Ezetimibe Aurobindo
Italy
Table of Contents
Package leaflet: Information for the user
Ezetimibe Aurobindo 10 mg tablets
Ezetimibe
Generic 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 or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Ezetimibe Aurobindo is and what it is used for
- What you need to know before taking Ezetimibe Aurobindo
- How to take Ezetimibe Aurobindo
- Possible side effects
- How to store Ezetimibe Aurobindo
- Contents of the pack and other information
1. What Ezetimibe Aurobindo is and what it is used for
Ezetimibe Aurobindo is a medicine used to lower elevated cholesterol levels.
Ezetimibe Aurobindo reduces total cholesterol, "bad" cholesterol (LDL cholesterol), and fats in the blood known as triglycerides. Ezetimibe Aurobindo also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimibe Aurobindo tablets, works by reducing the cholesterol absorbed in the digestive tract.
The cholesterol-lowering effect of Ezetimibe Aurobindo adds to that provided by statins, a group of medicines that reduce cholesterol production by the body itself.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it deposits in the walls of arteries, forming plaque. Over time, this plaque buildup can lead to narrowing of the arteries, which may slow down or block blood flow to vital organs such as the heart and brain. This blockage can cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it prevents bad cholesterol from depositing 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.
Ezetimibe Aurobindo is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must follow a cholesterol-lowering diet.
Ezetimibe Aurobindo is used in addition to a cholesterol-lowering diet if you have:
- elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]), either alone or in combination with a statin, when your cholesterol level is not adequately controlled by a statin alone, or alone when treatment with statins is not appropriate or not 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 medicines
- an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.
If you have heart disease, Ezetimibe Aurobindo, when used together with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.
Ezetimibe Aurobindo does not help with weight loss.
2. What you need to know before taking Ezetimibe Aurobindo
If Ezetimibe Aurobindo is prescribed together with a statin, please read the package leaflet of that
specific medicine.
Do not take Ezetimibe Aurobindo
- if you are allergic to ezetimibe or to any of the other ingredients of this medicine (listed in section 6).
Do not take Ezetimibe Aurobindo 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 Ezetimibe Aurobindo.
- Tell your doctor about all medical conditions you have, including allergies.
- Your doctor should perform a blood test before starting treatment with Ezetimibe Aurobindo 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 liver function after you start taking Ezetimibe Aurobindo together with a statin.
If you have moderate or severe liver problems, the use of Ezetimibe Aurobindo is not recommended.
The safety and efficacy of Ezetimibe Aurobindo when administered in combination with certain cholesterol-lowering medicines, fibrates, have not been established.
Children and adolescents
Do not administer this medicine to children and adolescents (aged 6 to 17 years) unless prescribed by a specialist, as there is limited data on its safety and efficacy. Do not administer this medicine to children under 6 years of age, as there is no information available for this age group.
Other medicines and Ezetimibe Aurobindo
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:
- ciclosporin (a medicine often used in patients who have had an organ transplant)
- medicines that prevent blood clotting, such as warfarin, fenprocumone, acenocoumarol or fluindione (anticoagulants)
- colestyramine (a medicine used to reduce cholesterol), as it may alter the effectiveness of Ezetimibe Aurobindo
- fibrates (medicines used to reduce cholesterol).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Ezetimibe Aurobindo 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 Aurobindo together with a statin, you must stop both treatments immediately and contact your doctor.
There is no experience with the use of Ezetimibe Aurobindo without a statin during pregnancy. If you are pregnant, consult your doctor for appropriate recommendations before using Ezetimibe Aurobindo.
Do not take Ezetimibe Aurobindo together with a statin while breastfeeding, as it is not known whether both medicines are excreted in human milk.
Ezetimibe Aurobindo, even when taken alone without a statin, should not be used during breastfeeding. Consult your doctor for advice.
Driving and using machines
Ezetimibe Aurobindo is not expected to affect the ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking Ezetimibe Aurobindo.
Ezetimibe Aurobindo contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Ezetimibe Aurobindo
Take this medicine exactly as your doctor has told you. Continue taking your other cholesterol-lowering medicines unless your doctor tells you otherwise. If you are unsure, consult your doctor or pharmacist.
- Before starting to take Ezetimibe Aurobindo, you must follow a cholesterol-lowering diet.
- You must continue this diet while taking Ezetimibe Aurobindo.
The recommended dose is one 10 mg Ezetimibe Aurobindo tablet once daily, taken by mouth.
You may take Ezetimibe Aurobindo at any time of day, with or without food.
If your doctor has prescribed Ezetimibe Aurobindo together with a statin, the two medicines may be taken at the same time. In this case, also refer to the specific dosing instructions provided in the package leaflet of the other prescribed medicine.
If your doctor has prescribed Ezetimibe Aurobindo together with colestyramine or any other bile acid sequestrant (cholesterol-lowering medicines), you must take Ezetimibe Aurobindo at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimibe Aurobindo than you should
Contact your doctor or pharmacist.
If you forget to take Ezetimibe Aurobindo
Do not take a double dose to make up for the missed dose. Take your next dose at the usual time the following day.
If you stop taking Ezetimibe Aurobindo
Consult 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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following terms are used to describe how frequently 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 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
damage, can be serious and potentially life-threatening.
With common use of the medicine, allergic reactions have been reported, including swelling of the face,
lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate
treatment).
When used alone, the following side effects have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling of fatigue.
Uncommon: increases in liver function laboratory 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.
Additionally, when the medicine was used in combination with a statin, the following side effects have
been reported:
Common: increases in liver function laboratory tests (transaminases); headache; muscle pain, tenderness,
or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in
arms and legs; unusual tiredness or weakness; swelling, especially of 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 pain; liver problems; allergic reactions including rash and urticaria; raised red rash, sometimes
with target-like lesions (erythema multiforme); muscle pain, tenderness, or weakness; damage to muscle
tissue; 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 cells, 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 the website
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 Aurobindo
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 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 Aurobindo contains
- The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
- The other components are: monohydrate lactose, hypromellose [type 2910 (3 cp)], sodium croscarmellose, sodium lauryl sulfate, crospovidone (type B), microcrystalline cellulose (type 102), magnesium stearate.
Description of the appearance of Ezetimibe Aurobindo and contents of the pack
Tablets.
White to almost white, uncoated, capsule-shaped tablets with bevelled edges, imprinted with “E Z” on one side and “10” on the other. Size: 8.1 mm x 4.1 mm.
Ezetimibe Aurobindo 10 mg tablets are available in blister packs.
Pack sizes:
Blister packs: 10, 15, 28, 30, 50, 100 and 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Aurobindo Pharma (Italia) S.r.l. - Via San Giuseppe 102 - 21047 Saronno (VA) - Italy
Manufacturer:
APL Swift Services (Malta) Ltd. - HF26, Hal Far Industrial Estate, Hal Far - Birzebbugia, BBG 3000, Malta
Generis Farmacêutica, S.A. - Rua João de Deus, 19, Amadora 2700-487, Portugal
This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Ezetimib Aurobindo 10 mg Tabletten
Italy: Ezetimibe Aurobindo
Portugal: Ezetimiba PharmConsul
Spain: Ezetimiba Aurobindo 10 mg comprimidos EFG