ESETIN 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Esetin, 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 Esetin and what is it used for
4. Important information before taking Esetin
   1. When not to take Esetin:
   2. When not to take Esetin with a statin:
   3. Warnings and precautions
   4. Children and adolescents
   5. Esetin and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Esetin contains lactose
5. How to take Esetin
   1. If you take more Esetin than you should
   2. If you forget to take Esetin
   3. If you stop taking Esetin
6. Possible side effects
   1. Immediately contact your doctor if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems, including muscle breakdown, can be serious and life-threatening.
   2. Reporting side effects
7. How to store Esetin
8. Contents of the pack and other information
   1. What Esetin contains
   2. What Esetin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Esetin, 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Esetin and what is it used for

Esetin is a medicine used to lower high cholesterol levels.
Esetin reduces the amount of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. Additionally, Esetin increases the level of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Esetin, reduces the absorption of cholesterol in the gut.
Esetin enhances the action of statins, a group of medicines that lower 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 build up 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 buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat found in the blood, which can contribute to an increased risk of heart disease.
The medicine is used in patients for whom diet alone is not enough to control their cholesterol levels. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Esetin is used as a supplement to a cholesterol-lowering diet in the following cases:

• high cholesterol levels in the blood (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 cholesterol levels in the blood. The patient will be treated with a statin and may be treated with other lipid-lowering therapies.

If the patient has heart disease, taking Esetin 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.
Esetin has no effect on weight loss.

2. Important information before taking Esetin

If you are taking Esetin with a statin, read the package leaflet for that medicine as well.

When not to take Esetin:

When not to take Esetin with a statin:

Warnings and precautions

Before taking Esetin, discuss it with your doctor or pharmacist.

• Tell your doctor about any medical conditions, including allergies.
• Before taking Esetin 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 Esetin with a statin.

Esetin is not recommended for patients with moderate or severe liver impairment.
The safety and efficacy of Esetin 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 to 17 years) unless it has been prescribed by a specialist, as there is limited data on the safety and efficacy of Esetin in this population.
Do not give this medicine to children under 6 years of age, as there is no data available for this age group.

Esetin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially 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 (anticoagulant medicines)
• cholestyramine (also used to lower cholesterol levels), as it affects the action of Esetin
• fibrates (also used to lower cholesterol levels)

Pregnancy and breastfeeding

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

Driving and using machines

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

Esetin contains lactose

Esetin tablets contain a sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Esetin

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Before starting to take Esetin, follow a cholesterol-lowering diet. While taking Esetin, continue to follow a cholesterol-lowering diet.

• Take one Esetin 10 mg tablet orally once a day. Esetin can be taken at any time of day, with or without food.

If your doctor has prescribed a statin, you can take both medicines at the same time. In this case, read the package leaflet for the statin medicine for dosing information.
If your doctor has prescribed Esetin and another cholesterol-lowering medicine that contains cholestyramine or another bile acid sequestrant, take Esetin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Esetin than you should

Contact your doctor or pharmacist.

If you forget to take Esetin

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

If you stop taking Esetin

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).

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

These conditions can be life-threatening.
During normal use, allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing, have been reported (requiring immediate treatment).
The following side effects have been reported in patients taking Esetin alone:
Common: abdominal pain; diarrhea; bloating with gas; feeling tired.
Uncommon: increased levels of some liver function tests (aminotransferases) or muscle (CK) tests; cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; flushing.
Additionally, the following side effects have been reported in patients taking Esetin with a statin:
Common: increased levels of some liver function tests (aminotransferases); headache; muscle pain, tenderness, or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in arms and legs; unexplained tiredness or weakness; swelling, particularly of the hands and feet.
The following side effect has been reported in patients taking Esetin with fenofibrate:
Common: abdominal pain.
Additionally, the following side effects have been reported during normal use:
dizziness; muscle pain, liver problems; allergic reactions, including rash and hives; red, raised rash, sometimes in a butterfly shape (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased platelet count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, 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, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Esetin

• 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.
• There are no special storage precautions.

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 Esetin contains

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

What Esetin looks like and contents of the pack

White or almost white capsules-shaped tablets, with "713" engraved on one side and smooth on the other side.
Unit packs: PVC/Aclar/Aluminium blisters in packs of 28, 30, 56, 60, 90, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Manufacturer:
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Street
Dupnitsa, 2600
Bulgaria
Actavis Ltd.
BLB 015-016
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

Date of last revision of the leaflet: