SIMVASTATIN 10MG TABLETS
Active substance: SIMVASTATIN
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PACK AGE LEAFLET: INFORMATION FOR THE USER
In This Leaflet 1 What Simvador is and what it is used for 2 Before you take Simvador 3 How to take 4 Possible side ef fects 5 How to store 6 Contents of the pack and further information
Read all of this leaflet carefully before you start taking this medicine. Keep the leaflet. You may need to read it again. If you have any 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. Simvador is used to lower levels of cholesterol and triglycerides in your blood and can help reduce your risk of developing coronary heart disease. (See Section 1 What Simvador is and what it is used for). Simvador can cause serious muscle problems in a very small number of patients. If you suf fer from unexplained pain, tenderness or weakness in your muscles STOP TAKING the medicine and talk to your doctor at once. DO NOT TAKE this medicine if you are already taking medicines for fungal infections (such as itraconazole, ketoconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), antibiotics (such as ery thromycin, clarithromycin, telithromycin) or nefazodone which is used to treat depression. (See Section 2 Taking other medicines). If you are pregnant or trying to get pregnant or breast feeding you MUST NOT take Simvador (See Section 2 Before you take Simvador). If you have high blood pressure, high levels of fats or sugars in your blood or have a body mass index of more than 30kg/m2 you may be at risk of developing diabetes. Your doctor will monitor you closely if this applies. (See section 2 Before you take Simvadorand Section 4 Possible side ef fects).
Simvador 10mg, 20mg, 40mg and 80mg Tablets Simvastatin
Coronary heart disease or are at high risk of suf fering from coronary heart disease. You are more likely to suf fer from coronary heart disease if you have diabetes, have previously had a stroke, or have other blood vessel disease). Most people will not have any symptoms related to raised cholesterol. Your doctor or pharmacist can measure your cholesterol level by means of a simple blood test. Having too much cholesterol in your bloodstream can lead to coronary heart disease. It can clog up blood vessels leading to hardening of the arteries (atherosclerosis). Hardened arteries are less able to carry blood to the heart and around the body. This can lead to chest pain (angina) and heart at tacks. If you have high levels of cholesterol you are more likely to get heart disease if you also: Have high blood pressure (hypertension) Have diabetes (high blood sugar) Do lit tle physical exercise Smoke Are overweight or eat a high fat diet Talk to your doctor or pharmacist if you would like advice about any of these factors. 2. Before you take Simvador Do not take Simvador if you: are allergic to simvastatin, or to any of the other ingredients (see section 6) suf fer from liver problems are pregnant or breast feeding are taking medicines for fungal infections (such as itraconazole, ketoconazole or posaconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and sequinavir), antibiotics (such as ery thromycin, clarithromycin, telithromycin) or nefazodone which is used to treat depression (See section 2 Taking other medicines). If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment. Check with your doctor or pharmacist before taking these tablets if you: Have previously had problems with your liver Have high blood pressure or high levels of fats and sugars in your blood or if you have a body mass index of more than 30kg/ m2. You may be more at risk of developing diabetes. Your doctor will monitor you closely if this applies to you. Regularly drink large amounts of alcohol Have to go into hospital for an operation -. you may need to stop taking Simvastatin Have severe lung disease Blood tests Before your start taking simvastatin your doctor will do a blood test to see how well your liver is working. Once you start taking the medicine your doctor will want you to have regular blood tests to see how well the medicine is working. Important - Keep healthcare professionals informed Contact your doctor immediately if you suf fer from any
1. What Simvador is and what it is used for Simvador is used to lower levels of cholesterol and fat ty substances called triglycerides in your blood. While taking this medicine you should stick to a cholesterol-lowering diet. This medicine belongs to the class of drugs called statins. Simvador is used along with dieting if you have: A raised cholesterol level in your blood (primary hypercholesterolaemia) or high fat levels in your blood (mixed hyperlipidaemia) when exercise and weight loss have not worked. A hereditary illness called homozygous familial hypercholesterolaemia which causes the cholesterol levels in your blood to rise. You may get other medicines as well for this condition.
