Ezetimibe Milan

PATIENT INFORMATION LEAFLET

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Ezetimibe Mylan, 10 mg, tablets
Ezetimibe
Read the leaflet carefully before taking the medicine, as it contains important information for you.

• 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

TABLE OF CONTENTS OF THE LEAFLET

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

1. WHAT IS EZETIMIBE MYLAN AND WHAT IS IT USED FOR

Ezetimibe Mylan contains the active substance ezetimibe. Ezetimibe Mylan is used to lower elevated cholesterol levels. Ezetimibe Mylan reduces the level of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. Additionally, Ezetimibe Mylan increases the level of "good" cholesterol (HDL cholesterol).
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Eventually, these plaques can lead to narrowing of the arteries. Narrowing can slow down or block blood flow to vital organs such as the heart and brain. Blocking blood flow can cause a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the walls of arteries and protects against heart disease.
Triglycerides are another type of fat found in the blood that can increase the risk of heart disease.
Ezetimibe Mylan reduces the absorption of cholesterol in the gut. Ezetimibe Mylan has no effect on weight loss.
Ezetimibe Mylan enhances the action of statins - a group of medicines that lower cholesterol produced in the body.
Ezetimibe Mylan is used in patients who are unable to control their cholesterol levels solely through dietary restrictions. While taking this medicine, the patient should remain on a cholesterol-lowering diet.
Ezetimibe Mylan is used as a complementary measure to a cholesterol-lowering diet in the following cases:

• high blood cholesterol levels (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 well tolerated;
• a hereditary disorder (homozygous familial hypercholesterolemia) that causes high blood cholesterol levels. The patient will also be treated with a statin and may be treated with other cholesterol-lowering medications;
• a hereditary disorder (homozygous sitosterolemia, also known as phytosterolemia, which causes high levels of plant sterols in the blood.

In patients with heart disease, Ezetimibe Mylan in combination with cholesterol-lowering medicines (statins) reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, and hospitalization for chest pain.
Ezetimibe Mylan has no effect on weight loss.

2. IMPORTANT INFORMATION BEFORE TAKING EZETIMIBE MYLAN

When taking Ezetimibe Mylan in combination with a statin, read the leaflet for that particular medicine.

WHEN NOT TO TAKE EZETIMIBE MYLAN:

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

WHEN NOT TO TAKE EZETIMIBE MYLAN IN COMBINATION WITH A STATIN:

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

PRECAUTIONS AND WARNINGS

Before starting treatment with Ezetimibe Mylan, discuss it with your doctor or pharmacist.
Tell your doctor about all your symptoms, including allergies.
Before starting treatment with Ezetimibe Mylan and a statin, your doctor should perform blood tests to assess liver function.
Your doctor may also perform blood tests to assess liver function after starting treatment with Ezetimibe Mylan and a statin.
Ezetimibe Mylan is not recommended for use in patients with moderate or severe liver impairment.
The safety and efficacy of Ezetimibe Mylan used in combination with fibrates (cholesterol-lowering medicines) have not been established.
Tell your doctor if you experience muscle pain, tenderness, or weakness of unknown origin, especially if accompanied by fever.

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 limited 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 MYLAN AND OTHER MEDICINES

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. In particular, tell your doctor or pharmacist if you are taking:

• cyclosporine (a medicine often used in patients who have had an organ transplant);
• medicines that prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants);
• cholestyramine (a medicine used to lower cholesterol levels), as it affects the action of Ezetimibe Mylan;
• fibrates (cholesterol-lowering medicines).

PREGNANCY AND BREASTFEEDING

Do not take Ezetimibe Mylan with a statin if you are pregnant, plan to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Ezetimibe Mylan with a statin, stop taking the medicine immediately and contact your doctor.
There are no data on the use of Ezetimibe Mylan without a statin during pregnancy.
Do not take Ezetimibe Mylan with a statin during breastfeeding, as it is not known whether the medicine passes into breast milk. Ezetimibe Mylan should not be used in breastfeeding women, even without a statin.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

DRIVING AND USING MACHINES

You should not expect Ezetimibe Mylan to affect your ability to drive or operate machinery. However, consider that some people may experience dizziness after taking Ezetimibe Mylan. In this case, do not drive or operate machinery.

EZETIMIBE MYLAN CONTAINS LACTOSE AND SODIUM

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. HOW TO TAKE EZETIMIBE MYLAN

Always take this medicine exactly as your doctor or pharmacist has told you. Unless your doctor has told you otherwise, continue taking any other cholesterol-lowering medicines you are currently taking.
If you are unsure, ask your doctor or pharmacist.
Before starting treatment with Ezetimibe Mylan, you should be on a cholesterol-lowering diet. While taking Ezetimibe Mylan, you should continue to follow this diet.

ADULTS AND ADOLESCENTS (AGED 10 TO 17 YEARS)

The recommended dose is one 10 mg Ezetimibe Mylan tablet, taken orally once a day.
The tablets can be taken at any time of the day, with or without food.

