10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg tablets 
ezetimibe and simvastatin

What Ezetimibe / Simvastatin Glenmark is and what it is used for

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 ).

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.

Cholesterol is one of several fats found in your blood. Your total cholesterol is made up mainly of LDL – and HDL – cholesterol.

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.

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.

Triglycerides are another type of fat in the blood that can increase the risk of heart disease.

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.

Ezetimibe / Simvastatin Glenmark is used as a supplement to your cholesterol-lowering diet if you have:

  • elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated blood lipids (combined hyperlipidemia ):
    • when a statin alone does not provide satisfactory regulation,
    • after using a statin and ezetimibe as two different tablets,
  • hereditary disease ( homozygous familial hypercholesterolemia ) which causes elevated cholesterol levels in the blood. You can also receive other treatment.
  • heart disease, Ezetimibe / Simvastatin Glenmark reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe / Simvastatin Glenmark does not help you lose weight.

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.

What you need to know before you take Ezetimibe / Simvastatin Glenmark

Do not take Ezetimibe / Simvastatin Glenmark:

  • if you are allergic to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information)
  • if you have liver problems
  • if you are pregnant or breastfeeding
  • if you are taking medicines containing one or more of the following active ingredients:
    • itraconazole, ketoconazole , posaconazole or voriconazole (used to treat fungal infections),
    • erythromycin, clarithromycin or telithromycin (used to treat infections ),
    • HIV – protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir ( HIV – protease inhibitors used in the treatment of HIV – infection s),
    • boceprevir or telaprevir (used to treat hepatitis C virus infections),
    • nefazodone (used to treat depression),
    • cobicistat,
    • gemfibrozil (used to lower cholesterol),
    • cyclosporine (commonly used in organ transplant patients),
    • danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
  • if you are taking, or have taken in the last 7 days, a medicine called fusidic acid (a medicine used to treat bacterial infections ), either by mouth or by injection. The combination of fusidic acid and Ezetimibe / Simvastatin Glenmark can lead to severe muscle problems ( rhabdomyolysis ).
  • Do not take more than 10 mg / 40 mg Ezetimibe / Simvastatin Glenmark if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).

Consult a doctor if you are unsure if your medicine is listed above.

Warnings and cautions

Talk to your doctor or pharmacist before taking Ezetimibe / Simvastatin Glenmark

  • about all your medical ailments, including allergies,
  • if you have a high alcohol consumption or if you have or have previously had any liver disease. Ezetimibe / Simvastatin Glenmark may not be the right drug for you
  • if you are going to have surgery. Discontinuation of treatment with Ezetimibe / Simvastatin Glenmark may be necessary for a shorter period,
  • If you are of Asian descent, then another dose may apply to you.

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.

Your doctor may also need to take a blood test to check your liver function after you start taking Ezetimibe / Simvastatin Glenmark.

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.

Tell your doctor if you have any serious lung disease.

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.

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.

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:

  • you have kidney problems,
  • you have thyroid problems,
  • you are 65 years or older,
  • you are a woman,
  • if you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil and bezafibrate),
  • you or a close relative has a hereditary muscle disease.

Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.

Children and young people

  • Ezetimibe / Simvastatin Glenmark is not recommended for use in children below 10 years of age.

Other medicines and Ezetimibe / Simvastatin Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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”).

  • If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to start using Ezetimibe / Simvastatin Glenmark again. Taking Ezetimibe / Simvastatin Glenmark with fusidic acid may in rare cases lead to muscle weakness, tenderness, and pain ( rhabdomyolysis ). See more information on rhabdomyolysis in section 4.
  • ciclosporin (often used by patients who have had an organ transplant),
  • danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
  • drugs with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
  • fibrates with active ingredients such as gemfibrozil and bezafibrate (used to lower cholesterol),
  • erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
  • HIV – protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used in the treatment of AIDS ),
  • antiviral drugs for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
  • nefazodone (used to treat depression),
  • medicinal products containing the active substance cobicistat,
  • amiodarone (used to treat irregular heartbeat),
  • verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions),
  • lomitapide (used to treat a serious and rare genetic cholesterol condition),
  • high doses (1 gram/day or more) of niacin or nicotinic acid (also used to lower cholesterol),
  • colchicine (used in the treatment of gout ).

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:

  • anticoagulants with an active ingredient such as warfarin, fluindione, phenprocoumon, or acenocoumarol (so-called anticoagulants ),
  • cholestyramine (also used to lower cholesterol), as it affects the way Ezetimibe / Simvastatin Glenmark works,
  • fenofibrate (also used to lower cholesterol),
  • rifampicin (used to treat tuberculosis ).

Tell your doctor that you are prescribing a new medicine that you are taking Ezetimibe / Simvastatin Glenmark.

Ezetimibe / Simvastatin Glenmark with drink

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.

Pregnancy and breastfeeding

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.

Driving and using machines

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.

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.

Ezetimibe / Simvastatin Glenmark contains lactose

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.

How to take Ezetimibe / Simvastatin Glenmark

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.

  • Before you start taking Ezetimibe / Simvastatin Glenmark, eat a cholesterol-lowering diet.
  • You should continue with this cholesterol-lowering diet while you are being treated with Ezetimibe / Simvastatin Glenmark.

Adults: Dose a is 1 tablet Ezetimibe / Simvastatin Glenmark once daily by mouth

Use in young (aged 10 to 17 years) Dose a is 1 tablet 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.