unexplained muscle pain, tenderness or weakness. This is because in a very small number of patients, muscle problems can be serious. This can lead to kidney damage and in very rare cases deaths have occurred. You will be more at risk of muscle breakdown if you are on high doses of simvastatin. Also some other patients are more at risk. Talk to your doctor if any of the following apply: you drink large amounts of alcohol you have kidney problems you have thyroid problems you are 65 years or older you are a woman you have ever had muscle problems whilst being treated with cholesterol-lowering medicines such as statins or fibrates you or a close family member have hereditary muscle problems. Taking other medicines Many medicines af fect the way simvastatin works. You must tell your doctor before you start taking any other medicines including over the counter medicines, herbal remedies and vitamin supplements. Do not take Simvastatin and tell your doctor if you are taking: Ciclosporin used to prevent rejection in organ transplant patients A hormone called danazol Antifungal medicines such as ketoconazole, itraconazole, fluconazole or posaconazole Fibrates such as gemfibrozil or bezafibrate which are also used to treat high cholesterol Niacin or nicotinic acid in large doses which are also used to treat high cholesterol Antibiotics such as ery thromycin, clarithromycin, telithromycin, or fusidic acid HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, or saquinavir. an antidepressant called nefazodone drugs such as amiodarone, verapamil, diltiazem or amlodipine which are used to treat heart problems. If you are taking any of the medicines in the list above you must tell your doctor and not take Simvador because these medicines can make it more likely that you will have muscle problems. Check with your doctor first before taking Simvador if you are taking any of these medicines: Medicines used to treat blood clots, such as warfarin because the dose of warfarin may need to be changed. A drug used to treat tuberculosis called rifampicin A drug used to treat gout called colchicine Food and Drink Grapefruit juice can interfere with the way in which your body handles simvastatin. You should not drink grapefruit juice if you are taking Simvador. Pregnancy and breast-feeding DO NOT take Simvador if you are pregnant, think you may be pregnant or are trying to get pregnant or if you get pregnant while
taking Simvador STOP taking the medicine and see your doctor immediately. You should stop taking simvador 1 month before trying to get pregnant. Do not take Simvador if you are breast feeding because it is not known if simvastatin passes into the breast milk. Driving and using machinery Simvador has no known ef fect on the ability to drive or operate machines. Simvastatin can cause dizziness so make sure you are not af fected before you drive or use machines. Important information about some of the ingredients of Simvador Simvador tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you forget to take Simvador If you forget to take a dose, take it as soon as you remember unless it is nearly time for your nex t dose. Do not take a double dose.
3. How to take Always take simvador exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Your dose will be decided by your doctor and will depend on the results of the blood tests. The dose you should take will be on the label at tached by your pharmacist. Swallow the medicine with plenty of water. Remember to keep to a low-fat diet and to take physical exercise. People with coronary heart disease (CHD) The usual dose is 20mg 40mg which you should take in the evening. Your doctor may increase the dose you take every 4 weeks. The ma ximum dose is 80mg. People with high levels of blood fats (Hyperlipidaemia) The usual starting dose is 10mg taken in the evening. Your doctor may increase the dose you take every 4 weeks. The ma ximum dose is 80mg. People with hereditary high cholesterol (homozygous familial hypercholesterolaemia) The usual dose is 40mg taken in the evening. Your doctor may ask you to take 80mg each day in three doses through the day (20mg, 20mg and 40mg). This 80mg dose is only for patients who have very high levels of cholesterol in their blood or are at a high risk of developing heart problems. Children (10-17 years) The usual starting dose for children (10 -17 years old) is 10 mg. This dose should usually be taken in the evening. If necessary the dose may be increased to a ma ximum of 40 mg. Some patients will need a lower dose particularly if they are also taking medicines such as ciclosporin, danazol, fibrates or niacin and also if they have kidney problems. Taking other cholesterol-lowering medicines at the same time as Simvador Your doctor may ask you to take a medicine called colestyramine whilst you are taking simvastatin. This medicine can interfere with the way in which Simvador works. You must take Simvador 2 hours before or 4 hours af ter you have taken colestyramine. If you take more Simvador than you should Talk to your doctor or go to your nearest hospital casualty department straight away. Take the medicine pack with you.
