EZETROL 10MG TABLETS
Active substance: EZETIMIBE
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Ezetrol 10mg Tablets
(ezetimibe)
Patient information Leaflet 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Ezetrol 10mg Tablets are and what they are used for 2. Before you take Ezetrol 10mg Tablets 3. How to take Ezetrol 10mg Tablets 4. Possible side effects 5. How to store Ezetrol 10mg Tablets 6. Further information
The safety and efficacy of the combined use of Ezetrol 10mg Tablets and fibrates (medicines for lowering cholesterol) have not been established. Children Ezetrol 10mg Tablets are not recommended for children under the age of 10. Taking other medicines: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following: ciclosporin (a medicine often used in organ transplant patients) medicines to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants) colestyramine (a medicine for lowering cholesterol), because it affects the way Ezetrol 10mg Tablets work fibrates (medicines for lowering cholesterol) Pregnancy and breast-feeding Do not take Ezetrol 10mg Tablets with a statin if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking Ezetrol 10mg Tablets with a statin, stop taking both medicines immediately and tell your doctor. There is no experience from the use of Ezetrol 10mg Tablets without a statin during pregnancy. Ask your doctor for advice before using Ezetrol 10mg Tablets if you are pregnant. Do not take Ezetrol 10mg Tablets with a statin if you are breastfeeding, because it is not known if the medicines are passed into breast milk. Ezetrol 10mg Tablets without a statin should not be used if you are breast-feeding. Ask your doctor for advice. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Ezetrol 10mg Tablets are not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people may get dizzy after taking Ezetrol 10mg Tablets. Important information about some of the ingredients of Ezetrol 10mg Tablets Ezetrol 10mg 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.
1. WHAT EZETROL 10mg TABLETS ARE AND WHAT THEY ARE USED FOR
Ezetrol 10mg Tablets are a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetrol 10mg Tablets raises levels of "good" cholesterol (HDL cholesterol). It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. Ezetrol 10mg Tablets work by reducing the cholesterol absorbed in your digestive tract. Ezetrol 10mg Tablets do not help you lose weight. Ezetrol 10mg Tablets add to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself. Ezetrol 10mg Tablets are used in addition to diet if you have:
a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) together with a statin, when your cholesterol level is not well controlled with a statin alone alone, when statin treatment is inappropriate or is not tolerated a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You will also be prescribed a statin and may also receive other treatments a hereditary illness (homozygous sitosterolaemia, also known as phytosterolaemia) that increases the levels of plant sterols in your blood.
3. HOW TO TAKE EZETROL 10mg TABLETS
Always take Ezetrol 10mg Tablets exactly as your doctor has told you. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. You should check with your doctor or pharmacist if you are not sure. Before starting Ezetrol 10mg Tablets, you should be on a diet to lower your cholesterol. You should keep on this diet whilst taking Ezetrol 10mg Tablets. Adults and adolescents (10 to 17 years of age): The dose is one Ezetrol 10 mg Tablet by mouth once a day. Take Ezetrol 10mg Tablets at any time of the day. You can take it with or without food. If your doctor has prescribed Ezetrol 10mg Tablets along with a statin, both medicines can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of that particular medicine. If your doctor has prescribed Ezetrol 10mg Tablets along with colestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), you should take Ezetrol 10mg Tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more Ezetrol 10mg Tablets than you should: Please contact your doctor or pharmacist. If you forget to take Ezetrol 10mg Tablets: Do not take an extra dose, just take your normal amount of Ezetrol 10mg Tablets at the usual time the next day. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
2. BEFORE YOU TAKE EZETROL 10mg TABLETS
If you use Ezetrol 10mg Tablets together with a statin, please read the package leaflet of that particular medicine. Do not take Ezetrol 10mg Tablets if: you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of Ezetrol 10mg Tablets (see Section 6: Further information). Do not take Ezetrol 10mg Tablets together with a statin if: you currently have liver problems. you are pregnant or breast-feeding. Take special care with Ezetrol 10mg Tablets: Tell your doctor about all your medical conditions including allergies. Your doctor should do a blood test before you start taking Ezetrol 10mg Tablets with a statin. This is to check how well your liver is working. Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Ezetrol 10mg Tablets with a statin. If you have moderate or severe liver problems, Ezetrol 10mg Tablets are not recommended.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ezetrol 10mg Tablet can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects have been reported: Very common (occurring in 1 or more of 10 patients treated) Common (occurring in 1 or more of 100 and less than 1 of 10 patients treated) Uncommon (occurring in 1 or more of 1000 and less than 1 of 100 patients treated) Rare (occurring in 1 or more of 10000 and less than 1 of 1000 patients treated) Very rare (occurring in less than 1 of 10000 patients treated including isolated reports). Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems, including muscle breakdown resulting in kidney damage, can be serious and may become a potentially life-threatening condition. Allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which requires treatment right away) have been reported in general use. When used alone, the following side effects were reported: Common: abdominal pain; diarrhoea; flatulence; feeling tired. Uncommon: elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function; cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flush; high blood pressure. Additionally, when used with a statin, the following side effects were reported: Common: elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain; tenderness or weakness. Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness, pain in arms and legs; unusual tiredness or weakness; swelling, especially in the hands and feet. When used with fenofibrate, the following common side effect was reported: abdominal pain. Additionally, the following side effects have been reported in general use: dizziness; muscle aches; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target shaped lesions; muscle pain, tenderness or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas often with severe abdominal pain; constipation; reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopaenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath. 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.
