10 mg tablets 
ezetimibe

What Ezetimibe Sandoz is and what it is used for

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

Sandoz Ezetimibe reduces blood levels of total cholesterol, the “bad” cholesterol et ( LDL – cholesterol ), and one type of blood lipids called triglycerides s. Ezetimibe Sandoz also increases the levels of “good” cholesterol ( HDL – cholesterol ).

Ezetimibe, the active substance in Ezetimibe Sandoz, works by reducing the cholesterol uptake into the gastrointestinal tract. 

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

This medicine is used for patients whose cholesterol levels can not be kept down by a cholesterol-lowering diet alone. You should continue with a cholesterol-lowering diet while you are taking this medicine. 

Ezetimibe Sandoz 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 Sandoz 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 Sandoz does not help you lose weight.

Ezetimibe contained in Ezetimibe Sandoz 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 Sandoz

Do not take Ezetimibe Sandoz

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

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


Do not take Ezetimibe Sandoz with a statin

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Ezetimibe Sandoz.

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


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


The safety and efficacy of concomitant use of Ezetimibe Sandoz and fibrates(cholesterol-lowering drugs) have not been established. Concomitant use should be avoided.


Contact a doctor immediately if you get it

  • 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.


The risk of muscle breakdown is greater in some patients taking Ezetimibe Sandoz with cholesterol-lowering medicines, such as statins.

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 Sandoz

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

  • ciclosporin (a medicine often used by organ transplant patients)
  • anticoagulants such as warfarin , phenprocoumon, acenocoumarol, or fluindione
  • cholestyramine (a cholesterol-lowering drug), as it affects the effect of ezetimibe (see also section 3)
  • fibrates (cholesterol-lowering drugs) (see also section 2: Warnings and precautions).

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. 

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

without a statin during pregnancy is missing.


Breast-feeding

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

Driving and using machines

Ezetimibe Sandoz is not expected to affect your ability to drive or use machines. However, some people may get dizzy when they take Ezetimibe Sandoz. If this happens to you, do not drive or use machines until you feel better.

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 Sandoz contains lactose

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 Sandoz

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

The recommended dose is one tablet once a day by mouth.


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


If your doctor has prescribed Ezetimibe Sandoz 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 Sandoz together with cholestyramine or any other bile acid sequestrant (a cholesterol-lowering medicine), you should take Ezetimibe Sandoz at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Sandoz then you should

If you have ingested too much medicine or if e.g. a child accidentally ingests the medicine, contact a doctor,

hospital or the Poison Information Center for risk assessment and counseling.

If you forget to take Ezetimibe Sandoz

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

If you stop taking Ezetimibe Sandoz

Talk to your doctor or pharmacist as your cholesterol levels may rise again if you stop taking this medicine.


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 get it

  • unexplained muscle aches
  • muscle 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 breathing or swallowing difficulties
  • dizziness or fainting and unusually fast or irregular heartbeat requiring immediate treatment have been reported during normal use.

Other side effects have been reported in clinical trials 

When this medicine alone was used, the following side effects were reported:


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

  • abdominal pain
  • diarrhea
  • gas formation
  • fatigue.

Uncommon side effects (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
  • neck pain
  • decreased appetite
  • pain
  • chest pain
  • hot redness ( flushing )
  • high blood pressure.


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

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

  • elevations of certain blood test values ​​showing liver function ( transaminases )
  • headache
  • muscle aches or soreness.

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

  • stinging sensation
  • dry mouth
  • inflammation of the gastric mucosa
  • itching
  • rash
  • hives
  • back pain
  • muscle weakness
  • pain in arms and legs
  • unusual tiredness or weakness
  • swelling, especially in the hands and feet.


When this medicine was used with fenofibrate cholesterol-lowering medicine) the following side effects were reported:

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

  • abdominal pain.

Besides, the following side effects have been reported after the medicine has come into general use (after the medicine has been marketed):


No known frequency (cannot be calculated from the available data):

  • dizziness
  • liver problems,
  • allergic reactions including skin and hives, swelling of the face, tongue, or throat, and fainting
  • raised red, sometimes target-like rashes, e.g. light red annular rash around a pale center
  • muscle aches or soreness
  • muscle weakness: cramps, stiffness, or spasm
  • severe muscle pain or weakness as well as red-brown urine caused by muscle breakdown
  • gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
  • inflammation of the pancreas, often with severe abdominal pain
  • constipation
  • decreased number of platelets which may cause bruising/bleeding ( thrombocytopenia )
  • stinging sensation
  • Depression
  • unusual tiredness or weakness
  • shortness of breath.

5. How to store Ezetimibe Sandoz

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

Blister: Store in the original package. Moisture sensitive.

Jar: Close the jar tightly. Moisture sensitive.

After opening: Do not store above 25 ° C. Use any later than 9 months after 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 the end of section 2 for more information), hypromellose, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, and magnesium stearate.

What the medicine looks like and the contents of the pack

Ezetimibe Sandoz tablets are white or almost white, oval (7.4 mm x 4.0 mm), and marked with “10” on one side and “EZT” on the other side.

Al / Al blisters or PVC / PVDC / Al blisters: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital packaging) tablets.

HDPE cans, with polypropylene screw caps: 100 and 250 tablets (only for hospital use and dose dispensing).

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia

or

LEK SA, ul. Domaniewska 50 C, 02-672 Warsaw, Poland

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

SC Sandoz, SRL, Str. Livezeni no. 7A, 540472 Targu-Mures, Romania

or

Lek Pharmaceuticals dd, Trimlini 2D, 9220 Lendava, Slovenia

Muhammad Nadeem

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