5. How to store Keep this medicine out of the sight and reach of children. Do not store them above 25C. Do not use these tablets af ter the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Disposal 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. 6. Contents of the pack and other information What Simvador Tablets contain The active substance is simvastatin. The other ingredients are: Lactose monohydrate, cellulose microcrystalline (E460), starch
4. Possible side ef fects Like all medicines Simvador can cause side ef fects. Do not be concerned about this list of side ef fects. You may not get any of them, but it is important to know what to do if they occur. Stop taking Simvador and go to hospital at once if you have: a rare allergic reaction such as swelling of the face, tongue, lips and throat, dif ficulty breathing, severe itching of your skin with raised lumps, joint pain, sensitivity to the sun, general feeling of being unwell. You may need urgent medical at tention. Unexplained muscle problems such as pain, tenderness or weakness. In rare cases, these muscle problems can be very serious and result in muscle breakdown and kidney damage. In some cases these problems can be life-threatening. Inflammation of the liver with yellowing of the skin and eyes, dark coloured urine or pale coloured stools). Tell your doctor or pharmacist if any of the following side ef fects persist, get worse or if you notice any other side ef fects not listed. Diabetes. This is more likely if you have high blood pressure, high levels of sugar or fats in your blood or if you have a body mass index of more than 30kg/m2. Your doctor will monitor you more closely if these factors apply to you: Low red blood cell count (anaemia) Numbness in the arms and legs Headache, or dizziness Gastrointestinal disturbances such as feeling or being sick, constipation, wind, diarrhoea, indigestion, stomach pain Rash, itching or hair loss Sleep disturbances such as dif ficulty sleeping and nightmares Poor memory Sexual dif ficulties such as erectile dysfunction Depression Inflammation of the lungs causing dif ficulty in breathing, persistent cough and shortness of breath
pregelatinised, citric acid monohydrate (E330), ascorbic acid (E300), butylhydroxyanisole (E320), isopropyl alcohol and magnesium stearate (E572), hydroxypropylcellulose (E463), hydroxypropylmethylcellulose (E464), titanium dioxide (E171), talc (E553b). In addition Simvador 10mg, 20mg, 40mg, 80mg Tablets contain iron oxide red (E172), Simvador 10mg, 20mg, 80mg Tablets contain iron oxide yellow (E172) and Simvador 20mg, 40mg, 80mg Tablets contain iron oxide black (E172). What Simvador Tablets look like and the contents of the pack Simvador Tablets are available in four strengths. The peach coloured, oval-shaped, biconvex, film-coated tablets marked 10 on one side and breakline on the other side contain 10 mg Simvastatin. The tan coloured, oval-shaped, biconvex, film-coated tablets marked 20 on one side and breakline on the other side contain 20mg Simvastatin. The brick-red coloured, oval-shaped, biconvex, film-coated tablets marked 40 on one side and breakline on the other side contain 40mg Simvastatin. The brick-red coloured, capsule-shaped, biconvex, film-coated tablets marked 80 on one side and breakline on the other side contain 80mg Simvastatin. Simvador Tablets are available in blister packs of 28 tablets. Marketing Authorisation Holder & Manufacturer The Marketing Authorisation Holder is: Lupin (Europe) Limited, Victoria Court, Bex ton Road, Knutsford, Cheshire, WA16 0PF United Kingdom Distributed by: Discovery Pharmaceuticals The Old Vicarage Market Place Castle Donington Derbyshire DE74 2JB United Kingdom Code No. GO/DRUGS/654
This leaflet was last revised in March 2012 ID#: 227071
In This Leaflet 1 What Simvador is and what it is used for 2 Before you take Simvador 3 How to take 4 Possible side ef fects 5 How to store 6 Contents of the pack and further information
