EZETIMIBE 10 mg Tabletka Powlekana

Treść ulotki

1. Ezetimibe Mylan 10 mg tablets
   1. What Ezetimibe Mylan is and what it is used for
   2. What you need to know 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

Ezetimibe Mylan 10 mg tablets

ezetimibe

Equivalent Medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ezetimibe Mylan is and what it is used for
• 2. What you need to know before you take 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 Ezetimibe Mylan is and what it is used for

Ezetimibe Mylan contains the active ingredient ezetimibe. Ezetimibe Mylan is a medicine used to
decrease high cholesterol levels. Ezetimibe Mylan decreases total cholesterol levels, the
“bad” cholesterol (LDL cholesterol) and fats in the blood called triglycerides. Ezetimibe Mylan also
increases levels of “good” cholesterol (HDL cholesterol).
LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of the arteries
forming plaques. Eventually this build-up of plaques can lead to a narrowing of the arteries.
This narrowing can slow down or block the flow of blood to vital organs such as the heart and the
brain. This blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol, because it helps prevent bad cholesterol from
building up in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of heart disease.
Ezetimibe Mylan works by decreasing the absorption of cholesterol from the digestive tract. Ezetimibe
Mylan does not help you lose weight.
The decrease in cholesterol levels due to Ezetimibe Mylan is added to that due to statins,
a group of medicines that work by reducing the production of cholesterol by the body itself.
Ezetimibe Mylan is used for patients who are unable to control their cholesterol levels with diet alone.
You must follow a cholesterol-lowering diet while taking this
medicine.
Ezetimibe Mylan is used in addition to diet if you have:

• a high level of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non- familial])

together with a statin, when your cholesterol is not adequately controlled with a
statin alone
alone, when treatment with statins is not appropriate or is not tolerated

• an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and you may be prescribed other medicines
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) - which increases levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Mylan in combination with medicines to lower cholesterol
called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the
heart or hospitalization for chest pain.
Ezetimibe Mylan does not help you lose weight.

2. What you need to know before taking Ezetimibe Mylan

medicinal product.

Do not take Ezetimibe Mylan if:
if you are allergic to ezetimibe or any of the other ingredients of this medicinal product (listed in
section 6).

Do not take Ezetimibe Mylan together with a statin if:
you currently have liver problems
you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ezetimibe Mylan.
Tell your doctor about any medical conditions you have, including allergies.
Your doctor should prescribe a blood test before starting therapy with Ezetimibe Mylan together with
a statin. This is to check how your liver is functioning.
Your doctor may also ask you to have blood tests to check how your liver is functioning after you have
started taking Ezetimibe Mylan together with a statin.
If you have moderate or severe liver problems, the use of Ezetimibe Mylan is not recommended.
The safety and efficacy of Ezetimibe Mylan administered in combination with fibrates
(medicines that reduce cholesterol) have not been established.
If you experience muscle pain, tenderness or weakness while taking these tablets, especially
if this is accompanied by fever, tell your doctor.

Children and adolescents
Do not give this medicine to children and adolescents between 6 and 17 years of age, unless
prescribed by a specialist as there is limited data on safety and efficacy.
Do not give this medicine to children under 6 years of age because there is no information in
this age group.

Other medicines and Ezetimibe Mylan
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription. In particular, tell your doctor or pharmacist if you are taking any
of the following medicines:

• cyclosporine (a medicine often used in patients with organ transplantation)
• medicines that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• cholestyramine (a medicine used to lower cholesterol), as it alters the effectiveness of Ezetimibe Mylan
• fibrates (medicines to reduce cholesterol).

Pregnancy and breastfeeding
Do not take Ezetimibe Mylan together with a statin if you are pregnant, if you are trying to become
pregnant, or if you think you may be pregnant. If you become pregnant while taking Ezetimibe Mylan
together with a statin, you should stop both treatments immediately and contact your doctor.
There is no experience on the use of Ezetimibe Mylan without a statin during pregnancy.
Do not take Ezetimibe Mylan together with a statin during breastfeeding, as it is not known whether the two
medicines are excreted in human milk. Ezetimibe Mylan, even when taken alone without a statin,
should not be used during breastfeeding.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No effects of Ezetimibe Mylan on the ability to drive or operate machines are expected. However, you
should consider that some people may experience dizziness after taking
Ezetimibe Mylan.

Ezetimibe Mylan contains lactose monohydrate and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ezetimibe Mylan

Take Ezetimibe Mylan following your doctor’s instructions exactly. Continue to take your other
medicines to reduce cholesterol, unless your doctor tells you to stop. If you have any
doubts, ask your doctor or pharmacist.
Before starting to take Ezetimibe Mylan, you must follow a diet to lower cholesterol.
You should continue to follow this diet while taking Ezetimibe Mylan.

Adults and adolescents (10 to 17 years of age)
The recommended dose is one 10 mg tablet of Ezetimibe Mylan once a day, to be taken by
mouth.
Take the tablets at any time of day. You can take them with or without food.

Instructions for opening the blister pack with a peel-off film

• 1. Do not push on the blister cavity to open it.
• 2. For perforated blisters: remove any side of the perforated area as shown in the figure.

