10 mg tablets 
ezetimibe

1. What Ezetrol is and what it is used for

Ezetrol is a drug used to lower elevated blood cholesterol levels.

Ezetrol lowers the blood levels of total cholesterol, the “bad” cholesterol ( LDL – cholesterol ), and a type of blood fat called triglycerides. Ezetrol also increases the levels of “good” cholesterol ( HDL – cholesterol ).

Ezetimibe, the active ingredient in Ezetrol, works by reducing cholesterol uptake into the gastrointestinal tract.

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

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.

It is used for patients who can not control their cholesterol levels through a cholesterol-lowering diet alone. You should continue with your cholesterol-lowering diet while you are taking this medicine.

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

  • elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])
    • along with a statin, when a statin alone does not provide adequate 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.
  • an inherited disease ( homozygous sitosterolemia, also known as phytosterolemia) that increases the levels of plant sterols in the blood.

If you have heart disease, Ezetrol 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.

Ezetrol does not help you lose weight.

Ezetimibe contained in Ezetrol 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.

2. What you need to know before taking Ezetrol

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

Do not take Ezetrol

– if you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).

Do not take Ezetrol with a statin if:

– you have liver problems

– you are pregnant or breastfeeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Ezetrol.

  • Inform your doctor about all your medical ailments, including allergies 
  • Your doctor should take a blood test before you start taking Ezetrol 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 Ezetrol with a statin.

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

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

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 Ezetrol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking medicines with any of the following active ingredients:

  • ciclosporin (often used by organ transplant patients)
  • drugs with an active ingredient that prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (so-called anticoagulants )
  • cholesterol (also used to lower cholesterol), as it affects the effect of Ezetrol
  • fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

Do not take Ezetrol with a statin if you are pregnant, trying to conceive, or think you may be pregnant. If you become pregnant while taking Ezetrol with a statin, stop taking both medicines immediately and tell your doctor. There is no experience with the use of Ezetrol without a statin during pregnancy. If you are pregnant, consult your doctor before using Ezetrol.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ezetrol is not expected to affect your ability to drive or use machines. However, some people may get dizzy when they take Ezetrol.

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.

Ezetrol contains lactose

Ezetrol 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 medicine.

Ezetrol contains sodium

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

3. How to take Ezetrol

Always take this medicine exactly as your doctor 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 Ezetrol, you should keep a cholesterol-lowering diet.
  • You should continue with this cholesterol-lowering diet while you are taking Ezetrol.

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

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

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

If you take more Ezetrol then you should

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

If you forget to take Ezetrol

Do not take a double dose to make up for a forgotten tablet. Only take your usual dose of Ezetrol at the time you usually take the next day.

If you stop taking Ezetrol

Talk to your doctor or pharmacist 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.

The following terms are used to describe how often different side effects have been reported:

  • Very common (may affect more than 1 user in 10)
  • Common (may affect up to 1 in 10 people)
  • Uncommon (may affect up to 1 in 100 people)
  • Rare (may affect up to 1 in 1,000 people)
  • Very rare (may affect up to 1 in 10,000 users, including individual reports)

Contact a doctor immediately if you experience 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 that may cause breathing or swallowing difficulties (requiring immediate treatment) have been reported during normal use.

When Ezetrol alone was used, the following side effects were reported:
Usual: abdominal pain, diarrhea, flatulence, fatigue.
Uncommon: elevations of certain blood test values ​​showing liver function ( transaminases ) and muscle function (CK), cough, indigestion, heartburn, nausea, joint pain, muscle cramps, neck pain, decreased appetite, pain, chest pain, hot redness ( flush ), high blood pressure.

When Ezetrol was used with a statin, the following side effects were also reported:
Usual: elevations of certain blood test values ​​showing liver function ( transaminases ), headache, muscle aches, tenderness, or weakness.
Uncommon: stinging sensation, dry mouth, itching, rash, hives, back pain, muscle weakness, pain in arms and legs, unusual tiredness or weakness, swelling, especially in hands and feet.

When Ezetrol was used with fenofibrate, the following common side effects were reported: abdominal pain.

The following side effects have also been reported during normal use:

dizziness, muscle aches, liver problems, allergic reactions including skin and hives, raised red, sometimes target-like rashes (erythema multiforme), muscle aches, tenderness or weakness, muscle breakdown, gallstones or gallbladder inflammation(which may cause abdominal pain, nausea, vomiting), inflammation of the pancreas, often with severe abdominal pain, constipation, decreased platelet count which may cause bruising/bleeding ( thrombocytopenia ), stinging sensation, depression, unusual tiredness or weakness, shortness of breath.

5. How to store Ezetrol

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 or package after EXP. or EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Blister: Store in the original package. Moisture sensitive.

Jar: Close the jar tightly. 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 substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.

What the medicine looks like and the contents of the pack

Ezetrol tablets are white to off-white, capsule-shaped tablets marked with “414” on one side.

Pack sizes:

7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets inexpressible blisters or single-dose blisters with removable backing; 84 or 90 tablets inexpressible blisters; 50, 100 or 300 tablets inexpressible unit dose blisters; 100 tablets in a jar.

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Manufacturer

SP Labo NV

Industrial Park 30 – Zone A

B-2220 Heist-op-den-Berg

Belgium

Information provided by:

Merck Sharp & Dohme AB

Box 45192

104 30 Stockholm

Tel: 077-570 04 88

This medicinal product is authorized under the European Economic Area under the name EZETROL in Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Iceland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, the United Kingdom, Czech Republic, Germany, Hungary, and Austria.

Muhammad Nadeem

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