\n\n10 mg \/ 10 mg, 10 mg \/ 20 mg, 10 mg \/ 40 mg, 10 mg \/ 80 mg tablets
ezetimibe and simvastatin<\/p>\n\n\n\n
Ezetimibe \/ Simvastatin Glenmark contains the active substances ezetimibe and simvastatin. Ezetimibe \/ Simvastatin Glenmark is a drug used to lower the levels of total cholesterol in the blood, the “bad” cholesterol ( LDL – cholesterol ), and blood fats called triglycerides. Ezetimibe \/ Simvastatin Glenmark also increases the levels of “good” cholesterol ( HDL – cholesterol ).
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Ezetimibe \/ Simvastatin Glenmark lowers cholesterol levels in two ways. The active substance ezetimibe reduces the cholesterol uptake into the gastrointestinal tract. The active ingredient simvastatin, which belongs to the class “statins”, inhibits the production of cholesterol that the body itself produces.
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Cholesterol is one of several fats found in your blood. Your total cholesterol is made up mainly of LDL – and HDL – cholesterol.
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LDL – cholesterol is often called “bad” cholesterol et because it can build up in the walls of your arteries and form plaque. This plaque storage can eventually lead to a narrowing of your vessels. This narrowing can reduce or block blood flow to important organs such as the heart and brain. Blockage of blood flow can result in a heart attack or stroke.
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HDL – cholesterol is often called “good” cholesterol et because it helps prevent the “bad” cholesterol et from building up in container one and protects against heart disease.
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Triglycerides are another type of fat in the blood that can increase the risk of heart disease.<\/p>\n\n\n\n
Ezetimibe \/ Simvastatin Glenmark is indicated for patients whose cholesterol levels cannot be controlled by diet alone. You should continue with a cholesterol-lowering diet while you are taking this medicine.
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Ezetimibe \/ Simvastatin Glenmark is used as a supplement to your cholesterol-lowering diet if you have:<\/p>\n\n\n\n
Ezetimibe \/ Simvastatin Glenmark does not help you lose weight.
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Ezetimibe and simvastatin contained in Ezetimibe \/ Simvastatin Glenmark may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
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Consult a doctor if you are unsure if your medicine is listed above.<\/p>\n\n\n\n
Talk to your doctor or pharmacist before taking Ezetimibe \/ Simvastatin Glenmark<\/p>\n\n\n\n
Your doctor should take a blood sample before you start taking Ezetimibe \/ Simvastatin Glenmark, and if you have any symptoms of liver problems during treatment with Ezetimibe \/ Simvastatin Glenmark. This blood test is taken to check your liver function.
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Your doctor may also need to take a blood test to check your liver function after you start taking Ezetimibe \/ Simvastatin Glenmark.
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During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to get diabetes if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure.
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Tell your doctor if you have any serious lung disease.
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Concomitant use of Ezetimibe \/ Simvastatin Glenmark and fibrates (a specific type of cholesterol-lowering drug) should be avoided as the use of the combination of Ezetimibe \/ Simvastatin Glenmark and fibrates has not been studied.
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Contact a doctor immediately if you experience unexplained muscle aches, soreness, or weakness. The reason for this is that in rare cases, muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result, and deaths have occurred in very rare cases.<\/strong> The risk of muscle breakdown is greater with higher doses of Ezetimibe \/ Simvastatin Glenmark, especially for a dose of 10 mg \/ 80 mg. The risk of muscle breakdown is also greater in some patients. Talk to your doctor if any of the following apply to you:<\/p>\n\n\n\n Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Taking Ezetimibe \/ Simvastatin Glenmark with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the section above “Do not take Ezetimibe \/ Simvastatin Glenmark”).<\/p>\n\n\n\n Also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking any of the following:<\/p>\n\n\n\n Tell your doctor that you are prescribing a new medicine that you are taking Ezetimibe \/ Simvastatin Glenmark.<\/p>\n\n\n\n Grapefruit juice contains one or more substances that alter the breakdown of certain drugs, including Ezetimibe \/ Simvastatin Glenmark. Intake of grapefruit juice should be avoided as it may increase the risk of muscle problems. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Ezetimibe \/ Simvastatin Glenmark if you are pregnant, trying to conceive, or think you may be pregnant. If you become pregnant while taking Ezetimibe \/ Simvastatin Glenmark, stop treatment immediately and tell your doctor. Do not take Ezetimibe \/ Simvastatin Glenmark if you are breast-feeding as it is unknown if the medicine passes into breast milk. Ezetimibe \/ Simvastatin Glenmark is not expected to affect your ability to drive or use machines. However, keep in mind that some people get dizzy when they take Ezetimibe \/ Simvastatin Glenmark.