ZETIA 10 mg Coated Tablet

Содержание инструкции

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

ZETIA 10 mg tablets

ezetimibe

Read this leaflet carefully before taking this medicine because 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 may 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 ZETIA is and what it is used for
• 2. What you need to know before you take ZETIA
• 3. How to take ZETIA
• 4. Possible side effects
• 5. How to store ZETIA
• 6. Contents of the pack and other information

1. What is ZETIA and what is it used for

ZETIA is a medicine used to reduce elevated cholesterol levels.
ZETIA lowers total cholesterol levels, "bad" cholesterol (LDL cholesterol) and fats called
triglycerides in the blood. ZETIA also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of ZETIA, works by decreasing the absorption of cholesterol within
the digestive system.
The decrease in cholesterol levels due to ZETIA 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 accumulate in the walls of the arteries
forming plaques. Over time, this accumulation 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
accumulating 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 levels with
diet alone. You must follow a diet to reduce cholesterol during therapy with this
medicine.

ZETIA is used in addition to your cholesterol-lowering diet if you have:

• an elevated blood cholesterol level (primary hypercholesterolemia  familial heterozygous 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 (familial homozygous 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) - which increases levels of plant sterols in the blood. If you have heart disease, ZETIA combined 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.

ZETIA does not help with weight loss.

2. What you need to know before taking ZETIA

prescribed.

Do not take ZETIA 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 ZETIA 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 ZETIA.

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

If you have moderate or severe liver problems, the use of ZETIA is not recommended.
The safety and efficacy of ZETIA administered in combination with certain medicines that reduce cholesterol, 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 ZETIA
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) containing 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 reduce cholesterol), as it alters the effectiveness of ZETIA
• fibrates (also used to reduce cholesterol).

Pregnancy and breastfeeding
Do not take ZETIA together with a statin if you are pregnant, suspect you are pregnant or are planning a pregnancy. If you become pregnant while taking ZETIA together with a statin, you should stop both treatments immediately and contact your doctor.
There is no experience regarding the use of ZETIA without a statin during pregnancy. If you are pregnant, ask your doctor for advice before using ZETIA.
Do not take ZETIA together with a statin if you are breastfeeding, as it is not known whether the two medicines are excreted in human milk. ZETIA, even when 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
ZETIA is not expected to affect your ability to drive or use machines. However, you should consider that some people may experience dizziness after taking ZETIA.

ZETIA contains lactose
ZETIA tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take ZETIA

Take this medicine following exactly the instructions of your doctor. Continue to take the 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 ZETIA, you must follow a diet to lower cholesterol.
• You must continue to follow this cholesterol-lowering diet while taking ZETIA.

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

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

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

If you stop taking ZETIA
Contact your doctor or pharmacist because cholesterol levels may increase again.
If you have any doubts about 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.
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 in case of 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 that can cause difficulty breathing or swallowing (requiring
immediate treatment) have been reported with common use of the medicine.
The following side effects have been reported when 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, when the medicine is used together with a statin, the following side effects have been reported:
Common: increases in the values of some liver function tests (transaminases); headache; muscle pain; tenderness or muscle weakness.
Uncommon: sensation of tingling; 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 side effect has been reported:
Common: abdominal pain.
In addition, with the general use of the medicine, the following side effects have been reported:
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); sensation of tingling; 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 ZETIA

• 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 ZETIA 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 ZETIA contains

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

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano
Italy

Manufacturer
SP Labo N.V., Industriepark 30 – Zone A
B-2220 Heist-op-den-Berg, Belgium
This medicinal product is authorised under the name ZETIA in Italy and ZIENT in Germany.