EZETROL 10 mg Tablet

Зміст інструкції

1. EZETROL 10 mg tablets
   1. What is EZETROL and what is it used for
   2. What you need to know before taking EZETROL
   3. How to take EZETROL
   4. Possible side effects
   5. How to store EZETROL
   6. Contents of the pack and other information

EZETROL 10 mg tablets

ezetimibe

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 they have the same symptoms as you, 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 EZETROL is and what it is used for
• 2. What you need to know before you take EZETROL
• 3. How to take EZETROL
• 4. Possible side effects
• 5. How to store EZETROL
• 6. Contents of the pack and other information

1. What is EZETROL and what is it used for

EZETROL is a medicine used to reduce increased cholesterol levels.
EZETROL lowers levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fats
called triglycerides in the blood. EZETROL also increases levels of “good” cholesterol (HDL
cholesterol).
Ezetimibe, the active ingredient of EZETROL, works by decreasing the absorption of cholesterol
within the digestive system.
The decrease in cholesterol levels due to EZETROL is added to that due to statins,
a group of medicines that work by reducing the production of cholesterol by the body
itself.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is composed mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of the
arteries forming plaques. Over time, this buildup in the form of plaque 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 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 present in the blood that can increase the risk of heart
disease.
It is used for patients who cannot control cholesterol levels by reducing cholesterol
with diet alone. You must follow a diet to reduce cholesterol during therapy with
this medicine.

EZETROL is used in addition to your cholesterol-lowering diet in the case you

have:

• an elevated blood cholesterol level (primary hypercholesterolemia  heterozygous familial and non-familial  )
• together with a statin, when your cholesterol level 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 treatment
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

If you have heart disease, EZETROL 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.
EZETROL does not help with weight loss.

2. What you need to know before taking EZETROL

medicinal product prescribed.

Do not take EZETROL if:

• you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (see section 6: Contents of the pack and other information).

Do not take EZETROL 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 EZETROL.

• Tell your doctor about all medical conditions you have, including allergies.
• Your doctor should prescribe a blood test before starting therapy with EZETROL 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 EZETROL together with a statin.

If you have moderate or severe liver problems, the use of EZETROL is not recommended.
Safety and efficacy of EZETROL 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 (from 6 to 17 years of age) unless it has been
prescribed by a specialist because there are 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 EZETROL
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 any medicine(s) with
one of the following active ingredients:

• cyclosporine (often used in patients with organ transplant)
• medicines with an active ingredient that prevents blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol), as it alters the effectiveness of EZETROL
• fibrates (also used to lower cholesterol).

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

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

EZETROL contains lactose
EZETROL tablets contain a sugar called lactose. If your doctor has
diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.

EZETROL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take EZETROL

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

• Before starting to take EZETROL, you must follow a diet to lower cholesterol.
• You must continue to follow this cholesterol-lowering diet while taking EZETROL.

The recommended dose is one 10 mg EZETROL tablet once a day to be taken by
mouth.
You can take EZETROL at any time of the day and independently of meals.
If your doctor has prescribed EZETROL together with a statin, the two medicines can be taken
at the same time. In this case, consult the specific dosage instructions contained in the
If your doctor has prescribed EZETROL together with another medicine to reduce cholesterol
containing the active ingredient colestyramine or any other medicine containing bile acid sequestrants,
you must take EZETROL at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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

If you forget to take EZETROL
Do not take a double dose to make up for the missed tablet, it is sufficient to resume
the usual dose of EZETROL at the usual time the next day.

If you stop taking EZETROL
Consult your doctor or pharmacist because cholesterol levels may increase again.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported:

• 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 if you experience unexplained muscle pain, tenderness or
muscle weakness. 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 which can cause difficulty breathing or swallowing
(requiring immediate medical treatment), have been reported with common use of the medicine.
The following side effects have been reported when used alone:
Common: abdominal pain; diarrhoea; 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 medicine is 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 tiredness or weakness; swelling, especially of the hands and feet.
When used together with fenofibrate, the following common side effect has been reported:
abdominal pain.
In addition, the following side effects have been reported with 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;
reduction in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia);
feeling of pins and needles; depression; unusual tiredness 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 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 EZETROL

• 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 or container after “EXP”. The expiry date refers to the last day of that month.
• Do not store EZETROL at a temperature above 30°C.

Blisters: store in the original container.
Bottles: keep the bottles tightly closed. These measures will help protect the medicine from moisture.
Do not dispose of any medicine in wastewater 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 the medicine containsEZETROL

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of EZETROL and contents of the pack
EZETROL tablets are white/off-white, capsule-shaped with “414” imprinted on one side.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in blister packs with push-through openings or unit dose blisters with peel-off foil;
84 or 90 tablets in blister packs with push-through openings;
50, 100 or 300 tablets in blister packs with push-through openings for unit doses;
100 tablets in bottles.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome

Manufacturer
SP Labo N.V.
Industriepark 30 – Zone A
B-2220 Heist-op-den-Berg
Belgium
This medicinal product is authorised under the name EZETROL in Austria, Belgium, Cyprus,
Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and
United Kingdom.