EZETIMIBE 10 mg Coated Tablet

Содержание инструкции

1. Ezetimibe TecniGen 10 mg tablets
   1. What is Ezetimibe TecniGen and what is it 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

Ezetimibe TecniGen 10 mg tablets

Generic medicine

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, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not ever give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, ask 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 you take 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 is Ezetimibe TecniGen and what is it used for

Ezetimibe TecniGen is a medicine used to lower high cholesterol levels.
Ezetimibe TecniGen lowers total cholesterol levels, “bad” cholesterol (LDL cholesterol) and fatty substances in the blood, called triglycerides. Furthermore, Ezetimibe TecniGen
increases levels of “good” cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of Ezetimibe TecniGen, works by reducing the levels of cholesterol
absorbed in the intestine.
Ezetimibe TecniGen adds to the cholesterol-lowering effect of statins, a
group of medicines that reduce the 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 the arteries forming plaques. The formation of these plaques can
eventually 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. Blocking the flow
of blood can cause a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps prevent the accumulation
of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another form of fat in the body that can increase the risk of
heart disease.
This medicine is used for patients who cannot control their cholesterol levels through
diet alone. You must maintain 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:

• Increased cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial])
• Together with a statin when cholesterol levels are not well controlled by the statin alone
• Alone, when treatment with statins is not appropriate or 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 prescribed other 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 medicines that
lower cholesterol called statins, reduces the risk of heart attack, myocardial infarction, stroke,
surgery to increase 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

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

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

If you have moderate or severe liver problems, Ezetimibe TecniGen is not recommended.
The safety and effectiveness of the combined use of 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) unless it has been
prescribed by the specialist, as there is limited data on safety and effectiveness.
Do not give this medicine to children under 6 years of age as information is not available
in this age group.

Other medicines and Ezetimibe TecniGen
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Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription. In particular,
tell your doctor if you are taking medicines containing one of the following active ingredients:

• Cyclosporine (often used in patients with organ transplants)
• Medicines with active ingredients that prevent blood clot formation, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• Cholestyramine (also used to lower cholesterol levels), due to its effect on the action of Ezetimibe TecniGen
• Fibrates (used to lower cholesterol levels) Pregnancy and breastfeedingDo not take Ezetimibe TecniGen with a statin if you are pregnant, if you suspect you are pregnant or are planning to become pregnant. If you become pregnant while taking Ezetimibe TecniGen with a statin, stop taking both medicines and contact a 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 should not use Ezetimibe TecniGen without a statin while breastfeeding. Ask your
doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Ezetimibe TecniGen is not expected to interfere with your ability to drive vehicles and
use machines. However, you should consider the fact that some people
may experience dizziness after using Ezetimibe TecniGen.

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

3. How to take Ezetimibe TecniGen

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

• Before starting treatment with Ezetimibe TecniGen, you must follow a diet to lower cholesterol levels
• You must continue to follow this diet while you are taking Ezetimibe TecniGen.

The recommended dose is one Ezetimibe TecniGen 10 mg tablet per day, to be taken
by mouth.
Take Ezetimibe TecniGen at any time of day. You can take this medicine
independently of meals.
If your doctor has prescribed taking Ezetimibe TecniGen together with a statin, the
medicines can be taken simultaneously. In this case, read the instructions
If your doctor has prescribed Ezetimibe TecniGen together with another medicine for
lowering cholesterol containing the active ingredient colestyramine, or any other
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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 a missed dose, but take the usual
dose of Ezetimibe TecniGen the next day at the usual time.

If you stop taking Ezetimibe TecniGen
Contact your doctor or pharmacist as cholesterol levels may increase again.
If you have any further questions on the use of this medicine, ask 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)

Seek immediate medical attention if you experience unexplained muscle pain,
tenderness or weakness. This is because, in rare cases, muscle problems, including
muscle 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 (require immediate treatment) have been reported with normal
use of the medicine.
When this medicine is used alone, the following side effects have been reported:
Common: abdominal pain, diarrhoea, flatulence, feeling tired.
Uncommon: increased values of some liver function tests (transaminases) or of the muscles (CK),
cough, indigestion, heartburn, nausea, joint pain, muscle spasms, neck pain, loss of appetite,
pain, chest pain, hot flushes, high blood pressure.
In addition, when the medicine is used with a statin, the following side effects have been reported:
Common: increased values of some liver function tests (transaminases), headache, muscle pain,
tenderness, weakness.
Uncommon: feeling of pins and needles, dry mouth, itching, rash, blisters, back pain, muscle
weakness, pain in the arms and legs, unusual tiredness or weakness, swelling, especially of hands
and feet.
When used with a 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-like lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle 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
blood cell count 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, talk to your doctor or pharmacist or nurse. 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 TecniGen

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 packaging after
“Exp”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
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 Ezetimibe TecniGen contains

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, 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 and oblong tablets.
Ezetimibe TecniGen 10 mg tablets are supplied in blisters of 28 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra, Portugal

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