Ezetimibe Genoptim

Package Leaflet: Information for the Patient

Ezetimibe Genoptim, 10 mg, Tablets

Ezetimibe

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ezetimibe Genoptim and what is it used for
• 2. Important information before taking Ezetimibe Genoptim
• 3. How to take Ezetimibe Genoptim
• 4. Possible side effects
• 5. How to store Ezetimibe Genoptim
• 6. Contents of the pack and other information

1. What is Ezetimibe Genoptim and what is it used for

Ezetimibe Genoptim is a medicine used to lower high blood cholesterol levels. Ezetimibe Genoptim lowers the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetimibe Genoptim increases the level of "good" cholesterol (HDL cholesterol). The active substance of Ezetimibe Genoptim, ezetimibe, reduces the absorption of cholesterol in the gut. Ezetimibe Genoptim enhances the action of statins, a group of medicines that lower the level of cholesterol produced by the body. Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol fractions. LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of arteries in the form of plaques. The accumulation of these plaques can eventually lead to narrowing of the arteries, which can cause a reduction in blood flow or blockage of blood flow to vital organs, such as the heart and brain. Blockage of blood flow can cause a heart attack or stroke. HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the arteries and protects against the development of heart disease. Triglycerides are another type of fat found in the blood that can contribute to an increased risk of developing heart disease. The medicine is used in patients for whom a cholesterol-lowering diet is not sufficient to control their blood cholesterol levels. While taking this medicine, you should continue to follow a cholesterol-lowering diet.

Ezetimibe Genoptim is used as an adjunct to a cholesterol-lowering diet in the following cases:

• high blood cholesterol levels (primary hypercholesterolemia [heterozygous familial or non-familial])
• in combination with a statin, if cholesterol levels are not adequately controlled with statin therapy alone
• as monotherapy, if statin therapy is not appropriate or is not tolerated
• homozygous familial hypercholesterolemia, a genetic disorder that causes high blood cholesterol levels. The patient will also be treated with a statin and may be treated with other cholesterol-lowering medicines.
• homozygous sitosterolemia (also known as phytosterolemia), a genetic disorder that causes high levels of plant sterols in the blood.

If you have heart disease, taking Ezetimibe Genoptim with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain. Ezetimibe Genoptim has no effect on weight loss.

2. Important information before taking Ezetimibe Genoptim

When taking Ezetimibe Genoptim in combination with a statin, read the package leaflet for that medicine.

When not to take Ezetimibe Genoptim:

• 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).

When not to take Ezetimibe Genoptim in combination with a statin:

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

Warnings and precautions

Before taking Ezetimibe Genoptim, discuss it with your doctor or pharmacist.

• Tell your doctor about all your illnesses, including allergies.
• Before taking Ezetimibe Genoptim in combination with a statin, your doctor should do blood tests to check your liver function.
• Your doctor may also do blood tests to check your liver function after you start taking Ezetimibe Genoptim in combination with a statin.

Ezetimibe Genoptim is not recommended for use in patients with moderate or severe liver impairment. The safety and efficacy of Ezetimibe Genoptim in combination with certain cholesterol-lowering medicines, fibrates, have not been established.

Children and adolescents

Do not use this medicine in children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist due to a lack of data on safety and efficacy. Do not use this medicine in children under 6 years of age due to a lack of data in this age group.

Ezetimibe Genoptim and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, tell your doctor if you are taking medicines containing any of the following active substances:

• cyclosporine (often used in patients who have had an organ transplant)
• medicines that prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol levels), as it affects the action of Ezetimibe Genoptim
• fibrates (also used to lower cholesterol levels)

Pregnancy and breastfeeding

Do not take Ezetimibe Genoptim in combination with a statin if you are pregnant, plan to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimibe Genoptim in combination with a statin, stop taking both medicines immediately and contact your doctor. There are no clinical data on the use of Ezetimibe Genoptim alone in pregnancy. If you are pregnant, ask your doctor for advice before taking Ezetimibe Genoptim. Do not take Ezetimibe Genoptim in combination with a statin while breastfeeding, as it is not known whether the medicine passes into breast milk. Ezetimibe Genoptim alone should not be used in breastfeeding women. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ezetimibe Genoptim is unlikely to affect your ability to drive or use machines. However, consider that some people may experience dizziness after taking Ezetimibe Genoptim.

Ezetimibe Genoptim contains lactose

Ezetimibe Genoptim tablets contain a sugar called lactose. If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

Ezetimibe Genoptim contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially "sodium-free".

3. How to take Ezetimibe Genoptim

Always take this medicine exactly as your doctor has told you. Unless your doctor has told you otherwise, continue to take any other cholesterol-lowering medicines you are currently taking. If you are unsure, ask your doctor or pharmacist.

• Before starting to take Ezetimibe Genoptim, follow a cholesterol-lowering diet.
• While taking Ezetimibe Genoptim, follow a cholesterol-lowering diet.

The recommended dose is one 10 mg Ezetimibe Genoptim tablet, taken once daily. You can take Ezetimibe Genoptim at any time of the day, with or without food. If your doctor has prescribed Ezetimibe Genoptim and a statin, you can take both medicines at the same time. In this case, read the package leaflet for the other medicine for information on dosing. If your doctor has prescribed Ezetimibe Genoptim and another cholesterol-lowering medicine that contains the active substance cholestyramine or any other medicine that contains a bile acid sequestrant, take Ezetimibe Genoptim at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Genoptim than you should

Contact your doctor or pharmacist.

If you forget to take Ezetimibe Genoptim

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

If you stop taking Ezetimibe Genoptim

Discuss this with your doctor or pharmacist, as your cholesterol levels may rise again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is classified as follows:

• Very common (may affect more than 1 in 10 people)
• 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 people, including isolated cases)

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems, including muscle breakdown, can be serious and life-threatening.

This can be a life-threatening condition.Allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing, have been reported. When used alone, the following side effects have been reported: Common:abdominal pain, diarrhea, flatulence, feeling tired. Uncommon:increased levels of some liver or muscle enzymes in the blood; cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; flushing. In addition, when used in combination with a statin, the following side effects have been reported: Common:increased levels of some liver enzymes in the blood; headache; muscle pain, tenderness, or weakness. Uncommon:tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in the arms and legs; unexplained tiredness or weakness; swelling, particularly of the hands and feet. When used in combination with fenofibrate, the following common side effect has been reported: abdominal pain. In addition, the following side effects have been reported: dizziness; muscle pain, liver problems; allergic reactions, including rash and hives; red, raised rash, sometimes in the shape of a target (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased platelet count, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ezetimibe Genoptim

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month. Store in a cool, dry place. Keep the blister in the outer carton in order to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ezetimibe Genoptim contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, crospovidone (type B), copovidone K28, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate.

What Ezetimibe Genoptim looks like and contents of the pack

Ezetimibe Genoptim tablets are white or almost white, round, biconvex, approximately 6 mm in diameter. The pack sizes are: blisters of transparent Triplex (PVC/PE/PVDC)/aluminum in packs of 7, 10, 14, 20, 28, 30, 50, 84, 90, 98, 100, or 300 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Synoptis Pharma Sp. z o.o., ul. Krakowiaków 65, 02-255 Warsaw

Manufacturer:

Laboratorios Liconsa, S.A., Polígono Industrial Miralcampo. Avda. Miralcampo, 7, 19200 Azuqueca de Henares – Guadalajara, Spain. Date of last revision of the leaflet:02/2021