could cause severe heart problems, The 80 mg product is available in pack sizes including heart attack and death. of 20, 28, 30, 40, 50, 60, 90 and 100 tablets. Your doctor will decide when and how you The 160 mg product is available in pack sizes should stop taking Sotalol. You must follow of 20, 28, 30, 50, 60, 100 and 120 tablets. your doctors instructions. Not all pack sizes may be marketed. If you have any further questions on the use of Marketing Authorisation Holder and this product, ask your doctor or pharmacist. Manufacturer The Marketing Authorisation Holder is TEVA 4 POSSIBLE SIDE EFFECTS UK Limited, Eastbourne, BN22 9AG. Like all medicines, Sotalol can cause side This leaflet was last revised in: January 2009 effects, although not everybody gets them. The following side effects have been reported: blood disorders (such as changes in the numbers of white or red blood cells) which may be characterised by unusual bleeding or unexplained bruising, fever or chills, sore throat, ulcers in the mouth or throat. If you develop these symptoms, you should contact your doctor. low blood sugar cold hands and/or feet problems with sight slow heartbeat, breathlessness, wheezing, PL 00289/0389-0390
What Sotalol contains: The active ingredient is sotalol hydrochloride. Each tablet contains either 80 mg or 160 mg of sotalol hydrochloride. The other ingredients are lactose monohydrate, maize starch, magnesium stearate, povidone and indigo carmine (E132).
85697-T 160 x 323
PAGE 2: REAR FACE (OUTSIDE OF REEL)
SOTALOL 80 mg AND 160 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
are also receiving injections of erythromycin (an antibiotic) or vincamine (which may be used to treat some forms of brain disease, notably dementia), or if you are taking bepridil (used to treat angina), cisapride (used to treat certain gastrointestinal problems), diphenamil (which may be used to treat a slow heart beat), mizolastine (used to treat hayfever), moxifloxacin (an antibiotic) or floctafenine (used to treat pain). If you are elderly, it is especially important for you not to take Sotalol if any of the above applies to you. Take special care with Sotalol: Sotalol may sometimes make an abnormal heart beat worse or cause new heart rhythm problems. Tell your doctor before you start to take this medicine if you have: heart failure which is being treated or a heart rhythm disorder called first degree atrioventricular (AV) block, or you have recently had a heart attack an electrolyte imbalance (low levels of potassium and magnesium in your blood) severe or prolonged diarrhoea frequent allergic reactions an over-active thyroid gland psoriasis (patches of thickened and sore skin) diabetes, treated with insulin or sulphonylureas, as warning signs of low blood sugar may be less obvious than usual kidney disease. Other precautions you should take: Tell the hospital staff or dentist you are taking Sotalol if you are to have an operation requiring an anaesthetic or need X-rays. Never stop taking Sotalol abruptly (see 3. How to take Sotalol). Athletes should note that sotalol can cause positive results in drug tests. Taking other medicines: Some medicines must not be taken at the same time as sotalol. These are listed above, under the heading Do not take Sotalol if you. Talk to your doctor if you are taking any of the medicines listed below. Sotalol should not generally be taken at the same time as the following medicines because of the risk of further heart problems: halofantrine (used to treat malaria) pentamidine (used to treat pneumonia) sparfloxacin (an antibiotic) methadone (which may be used to treat cough, pain and heroin addiction) diltiazem or verapamil (called calcium channel blockers or antagonists, used to treat abnormal heart beats) medicines that can cause high blood pressure such as monoamine oxidase inhibitors (MAOIs) e.g. moclobemide, phenelzine, isocarboxazid. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice. Your doctor may prescribe Sotalol during pregnancy if it is clearly necessary. Do not take Sotalol unless your doctor tells you to and always take it exactly as prescribed. Breast-feeding is not recommended during treatment with Sotalol.
Driving and using machines Sotalol may affect your eyesight or make you feel dizzy. Do not drive or operate any tools or machines if you are affected. Important information about some of the ingredients of Sotalol Sotalol tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3
HOW TO TAKE SOTALOL
chest pain, palpitations, ankle swelling, ECG (cardiogram) abnormalities, low blood pressure, worsened irregular heartbeat, fainting, heart failure skin rashes, itching, sweating, sensitivity to light nausea, vomiting, diarrhoea, indigestion, abdominal pain and flatulence cramp, muscle or joint pain sexual problems including impotence fatigue, dizziness, light-headedness, vertigo, lethargy, headaches, depression, sleeping difficulties, pins-and-needles, numbness, anxiety.
Pharma code 236 (Main)
Always take Sotalol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is: Adults (including the elderly): The initial dose is 80 mg of Sotalol taken once daily or in two divided doses at 12 hour intervals. Your doctor will then gradually increase this according to your needs.
In exceptional cases, there have been reports of inflammation of the joints and connective tissue (e.g. tendons) with skin rashes. These symptoms usually disappear once treatment is stopped. If you have psoriasis, or intermittent claudication (cramp-like leg pain brought on by walking), your symptoms may become worse.
