Ezetimibe Doc Generici

Package leaflet: Information for the user

EZETIMIBE DOC Generici 10 mg tablets

Equivalent medicine
Please 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What EZETIMIBE DOC Generici is and what it is used for
EZETIMIBE DOC Generici is a medicine used to reduce elevated cholesterol levels.
EZETIMIBE DOC Generici lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. Additionally, EZETIMIBE DOC Generici increases levels of "good" cholesterol (HDL cholesterol).
EZETIMIBE DOC Generici works by reducing cholesterol absorption in the intestine.
The cholesterol-lowering effect of EZETIMIBE DOC Generici adds to that provided by statins, a group of medicines that reduce cholesterol produced by the body.
Cholesterol is one of several 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 can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage of blood flow may 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 type of fat present in the blood that may increase the risk of heart disease.
It is used for patients who cannot control their cholesterol levels with diet alone. You must follow a cholesterol-lowering diet while taking this medicine.
EZETIMIBE DOC Generici is used in addition to diet if you have:

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

If you have had a heart attack, EZETIMIBE DOC Generici, in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgical procedures to improve blood flow, or hospitalization due to chest pain.
EZETIMIBE DOC Generici does not help with weight loss.

2. What you need to know before taking EZETIMIBE DOC Generici

If you are taking EZETIMIBE DOC Generici with a statin, please read the package leaflet of that
medicine.
Do not take EZETIMIBE DOC Generici:

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

Do not take EZETIMIBE DOC Generici together with a statin:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking EZETIMIBE DOC Generici.

• inform your doctor about all medical conditions you have, including allergies
• your doctor should prescribe a blood test before starting treatment with EZETIMIBE DOC Generici together with a statin. This is to check how your liver is functioning
• your doctor may also ask you to have blood tests to monitor liver function after you start taking EZETIMIBE DOC Generici together with a statin.

The use of EZETIMIBE DOC Generici is not recommended if you have moderate or
severe liver problems.
The safety and efficacy of EZETIMIBE DOC Generici in combination with certain cholesterol-lowering medicines, fibrates, have not been established.
Children and adolescents
Do not give this medicine to children and adolescents aged between 6 and 17 years unless prescribed by a specialist, as data on safety and efficacy are limited. Do not give this medicine to children under 6 years of age, as there is no available information in this age group.
Other medicines and EZETIMIBE DOC Generici
Inform 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 substances:

• cyclosporine (often used in patients who have had an organ transplant)
• medicines containing an active substance that prevents blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• colestyramine (also used to reduce cholesterol), as it affects how EZETIMIBE DOC Generici works
• fibrates (also used to reduce cholesterol).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take EZETIMIBE DOC Generici together with a statin if you are pregnant, trying to become pregnant, or think you could be pregnant. If you become pregnant while taking EZETIMIBE DOC Generici together with a statin, you must stop taking both medicines immediately and inform your doctor.
There is no experience with the use of EZETIMIBE DOC Generici without a statin during pregnancy. If you are pregnant, consult your doctor before using EZETIMIBE DOC Generici.
Do not take EZETIMIBE DOC Generici together with a statin while breastfeeding, as it is not known whether both medicines are excreted in human milk.
EZETIMIBE DOC Generici, without a statin, should not be used while breastfeeding. Consult your doctor.
Driving and using machines
EZETIMIBE DOC Generici is not expected to affect the ability to drive or use machinery. However, you should consider that some people may experience dizziness after taking EZETIMIBE DOC Generici.
EZETIMIBE DOC Generici contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take EZETIMIBE DOC Generici

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop.

• Before taking EZETIMIBE DOC Generici, you must follow a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking EZETIMIBE DOC Generici.

The recommended dose is one 10 mg tablet of EZETIMIBE DOC Generici taken once daily by mouth.
You may take EZETIMIBE DOC Generici at any time of day. You may take it with or without food.
If your doctor has prescribed EZETIMIBE DOC Generici together with a statin, the two medicines may be taken at the same time. In this case, read the dosing instructions in the package leaflet of the other medicine.
If your doctor has prescribed EZETIMIBE DOC Generici together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing bile acid sequestrants, you must take EZETIMIBE DOC Generici at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETIMIBE DOC Generici than you should
Contact your doctor or pharmacist.

If you forget to take EZETIMIBE DOC Generici
Do not take a double dose to make up for the forgotten dose; simply take your next dose at the usual time the following day.

If you stop taking EZETIMIBE DOC Generici
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one may cause side effects, although not everybody gets them.
Stop taking EZETIMIBE DOC Generici and contact your doctor or go immediately to the nearest
emergency room if you experience any of the following symptoms:

• unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems, including muscle tissue damage leading to kidney injury, can be serious and potentially life-threatening
• allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing

When used alone, the following side effects have been reported:
Common (may affect up to 1 in 10 people):

• abdominal pain, diarrhoea, flatulence
• feeling of fatigue.

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

• increases in blood tests indicating liver function (transaminases) and/or muscle function (CK)
• cough
• indigestion, heartburn
• nausea
• joint pain, muscle spasms, neck pain
• pain
• chest pain
• decreased appetite
• hot flushes
• high blood pressure

In addition, when used with a statin, the following side effects have been reported:
Common (may affect up to 1 in 10 people):

• increases in blood tests indicating liver function (transaminases)
• headache
• muscle pain, tenderness or weakness

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

• tingling sensation
• 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 with fenofibrate, the following common side effect has been reported (may affect up to 1 in 10 people):

• abdominal pain

In addition, the following side effects have been reported with general use:

• dizziness
• muscle pain
• liver problems
• allergic reactions including skin rash and hives, raised red rash, sometimes with target-shaped lesions (erythema multiforme)
• muscle pain, tenderness or weakness, muscle injury
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• inflammation of the pancreas, often accompanied by severe abdominal pain
• constipation
• reduction in blood cell count, which may cause bruising/bleeding (thrombocytopenia)
• tingling sensation
• depression
• unusual tiredness or weakness
• shortness of breath

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store EZETIMIBE DOC Generici
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or blister pack after "Exp". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EZETIMIBE DOC Generici contains
The active substance in EZETIMIBE DOC Generici is ezetimibe. Each tablet of
EZETIMIBE DOC Generici contains 10 mg of ezetimibe.
The other components are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
sodium lauryl sulphate, magnesium stearate, hypromellose and crospovidone.

Description of the appearance of EZETIMIBE DOC Generici and package contents
EZETIMIBE DOC Generici tablets are white/whiteish, capsule-shaped, 8 mm x 4 mm in size, with "713" engraved on one side and smooth on the other.
EZETIMIBE DOC Generici is available in press-through or peelable blisters.
Pack sizes:
30 tablets in blister

Marketing Authorization Holder
DOC Generici Srl
Via Turati 40
20121 Milano
Italy

Manufacturer
Balkanpharma, Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark: Ezetimib DOC Generici
Italy: EZETIMIBE DOC Generici