Ezetimibe aurovitas

Package leaflet: Information for the user

Ezetimibe Aurovitas, 10 mg, tablets
Ezetimibum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Ezetimibe Aurovitas is and what it is used for
2. Important information before taking Ezetimibe Aurovitas
3. How to take Ezetimibe Aurovitas
4. Possible side effects
5. How to store Ezetimibe Aurovitas
6. Contents of the pack and other information

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

Ezetimibe Aurovitas is a medicine used to lower elevated cholesterol levels.
Ezetimibe Aurovitas reduces blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides.
In addition, Ezetimibe Aurovitas increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimibe Aurovitas, reduces the amount of cholesterol absorbed by the body.
Ezetimibe Aurovitas complements the action of statins, a group of medicines that reduce cholesterol produced in the body.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the walls of arteries as atherosclerotic plaques. The accumulation of these plaques may eventually lead to narrowing of the arteries, slowing down or blocking blood flow to vital organs such as the heart and brain. Blocked blood flow may result in heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the deposition of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that may contribute to an increased risk of heart disease.
This medicine is used in patients in whom a cholesterol-lowering diet alone is not sufficient to control blood cholesterol levels. While taking this medicine, a cholesterol-lowering diet should be maintained.
Ezetimibe Aurovitas is used in combination with a cholesterol-lowering diet when:

• the patient has elevated blood cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]), either in combination with a statin if adequate cholesterol reduction cannot be achieved with a statin alone, or as monotherapy if statin therapy is contraindicated or not well tolerated.
• the patient has a hereditary condition (homozygous familial hypercholesterolemia) causing increased blood cholesterol. The patient will be treated with a statin and other treatment methods may also be used.
• the patient has a hereditary condition (homozygous sitosterolemia, also known as phytosterolemia) causing increased levels of plant sterols in the blood.

If the patient has heart disease, Ezetimibe Aurovitas, when used in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgical procedures performed to improve blood flow to the heart, and hospitalization due to chest pain.
Ezetimibe Aurovitas does not help with weight loss.

2. Important information before taking Ezetimibe Aurovitas

If the patient is taking Ezetimibe Aurovitas together with a statin, please read the patient leaflet for that specific medicine.

When not to take Ezetimibe Aurovitas:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

When not to take Ezetimibe Aurovitas in combination with a statin:

• if the patient currently has liver problems,
• if the patient is pregnant or breastfeeding.

Warnings and precautions

Before starting to take Ezetimibe Aurovitas, discuss this with a doctor or pharmacist.

• Inform the doctor about all medical conditions, including allergies.
• Before starting to take Ezetimibe Aurovitas in combination with a statin, the doctor should perform blood tests to assess liver function.
• The doctor may also perform blood tests to monitor liver function after starting treatment with Ezetimibe Aurovitas in combination with a statin.

Ezetimibe Aurovitas is not recommended for use in patients with moderate or severe liver impairment.

The safety and efficacy of Ezetimibe Aurovitas used in combination with fibrates, drugs that lower cholesterol levels, have not been established.

Children and adolescents

Due to lack of data on safety and efficacy, this medicine should not be used in children and adolescents (aged 6 to 17 years) unless specifically prescribed by a specialist. This medicine should not be used in children under 6 years of age due to lack of data in this age group.

Ezetimibe Aurovitas and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

In particular, inform the doctor if taking medicines containing any of the following active substances:

• cyclosporine (e.g. used after organ transplantation),
• warfarin, phenprocoumon, acenocoumarol or fluindione, and other medicines that prevent blood clots (anticoagulants),
• cholestyramine (also used to reduce cholesterol levels), as it affects the action of Ezetimibe Aurovitas,
• fibrates (used to reduce cholesterol levels).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Do not take Ezetimibe Aurovitas in combination with a statin if the patient is pregnant, planning to become pregnant, or suspects she may be pregnant. If the patient becomes pregnant while taking Ezetimibe Aurovitas in combination with a statin, she should immediately stop taking both medicines and contact her doctor.

There are no clinical data on the use of Ezetimibe Aurovitas without a statin during pregnancy. If the patient is pregnant, she should consult her doctor for advice.

Do not take Ezetimibe Aurovitas in combination with a statin during breastfeeding, as it is unknown whether these medicines pass into breast milk.

Ezetimibe Aurovitas without a statin should not be used during breastfeeding. The patient should consult her doctor for advice.

Driving and operating machinery

Ezetimibe Aurovitas is not expected to impair the ability to drive or operate machinery. However, it should be noted that dizziness may occur in some patients after taking Ezetimibe Aurovitas.

Ezetimibe Aurovitas contains lactose

If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Ezetimibe Aurovitas

This medicine should always be taken exactly as directed by your doctor. Unless otherwise advised by your doctor,
you should continue taking any cholesterol-lowering medicines you were previously using. If in doubt, consult your doctor or pharmacist.

• Before starting treatment with Ezetimibe Aurovitas, you should follow a cholesterol-lowering diet.
• While taking Ezetimibe Aurovitas, you should continue to follow a cholesterol-reducing diet.

The recommended dose is one 10 mg tablet of Ezetimibe Aurovitas taken orally once daily.
Ezetimibe Aurovitas can be taken at any time of day, with or without food.
If your doctor has prescribed Ezetimibe Aurovitas together with a statin, both medicines may be taken at the same time. In this case, please refer to the dosing instructions provided in the package leaflet for that medicine.
If your doctor has prescribed Ezetimibe Aurovitas together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant resin, Ezetimibe Aurovitas should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant resin.

Taking more Ezetimibe Aurovitas than prescribed
Contact your doctor or pharmacist immediately.

Missing a dose of Ezetimibe Aurovitas
Do not take a double dose to make up for a missed dose. Simply take the next dose at the usual time the following day.

Stopping Ezetimibe Aurovitas
Consult your doctor if you are considering stopping this medicine, as cholesterol levels may rise again.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is classified as follows:

• Very common (may occur in more than 1 in 10 patients);
• Common (may occur in up to 1 in 10 patients);
• Uncommon (may occur in up to 1 in 100 patients);
• Rare (may occur in up to 1 in 1,000 patients);
• Very rare (may occur in up to 1 in 10,000 patients, including single cases).

You should contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. In rare cases, muscle-related problems, including rhabdomyolysis
leading to kidney damage, may be severe and progress to a potentially life-threatening condition.
Allergic reactions have been reported since the medicine was placed on the market, including swelling of the face,
lips, tongue and/or throat, which may cause difficulty in breathing or swallowing (these require
immediate treatment).

When used without concomitant medications, the following adverse reactions have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling tired.
Uncommon: increased parameters in certain liver function tests (aminotransferases) or muscle tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite, pain, chest pain, sudden redness of the face; high blood pressure.

Additionally, when used in combination with a statin, the following adverse reactions have occurred:
Common: increased parameters in certain liver function tests (aminotransferases); headache; muscle pain, tenderness or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unexplained tiredness or weakness; oedema, particularly in hands and feet.

Additionally, the following adverse reactions are possible when used with or without a statin: abdominal pain.

Other adverse reactions reported during general use include: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; difficulty breathing or swallowing with or without swelling of the face, lips, tongue or throat; red, raised rash, sometimes with lesions shaped like a target (erythema multiforme); muscle pain, tenderness or weakness; rhabdomyolysis; gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ezetimibe Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and bottle
after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Ezetimibe Aurovitas contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• Other ingredients are: lactose monohydrate, hypromellose (type 2910), sodium croscarmellose, sodium lauryl sulphate, crospovidone (type B), microcrystalline cellulose (PH 102), magnesium stearate.

What Ezetimibe Aurovitas looks like and contents of the pack
Tablet.
White to off-white, uncoated, biconvex tablets with bevelled edges, embossed with ‘E\Z’ on one side and ‘10’ on the other side. The tablet size is 8.1 mm x 4.1 mm.
Ezetimibe Aurovitas tablets are available in blister packs and HDPE bottles.
Blister packs: 10, 14, 15, 28, 30, 50, 56, 90, 98, 100 and 300 tablets.
HDPE bottles: 28, 98, 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland
Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Arrow Génériques - Lyon
26 avenue Tony Garnier
69007 Lyon
France
Generis Farmacêutica, S.A.
Rua João de Deus, n.º 19, Venda Nova
2700-487 Amadora
Portugal
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Ezetimib AB 10 mg tabletten
Czech Republic: Ezetimib Aurovitas
France: Ezétimibe Arrow 10 mg comprimé
Germany: Ezetimib PUREN 10 mg Tabletten
Netherlands: Ezetimibe Aurobindo 10 mg, tabletten
Poland: Ezetimibe Aurovitas
Portugal: Ezetimiba Aurovitas
Spain: Ezetimiba Aurovitas 10 mg comprimidos EFG