Ezetimibe Pensà

Package leaflet: Information for the patient

EZETIMIBE PENSA 10 mg tablets

Generic 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 others, even if their symptoms are the same as yours, as 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 PENSA is and what it is used for
2. What you need to know before taking EZETIMIBE PENSA
3. How to take EZETIMIBE PENSA
4. Possible side effects
5. How to store EZETIMIBE PENSA
6. Contents of the pack and other information

1. What EZETIMIBE PENSA is and what it is used for

EZETIMIBE PENSA is a medicine used to reduce elevated cholesterol levels.
EZETIMIBE PENSA lowers total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. EZETIMIBE PENSA also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in EZETIMIBE PENSA, works by reducing the absorption of cholesterol from the intestine.
The cholesterol-lowering effect of EZETIMIBE PENSA adds to that provided by statins, a group of medicines that work by reducing cholesterol production within the body itself.
Cholesterol is one of several types of fat 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. 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 in the blood that may increase the risk of heart disease.
It is used for patients who cannot control their cholesterol levels by reducing cholesterol through diet alone. You must follow a cholesterol-lowering diet while taking this medicine.
EZETIMIBE PENSA is used in addition to your 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 your cholesterol is not adequately controlled with a statin alone
as monotherapy, when treatment with statins is not appropriate or not tolerated
a hereditary disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin, and other treatments may be prescribed as well.
a hereditary disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.
If you have heart disease, EZETIMIBE PENSA, when used in combination with statins (medicines used to lower cholesterol), will reduce the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.
EZETIMIBE PENSA does not help with weight loss.

2. What you need to know before taking EZETIMIBE PENSA

If you are prescribed EZETIMIBE PENSA together with a statin, please read the
package leaflet of the specific medicine prescribed.
Do not take EZETIMIBE PENSA if:
you are allergic (hypersensitive) to ezetimibe or to any of the other ingredients
of this medicine (see section 6 “Contents of the pack and other
information”).
Do not take EZETIMIBE PENSA together with a statin if:
you currently have liver problems
you are pregnant or breastfeeding.
Warnings and precautions
Tell your doctor or pharmacist before taking EZETIMIBE PENSA

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

If you have moderate or severe liver problems, the use of EZETIMIBE PENSA is not
recommended.
The safety and efficacy of EZETIMIBE PENSA when administered in combination with certain cholesterol-lowering medicines, 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 specifically 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 information available for this age group.
Other medicines and EZETIMIBE PENSA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking any of the following:
cyclosporine (often used in patients who have had an organ transplant)
medicines containing active substances that prevent blood clotting, such as warfarin, fenprocoumone, acenocoumarol, or fluindione (anticoagulants)
cholestyramine (also used to reduce cholesterol), as it may interfere with the effectiveness of EZETIMIBE PENSA
fibrates (also used to reduce cholesterol).
Pregnancy and breastfeeding
Do not take EZETIMIBE PENSA together with a statin if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking EZETIMIBE PENSA together with a statin, you must stop both treatments immediately and contact your doctor.
There is no experience with the use of EZETIMIBE PENSA without a statin during pregnancy.
If you are pregnant, consult your doctor for appropriate advice before using EZETIMIBE PENSA.
Do not take EZETIMIBE PENSA together with a statin while breastfeeding, as it is not known whether these two medicines are excreted in human milk.
EZETIMIBE PENSA, even when taken alone without a statin, should not be used during breastfeeding. Consult your doctor for appropriate advice.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No effects of EZETIMIBE PENSA on the ability to drive or use machines are expected. However, some people may experience dizziness after taking EZETIMIBE PENSA. If this occurs, you should not drive or operate machinery.
EZETIMIBE PENSA contains lactose
EZETIMIBE PENSA tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take EZETIMIBE PENSA

Take this medicine exactly as your doctor has told you.
Continue taking your other cholesterol-lowering medicines unless your doctor
tells you otherwise. If in doubt, consult your doctor or pharmacist.

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

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

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

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

If you stop taking EZETIMIBE PENSA
Inform your doctor or pharmacist first, as your cholesterol levels may rise again.
If you have any doubts about how to use 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.
Contact your doctor immediately if you experience unexplained muscle pain,
tenderness or weakness. This is because, in rare cases, muscle problems, including damage to muscle tissue leading to kidney injury, can be serious and potentially life-threatening.
Allergic reactions have been reported with the usual use of this medicine, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (this requires immediate treatment).

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

• abdominal pain; diarrhoea; flatulence; feeling of tiredness.

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

• increases in laboratory test values indicating liver function (transaminases) or muscle function (creatine kinase); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flushes; high blood pressure.

Additionally, when this medicine has been used in combination with a statin, the following side effects have been reported:
Common (may affect up to 1 in 10 people):

• increases in laboratory test values indicating liver function (transaminases); headache; muscle pain, tenderness or weakness.

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

• sensation of tingling; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially in the hands and feet.

When used in combination with fenofibrate, the following common side effect has been reported:

• abdominal pain.

Furthermore, with general use of the medicine, the following side effects have been reported: dizziness; muscle aches; liver problems; allergic reactions including rash and urticaria; raised red rash, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle tissue 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; reduced number of blood cells, which may cause bruising/bleeding (thrombocytopenia); sensation of tingling; 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 the following website: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EZETIMIBE PENSA

• 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 that month.
• This medicine does not require any special storage conditions.

Do not dispose of medicines 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 PENSA contains
The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
The other components are: monohydrate lactose, microcrystalline cellulose,
sodium croscarmellose, povidone, sodium lauryl sulfate, sodium stearyl fumarate.

Description of the appearance of EZETIMIBE PENSA and package contents
EZETIMIBE PENSA tablets are white, oval-shaped, biconvex, without a breakline, and marked with the code "EZ1".
The tablets are available in Al/Al blisters, pack size: 30 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturers
Laboratorios Cinfa, S.A.
Olaz-Chipi, 10
Polígono Industrial Areta, 31620 Huarte – Pamplona, Spain
Laboratorios Cinfa, S.A.
Avda. Roncesvalles s/n, 31699 Olloki (Navarra)
Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Portugal – Ezetimiba Lumec 10 mg comprimidos
Italy – Ezetimibe Pensa

This summary of product characteristics was last approved on