INSTRUCTIONS FOR HANDLING A PERFORATED UNIT DOSE BLISTER PACK:

• 1. Do not press on the tablet pocket to open it.
• 2. For a perforated blister: remove one edge with a perforation as shown in the picture.
• 3. Hold the blister by the edges and separate one tablet pocket carefully by tearing it off along the perforation.
• 4. Carefully remove the paper layer from the unsealed edge of the tablet pocket.
• 5. Remove the tablet from the opened pocket.

If your doctor has prescribed Ezetimibe Mylan and a statin, you can take both medicines at the same time.
In this case, read the information on dosing in the leaflet for that particular medicine.
If your doctor has prescribed Ezetimibe Mylan and cholestyramine or any other bile acid sequestrant (cholesterol-lowering medicines), take Ezetimibe Mylan at least 2 hours before or 4 hours after taking the bile acid sequestrant.

TAKING A HIGHER DOSE OF EZETIMIBE MYLAN THAN RECOMMENDED

If you have taken more Ezetimibe Mylan than recommended, contact your doctor or pharmacist.

MISSING A DOSE OF EZETIMIBE MYLAN

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

STOPPING TREATMENT WITH EZETIMIBE MYLAN

Before stopping treatment with this medicine, talk to 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.

YOU SHOULD IMMEDIATELY CONTACT YOUR DOCTOR OR GO TO THE EMERGENCY ROOM OF YOUR NEAREST HOSPITAL IF YOU EXPERIENCE ANY OF THE FOLLOWING SERIOUS SIDE EFFECTS; THESE SIDE EFFECTS ARE OF UNKNOWN FREQUENCY (FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE DATA), BUT MAY REQUIRE MEDICAL ATTENTION:

Unexplained muscle pain, tenderness, or weakness. In rare cases, muscle symptoms can be severe and potentially life-threatening, including muscle breakdown leading to kidney damage;

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (which require immediate treatment);
• pancreatitis, often with severe abdominal pain;
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, or vomiting);
• a red, raised rash, sometimes with target-like lesions;
• liver inflammation (which can cause tiredness, fever, nausea, vomiting, general feeling of being unwell, yellowing of the skin and eyes, pale stools, and dark urine).

THE FOLLOWING SIDE EFFECTS HAVE BEEN REPORTED IN PATIENTS TAKING EZETIMIBE MYLAN ALONE:

COMMON (MAY AFFECT UP TO 1 IN 10 PEOPLE):

• abdominal pain;
• diarrhea;
• flatulence (bloating);
• feeling tired.

UNCOMMON (MAY AFFECT UP TO 1 IN 100 PEOPLE):

• increased activity of some liver or muscle enzymes seen in blood tests;
• cough;
• indigestion;
• heartburn;
• nausea;
• joint pain;
• muscle cramps;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• hot flushes;
• high blood pressure.

In addition, when taken in combination with a statin, the following side effects are possible:

COMMON (MAY AFFECT UP TO 1 IN 10 PEOPLE):

• increased activity of some liver enzymes seen in blood tests;
• headache;
• muscle pain.

UNCOMMON (MAY AFFECT UP TO 1 IN 100 PEOPLE):

• tingling sensation;
• dry mouth;
• abdominal pain, nausea, vomiting with blood, blood in the stool;
• itching;
• rash;
• hives;
• back pain;
• muscle weakness;
• arm or leg pain;
• unusual tiredness or weakness;
• swelling, especially of the hands and feet.

In addition, when taken with or without a statin, the following side effects are possible:

Frequency not known (frequency cannot be estimated from the available data):

• dizziness;
• allergic reactions, including rash and hives;
• constipation;
• reduced platelet count, which may cause bruising and bleeding (thrombocytopenia);
• tingling sensation;
• depression;
• unusual tiredness or weakness;
• shortness of breath.

When taken with fenofibrate, the following side effect is possible:

COMMON (MAY AFFECT UP TO 1 IN 10 PEOPLE):

• abdominal pain.

REPORTING SIDE EFFECTS

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Post-Marketing Surveillance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49 21 301, Fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 EZETIMIBE MYLAN

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 blister, carton, or bottle after EXP. The expiry date refers to the last day of that month.
There are no special storage precautions.
Bottles: Use within 100 days of opening.
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 EZETIMIBE MYLAN CONTAINS

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate (see section 2 "Ezetimibe Mylan contains lactose monohydrate."); sodium lauryl sulfate (E487); croscarmellose sodium; hypromellose (E464); crospovidone (Type B); microcrystalline cellulose; magnesium stearate.

WHAT EZETIMIBE MYLAN LOOKS LIKE AND CONTENTS OF THE PACK

Ezetimibe Mylan, 10 mg, is a white or almost white capsule-shaped tablet with a broken line on one side and engraved with "M" on one side and "EE1" on the other.
Ezetimibe Mylan, 10 mg, tablets are available in blisters or perforated unit dose blisters containing 14, 28, 30, 56, 84, 90, 98, or 100 tablets, in calendar blisters containing 28 or 30 tablets, and in plastic bottles containing 14, 28, 50, 56, 84, or 100 tablets.
Not all pack sizes may be marketed.

MARKETING AUTHORIZATION HOLDER

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

MANUFACTURER/IMPORTER

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
To obtain more detailed information on this medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

DATE OF LAST REVISION OF THE LEAFLET: 11/2021