Read all of this leaflet carefully before you start taking this medicine. Keep the leaflet. You may need to read it again. If you have any 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. Simvador is used to lower levels of cholesterol and triglycerides in your blood and can help reduce your risk of developing coronary heart disease. (See Section 1 What Simvador is and what it is used for). Simvador can cause serious muscle problems in a very small number of patients. If you suf fer from unexplained pain, tenderness or weakness in your muscles STOP TAKING the medicine and talk to your doctor at once. DO NOT TAKE this medicine if you are already taking medicines for fungal infections (such as itraconazole, ketoconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), antibiotics (such as ery thromycin, clarithromycin, telithromycin) or nefazodone which is used to treat depression. (See Section 2 Taking other medicines). If you are pregnant or trying to get pregnant or breast feeding you MUST NOT take Simvador (See Section 2 Before you take Simvador). If you have high blood pressure, high levels of fats or sugars in your blood or have a body mass index of more than 30kg/m2 you may be at risk of developing diabetes. Your doctor will monitor you closely if this applies. (See section 2 Before you take Simvadorand Section 4 Possible side ef fects).
Simvador 10mg, 20mg, 40mg and 80mg Tablets Simvastatin
Coronary heart disease or are at high risk of suf fering from coronary heart disease. You are more likely to suf fer from coronary heart disease if you have diabetes, have previously had a stroke, or have other blood vessel disease). Most people will not have any symptoms related to raised cholesterol. Your doctor or pharmacist can measure your cholesterol level by means of a simple blood test. Having too much cholesterol in your bloodstream can lead to coronary heart disease. It can clog up blood vessels leading to hardening of the arteries (atherosclerosis). Hardened arteries are less able to carry blood to the heart and around the body. This can lead to chest pain (angina) and heart at tacks. If you have high levels of cholesterol you are more likely to get heart disease if you also: Have high blood pressure (hypertension) Have diabetes (high blood sugar) Do lit tle physical exercise Smoke Are overweight or eat a high fat diet Talk to your doctor or pharmacist if you would like advice about any of these factors. 2. Before you take Simvador Do not take Simvador if you: are allergic to simvastatin, or to any of the other ingredients (see section 6) suf fer from liver problems are pregnant or breast feeding are taking medicines for fungal infections (such as itraconazole, ketoconazole or posaconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and sequinavir), antibiotics (such as ery thromycin, clarithromycin, telithromycin) or nefazodone which is used to treat depression (See section 2 Taking other medicines). If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment. Check with your doctor or pharmacist before taking these tablets if you: Have previously had problems with your liver Have high blood pressure or high levels of fats and sugars in your blood or if you have a body mass index of more than 30kg/ m2. You may be more at risk of developing diabetes. Your doctor will monitor you closely if this applies to you. Regularly drink large amounts of alcohol Have to go into hospital for an operation -. you may need to stop taking Simvastatin Have severe lung disease Blood tests Before your start taking simvastatin your doctor will do a blood test to see how well your liver is working. Once you start taking the medicine your doctor will want you to have regular blood tests to see how well the medicine is working. Important - Keep healthcare professionals informed Contact your doctor immediately if you suf fer from any
1. What Simvador is and what it is used for Simvador is used to lower levels of cholesterol and fat ty substances called triglycerides in your blood. While taking this medicine you should stick to a cholesterol-lowering diet. This medicine belongs to the class of drugs called statins. Simvador is used along with dieting if you have: A raised cholesterol level in your blood (primary hypercholesterolaemia) or high fat levels in your blood (mixed hyperlipidaemia) when exercise and weight loss have not worked. A hereditary illness called homozygous familial hypercholesterolaemia which causes the cholesterol levels in your blood to rise. You may get other medicines as well for this condition.
unexplained muscle pain, tenderness or weakness. This is because in a very small number of patients, muscle problems can be serious. This can lead to kidney damage and in very rare cases deaths have occurred. You will be more at risk of muscle breakdown if you are on high doses of simvastatin. Also some other patients are more at risk. Talk to your doctor if any of the following apply: you drink large amounts of alcohol you have kidney problems you have thyroid problems you are 65 years or older you are a woman you have ever had muscle problems whilst being treated with cholesterol-lowering medicines such as statins or fibrates you or a close family member have hereditary muscle problems. Taking other medicines Many medicines af fect the way simvastatin works. You must tell your doctor before you start taking any other medicines including over the counter medicines, herbal remedies and vitamin supplements. Do not take Simvastatin and tell your doctor if you are taking: Ciclosporin used to prevent rejection in organ transplant patients A hormone called danazol Antifungal medicines such as ketoconazole, itraconazole, fluconazole or posaconazole Fibrates such as gemfibrozil or bezafibrate which are also used to treat high cholesterol Niacin or nicotinic acid in large doses which are also used to treat high cholesterol Antibiotics such as ery thromycin, clarithromycin, telithromycin, or fusidic acid HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, or saquinavir. an antidepressant called nefazodone drugs such as amiodarone, verapamil, diltiazem or amlodipine which are used to treat heart problems. If you are taking any of the medicines in the list above you must tell your doctor and not take Simvador because these medicines can make it more likely that you will have muscle problems. Check with your doctor first before taking Simvador if you are taking any of these medicines: Medicines used to treat blood clots, such as warfarin because the dose of warfarin may need to be changed. A drug used to treat tuberculosis called rifampicin A drug used to treat gout called colchicine Food and Drink Grapefruit juice can interfere with the way in which your body handles simvastatin. You should not drink grapefruit juice if you are taking Simvador. Pregnancy and breast-feeding DO NOT take Simvador if you are pregnant, think you may be pregnant or are trying to get pregnant or if you get pregnant while
taking Simvador STOP taking the medicine and see your doctor immediately. You should stop taking simvador 1 month before trying to get pregnant. Do not take Simvador if you are breast feeding because it is not known if simvastatin passes into the breast milk. Driving and using machinery Simvador has no known ef fect on the ability to drive or operate machines. Simvastatin can cause dizziness so make sure you are not af fected before you drive or use machines. Important information about some of the ingredients of Simvador Simvador tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you forget to take Simvador If you forget to take a dose, take it as soon as you remember unless it is nearly time for your nex t dose. Do not take a double dose.
3. How to take Always take simvador exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Your dose will be decided by your doctor and will depend on the results of the blood tests. The dose you should take will be on the label at tached by your pharmacist. Swallow the medicine with plenty of water. Remember to keep to a low-fat diet and to take physical exercise. People with coronary heart disease (CHD) The usual dose is 20mg 40mg which you should take in the evening. Your doctor may increase the dose you take every 4 weeks. The ma ximum dose is 80mg. People with high levels of blood fats (Hyperlipidaemia) The usual starting dose is 10mg taken in the evening. Your doctor may increase the dose you take every 4 weeks. The ma ximum dose is 80mg. People with hereditary high cholesterol (homozygous familial hypercholesterolaemia) The usual dose is 40mg taken in the evening. Your doctor may ask you to take 80mg each day in three doses through the day (20mg, 20mg and 40mg). This 80mg dose is only for patients who have very high levels of cholesterol in their blood or are at a high risk of developing heart problems. Children (10-17 years) The usual starting dose for children (10 -17 years old) is 10 mg. This dose should usually be taken in the evening. If necessary the dose may be increased to a ma ximum of 40 mg. Some patients will need a lower dose particularly if they are also taking medicines such as ciclosporin, danazol, fibrates or niacin and also if they have kidney problems. Taking other cholesterol-lowering medicines at the same time as Simvador Your doctor may ask you to take a medicine called colestyramine whilst you are taking simvastatin. This medicine can interfere with the way in which Simvador works. You must take Simvador 2 hours before or 4 hours af ter you have taken colestyramine. If you take more Simvador than you should Talk to your doctor or go to your nearest hospital casualty department straight away. Take the medicine pack with you.
