10 mg tablets 
ezetimibe

What Ezetimibe Orion is and what it is used for

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

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

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

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

Ezetimibe Orion is used in patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. You should continue with a cholesterol-lowering diet while you are taking this medicine.

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

  • elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]). It can be used alone, when treatment with statins is considered inappropriate or if you do not tolerate statins or together with a statin when cholesterol levels are not well controlled by statins alone
  • 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 Orion 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 Orion does not help you lose weight.

Ezetimibe contained in Ezetimibe Orion 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 use Ezetimibe Orion

Do not use Ezetimibe Orion

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

If you are taking Ezetimibe Orion with a statin, read the package leaflet for the medicine in question.

Do not take Ezetimibe Orion with a statin if:

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

Warnings and cautions

  • Inform your doctor about all your medical ailments, including allergies.
  • Your doctor should take a blood test before you start taking Ezetimibe Orion with a statin. This blood sample is taken to check liver function.
  • Your doctor may also need to take a blood test to check your liver function after you start taking Ezetimibe Orion with a statin.

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

The safety and efficacy of concomitant use of Ezetimibe Orion and certain cholestasis

role-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 Orion

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 ( anticoagulants )
  • cholestyramine (also used to lower cholesterol), as it affects the effect of ezetimibe – see also section 3. How to use Ezetimibe Orion
  • fibrates (also used to lower cholesterol)

Pregnancy, breastfeeding, and fertility

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

If you are taking Ezetimibe Orion without a statin consult your doctor if you are pregnant, trying to conceive, or think you may be pregnant.

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

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

Driving and using machines

Some people may feel dizzy after taking ezetimibe. Talk to your doctor or pharmacist before driving or using machines if you feel dizzy.

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 Orion contains lactose monohydrate, sodium lauryl sulfate, croscarmellose sodium, microcrystalline cellulose, povidone K30, and magnesium stearate

Ezetimibe Orion contains 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.

How to use Ezetimibe Orion

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

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

Ezetimibe Orion can be taken at any time of the day or night. It can be taken with or without food.

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

If you use more Ezetimibe Orion then you should 

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

If you forget to use Ezetimibe Orion

Do not take an extra dose, just take your usual dose of Ezetimibe Orion at the usual time the next day.

If you stop using Ezetimibe Orion

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 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
  • digestive problems
  • heartburn
  • nausea
  • joint pain
  • muscle cramps
  • neck pain
  • decreased appetite
  • pain
  • chest pain
  • heatwave
  • high blood pressure

When ezetimibe 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
  • tenderness
  • weakness

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

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

When ezetimibe was used with fenofibrate, the following common side effects were reported:

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

  • 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 inflammation in the gallbladder (which can cause abdominal pain, nausea, vomiting), inflammation of the pancreas, often with severe abdominal pain, constipation, decreased number of platelets which can cause bruising/bleeding ( thrombocytopenia ), stinging sensation, depression, unusual fatigue or weakness, shortness of breath.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

You can also report side effects directly via

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se.

By reporting side effects, you can help increase drug safety information.

5. How to store Ezetimibe Orion

  • 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 label after ‘EXP’. The expiration date is the last day of the specified month.
  • No special storage instructions.
  • Can only: Use within 200 days after opening the can

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.

Other ingredients are:

lactose monohydrate, sodium lauryl sulfate, croscarmellose sodium, microcrystalline cellulose, povidone K30, and magnesium stearate.

What the medicine looks like and the contents of the pack

Ezetimibe Orion tablet is a white to off-white, capsule-shaped, uncoated, flat tablet with a beveled edge and approximately 8.0 x 4.0 x 2.6 mm in size, marked with “G” on one side and “44” on the Other.

Ezetimibe Orion, 10 mg tablets are available in blister packs (PVC / Aclar aluminum) with 14, 28, 30, 50, 90, 98, and 100 tablets and in cans of HDPE plastic with 100 tablets.

* Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Muhammad Nadeem

Leave a Reply