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n Ezetimibe \/ Simvastatin Glenmark contains a sugar called lactose, milk sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<\/p>\n\n\n\n Your doctor will decide which dose is right for you, depending on your current treatment and your personal risk profile. The tablets are not scored and should not be divided. Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n Adults: Dose a is 1 tablet<\/strong> Ezetimibe \/ Simvastatin Glenmark once daily by mouth Use in young<\/strong> (aged 10 to 17 years) Dose a is 1 tablet<\/strong> Ezetimibe \/ Simvastatin Glenmark once daily by mouth. (a maximum dose of 10 mg \/ 40 mg should not be exceeded). Ezetimibe \/ Simvastatin Glenmark dose of 10 mg \/ 80 mg is recommended only for adult patients with very high cholesterol levels and who are at high risk of heart disease and who have not achieved their treatment goals at lower doses. Take Ezetimibe \/ Simvastatin Glenmark in the evening. You can take the tablet with or without food. If your doctor has prescribed Ezetimibe \/ Simvastatin Glenmark in combination with another cholesterol-lowering medicine containing the active substance cholestyramine or any other bile acid sequestrant, you should take Ezetimibe \/ Simvastatin Glenmark at least 2 hours before or 4 hours after taking the bile acid sequestrant.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everybody gets them. (See section 2. What you need to know before you take Ezetimibe \/ Simvastatin Glenmark). The following common side effects have been reported (may affect up to 1 in 10 people):<\/p>\n\n\n\n The following common side effects have been reported (may affect up to 1 in 100 people):<\/p>\n\n\n\n The following side effects have also been reported in people taking Ezetimibe \/ Simvastatin Glenmark or medicines containing the active substance ezetimibe or simvastatin:<\/p>\n\n\n\n Additional possible side effects that have been reported with certain statins:<\/p>\n\n\n\n Contact a doctor immediately if you experience unexplained muscle aches, soreness or weakness. The reason for this is that in rare cases, muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result and deaths have occurred in very rare cases.<\/strong> Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n <\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton, jar or blister after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n <\/p>\n\n\n\n Do not store above 25 \u00b0 C.<\/p>\n\n\n\n <\/p>\n\n\n\n Blister: Store in the original package. Moisture sensitive.<\/p>\n\n\n\n Jar: Close the jar tightly. Store in the outer carton. Moisture sensitive.<\/p>\n\n\n\n <\/p>\n\n\n\n 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.<\/p>\n\n\n\n See also section 2 \u201cWhat you need to know before taking Ezetimibe \/ Simvastatin Glenmark\u201d<\/p>\n\n\n\n 10 mg \/ 10 mg:<\/strong><\/p>\n\n\n\n White to off-white capsule-shaped uncoated tablet marked with \u201cG\u201d on one side and \u201c321\u201d on the other side, approximately 8.5 mm long and 4.25 mm wide. 10 mg \/ 20 mg:<\/strong><\/p>\n\n\n\n White to off-white capsule-shaped uncoated tablet marked with \u201cG\u201d on one side and \u201c322\u201d on the other side, approximately 10.7 mm long and 5.3 mm wide. 10 mg \/ 40 mg:<\/strong><\/p>\n\n\n\n White to off-white capsule-shaped uncoated tablet marked with \u201cG\u201d on one side and \u201c323\u201d on the other side, approximately 14.0 mm long and 6.0 mm wide. 10 mg \/ 80 mg:<\/strong><\/p>\n\n\n\n White to off-white capsule-shaped uncoated tablet marked with \u201cG\u201d on one side and \u201c324\u201d on the other side, approximately 17.5 mm long and 7.5 mm wide. Pack sizes<\/em><\/p>\n\n\n\n 10 mg \/ 10 mg, 10 mg \/ 20 mg, 10 mg \/ 40 mg, and 10 mg \/ 80 mg tablets in PVC-Aluminum-OPA \/ Aluminum blisters: 7, 10, 14, 28, 30, 30 x 1, 49, 50, 50 x 1, 56, 84, 90, 98, multiple pack 98 (2 x 49), 100, 100×1, 196, 300, 300 x 1 and 392 tablets and HDPE can with 90 tablets (10 mg \/ 80 mg), 100 tablets (10 mg \/ 10 mg 10 mg \/ 20 mg, and 10 mg \/ 40 mg). The tablets in HDPE jars contain desiccant against moisture. The desiccant should not be swallowed. Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong> <\/p>\n\n\n\n Glenmark Arzneimittel GmbH<\/p>\n\n\n\n Industriestr. 31, 82194 Gr\u00f6benzell,<\/p>\n\n\n\n Germany Manufacturer<\/strong><\/p>\n\n\n\n Glenmark Pharmaceuticals Europe Limited<\/p>\n\n\n\n Building 2, Croxley Green Business Park<\/p>\n\n\n\n Croxley Green, Hertfordshire, WD18 8YA<\/p>\n\n\n\n UK Glenmark Pharmaceuticals sro<\/p>\n\n\n\n Fibichova 143<\/p>\n\n\n\n 56617 Vysoke Myto<\/p>\n\n\n\n Czech Republic Pharmadox Healthcare Ltd. 10 mg \/ 10 mg, 10 mg \/ 20 mg, 10 mg \/ 40 mg, 10 mg \/ 80 mg tablets
<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and Ezetimibe \/ Simvastatin Glenmark<\/h2>\n\n\n\n
Ezetimibe \/ Simvastatin Glenmark with drink<\/h2>\n\n\n\n
<\/p>\n\n\n\nPregnancy and breastfeeding<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Ezetimibe \/ Simvastatin Glenmark contains lactose<\/h2>\n\n\n\n
How to take Ezetimibe \/ Simvastatin Glenmark<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you take more Ezetimibe \/ Simvastatin Glenmark then you should<\/h2>\n\n\n\n
If you forget to take Ezetimibe \/ Simvastatin Glenmark<\/h2>\n\n\n\n
If you stop taking Ezetimibe \/ Simvastatin Glenmark<\/h2>\n\n\n\n
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n5. How to store Ezetimibe \/ Simvastatin Glenmark<\/h2>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
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<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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KW20A Kordin Industrial Park
Paola PLA3000
Malta
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