10 mg tablets 
ezetimibe

What Ezetimibe Accord is and what it is used for

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

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

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

Ezetimibe Accord 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 can not 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 Accord 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 in combination with cholesterol-lowering drugs called statins may reduce the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe Accord does not help you lose weight.

Ezetimibe contained in the Ezetimibe Accord 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 taking Ezetimibe Accord

Do not take Ezetimibe Accord

  • if you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).

Do not take Ezetimibe Accord with a statin if:

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

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Ezetimibe Accord.

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

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

The safety and efficacy of the concomitant use of Ezetimibe Accord 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 Accord

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

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.

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

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

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

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 Accord contains lactose

Ezetimibe Accord 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 take Ezetimibe Accord

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 Accord, you should follow a cholesterol-lowering diet.
  • You should continue with this cholesterol-lowering diet while you are taking this medicine.

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

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

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

If you take more Ezetimibe Accord 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 Accord

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

If you stop taking Ezetimibe Accord

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.

The following terms are used to describe how often different side effects have been reported:

  • Very common (may affect more than 1 user in 10)
  • Common (may affect up to 1 in 10 people)
  • Uncommon (may affect up to 1 in 100 people)
  • Rare (may affect up to 1 in 1,000 people)
  • Very rare (may affect up to 1 in 10,000 users, including individual reports).

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 Accord alone was used, the following side effects were reported:

Common: abdominal pain, diarrhea, flatulence, fatigue.

Uncommon: elevations of certain blood sample values showing liver function ( transaminase s) and muscle function (CK), cough, indigestion, heartburn, nausea, joint pain, muscle cramps, neck pain, loss of 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: elevations of certain blood test values ​​showing liver function ( transaminases ), headache, muscle aches, tenderness, or weakness.

Uncommon: stinging 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 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 gallbladder inflammation(which may 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 Accord

  • 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 blister, carton, and jar after EXP. The expiration date is the last day of the specified month.
  • No special temperature instructions.

Blister cards: Store in the original package. Moisture sensitive.

Jar: Close the jar tightly. 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. One tablet contains 10 mg ezetimibe.
  • The other ingredients are lactose monohydrate, croscarmellose sodium (E468), povidone k ‑ 30 (E1201), sodium lauryl sulfate, magnesium stearate (E470b), polysorbate 80 (E433).

What the medicine looks like and the contents of the pack

White to off-white capsule-shaped, flat tablets with a beveled edge, without coating, embossed with “10” on one side and smooth on the other side

Pack sizes:

7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in aluminum ‑ aluminum or aluminum ‑ PVC / Aclar ‑ blister packs.

30 and 100 tablets in HDPE cans with polypropylene lids.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF,

UK

Wessling Hungary Kft.

Foot out 56., Budapest 1047

Hungary

Laboratories FUNDACIO DAU

C / De la letter C, 12-14, Poligono Industrial de la Zona,

Franca, 08040 Barcelona, ​​Spain

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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