6. FURTHER INFORMATION
What Ezetrol 10mg Tablets contain The active ingredient is ezetimibe and each 10mg tablet contains 10mg ezetimibe. The other non-active ingredients are: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium laurylsulphate. What Ezetrol 10mg Tablets look like and contents of the pack Ezetrol 10mg Tablets are white to off-white, capsule-shaped tablets marked 414 on one side and plain on the other side. Ezetrol 10mg Tablets are supplied in packs of 28 or 98 tablets. Ezetrol 10mg Tablets are manufactured by SP Labo N.V., Industriepark 30-Zone A, B-2220 Heist-op-den-Berg, Belgium and are procured from within the EU by Product Licence holder: Caseview (PL) Limited, 20 Alliance Court, Alliance Road, London W3 0RB and repackaged by OPD Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR. PL 13826/1134 POM
This leaflet does not contain complete information about your medicine. If you are not sure about anything or have any questions, seek the advice of your doctor or pharmacist who has access to additional information. Ezetrol 10mg Tablets Leaflet revision date (ref) 08/10/2012 Ezetrol is a registered trademark of MSP Singapore Company, LLC.
5. HOW TO STORE EZETROL 10mg TABLETS
Keep out of the sight and reach of children. Do not take the tablets if they are past the expiry date which is clearly marked on the blister package and carton. Take any tablets that are out of date back to your pharmacist. Do not store above 30C. Store in the original package and do not remove the tablet from its blister until you are ready to take it, as the tablets are moisture sensitive. Do not put the tablets into another container, as they might get mixed up. There are no other special storage conditions required for this medicine. 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.
(ezetimibe)
Patient information Leaflet 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Ezetrol 10mg Tablets are and what they are used for 2. Before you take Ezetrol 10mg Tablets 3. How to take Ezetrol 10mg Tablets 4. Possible side effects 5. How to store Ezetrol 10mg Tablets 6. Further information
The safety and efficacy of the combined use of Ezetrol 10mg Tablets and fibrates (medicines for lowering cholesterol) have not been established. Children Ezetrol 10mg Tablets are not recommended for children under the age of 10. Taking other medicines: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following: ciclosporin (a medicine often used in organ transplant patients) medicines to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants) colestyramine (a medicine for lowering cholesterol), because it affects the way Ezetrol 10mg Tablets work fibrates (medicines for lowering cholesterol) Pregnancy and breast-feeding Do not take Ezetrol 10mg Tablets with a statin if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking Ezetrol 10mg Tablets with a statin, stop taking both medicines immediately and tell your doctor. There is no experience from the use of Ezetrol 10mg Tablets without a statin during pregnancy. Ask your doctor for advice before using Ezetrol 10mg Tablets if you are pregnant. Do not take Ezetrol 10mg Tablets with a statin if you are breastfeeding, because it is not known if the medicines are passed into breast milk. Ezetrol 10mg Tablets without a statin should not be used if you are breast-feeding. Ask your doctor for advice. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Ezetrol 10mg Tablets are not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people may get dizzy after taking Ezetrol 10mg Tablets. Important information about some of the ingredients of Ezetrol 10mg Tablets Ezetrol 10mg 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.
1. WHAT EZETROL 10mg TABLETS ARE AND WHAT THEY ARE USED FOR
Ezetrol 10mg Tablets are a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetrol 10mg Tablets raises levels of "good" cholesterol (HDL cholesterol). It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. Ezetrol 10mg Tablets work by reducing the cholesterol absorbed in your digestive tract. Ezetrol 10mg Tablets do not help you lose weight. Ezetrol 10mg Tablets add to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself. Ezetrol 10mg Tablets are used in addition to diet if you have:
a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) together with a statin, when your cholesterol level is not well controlled with a statin alone alone, when statin treatment is inappropriate or is not tolerated a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You will also be prescribed a statin and may also receive other treatments a hereditary illness (homozygous sitosterolaemia, also known as phytosterolaemia) that increases the levels of plant sterols in your blood.
