LIPEGIS 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lipegis, 10 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Lipegis and what is it used for
4. Important information before taking Lipegis
   1. When not to take Lipegis:
   2. When not to take Lipegis in combination with a statin:
   3. Warnings and precautions
   4. Children and adolescents
   5. Other medicines and Lipegis
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Lipegis contains sodium
5. How to take Lipegis
   1. What to do if you take more Lipegis than you should:
   2. What to do if you forget to take Lipegis:
   3. What to do if you stop taking Lipegis:
6. Possible side effects
   1. If you experience unexplained muscle pain, tenderness, or weakness while taking Lipegis, contact your doctor.
   2. Reporting of side effects
7. How to store Lipegis
8. Contents of the pack and other information
   1. What Lipegis contains
   2. What Lipegis looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 23.05.2021

Package Leaflet: Information for the Patient

Lipegis, 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Lipegis and what is it used for

Lipegis is a medicine that reduces elevated cholesterol levels.
Lipegis reduces the levels of total cholesterol, "bad" cholesterol (LDL cholesterol)
and fatty substances called triglycerides in the blood. Additionally, Lipegis increases the levels of "good"
cholesterol (HDL cholesterol).
Lipegis works by reducing the amount of cholesterol absorbed from the gut.
Lipegis has 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 found in the blood. Your total cholesterol level is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" because it can build up in the walls of the arteries, forming plaques. Over time, this can lead to narrowing of the arteries, which can reduce or block blood flow to important organs such as the heart and brain. This blocking of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called "good" because it helps prevent "bad" cholesterol from building up in the walls of the arteries and protects against heart disease.
Another form of fat in the blood that can increase the risk of coronary heart disease is triglycerides.
It is used in patients who cannot control their cholesterol levels by diet alone. While taking the medicine, you should continue with a low-cholesterol diet.
Lipegis is used in addition to a low-cholesterol diet in the treatment of:

• high cholesterol levels in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial])
• in combination with a statin, when cholesterol levels are not well controlled with a statin alone
• alone, when statin treatment is not suitable or not tolerated
• high cholesterol levels in the blood in homozygous familial hypercholesterolaemia (a hereditary disease). Your doctor may also prescribe a statin or other treatment.

In patients with heart disease, Lipegis in combination with statins reduces the risk of heart attack, stroke, the need for surgical procedures to increase blood flow to the heart, and hospitalization due to chest pain.
Lipegis does not help to lose weight.

2. Important information before taking Lipegis

If you are taking Lipegis in combination with a statin, please read the package leaflet for that statin.

When not to take Lipegis:

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

When not to take Lipegis in combination with a statin:

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

Warnings and precautions

Before taking Lipegis, tell your doctor or pharmacist.

• Tell your doctor about all your health problems, including any allergies.
• Before taking Lipegis 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 Lipegis in combination with a statin.

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

Children and adolescents

Do not give this medicine to children and adolescents (aged 6-17 years) unless prescribed by a specialist, as the data on safety and efficacy are limited. Do not give this medicine to children under 6 years of age, as there is no information on this age group.

Other medicines and Lipegis

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and any you plan to take. In particular, tell your doctor or pharmacist about the following medicines:

• cyclosporin (a medicine often used in patients who have had an organ transplant)
• medicines that prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindion (anticoagulants)
• cholestyramine (also used to lower cholesterol levels), as it affects the action of Lipegis
• fibrates (also used to lower cholesterol levels)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or planning to become pregnant, do not take Lipegis in combination with a statin. If you become pregnant while taking Lipegis in combination with a statin, stop taking both medicines immediately and tell your doctor. There is no experience with the use of Lipegis alone in pregnancy.
Do not take Lipegis in combination with a statin while breastfeeding, as it is not known whether the medicine is excreted in human milk. Lipegis should not be taken alone while breastfeeding.
Before taking any medicine, ask your doctor or pharmacist for advice.

Driving and using machines

Lipegis is unlikely to affect your ability to drive or use machines. However, remember that some people may experience dizziness while taking Lipegis.

Lipegis contains sodium

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

3. How to take Lipegis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Continue to take your other cholesterol-lowering medicines unless your doctor tells you to stop.

• Before starting to take Lipegis, you should be on a low-cholesterol diet.
• Continue with a low-cholesterol diet while taking Lipegis.

The recommended dose is one 10 mg tablet of Lipegis per day, taken by mouth.
Lipegis can be taken at any time of day, with or without food.
If your doctor has prescribed Lipegis in combination with a statin, you can take both medicines at the same time.
In this case, please read the information on dosing for the relevant statin in the package leaflet.
If your doctor has prescribed Lipegis in combination with cholestyramine or another bile acid sequestrant
(cholesterol-lowering medicines), take Lipegis at least 2 hours before or 4 hours after taking the bile acid sequestrant.

What to do if you take more Lipegis than you should:

Contact your doctor or pharmacist.

What to do if you forget to take Lipegis:

Do not take a double dose to make up for a forgotten tablet. Take your normal dose of Lipegis the next day at the same time.

What to do if you stop taking Lipegis:

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.

If you experience unexplained muscle pain, tenderness, or weakness while taking Lipegis, contact your doctor.

This is because muscle problems, including muscle breakdown, can be serious and potentially life-threatening.
During normal use, allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing, have been reported (which requires immediate treatment).
During treatment with ezetimibe alone,the following side effects have been reported in clinical trials:
Common (may affect up to 1 in 10 people):
abdominal pain; diarrhea; bloating; feeling tired.
Uncommon (may affect up to 1 in 100 people):
increased results of some liver function tests; cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; hot flushes; high blood pressure.
During treatment with ezetimibe in combination with a statin, the following side effects have been reported in clinical trials:
Common (may affect up to 1 in 10 people):
increased results of some liver function tests; headache; muscle pain.
Uncommon (may affect up to 1 in 100 people):
tingling sensation; dry mouth; itching, rash, hives; gastritis; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, particularly of the hands and feet.
During treatment with ezetimibe in combination with a fibrate (a cholesterol-lowering medicine), abdominal pain has been reported.
In addition, the following side effects have been reported during widespread use (the frequency of which is unknown):
dizziness; liver problems; allergic reactions, including rash and hives; red, raised rash, sometimes with changes in the shape of the skin (erythema multiforme); pain, tenderness, or weakness in the muscles; 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 and (or) bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell 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
Phone: +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 Lipegis

The medicinal product does not require any special storage conditions regarding temperature.
Store in the original package, protect from moisture.
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 packaging after "EXP". The expiry date refers to the last day of that month.
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 protect the environment.

6. Contents of the pack 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 with beveled edges, with a stylized "E" on one side and "612" on the other side.
30x (3x10), 60x (6x10), 80x (8x10), 90x (9x10), or 100x (10x10) tablets in a blister pack OPA/Aluminum/PVC/Aluminum, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized 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

Date of last revision of the leaflet: 23.05.2021