10 mg tablet 
ezetimibe

What Ezetimibe STADA is and what it is used for

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

Cholesterol is one of several fats found in your blood. Your total cholesterol consists essentially 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.

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

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

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

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.

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

  • an elevated blood cholesterol level (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 Stada 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 Stada does not help you lose weight.

Ezetimibe contained in Ezetimibe Stada 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 STADA

Do not take Ezetimibe STADA:

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

Do not take Ezetimibe Stada:

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

Do not take Ezetimibe Stada  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 Stada.

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

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

The safety and efficacy of concomitant use of Ezetimibe Stada 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 STADA

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), affects the effect of Ezetimibe Stada
  • fibrates (also used to lower cholesterol levels).

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 Stada with a statin if you are pregnant, trying to conceive, or think you may be pregnant.

If you become pregnant while taking Ezetimibe Stada with a statin, stop treatment with both medicines immediately and tell your doctor.

There is no experience with the use of Ezetimibe Stada without a statin during pregnancy.

If you are pregnant, consult your doctor before using Ezetimibe Stada.

Breast-feeding

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

Ezetimibe Stada without a statin should not be used if you are breast-feeding. Consult a doctor.

Driving and using machines

Ezetimibe Stada is not expected to affect your ability to drive or use machines. However, some people may get dizzy when taking Ezetimibe Stada, if you are affected in this way, 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 STADA contains lactose and sodium

Ezetimibe Stada 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.

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

How to use Ezetimibe STADA

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

Dosage

The recommended dose is one Ezetimibe Stada 10 mg tablet once daily.

Administration

This medicine should be swallowed.

Ezetimibe Stada can be taken at any time of the day or night. You can take it with or without food.

If your doctor has prescribed Ezetimibe Stada together with a statin, both medicines can be taken at the same time. Then also read the dosing instructions in the package leaflet for the statin.

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

If you take more Ezetimibe STADA then you should

If you have ingested too much medicine or if e.g. 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 Ezetimibe STADA

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

If you stop taking Ezetimibe STADA

Continue to take your cholesterol-lowering medication unless your doctor tells you to stop. 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 Stada alone was used, the following side effects were reported:

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

  • abdominal pain
  • diarrhea
  • gas formation
  • 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
  • decreased appetite
  • pain
  • chest pain
  • hot redness ( flushing )
  • high blood pressure .

When 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):

  • 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 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 rash (erythema multiforme)
  • muscle aches, soreness or weakness
  • breakdown of muscles
  • 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 STADA

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.

Other ingredients are:

Lactose monohydrate

Microcrystalline cellulose (E460)

Povidone (E1201)

Croscarmellose sodium (E468)

Sodium lauryl sulfate

Magnesium stearate (E470b)

What the medicine looks like and contents of the pack

White to off-white, oval, capsule-shaped tablets with a length of about 8 mm and a width of about 4 mm.

The product is available as

10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 156, 168 tablets in PVC / PCTFE / PVC or PVC / PE / PVdC (clear, transparent ) foil // Al- blister or PVC / PCTFE / PVC or PVC / PE / PVdC (clear, transparent ) foil // All single dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

STADA Arzneimittel GmbH

Mutgasse 36, 1190 Vienna

Austria

STADA Nordic ApS

Marielundvej 46A, 2730 Herlev

Denmark

Centrafarm Services BV

Nieuwe Donk 9, 4879 AC Etten-Leur

Netherlands

Clonmel Healthcare Ltd

Waterford Road, Clonmel, Co. Tipperary

Ireland

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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