Package leaflet: Information for the patient

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

Keep this leaflet, as 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 you personally. Do not pass it on to others. It may harm someone else, 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.

Leaflet contents

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

1. What Esetin is and what it is used for

Esetin is a medicine used to lower elevated cholesterol levels.
Esetin reduces blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides. In addition, Esetin increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Esetin, reduces cholesterol absorption in the gastrointestinal tract.
Esetin 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 may deposit in the walls of arteries as atherosclerotic plaques. Accumulation of these plaques may eventually lead to narrowing of the arterial lumen, slowing blood flow or blocking blood supply to vital organs such as the heart and brain. Interruption of blood flow may result in heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the deposition 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 insufficient to control blood cholesterol levels. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Esetin is used as an adjunct to cholesterol-lowering diet in the following conditions:

Elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial or non-familial])
In combination with a statin when cholesterol levels are not adequately controlled with a statin 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.

If you have heart disease, Esetin taken with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, procedures to improve blood flow to the heart, or hospitalization due to chest pain.
Esetin has no effect on body weight loss.

2. Important information before taking Esetin

When taking Esetin in combination with a statin, please read the patient information leaflet for
that specific medicine.
When not to take Esetin:

if the patient is allergic (hypersensitive) to ezetimibe or to any of the other ingredients of this medicine (see section 6: Contents of the pack and other information).

When not to take Esetin in combination with a statin:

if the patient currently has liver problems.
during pregnancy or breastfeeding.

Warnings and precautions
Before starting Esetin, discuss this with your doctor or pharmacist.

Inform your doctor about all medical conditions, including allergies.
Before starting Esetin 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 Esetin in combination with a statin.

Esetin is not recommended for use in 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
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.
Esetin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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 Esetin
fibrates (also used to reduce cholesterol levels)

Pregnancy and breastfeeding
Do not take Esetin 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 Esetin in combination with a statin, stop taking both medicines immediately and contact your doctor.
There are no clinical data on the use of Esetin without a statin during pregnancy.
If you are pregnant, consult your doctor before taking Esetin.
Do not take Esetin in combination with a statin during breastfeeding, as it is unknown whether the medicine passes into breast milk.
Esetin, even without combination with a statin, should not be used in patients who are breastfeeding.
Consult your doctor for advice.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Esetin is not expected to affect the ability to drive or operate machinery.
However, bear in mind that dizziness may occur in some people after taking Esetin.
Esetin contains lactose
The Esetin tablet formulation contains a sugar called lactose. If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to take Esetin

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

Before starting Esetin, a cholesterol-lowering diet should be initiated.
While taking Esetin, a cholesterol-reducing diet should be maintained. The recommended dose is one 10 mg Esetin tablet taken orally once daily. Esetin may be taken at any time of day, with or without food.

If your doctor has prescribed both Esetin and a statin, both medicines may be taken at the same time. In this
case, refer to the dosing instructions provided in the package leaflet for the respective medicine.
If your doctor has prescribed Esetin together with another cholesterol-lowering medicine containing
cholestyramine or any other medicine containing a bile acid sequestrant resin, Esetin should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant resin.
Taking more Esetin than recommended
Contact your doctor or pharmacist immediately.
Missing a dose of Esetin
Do not take a double dose to make up for the missed tablet. Take your usual dose of Esetin at the usual time the next day.
Stopping Esetin
Discuss this with your doctor or pharmacist, as 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 get them.
The frequency of adverse reactions is classified as follows:

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

You should contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. In rare cases, muscle problems, including muscle breakdown
leading to kidney damage, may be severe and progress to a potentially life-threatening condition.
During routine 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).
When used as monotherapy, the following adverse reactions have been observed:
Common: abdominal pain; diarrhoea; bloating with passing of wind; feeling of fatigue.
Uncommon: increased levels in certain liver function tests (aminotransferases) or muscle tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; sudden flushing of the face; high blood pressure.
Additionally, when used in combination with a statin, the following adverse reactions have been observed:
Common: increased levels 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 of hands and feet.
When used in combination with fenofibrate, the following adverse reaction has been common: abdominal pain.
Additionally, during routine use, the following adverse reactions have been reported: dizziness; muscle pain, liver problems; allergic reactions including rash and urticaria; red, raised rash, sometimes with lesions in a target-like shape (erythema multiforme); muscle pain, tenderness or weakness; muscle breakdown; gallstones or gallbladder inflammation (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduction in 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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]
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 Esetin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or packaging after "Expiry date (EXP)". The expiry date refers to the last day of the specified month.
There are no special storage temperature requirements.

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 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, sodium croscarmellose, hypromellose, sodium lauryl sulfate, crospovidone (type A), microcrystalline cellulose, magnesium stearate.

What Esetin looks like and contents of the pack
White or almost white, capsule-shaped tablets, embossed with the number "713" 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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