3. HOW TO TAKE EZETROL 10mg TABLETS
Always take Ezetrol 10mg Tablets exactly as your doctor has told you. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. You should check with your doctor or pharmacist if you are not sure. Before starting Ezetrol 10mg Tablets, you should be on a diet to lower your cholesterol. You should keep on this diet whilst taking Ezetrol 10mg Tablets. Adults and adolescents (10 to 17 years of age): The dose is one Ezetrol 10 mg Tablet by mouth once a day. Take Ezetrol 10mg Tablets at any time of the day. You can take it with or without food. If your doctor has prescribed Ezetrol 10mg Tablets along with a statin, both medicines can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of that particular medicine. If your doctor has prescribed Ezetrol 10mg Tablets along with colestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), you should take Ezetrol 10mg Tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant. If you take more Ezetrol 10mg Tablets than you should: Please contact your doctor or pharmacist. If you forget to take Ezetrol 10mg Tablets: Do not take an extra dose, just take your normal amount of Ezetrol 10mg Tablets at the usual time the next day. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
2. BEFORE YOU TAKE EZETROL 10mg TABLETS
If you use Ezetrol 10mg Tablets together with a statin, please read the package leaflet of that particular medicine. Do not take Ezetrol 10mg Tablets if: you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of Ezetrol 10mg Tablets (see Section 6: Further information). Do not take Ezetrol 10mg Tablets together with a statin if: you currently have liver problems. you are pregnant or breast-feeding. Take special care with Ezetrol 10mg Tablets: Tell your doctor about all your medical conditions including allergies. Your doctor should do a blood test before you start taking Ezetrol 10mg Tablets with a statin. This is to check how well your liver is working. Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Ezetrol 10mg Tablets with a statin. If you have moderate or severe liver problems, Ezetrol 10mg Tablets are not recommended.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ezetrol 10mg Tablet can cause side effects, although not everybody gets them. The following terms are used to describe how often side effects have been reported: Very common (occurring in 1 or more of 10 patients treated) Common (occurring in 1 or more of 100 and less than 1 of 10 patients treated) Uncommon (occurring in 1 or more of 1000 and less than 1 of 100 patients treated) Rare (occurring in 1 or more of 10000 and less than 1 of 1000 patients treated) Very rare (occurring in less than 1 of 10000 patients treated including isolated reports). Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems, including muscle breakdown resulting in kidney damage, can be serious and may become a potentially life-threatening condition. Allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which requires treatment right away) have been reported in general use. When used alone, the following side effects were reported: Common: abdominal pain; diarrhoea; flatulence; feeling tired. Uncommon: elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function; cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flush; high blood pressure. Additionally, when used with a statin, the following side effects were reported: Common: elevations in some laboratory blood tests of liver function (transaminases); headache; muscle pain; tenderness or weakness. Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness, pain in arms and legs; unusual tiredness or weakness; swelling, especially in the hands and feet. When used with fenofibrate, the following common side effect was reported: abdominal pain. Additionally, the following side effects have been reported in general use: dizziness; muscle aches; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target shaped lesions; muscle pain, tenderness or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas often with severe abdominal pain; constipation; reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopaenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath. 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.
6. FURTHER INFORMATION
What Ezetrol 10mg Tablets contain The active ingredient is ezetimibe and each 10mg tablet contains 10mg ezetimibe. The other non-active ingredients are: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium laurylsulphate. What Ezetrol 10mg Tablets look like and contents of the pack Ezetrol 10mg Tablets are white to off-white, capsule-shaped tablets marked 414 on one side and plain on the other side. Ezetrol 10mg Tablets are supplied in packs of 28 or 98 tablets. Ezetrol 10mg Tablets are manufactured by SP Labo N.V., Industriepark 30-Zone A, B-2220 Heist-op-den-Berg, Belgium and are procured from within the EU by Product Licence holder: Caseview (PL) Limited, 20 Alliance Court, Alliance Road, London W3 0RB and repackaged by OPD Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR. PL 13826/1134 POM
This leaflet does not contain complete information about your medicine. If you are not sure about anything or have any questions, seek the advice of your doctor or pharmacist who has access to additional information. Ezetrol 10mg Tablets Leaflet revision date (ref) 08/10/2012 Ezetrol is a registered trademark of MSP Singapore Company, LLC.
5. HOW TO STORE EZETROL 10mg TABLETS
Keep out of the sight and reach of children. Do not take the tablets if they are past the expiry date which is clearly marked on the blister package and carton. Take any tablets that are out of date back to your pharmacist. Do not store above 30C. Store in the original package and do not remove the tablet from its blister until you are ready to take it, as the tablets are moisture sensitive. Do not put the tablets into another container, as they might get mixed up. There are no other special storage conditions required for this medicine. 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.
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.