1. What Sotalol is and what it is used for 2. Before you take Sotalol 3. How to take Sotalol 4. Possible side effects 5. How to store Sotalol 6. Further information
1
WHAT SOTALOL IS AND WHAT IT IS USED FOR
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, The usual dose is between 160 mg and 320 mg please tell your doctor or pharmacist. of Sotalol taken in two or three divided doses each day. HOW TO STORE SOTALOL
5
Sotalol belongs to a group of medicines called beta-blockers, which slow the heart beat, so the heart beats more efficiently. Sotalol is used to prevent a recurrence of serious heart beat problems.
2
BEFORE YOU TAKE SOTALOL
DO NOT take Sotalol if you: are allergic (hypersensitive) to sotalol or any of the other ingredients of this medicine are sensitive to sulphonamides e.g. co-trimoxazole, sulfadiazine have any heart problems, other than those for which your medicine has been prescribed, in particular: abnormal heart rhythms called long QT syndrome torsades de pointes atrioventricular (AV) block sick sinus syndrome (without a pacemaker) if your heart beats less than 50 times per minute if you suffer from uncontrolled heart failure if you are in shock due to heart problems (a condition which may be associated with low blood pressure, cold skin, a weak pulse, mental confusion and anxiety) suffer from any of the following conditions: asthma or any other breathing difficulties Prinzmetals angina (chest pain and palpitations at rest, usually during sleep) problems with your circulation (e.g. Raynauds phenomenon or pain in the calf muscles on walking) phaeochromocytoma (a benign adrenal tumour) which is not being treated low blood pressure (which is not due to an irregular heartbeat) severe kidney problems metabolic acidosis (acidification of the blood) are due to have a general anaesthetic are also taking other medicines to correct an abnormal heart rhythm, e.g. quinidine, hydroquinidine or disopyramide (called class Ia antiarrhythmic agents) or amiodarone, dofetilide or ibutilide (called class III antiarrhythmic agents) are also taking medicines used to treat schizophrenia and other serious mental disorders e.g. sulpiride, sultopride, amisulpride, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, tiapride, pimozide, haloperidol, droperidol (called neuroleptics)
For certain patients who have a life-threatening Keep out of the reach and sight of children. Do irregular heart beat, the dose can be increased not use Sotalol after the expiry date that is up to 480 mg or 640 mg of Sotalol daily. stated on the outer packaging. Store in the original package and protect from light. Patients with kidney problems may require a Medicines should not be disposed of via lower dose. wastewater or household waste. Ask your pharmacist how to dispose of medicines no Children: longer required. These measures will help to Due to a lack of data Sotalol is not recommended protect the environment. for use in children. Please check with your doctor. Method of administration You should swallow Sotalol whole with a full glass of water.
6
FURTHER INFORMATION
If you take more Sotalol than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, What Sotalol looks like and contents of the any remaining tablets and the container with pack: you to the hospital or doctor so that they know Sotalol 80 mg Tablets are light blue, oval which tablets were consumed. shaped tablets, scored on one side and debossed with the number 93 and 61 If you forget to take Sotalol on each side of the score, plain on the other If you forget to take a dose, take one as soon as side. you remember, unless it is nearly time to take Sotalol 160 mg Tablets are light blue, oval the next one. Never take two doses together. shaped tablets, scored on one side and Take the remaining doses at the correct time. debossed with the number 93 and 62 on each side of the score, plain on the other If you stop taking Sotalol side. You must not stop taking Sotalol suddenly, as The tablets can be divided into equal halves. this could cause severe heart problems, The 80 mg product is available in pack sizes including heart attack and death. of 20, 28, 30, 40, 50, 60, 90 and 100 tablets. Your doctor will decide when and how you The 160 mg product is available in pack sizes should stop taking Sotalol. You must follow of 20, 28, 30, 50, 60, 100 and 120 tablets. your doctors instructions. Not all pack sizes may be marketed. If you have any further questions on the use of Marketing Authorisation Holder and this product, ask your doctor or pharmacist. Manufacturer The Marketing Authorisation Holder is TEVA 4 POSSIBLE SIDE EFFECTS UK Limited, Eastbourne, BN22 9AG. Like all medicines, Sotalol can cause side This leaflet was last revised in: January 2009 effects, although not everybody gets them. The following side effects have been reported: blood disorders (such as changes in the numbers of white or red blood cells) which may be characterised by unusual bleeding or unexplained bruising, fever or chills, sore throat, ulcers in the mouth or throat. If you develop these symptoms, you should contact your doctor. low blood sugar cold hands and/or feet problems with sight slow heartbeat, breathlessness, wheezing, PL 00289/0389-0390
What Sotalol contains: The active ingredient is sotalol hydrochloride. Each tablet contains either 80 mg or 160 mg of sotalol hydrochloride. The other ingredients are lactose monohydrate, maize starch, magnesium stearate, povidone and indigo carmine (E132).
85697-T 160 x 323
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.
