Patient Information Leaflet

Ezetimibe TecniGen 10 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you start 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, pharmacist or nurse.
This medicine has been prescribed for you personally. Never give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
1. What Ezetimibe TecniGen is and what it is used for
2. What you need to know before taking Ezetimibe TecniGen
3. How to take Ezetimibe TecniGen
4. Possible side effects
5. How to store Ezetimibe TecniGen
6. Contents of the pack and other information

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

Ezetimibe TecniGen is a medicine used to lower elevated cholesterol levels.
Ezetimibe TecniGen reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances in the blood called triglycerides. In addition, Ezetimibe TecniGen increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimibe TecniGen, works by reducing the amount of cholesterol absorbed from your intestines.
Ezetimibe TecniGen adds to the cholesterol-lowering effect of statins, a group of medicines that reduce cholesterol produced by the body itself.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol is mainly composed of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. The buildup of these plaques may eventually lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Blocked blood flow can cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another form of body fat that may increase the risk of heart disease.
This medicine is used for patients who cannot control their cholesterol levels through diet alone. You must continue a cholesterol-lowering diet while taking this medicine.
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Ezetimibe TecniGen is used in addition to a cholesterol-lowering diet if you have:

Elevated cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial])
In combination with a statin when cholesterol levels are not adequately controlled by a statin alone
Alone, when treatment with statins is not appropriate or not well 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 given additional treatments
An inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

If you have heart disease, Ezetimibe TecniGen, in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization for chest pain.
Ezetimibe TecniGen does not help with weight loss.

2. What you need to know before taking Ezetimibe TecniGen

If you are taking Ezetimibe TecniGen together with a statin, please read the package leaflet of that specific medicine.
Do not take Ezetimibe TecniGen
if you are allergic to ezetimibe or to any of the other ingredients of this medicine (listed in section 6).
Do not take Ezetimibe TecniGen together with a statin if:

you currently have liver problems
you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Ezetimibe TecniGen

inform your doctor about your medical condition, including any allergies.
your doctor will prescribe a blood test before starting treatment with Ezetimibe TecniGen and a statin. This is to check how well your liver is functioning.
Your doctor may ask you to have blood tests to monitor liver function after starting treatment with Ezetimibe TecniGen and a statin.

Ezetimibe TecniGen is not recommended if you have moderate or severe liver problems.
The safety and efficacy of combining Ezetimibe TecniGen with fibrates, medicines used to lower cholesterol, have not been established.
Children and adolescents
Do not give this medicine to children and adolescents (from 6 to 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, as information is not available for this age group.
Other medicines and Ezetimibe TecniGen
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Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

Cyclosporine (often used in patients with transplanted organs)
Medicines with active substances that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
Colestiramine (also used to lower cholesterol levels), due to its effect on the action of Ezetimibe TecniGen
Fibrates (used to lower cholesterol levels) Pregnancy and breastfeeding Do not take Ezetimibe TecniGen with a statin if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking Ezetimibe TecniGen with a statin, stop taking both medicines and consult your doctor. There is no experience regarding the use of Ezetimibe TecniGen without a statin during pregnancy. Ask your doctor for advice before using Ezetimibe TecniGen if you are pregnant.

Do not take Ezetimibe TecniGen with a statin while breastfeeding, as it is not known whether these medicines pass into breast milk.
You must not use Ezetimibe TecniGen without a statin if you are breastfeeding. Consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ezetimibe TecniGen is not expected to affect your ability to drive or use machines. However, you should be aware that some people may experience dizziness after using Ezetimibe TecniGen.
Ezetimibe TecniGen contains lactose.
Ezetimibe TecniGen tablets contain a sugar called lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Ezetimibe TecniGen

Take this medicine exactly as your doctor has told you. Continue taking your other cholesterol-lowering medicine unless your doctor tells you to stop. If you are unsure, consult your doctor or pharmacist.

Before starting treatment with Ezetimibe TecniGen, you must follow a cholesterol-lowering diet.
You must continue this diet while taking Ezetimibe TecniGen.

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

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

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

If you stop taking Ezetimibe TecniGen
Contact your doctor or pharmacist, as your cholesterol levels may rise again.

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

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 are 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 reports)

Contact your doctor immediately if you experience unexplained muscle pain,
tenderness or weakness. This is because, in rare cases, muscle problems, including muscle
damage leading to kidney damage, can be serious and potentially life-threatening.
Allergic reactions have been reported during normal use of the medicine, including swelling
of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing
(these require immediate treatment).
When this medicine is used alone, the following side effects have been reported:
Common: abdominal pain, diarrhoea, flatulence, feeling of fatigue.
Uncommon: increased values in certain liver function tests (transaminases) or muscle tests (CK),
cough, indigestion, heartburn, nausea, joint pain, muscle spasms, neck pain, loss of appetite,
pain, chest pain, hot flushes, high blood pressure.
Additionally, when the medicine is used with a statin, the following side effects have been reported:
Common: increased values in certain liver function tests (transaminases), headache, muscle pain,
tenderness, weakness.
Uncommon: tingling sensation, dry mouth, itching, rash, blisters, back pain, muscle weakness,
pain in arms and legs, unusual tiredness or weakness, swelling, especially of hands and feet.
When used with fenofibrate, the following common side effect has been reported:

Abdominal pain

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In addition, the following side effects have been reported with normal use: dizziness; muscle
pains; liver problems; allergic reactions including rash and blisters, red rash sometimes with
target-shaped lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle
damage; 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 counts 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,
pharmacist or nurse. You can also report side effects directly via 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 TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ezetimibe TecniGen contains

The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
The other components are: monohydrate lactose, hypromellose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, sodium stearyl fumarate.

Description of the appearance of Ezetimibe TecniGen and contents of the pack
Ezetimibe TecniGen 10 mg tablets are white, oblong tablets.
Ezetimibe TecniGen 10 mg tablets are supplied in blisters of 28 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra, Portugal

This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
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Portugal: Ezetimiba Tecnigen
Italy: Ezetimibe TecniGen
Spain: Ezetimibe TecniGen 10 mg comprimidos EFG

This summary of product characteristics was last approved on
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