10 mg tablets 
ezetimibe

1. What Ezetimibe Krka is and what it is used for

Ezetimibe Krka is a drug used to lower elevated blood cholesterol levels.

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

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

Ezetimibe Krka 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 in pre-patients who cannot 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 Krka 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.

If you have heart disease, Ezetimibe Krka 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 Krka does not help you lose weight.

Ezetimibe contained in Ezetimibe Krka 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 use Ezetimibe Krka

Do not use Ezetimibe Krka

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

Do not take Ezetimibe Krka with a statin if:

  • you have liver problems
  • you are pregnant or breastfeeding

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Ezetimibe Krka.

  • Inform your doctor about all your medical ailments, including allergies.
  • Your doctor should take a blood test before you start taking Ezetimibe Krka 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 Krka with a statin.
  • Ezetimibe Krka is not recommended if you have moderate to severe hepatic impairment.
  • The safety and efficacy of the concomitant use of Ezetimibe Krka and certain cholesterol-lowering drugs 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 Ezetimibe Krka

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 )
  • cholestyramine (also used to lower cholesterol), as it affects the effect of Ezetimibe Krka
  • fibrates (also used to lower cholesterol)

Pregnancy, breastfeeding, and fertility

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

Do not take Ezetimibe Krka with a statin if you are breast-feeding as it is unknown if the medicines pass into breast milk. Ezetimibe Krka 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

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

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.

How to use Ezetimibe Krka

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 Ezetimibe Krka you should keep a cholesterol-lowering diet.
  • You should continue with this cholesterol-lowering diet while you are taking Ezetimibe Krka.

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

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

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

If you use more Ezetimibe Krka then you should 

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

If you forget to use Ezetimibe Krka

Do not take a double dose to make up for a forgotten tablet. Just take your usual dose of Ezetimibe Krka at the usual time the next day.

If you stop using Ezetimibe Krka

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.

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 ezetimibe alone was used, the following adverse reactions were reported:

Common (may affect up to 1 in 10 people): abdominal pain, diarrhea, flatulence, fatigue.

Uncommon (may affect up to 1 in 100 people): elevations of certain blood test values ​​showing liver function ( transaminases ) and muscle function (CK), cough, indigestion, heartburn, nausea, joint pain, muscle cramps, decreased neck pain, decreased appetite, pain, chest pain, hot flushing ( flushing ), high blood pressure.

When ezetimibe was used with a statin, the following side effects were also reported:

Common (may affect up to 1 in 10 people): elevations of certain blood test values ​​showing liver function ( transaminases ), headache, muscle aches, tenderness, or weakness.

Uncommon (may affect up to 1 in 100 people): tingling 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 ezetimibe was used with fenofibrate, the following common side effects were reported: abdominal pain.

The following side effects have also been reported with normal use ( occurs in unknown numbers of users ): dizziness, muscle aches, liver problems, allergic reactions including skin and hives, raised red, sometimes target-like rash ( erythema multiforme ), muscle aches, tenderness, or weakness, muscle breakdown, gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting), inflammation of the pancreas, often with severe abdominal pain, constipation, decreased platelet count which can cause bruising/bleeding ( thrombocytopenia), stinging sensation, depression, unusual tiredness or weakness, shortness of breath.

5. How to store Ezetimibe Krka

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

Store in the original package. 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 sodium lauryl sulfate, povidone K30, mannitol (E421), croscarmellose sodium, microcrystalline cellulose, (E460), and sodium stearyl fumarate.

What the medicine looks like and the contents of the pack

The tablets are white to off-white, capsule-shaped tablets with beveled edges. The tablet dimensions are 8 x 4 mm.

Ezetimibe Krka is available in cartons containing:

  • Blister (OPA / Alu / PVC // Alu): 14, 28, 30, 50, 56, 60, 90, 98, 100 tablets
  • Blisters (perforated unit dose blisters, OPA / Alu / PVC // Alu): 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1, 100 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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