• 3. Hold the blister strips at the edges and separate one blister cavity from the rest of the strip by gently tearing along the perforation around it.
• 4. Carefully peel off the paper backing material from the unsealed area.
• 5. Take the product from the open blister cavity.

If your doctor has prescribed Ezetimibe Mylan together with a statin, the two medicines can be taken
at the same time. In this case, also refer to the specific dosage instructions contained in the leaflet
of the other medicine.
If your doctor has prescribed Ezetimibe Mylan together with colestyramine or any other bile acid sequestrant
(medicines to reduce cholesterol), you must take Ezetimibe Mylan at least 2 hours before or 4 hours after
taking the bile acid sequestrant.

If you take more Ezetimibe Mylan than you should
If you take more Ezetimibe Mylan than you should, contact your doctor or pharmacist.

If you forget to take Ezetimibe Mylan
Do not take a double dose to make up for a missed dose; simply resume your usual dose of Ezetimibe Mylan at the usual time the next day.

If you stop taking Ezetimibe Mylan
Talk to your doctor or pharmacist before stopping treatment with this medicine because your
cholesterol levels may increase 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.
manifest.

Tell your doctor or go to the nearest hospital emergency room if you experience any of the
following serious side effects; these effects are not known (frequency cannot be estimated based on
available data), but you may need urgent medical assistance:

• muscle pain, tenderness or weakness of unexplained cause. This is because, in rare cases, muscle problems, including muscle tissue injury leading to kidney damage, can be serious and potentially life-threatening
• allergic reactions, including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (requiring immediate treatment)
• inflammation of the pancreas, often with severe abdominal pain
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, feeling unwell or being unwell)
• raised, red skin rash, sometimes with target-like lesions
• inflammation of the liver (which can cause fatigue, fever, feeling unwell or being unwell, general feeling of illness, yellowing of the skin and eyes, pale stools and dark urine).

The following side effects have been reported when it has been used alone:

Common (may affect up to 1 in 10 people):

• abdominal pain
• diarrhoea
• flatulence
• feeling tired.

Uncommon (may affect up to 1 in 100 people):

• increases in the values of some liver and muscle function laboratory tests
• cough
• indigestion
• heartburn
• feeling unwell
• joint pain
• muscle spasms
• neck pain
• loss of appetite
• pain
• chest pain
• hot flushes
• high blood pressure.

In addition, when the drug has been used together with a statin, the following side effects have been
reported:

Common (may affect up to 1 in 10 people):

• increases in the values of some liver function laboratory tests
• headache
• muscle pain

Uncommon (may affect up to 1 in 100 people):

• feeling of pins and needles
• dry mouth
• stomach pain, feeling unwell, vomiting with traces of blood, blood in the stool
• skin rash
• hives
• back pain
• muscle weakness
• pain in arms and legs
• unusual fatigue or weakness
• swelling, especially of the hands and feet.

In addition, when used with or without a statin, the following side effects have been reported:

Not known (frequency cannot be estimated based on available data):

• dizziness
• allergic reactions including rash and hives
• constipation
• reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia)
• feeling of pins and needles
• depression
• unusual fatigue or weakness
• shortness of breath.

When it has been used together with fenofibrate, the following side effect has been reported:

Common (may affect up to 1 in 10 people):

• abdominal pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
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.
This medicine does not require any particular storage conditions.
Bottles: use within 100 days of opening.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ezetimibe Mylan contains
The active ingredient 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.

Description of the appearance of Ezetimibe Mylan and contents of the pack
Ezetimibe Mylan 10 mg tablets are capsule-shaped, off-white to white tablets with bevelled edges
with “M” imprinted on one side of the tablet and “EE1” on the other side.
Ezetimibe Mylan 10 mg tablets are available in blisters or push-through blisters with 14, 28,
30, 56, 84, 90, 98 and 100 tablets; perforated unit-dose divisible blisters containing 14 x 1, 28 x 1, 30
x 1, 50 x 1 90 x 1 and 98 x 1 tablets, calendar blisters with 28 and 30 tablets and plastic bottles with
14, 28, 50, 56, 84, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano

Manufacturer
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

This medicinal product is authorised in other member states of the EEA and in the United Kingdom (Northern Ireland)
with the following names:
Belgium Ezetimibe Viatris10 mg tablets
Cyprus Ezetimibe/Mylan 10mg Tablets
Czech Republic Ezetimib Viatris10 mg, tablets
Denmark Ezetimibe Viatris
France EZETIMIBE VIATRIS 10 mg, coated tablet
Germany Ezetimib Mylan 10 mg Tablets
Greece Ezetimibe Mylan 10mg Tablets
Ireland Ezetimibe 10 mg Tablets
Italy Ezetimibe Mylan
Luxembourg Ezetimibe Viatris10 mg comprimés
Portugal Ezetimiba Mylan
Spain Ezetimiba Viatris 10 mg comprimidos EFG
Sweden Ezetimibe Viatris
Netherlands Ezetimibe Viatris 10 mg, tablets
United Kingdom (Northern
Ireland) Ezetimibe 10 mg Tablets