If you take more Ezetimibe / Simvastatin Glenmark then you should

  • Contact a doctor or pharmacist. If you have ingested too much or if e.g. If a child has inadvertently ingested a medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Ezetimibe / Simvastatin Glenmark

  • Do not take a double dose to make up for a forgotten tablet. Only take your usual dose of Ezetimibe / Simvastatin Glenmark at the usual time the next day.

If you stop taking Ezetimibe / Simvastatin Glenmark

  • Talk to your doctor or pharmacist if you stop taking Ezetimibe / Simvastatin Glenmark as your cholesterol levels may rise again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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):

  • muscle aches,
  • elevated liver function values ​​( transaminases ) and / or muscle function values ​​(CK) in the blood.

The following common side effects have been reported (may affect up to 1 in 100 people):

  • elevated liver function values ​​in the blood, elevated levels of uric acid in the blood, prolonged bleeding time, protein in the urine, weight loss,
  • dizziness, headache, “ant crawls”,
  • abdominal pain, indigestion, flatulence, nausea, vomiting, bloating, diarrhea, dry mouth , heartburn,
  • skin rash, itching , hives,
  • joint pain, muscle aches, soreness, weakness or muscle spasms, neck pain, pain in arms and legs, back pain,
  • unusual tiredness or weakness, fatigue, chest pain, swelling, especially in hands and feet,
  • sleep disorders, difficulty sleeping.

The following side effects have also been reported in people taking Ezetimibe / Simvastatin Glenmark or medicines containing the active substance ezetimibe or simvastatin:

  • low number of red blood cells ( anemia ), decreased number of blood cells that can cause bruising / bleeding ( thrombocytopenia ),
  • numbness or weakness in the arms and legs, poor memory, memory loss, confusion,
  • difficulty breathing including persistent cough and / or shortness of breath or fever,
  • constipation,
  • inflammation of the pancreas often with severe abdominal pain,
  • inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching , dark-colored urine or light-colored stools, feeling of tiredness or weakness, loss of appetite, liver failure, gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea and vomiting),
  • hair loss, raised red, sometimes target-like rash (erythema multiforme),
  • blurred vision and impaired vision (may affect up to 1 in 1,000 users)
  • rash that may occur on the skin or sores in the mouth (drug-related lichenoid rash) (may affect up to 1 in 10,000 users)
  • hypersensitivity reaction which includes any of the following: allergic reactions including swelling of the face, lips, tongue and / or throat, which may cause breathing or swallowing difficulties and require immediate treatment, joint pain or inflammation , inflammation of blood vessels, bruising of unknown cause, skin rash and swelling, hives , sensitivity of the skin to sunlight, fever, redness , shortness of breath and general malaise, lupus-like picture (including rash, joint problems and effects on white blood cells ),
  • pain, soreness, weakness or cramps in the muscles, breakdown of muscles, muscles, muscle strain (may occur in up to 1 in 10,000 users),tendon problems, sometimes aggravated by tendon rupture,
  • gynecomastia (breast augmentation in men) (may affect up to 1 in 10,000 people)
  • decreased appetite,
  • hot flashes, high blood pressure ,
  • pain,
  • erectile dysfunction,
  • Depression,
  • changes in certain liver function values ​​in the blood.

Additional possible side effects that have been reported with certain statins:

  • sleep disorders including nightmares,
  • impaired sexual ability,
  • diabetes . This is more likely if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure . Your doctor will check you while you are taking this medicine,
  • muscle pain, tenderness or weakness that is persistent and may not go away after stopping treatment with Ezetimibe / Simvastatin Glenmark (no known frequency).

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.

5. How to store Ezetimibe / Simvastatin Glenmark

Keep this medicine out of the sight and reach of children.

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.

Do not store above 25 ° C.

Blister: Store in the original package. Moisture sensitive.

Jar: Close the jar tightly. Store in the outer carton. Moisture sensitive.

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 packaging and other information

Content declaration

  • The active substances are ezetimibe and simvastatin . One tablet contains 10 mg ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg simvastatin .
  • The other ingredients are lactose monohydrate , microcrystalline cellulose (E460), hypromellose, croscarmellose sodium (E468), propyl gallate (E310), butylhydroxyanisole (E320), citric acid monohydrate (E330), sodium lauryl sulfate (magnesium stearate), magnesium stearate.

See also section 2 “What you need to know before taking Ezetimibe / Simvastatin Glenmark”

What the medicine looks like and contents of the pack

10 mg / 10 mg:

White to off-white capsule-shaped uncoated tablet marked with “G” on one side and “321” on the other side, approximately 8.5 mm long and 4.25 mm wide.

10 mg / 20 mg:

White to off-white capsule-shaped uncoated tablet marked with “G” on one side and “322” on the other side, approximately 10.7 mm long and 5.3 mm wide.

10 mg / 40 mg:

White to off-white capsule-shaped uncoated tablet marked with “G” on one side and “323” on the other side, approximately 14.0 mm long and 6.0 mm wide.

10 mg / 80 mg:

White to off-white capsule-shaped uncoated tablet marked with “G” on one side and “324” on the other side, approximately 17.5 mm long and 7.5 mm wide.

Pack sizes

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.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder 

Glenmark Arzneimittel GmbH

Industriestr. 31, 82194 Gröbenzell,

Germany

Manufacturer

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, Hertfordshire, WD18 8YA

UK

Glenmark Pharmaceuticals sro

Fibichova 143

56617 Vysoke Myto

Czech Republic

Pharmadox Healthcare Ltd. 
KW20A Kordin Industrial Park 
Paola PLA3000 
Malta

Muhammad Nadeem

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