EZETIMIBE 10 mg Tablet

Зміст інструкції

1. Ezetimibe Aurobindo 10 mg tablets
   1. What is Ezetimibe Aurobindo and what it is used for
2. Ezetimibe Aurobindo is used in addition to a cholesterol-lowering diet when you
   1. What you need to know before taking Ezetimibe Aurobindo
   2. How to take Ezetimibe Aurobindo
   3. Possible side effects
   4. How to store Ezetimibe Aurobindo
   5. Contents of the pack and other information

Ezetimibe Aurobindo 10 mg tablets

Ezetimibe

Generic medicine

Read this leaflet carefully before you start 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ezetimibe Aurobindo and what it is used for

Ezetimibe Aurobindo is a medicine used to decrease high cholesterol levels.
Ezetimibe Aurobindo reduces total cholesterol levels, “bad” cholesterol (LDL cholesterol) and
fats in the blood called triglycerides. Ezetimibe Aurobindo also increases levels of “good” cholesterol
(HDL cholesterol).
Ezetimibe, the active ingredient of Ezetimibe Aurobindo tablets, works by reducing the cholesterol absorbed
in the digestive tract.
The decrease in cholesterol levels due to Ezetimibe Aurobindo is added to that due to
statins, a group of medicines that reduce the production of cholesterol by the body itself.
Cholesterol is one of the many fatty substances found in the bloodstream. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it deposits in the walls of the arteries
forming plaque. Over time, the deposition of this plaque can lead to a narrowing of the
arteries, which can slow down or block the flow of blood to vital organs such as the heart and brain.
This blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it prevents bad cholesterol from
depositing 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.
It is used in patients who are unable to control cholesterol levels with diet alone. During
treatment with this medicine, a cholesterol-lowering diet must be followed.

Ezetimibe Aurobindo is used in addition to a cholesterol-lowering diet when you

have:

• an elevated blood cholesterol level (primary hypercholesterolemia [heterozygous familial and non-familial]) or together with a statin, when your cholesterol level is not adequately controlled with a statin alone or alone, when treatment with statins is not appropriate or is not tolerated
• a hereditary disease (homozygous familial hypercholesterolemia) that increases blood cholesterol levels. You will also be prescribed a statin and you may be prescribed other medicines
• a hereditary disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Aurobindo in combination with medicines that 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 Aurobindo does not help you lose weight.

2. What you need to know before taking Ezetimibe Aurobindo

specific medicine.

Do not take Ezetimibe Aurobindo

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

Do not take Ezetimibe Aurobindo 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 Aurobindo.

• Tell your doctor about all medical conditions you have, including allergies.
• Your doctor may need to prescribe a blood test before starting therapy with Ezetimibe Aurobindo 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 Aurobindo together with a statin.

If you have moderate or severe liver problems, the use of Ezetimibe Aurobindo is not recommended.
Safety and efficacy of Ezetimibe Aurobindo administered in combination
with certain medicines that lower cholesterol, the fibrates, have not been established.

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

Other medicines and Ezetimibe Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. In particular, tell your doctor if you are taking medicines containing any of the
following active ingredients:

• cyclosporine (a medicine often used in patients with organ transplant)
• 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 Aurobindo
• fibrates (medicines for lowering cholesterol).

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

Driving and using machines
Ezetimibe Aurobindo is not expected to affect your ability to drive or use machines. However,
you should be aware that some people may experience dizziness after
taking Ezetimibe Aurobindo.

Ezetimibe Aurobindo contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Ezetimibe Aurobindo

Take this medicine following exactly the instructions of your doctor. Continue to take
other medicines to reduce cholesterol, unless your doctor tells you to stop using them. If
you have any doubts, consult your doctor or pharmacist.

• Before starting to take Ezetimibe Aurobindo, you must follow a diet to lower cholesterol.
• You must continue to follow this diet while taking Ezetimibe Aurobindo.

The recommended dose is one 10 mg tablet of Ezetimibe Aurobindo once a day to be
taken orally.
You can take Ezetimibe Aurobindo at any time of the day with or without food.
If your doctor has prescribed Ezetimibe Aurobindo together with a statin, the two medicines can be
taken at the same time. In this case, also consult the specific dosage instructions
If your doctor has prescribed Ezetimibe Aurobindo together with cholestyramine or any other
bile acid sequestrant (medicines to reduce cholesterol), you must take Ezetimibe Aurobindo at least 2
hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Aurobindo than you should
Contact your doctor or pharmacist.

If you forget to take Ezetimibe Aurobindo
Do not take a double dose to make up for a missed dose, take your normal dose of
Ezetimibe Aurobindo at the usual time the next day.

If you stop taking Ezetimibe Aurobindo
Contact your doctor or pharmacist as cholesterol 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 everyone gets them.
The following terms are used to describe the frequency of reporting of side effects:

• 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)

Contact your doctor immediately in case of muscle pain, tenderness or weakness
of the muscles from unexplained causes. This is because, in rare cases, muscle problems,
including muscle tissue injury resulting in 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 (which requires immediate treatment), have been reported with common use of the
drug.
The following side effects have been reported when it was used alone:
Common: abdominal pain; diarrhea; flatulence; feeling tired.
Uncommon: increases in the values of some liver tests (transaminases) or muscle function (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flushes; high blood pressure.
In addition, the following side effects have been reported when the drug has been used together with a statin:
Common: increases in the values of some liver function tests (transaminases); headache; muscle pain, tenderness or weakness.
Uncommon: feeling of pins and needles; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in arms and legs; unusual fatigue or weakness; swelling, especially of the hands and feet.
When used together with fenofibrate, the following side effect has been reported as common: abdominal pain.
In addition, the following side effects have been reported with the general use of the medicine: dizziness;
muscle pain; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle tissue injury; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); inflammation of the pancreas often accompanied by severe abdominal pain; constipation; reduced number of blood cells, which can cause bruising/bleeding (thrombocytopenia); feeling of pins and needles; depression; unusual fatigue or weakness; shortness of breath.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ezetimibe Aurobindo

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 pack after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 Aurobindo contains

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, hypromellose [type 2910 (3cp)], sodium croscarmellose, sodium lauryl sulfate, crospovidone (type B), microcrystalline cellulose (type 102), magnesium stearate.

Description of the appearance of Ezetimibe Aurobindo and contents of the pack
Tablets.
Tablets from white to almost white, uncoated, capsule-shaped, with bevelled edges, with
“E Z” imprinted on one side and “10” on the other side. Size 8.1 mm x 4.1 mm.
Ezetimibe Aurobindo 10 mg tablets is available in blister packs.
Packs:
Blister packs: 10, 15, 28, 30, 50, 100 and 300 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurobindo Pharma (Italia) S.r.l. - Via San Giuseppe 102 - 21047 Saronno (VA) - Italy

Manufacturer:
APL Swift Services (Malta) Ltd. - HF26, Hal Far Industrial EstateHal Far - Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A. - Rua João de Deus, 19 Amadora 2700-487 Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Ezetimib Aurobindo10 mg Tabletten
Italy: Ezetimibe Aurobindo
Portugal: Ezetimiba PharmConsul
Spain: Ezetimiba Aurobindo 10 mg comprimidos EFG