10 mg tablets 
ezetimibe

What Ezetimibe Mylan is and what it is used for

Ezetimibe Mylan contains the active substance ezetimibe. Ezetimibe Mylan is a drug used to lower elevated blood cholesterol levels. Mylan Ezetimibe reduces blood levels of total cholesterol, the “bad” cholesterol et ( LDL – cholesterol ), and one type of blood lipids called triglycerides s. Ezetimibe Mylan also increases the levels of “good” cholesterol ( 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 Mylan works by reducing cholesterol uptake into the gastrointestinal tract. Ezetimibe Mylan does not help you lose weight.

Ezetimibe Mylan enhances the cholesterol-lowering effect of statins, a group of drugs that reduce the amount of cholesterol your body produces.

Ezetimibe Mylan is used for patients who are unable to control their cholesterol levels through a cholesterol-lowering diet alone. You should continue with a cholesterol-lowering diet while you are taking this medicine.

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

  • elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])- together with a statin, when only one statin does not provide satisfactory control of your cholesterol levels- alone, when treatment with statins is considered inappropriate or if you do not tolerate statins
  • an inherited disease ( homozygous familial hypercholesterolemia ) that causes elevated cholesterol levels in the blood. You will also be prescribed treatment with a statin and may also receive other treatment.

If you have heart disease, Ezetimibe Mylan in combination with cholesterol-lowering medicines called statins may reduce the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe Mylan does not help you lose weight.

Ezetimibe contained in Ezetimibe Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Ezetimibe Mylan

If you are taking Ezetimibe Mylan with a statin, also read the package leaflet for that medicine.

Do not take Ezetimibe Mylan

  • if you are allergic to ezetimibe or any of the other ingredients of this medicine (listed in section 6).

Do not take Ezetimibe Mylan with a statin:

  • if you have liver problems
  • if you are pregnant or breastfeeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Ezetimibe Mylan.

Inform your doctor about all your medical ailments, including allergies.

Your doctor should take a blood sample before you start taking Ezetimibe Mylan with a statin. 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 Mylan with a statin.

Ezetimibe Mylan is not recommended if you have moderate to severe hepatic impairment.

The safety and efficacy of concomitant use of Ezetimibe Mylan and certain cholesterol-lowering drugs, so-called fibrates, have not been established.

Tell your doctor if you experience unexplained muscle aches, soreness, or weakness while taking these tablets, especially if you also have a fever.

Children and young people

Do not give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist as there are limited data on safety and efficacy.

Do not give this medicine to children under 6 years of age as there is no information for this age group.

Other medicines and Ezetimibe Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • ciclosporin (often used by organ transplant patients)
  • anticoagulants such as warfarin, phenprocoumon, acenocoumarol, or fluindione (so-called anticoagulants )
  • Cholestyramine (also used to lower cholesterol), affects the effect of Ezetimibe Mylan
  • fibrates (also used to lower cholesterol levels).

Pregnancy and breastfeeding

Do not take Ezetimibe Mylan with a statin if you are pregnant, trying to conceive, or think you may be pregnant. If you become pregnant while taking Ezetimibe Mylan with a statin, discontinue treatment with both medicines immediately and tell your doctor.

There is no experience with the use of Ezetimibe Mylan without a statin during pregnancy.

Do not take Ezetimibe Mylan with a statin if you are breast-feeding as it is unknown if the medicines pass into breast milk. Ezetimibe Mylan without a statin should not be used if you are breast-feeding.

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.

Driving and using machines

Ezetimibe Mylan is not expected to affect your ability to drive or use machines. However, some people may get dizzy when they take Ezetimibe Mylan. If this applies to you, do not drive or use machines.

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 Mylan contains lactose monohydrate and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.

How to take Ezetimibe Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Continue to take your other cholesterol-lowering medications, unless your doctor tells you to stop. Ask your doctor or pharmacist if you are unsure.

Before you start taking Ezetimibe Mylan, you should keep a cholesterol-lowering diet. You should continue with this cholesterol-lowering diet while you are taking Ezetimibe Mylan.

Adults and adolescents (aged 10 to 17 years)

The recommended dose is one tablet of Ezetimibe Mylan 10 mg once daily by mouth.

Ezetimibe Mylan can be taken at any time of the day and can be taken with or without food.

