Ezetimibe genoptim

Package leaflet: Information for the patient

Ezetimibe Genoptim, 10 mg, tablets
Ezetimibum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ezetimibe Genoptim is and what it is used for
2. What you need to know 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 Ezetimibe Genoptim is and what it is used for

Ezetimibe Genoptim is a medicine used to lower elevated cholesterol levels.
Ezetimibe Genoptim reduces blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides. In addition, Ezetimibe Genoptim increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimibe Genoptim, reduces cholesterol absorption in the gastrointestinal tract.
Ezetimibe Genoptim enhances the effect of statins, a group of medicines that reduce cholesterol produced in the body.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL and HDL cholesterol fractions.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the walls of arteries as atherosclerotic plaques. Accumulation of these plaques may eventually lead to narrowing of the arteries, slowing or blocking blood flow to vital organs such as the heart and brain. Blocked blood flow may result in heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that may contribute to increased risk of heart disease.
This medicine is used in patients in whom a cholesterol-lowering diet alone is not sufficient to control cholesterol levels in the blood. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Ezetimibe Genoptim is used as an adjunct to cholesterol-lowering diet in the following cases:

• Elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial or non-familial])
• In combination with a statin when cholesterol levels are not adequately controlled on statin therapy alone
• As monotherapy when statin therapy is not appropriate or poorly tolerated
• In a hereditary disorder (homozygous familial hypercholesterolemia) causing increased blood cholesterol levels. A statin will be used and other treatment methods may also be applied.
• In a hereditary disorder (homozygous sitosterolemia, also known as phytosterolemia) causing increased levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Genoptim taken with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve 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

If Ezetimibe Genoptim is used in combination with a statin, please read the patient information leaflet for that specific medicine.
When not to take Ezetimibe Genoptim:

• if the patient is allergic (hypersensitive) to ezetimibe or to 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 the patient currently has liver problems,
• during pregnancy or breastfeeding.

Warnings and precautions
Before starting to take Ezetimibe Genoptim, discuss this with your doctor or
pharmacist.

• Inform your doctor about all medical conditions, including allergies.
• Before starting Ezetimibe Genoptim in combination with a statin, your doctor should perform blood tests to assess liver function.
• Your doctor may also perform blood tests to monitor liver function after starting treatment with 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 used in combination with certain cholesterol-lowering medicines, fibrates, have not been established.
Children and adolescents
This medicine should not be used in children and adolescents (aged 6 to 17 years) unless prescribed by a specialist due to lack of data on safety and efficacy.
This medicine should not be used in children under 6 years of age due to lack of data in this age group.
Ezetimibe Genoptim and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• cyclosporine (commonly used in organ transplant patients),
• medicines containing active substances that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants),
• cholestyramine (also used to reduce cholesterol levels), as it affects the action of Ezetimibe Genoptim,
• fibrates (also used to reduce cholesterol levels).

Pregnancy and breastfeeding
Do not take Ezetimibe Genoptim in combination with a statin if you are pregnant, planning to become pregnant, or suspect 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 without a statin during pregnancy. If you are pregnant, consult your doctor before using Ezetimibe Genoptim.
Do not take Ezetimibe Genoptim in combination with a statin while breastfeeding, as it is unknown whether the medicine passes into breast milk.
Ezetimibe Genoptim, even without combination with a statin, should not be used in women who are breastfeeding. Consult your doctor for advice.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Ezetimibe Genoptim is not expected to affect the ability to drive or operate machinery. However, consider that dizziness may occur in some individuals after taking Ezetimibe Genoptim.
Ezetimibe Genoptim contains lactose
Ezetimibe Genoptim tablets contain a sugar called lactose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Ezetimibe Genoptim contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Ezetimibe Genoptim

This medicine should always be taken exactly as prescribed by your doctor. Unless otherwise advised by your doctor,
you should continue taking any previously prescribed cholesterol-lowering medicines. If in doubt, consult your doctor or pharmacist.

• Before starting treatment with Ezetimibe Genoptim, a cholesterol-lowering diet should be initiated.
• While taking Ezetimibe Genoptim, a cholesterol-lowering diet should be maintained.

The recommended dose is one 10 mg tablet of Ezetimibe Genoptim taken orally once daily.
Ezetimibe Genoptim can be taken at any time of day, with or without food.
If your doctor has prescribed Ezetimibe Genoptim together with a statin, both medicines may be taken at the same time. In this case, please refer to the dosing information provided in the package leaflet of the respective medicine.
If your doctor has prescribed Ezetimibe Genoptim together with another cholesterol-lowering medicine containing the active substance cholestyramine or any other medicine containing a bile acid sequestrant resin, Ezetimibe Genoptim should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant resin.
Taking more Ezetimibe Genoptim than recommended
Contact your doctor or pharmacist immediately.
If you miss a dose of Ezetimibe Genoptim
Do not take a double dose to make up for the missed tablet. Take your usual dose of Ezetimibe Genoptim at the usual time the next day.
Stopping Ezetimibe Genoptim
Discuss this with your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The frequency of adverse reactions is classified as follows:

• Very common (may occur in more than 1 in 10 patients);
• Common (may occur in up to 1 in 10 patients);
• Uncommon (may occur in up to 1 in 100 patients);
• Rare (may occur in up to 1 in 1000 patients);
• Very rare (may occur in up to 1 in 10,000 patients, including single cases).

You should contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. In rare cases, muscle problems, including rhabdomyolysis
leading to kidney damage, may be severe and progress to a potentially life-threatening condition.
Hypersensitivity reactions have been reported during routine use, including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing (requiring immediate treatment).
The following adverse reactions have been observed during monotherapy:

Common:

• abdominal pain;
• diarrhoea;
• flatulence;
• fatigue.

Uncommon:

• increased parameters in certain liver function tests (aminotransferases) or muscle tests (CK);
• cough;
• dyspepsia;
• heartburn;
• nausea;
• joint pain;
• muscle cramps;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• sudden flushing of the face;
• high blood pressure.

Additionally, the following adverse reactions have been observed when used in combination with a statin:

Common:

• increased parameters in certain liver function tests (aminotransferases);
• headache;
• muscle pain, tenderness or weakness.

Uncommon:

• tingling sensation;
• dry mouth;
• itching;
• rash;
• urticaria;
• back pain;
• muscle weakness;
• pain in arms and legs;
• unexplained tiredness or weakness;
• swelling, particularly in hands and feet.

When used in combination with fenofibrate, the following adverse reaction was commonly observed:

• abdominal pain.

Additionally, during routine use, the following adverse reactions have been reported:

• dizziness;
• muscle pain;
• liver problems;
• hypersensitivity reactions including rash and urticaria;
• red, raised rash, sometimes with lesions in a target-like shape (erythema multiforme);
• muscle pain, tenderness or weakness;
• rhabdomyolysis;
• gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting);
• pancreatitis, often with severe abdominal pain;
• constipation;
• decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia);
• tingling sensation;
• depression;
• unexplained tiredness or weakness;
• shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, convex, with a diameter of approximately 6 mm.
Pack sizes:
Blister packs made of transparent Triplex film (PVC/PE/PVDC)/Aluminium containing 7, 10, 14, 20, 28, 30, 50, 84, 90, 98, 100 or 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Poland

Manufacturer:
Laboratorios Liconsa, S.A.
Polígono Industrial Miralcampo. Avda. Miralcampo, 7
19200 Azuqueca de Henares – Guadalajara
Spain