Package leaflet: Information for the patient

Lipegis, 10 mg, tablets
Ezetimibe
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are identical.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Lipegis is and what it is used for
Important information before taking Lipegis
How to take Lipegis
Possible side effects
How to store Lipegis
Contents of the pack and other information

1. What Lipegis is and what it is used for

Lipegis is a medicine that reduces elevated cholesterol levels.
Lipegis lowers blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol),
and fat substances called triglycerides. In addition, Lipegis increases levels of "good"
cholesterol (HDL cholesterol).
Lipegis works by reducing the amount of cholesterol absorbed from the gastrointestinal tract.
Lipegis provides an additional cholesterol-lowering effect to that of statins, a group
of medicines that reduce the amount of cholesterol produced in the body.
Cholesterol is one of several fatty substances present in the blood. Your total cholesterol
consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" because it can deposit in the walls of arteries, forming
atherosclerotic plaques. Over time, plaque buildup leads to narrowing of the arteries. This,
in turn, may slow down or block blood flow to vital organs such as the heart or
brain. Such blockage may cause heart attack or stroke.
HDL cholesterol is often called "good" because it helps prevent "bad"
cholesterol from depositing in artery walls and protects against heart disease.
Another type of fat in the blood that may increase the risk of coronary heart disease is triglycerides.
Lipegis is used in patients who cannot control their cholesterol levels through a low-cholesterol diet alone. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Lipegis is used in addition to a cholesterol-lowering diet for the treatment of:

elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])
in combination with a statin when cholesterol levels are not adequately controlled with a statin alone
alone, when treatment with a statin is inappropriate or not tolerated
elevated blood cholesterol levels in homozygous familial hypercholesterolemia (a hereditary condition). Your doctor may also recommend treatment with a statin or another treatment approach.

In patients with heart disease, Lipegis, when used in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, the need for surgical procedures to improve blood flow to the heart, and hospitalization due to chest pain.
Lipegis does not help with weight reduction.

2. Important information before using Lipegis

When using Lipegis in combination with a statin, please refer to the patient leaflet for the respective statin.
When not to use Lipegis:

if the patient is allergic to ezetimibe or any of the other ingredients of this medicine (listed in section 6).

When not to use Lipegis in combination with a statin:

if the patient has liver problems.
if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Lipegis, consult a doctor or pharmacist.

Inform the doctor about all your health conditions, including allergies.
Before starting treatment with Lipegis in combination with a statin, the doctor should perform blood laboratory tests to assess liver function.
The doctor may also perform blood laboratory tests to monitor liver function after initiating treatment with Lipegis in combination with a statin.

Lipegis is not recommended for patients with moderate or severe liver impairment.
The safety and efficacy of Lipegis used in combination with certain cholesterol-lowering drugs, fibrates, have not been established.
Children and adolescents
Do not use this medicine in children and adolescents (aged 6 to 17 years) unless prescribed by a specialist, as data on safety and efficacy are limited. Do not use in children under 6 years of age, as there is no information available for this age group.
Other medicines and Lipegis
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used. In particular, inform about the use of the following medicines:

cyclosporine (a medicine commonly used in organ transplant patients)
anticoagulant medicines used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
cholestyramine (also used to reduce cholesterol levels), as it may affect the action of Lipegis
fibrates (also used to reduce cholesterol levels)

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
If the patient is pregnant or planning to become pregnant, or suspects she may be pregnant, she should not use Lipegis in combination with a statin. If the patient becomes pregnant while taking Lipegis together with a statin, she should immediately stop taking both medicines and inform her doctor. There is no experience with the use of Lipegis without a statin during pregnancy.
Do not use Lipegis with a statin during breastfeeding, as it is unknown whether the medicine is excreted in breast milk. Lipegis should not be used without a statin during breastfeeding.
Before using any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Lipegis should not affect the ability to drive or operate machinery. However, it should be noted that dizziness may occur in some individuals after taking Lipegis.
Lipegis contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Lipegis

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
You should continue taking any cholesterol-lowering medicines you are currently using unless your
doctor advises otherwise.

