10 mg tablets 
ezetimibe

What Ezetimibe Actavis is and what it is used for

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

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

Ezetimibe Actavis works by reducing the cholesterol uptake into the gastrointestinal tract.

Ezetimibe Actavis 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.

It 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 Actavis 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 Actavis 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 Actavis does not help you lose weight.

Ezetimibe available Ezetimibe Actavis 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 Actavis

Do not take Ezetimibe Actavis

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

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

Do not take Ezetimibe Actavis  with a statin if:

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Ezetimibe Actavis.

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

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

The safety and efficacy of concomitant use of Ezetimibe Actavis 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 Actavis

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 ( anticoagulants ), such as warfarin, phenprocoumon, acenocoumarol, or fluindione
  • cholestyramine (also used to lower cholesterol) as it affects the effect of Ezetimibe Actavis
  • fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

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

Do not take Ezetimibe Actavis with a statin if you are breast-feeding as it is unknown if the medicines pass into breast milk. Ezetimibe Actavis 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 Actavis is not expected to affect your ability to drive or use machines. However, some people may get dizzy when they take Ezetimibe Actavis.

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 Actavis contains lactose 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 (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Ezetimibe Actavis

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

  • Before you start taking Ezetimibe Actavis, you should follow a cholesterol-lowering diet.
  • You should continue with this cholesterol-lowering diet while you are taking Ezetimibe Actavis.

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

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

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

If you take more Ezetimibe Actavis then you should

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 Actavis

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

If you stop taking Ezetimibe Actavis

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.

Discontinue treatment with Ezetimibe Actavis and contact a physician immediately or go to the nearest emergency department if you experience any of the following symptoms:

  • 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.

When Ezetimibe Actavis alone was used, the following side effects 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, neck pain
  • pain
  • chest pain
  • decreased appetite
  • hot redness ( flushing )
  • high blood pressure

When Ezetimibe Actavis 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, soreness, or weakness

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

  • stinging sensation
  • dry mouth
  • gastric catarrh
  • 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 Actavis was used with fenofibrate, the following side effects were reported:

Common (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 nettle rash , raised red, sometimes target-like rash (erythema multiforme)
  • muscle aches, soreness or weakness, 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 platelet count , which may cause bruising / bleeding ( thrombocytopenia ),
  • stinging sensation
  • Depression
  • unusual tiredness or weakness
  • shortness of breath

5. How to store Ezetimibe Actavis

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

No special storage instructions.

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 in Ezetimibe Actavis is ezetimibe. One tablet contains 10 mg ezetimibe.

The other ingredients are lactose monohydrate , microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, magnesium stearate, hypromellose and crospovidone.

What the medicine looks like and contents of the pack

Ezetimibe Actavis 10 mg tablets are white to off-white capsule-shaped tablets, 8 mm x 4 mm in size, debossed with “713” on one side and smooth on the other side.

Ezetimibe Actavis is available in push-through blisters, pull-out blisters or cans.

Pack sizes:

Blister packs: 10, 20, 28, 30, 50,60,90, 98 or 100 tablets.

Jars with 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitza 2600

Bulgaria

Teva Operations Poland Sp. z oo

ul. Mogilska 80

31-546 Kraków

Poland

Muhammad Nadeem

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