If your doctor has prescribed Ezetimibe Mylan with a statin, both medicines can be taken at the same time. Then also read the dosing instructions in the package leaflet for that medicine.

If your doctor has prescribed Ezetimibe Mylan together with another cholesterol-lowering medicine that contains the active ingredient cholestyramine or any other bile acid sequestrant, you should take Ezetimibe Mylan at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Mylan then you should

If you take more Ezetimibe Mylan than your doctor tells you to, contact your doctor or pharmacist.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Ezetimibe Mylan

Do not take a double dose to make up for a forgotten dose, just take your regular dose of Ezetimibe Mylan at the usual time the next day.

If you stop taking Ezetimibe Mylan

Talk to your doctor or pharmacist before stopping this medicine 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.

Tell a doctor immediately or see an emergency department at the nearest hospital if you experience any of the following serious side effects; the frequency of these is not known (can not be calculated from the available data) but you may need medical attention:

  • unexplained muscle aches, soreness, or weakness. The reason for this is that in rare cases, muscle problems, including the breakdown of muscles with kidney damage, as a result, can be serious and become life-threatening.
  • allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (requiring immediate treatment)
  • inflammation of the pancreas, often with severe abdominal pain
  • gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
  • raised red, sometimes target-like rashes
  • hepatitis (which may cause fatigue, fever, nausea or vomiting, general malaise, yellowing of the skin and eyes, light stools, and dark urine).

When Ezetimibe Mylan alone was used, the following side effects were reported:

Common (may affect up to 1 in 10 people):

  • abdominal pain
  • diarrhea
  • gas formation
  • fatigue.

Uncommon (may affect up to 1 in 100 people):

  • elevations of certain blood test values ​​showing liver function and muscle function
  • cough
  • indigestion
  • heartburn
  • nausea
  • joint pain
  • muscle cramps
  • neck pain
  • decreased appetite
  • pain
  • chest pain
  • hot redness ( flushing )
  • high blood pressure.

The following side effects are also possible when Ezetimibe Mylan is used with a statin:

Common (may affect up to 1 in 10 people):

  • elevations of certain blood test values ​​that show liver function
  • headache
  • muscle aches.

Uncommon (may affect up to 1 in 100 people):

  • stinging sensation
  • dry mouth
  • abdominal pain, nausea, vomiting, blood in the stool
  • itching
  • rash
  • hives
  • back pain
  • muscle weakness
  • pain in arms and legs
  • unusual tiredness or weakness
  • swelling, especially in the hands and feet.

The following side effects are possible when Ezetimibe Mylan is used with or without a statin:

Has been reported (occurs in an unknown number of users):

  • dizziness
  • allergic reactions including skin and hives
  • constipation
  • decreased number of platelets which may cause bruising/bleeding ( thrombocytopenia )
  • stinging sensation
  • Depression
  • unusual tiredness or weakness
  • shortness of breath.

The following side effects are possible when Ezetimibe Mylan is used with fenofibrate:

Common (may affect up to 1 in 10 people):

  • abdominal pain.

5. How to store Ezetimibe Mylan

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 blister, carton, or jar after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Jar: Use within 100 days of opening.

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 substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
  • The other ingredients are lactose monohydrate (see section 2 “Ezetimibe Mylan contains lactose monohydrate”), sodium lauryl sulfate (E487), croscarmellose sodium, hypromellose (E464), crospovidone (type B), microcrystalline cellulose, magnesium stearate.

What the medicine looks like and the contents of the pack

Ezetimibe Mylan 10 mg tablets are white to off-white, capsule-shaped tablets with beveled edges and marked with “M” on one side and “EE1” on the other.

Ezetimibe Mylan 10 mg tablets are available in blister packs or pull-out blister packs of 14, 28, 30, 56, 84, 90, 98 and 100 tablets; in perforated single-dose blister packs of 30 x 1, 50 x 1, 90 x 1 tablets, calendar packs of 28 and 30 tablets and in plastic jars of 14, 28, 50, 56, 84, 100 tablets.

Not all packaging may be marketed.

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

Mylan Germany GmbH

Branch drop Bad Homburg vd Hoehe, Benzstrasse 1

Bad Homburg vd Hoehe

Hessen, 61352,

Germany

Muhammad Nadeem

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