5. How to store Keep this medicine out of the sight and reach of children. Do not store them above 25C. Do not use these tablets af ter the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Disposal 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. 6. Contents of the pack and other information What Simvador Tablets contain The active substance is simvastatin. The other ingredients are: Lactose monohydrate, cellulose microcrystalline (E460), starch
4. Possible side ef fects Like all medicines Simvador can cause side ef fects. Do not be concerned about this list of side ef fects. You may not get any of them, but it is important to know what to do if they occur. Stop taking Simvador and go to hospital at once if you have: a rare allergic reaction such as swelling of the face, tongue, lips and throat, dif ficulty breathing, severe itching of your skin with raised lumps, joint pain, sensitivity to the sun, general feeling of being unwell. You may need urgent medical at tention. Unexplained muscle problems such as pain, tenderness or weakness. In rare cases, these muscle problems can be very serious and result in muscle breakdown and kidney damage. In some cases these problems can be life-threatening. Inflammation of the liver with yellowing of the skin and eyes, dark coloured urine or pale coloured stools). Tell your doctor or pharmacist if any of the following side ef fects persist, get worse or if you notice any other side ef fects not listed. Diabetes. This is more likely if you have high blood pressure, high levels of sugar or fats in your blood or if you have a body mass index of more than 30kg/m2. Your doctor will monitor you more closely if these factors apply to you: Low red blood cell count (anaemia) Numbness in the arms and legs Headache, or dizziness Gastrointestinal disturbances such as feeling or being sick, constipation, wind, diarrhoea, indigestion, stomach pain Rash, itching or hair loss Sleep disturbances such as dif ficulty sleeping and nightmares Poor memory Sexual dif ficulties such as erectile dysfunction Depression Inflammation of the lungs causing dif ficulty in breathing, persistent cough and shortness of breath
pregelatinised, citric acid monohydrate (E330), ascorbic acid (E300), butylhydroxyanisole (E320), isopropyl alcohol and magnesium stearate (E572), hydroxypropylcellulose (E463), hydroxypropylmethylcellulose (E464), titanium dioxide (E171), talc (E553b). In addition Simvador 10mg, 20mg, 40mg, 80mg Tablets contain iron oxide red (E172), Simvador 10mg, 20mg, 80mg Tablets contain iron oxide yellow (E172) and Simvador 20mg, 40mg, 80mg Tablets contain iron oxide black (E172). What Simvador Tablets look like and the contents of the pack Simvador Tablets are available in four strengths. The peach coloured, oval-shaped, biconvex, film-coated tablets marked 10 on one side and breakline on the other side contain 10 mg Simvastatin. The tan coloured, oval-shaped, biconvex, film-coated tablets marked 20 on one side and breakline on the other side contain 20mg Simvastatin. The brick-red coloured, oval-shaped, biconvex, film-coated tablets marked 40 on one side and breakline on the other side contain 40mg Simvastatin. The brick-red coloured, capsule-shaped, biconvex, film-coated tablets marked 80 on one side and breakline on the other side contain 80mg Simvastatin. Simvador Tablets are available in blister packs of 28 tablets. Marketing Authorisation Holder & Manufacturer The Marketing Authorisation Holder is: Lupin (Europe) Limited, Victoria Court, Bex ton Road, Knutsford, Cheshire, WA16 0PF United Kingdom Distributed by: Discovery Pharmaceuticals The Old Vicarage Market Place Castle Donington Derbyshire DE74 2JB United Kingdom Code No. GO/DRUGS/654
This leaflet was last revised in March 2012 ID#: 227071
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.