Before starting treatment with Lipegis, a cholesterol-lowering diet should be initiated.
This diet should be continued during treatment with Lipegis.

The recommended dose is 1 tablet of Lipegis 10 mg taken orally once daily.
Lipegis can be taken at any time of day. The medicine may be taken with food or independently of meals.
If your doctor has prescribed Lipegis together with a statin, both medicines may be taken at the same time.
In this case, refer to the dosing information for the respective statin provided in the patient leaflet.
If your doctor has prescribed Lipegis together with cholestyramine or another bile acid sequestrant
(cholesterol-lowering medicines), Lipegis should be taken at least 2 hours before or 4 hours after taking the bile acid-binding medicine.
Taking more Lipegis than prescribed:
Contact your doctor or pharmacist.
If you miss a dose of Lipegis:
Do not take a double dose to make up for the missed tablet. Take your next dose at the usual time the following day.
Stopping Lipegis:
Discuss this with your doctor or pharmacist, as blood 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 everyone will experience them.
If unexplained muscle pain, tenderness or weakness occurs during treatment with Lipegis, you should
contact your doctor. This is necessary because, in rare cases, muscle-related problems, including
rhabdomyolysis leading to kidney damage, may be serious or even life-threatening.
During regular use, allergic reactions have been reported, including swelling of the face, lips, tongue
and/or throat, which may cause difficulty in breathing or swallowing (requiring immediate treatment).
During use of ezetimibe as monotherapy, the following adverse reactions have been reported in
clinical trials:
Common (may occur in up to 1 in 10 patients):
abdominal pain; diarrhoea; flatulence; feeling of fatigue.
Uncommon (may occur in up to 1 in 100 patients):
increased results of certain blood laboratory tests assessing liver function (transaminases) or muscle
function (CK); cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased
appetite; pain; chest pain; hot flushes; high blood pressure.
During use of ezetimibe together with a statin, the following adverse reactions have been reported in
clinical trials:
Common (may occur in up to 1 in 10 patients):
increased results of certain blood laboratory tests assessing liver function (transaminases); headache;
muscle pain.
Uncommon (may occur in up to 1 in 100 patients):
tingling sensation; dry mouth; itching, rash; urticaria; gastritis; back pain; muscle weakness; pain in
arms and legs; unusual tiredness or weakness; oedema, particularly of hands and feet.
During use of ezetimibe together with a fibrate (a cholesterol-lowering medicine), the following
adverse reaction has been reported: abdominal pain.
In addition, during widespread use, the following adverse reactions have been reported (frequency
cannot be estimated from available data):
dizziness; liver problems; allergic reactions including rash and urticaria; red raised rash, sometimes
with target-like lesions (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; reduced platelet count leading to bruising and/or bleeding
(thrombocytopenia); tingling sensation; depression; unusual 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 Reactions of
Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lipegis

The medicinal product does not require any special storage conditions regarding temperature.
Store in the original packaging, protected from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Lipegis contains

The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
The other ingredients are: microcrystalline cellulose, mannitol, low-substituted hydroxypropylcellulose, povidone, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

What Lipegis looks like and contents of the pack
Lipegis tablets are white or almost white, round, flat tablets with bevelled edges,
with a stylised "E" on one side and the code "612" on the other side.
30x (3x10), 60x (6x10), 80x (8x10), 90x (9x10) or 100x (10x10) tablets in an OPA/Aluminium/PVC/Aluminium blister pack, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
H-1106 Budapest, Keresztúri út 30-38.
Hungary

Importer
Egis Pharmaceuticals PLC
H-1165 Budapest, Bökényföldi út 118-120.
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Hungary Ezetimib-Egis 10 mg tabletta
Bulgaria Lipobon 10 mg tablets
Czech Republic Egitim 10 mg
Poland Lipegis
Slovakia Lipobon 10 mg
France Ezetimibe Biogaran 10 mg comprimé