Ezetimibe Aurovitas

Package Leaflet: Information for the User

Ezetimibe Aurovitas, 10 mg, Tablets

Ezetimibe

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Ezetimibe Aurovitas is a medicine used to lower high cholesterol levels.
Ezetimibe Aurovitas lowers the level of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood.
Additionally, Ezetimibe Aurovitas increases the level 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 lower the level of cholesterol produced by the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the arteries in the form of plaques. The accumulation of these plaques can eventually lead to a narrowing of the arteries, which can cause a reduction in blood flow or blockage of blood flow to vital organs such as the heart and brain. Blockage of 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 the development of heart disease.
Triglycerides are another type of fat found in the blood that can contribute to an increased risk of developing heart disease.
The medicine is used in patients for whom diet alone is not enough to control their cholesterol levels. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Ezetimibe Aurovitas is used in combination with a cholesterol-lowering diet if:

• the patient has high cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) in combination with a statin, if it is not possible to achieve adequate cholesterol reduction with statin alone, or as monotherapy if statin is not indicated or is poorly tolerated.
• the patient has a hereditary disease (homozygous familial hypercholesterolemia) that causes high cholesterol levels in the blood. The patient will be treated with a statin and may be treated with other therapies. the patient has a hereditary disease (homozygous sitosterolemia, also known as phytosterolemia) that causes increased levels of plant sterols in the blood.

If the patient has heart disease, Ezetimibe Aurovitas, in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgical procedures to increase 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 with a statin, they should read the patient information leaflet for that particular medicine.

When not to take Ezetimibe Aurovitas:

• if the patient is allergic to the active substance or 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, the patient should discuss it with their doctor or pharmacist.

• The patient should inform their doctor about all their illnesses, 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 assess liver function after starting to take 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 in combination with fibrates, medicines that lower cholesterol levels, have not been established.

Children and adolescents

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

Ezetimibe Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should tell their doctor if they are taking medicines containing any of the following active substances:

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Ezetimibe Aurovitas should not be taken in combination with a statin if the patient is pregnant, plans to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Ezetimibe Aurovitas in combination with a statin, they should stop taking both medicines immediately and contact their doctor.
There are no clinical data on the use of Ezetimibe Aurovitas without a statin during pregnancy. If the patient is pregnant, they should ask their doctor for advice.
Ezetimibe Aurovitas should not be taken in combination with a statin during breastfeeding, as it is not known whether the medicines pass into breast milk.
Ezetimibe Aurovitas without a statin should not be used during breastfeeding. The patient should ask their doctor for advice.

Driving and using machines

The patient should not expect Ezetimibe Aurovitas to affect their ability to drive or use machines. However, they should take into account that after taking Ezetimibe Aurovitas, some people may experience dizziness.

Ezetimibe Aurovitas contains lactose

If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Ezetimibe Aurovitas

The patient should always take this medicine exactly as their doctor has told them. If the doctor has not prescribed otherwise, the patient should continue to take any other cholesterol-lowering medicines they have been taking. If they are in doubt, they should ask their doctor or pharmacist.

• Before starting to take Ezetimibe Aurovitas, the patient should follow a cholesterol-lowering diet.
• While taking Ezetimibe Aurovitas, the patient should follow a cholesterol-lowering diet.

The recommended dose is one 10 mg Ezetimibe Aurovitas tablet, taken orally once a day.
Ezetimibe Aurovitas can be taken at any time of the day, with or without food.
If the doctor has prescribed Ezetimibe Aurovitas and a statin, both medicines can be taken at the same time. In this case, the patient should read the information on dosing in the leaflet for the particular medicine.
If the doctor has prescribed Ezetimibe Aurovitas and another cholesterol-lowering medicine that contains cholestyramine or any other bile acid sequestrant, the patient should take Ezetimibe Aurovitas at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking more than the recommended dose of Ezetimibe Aurovitas

The patient should contact their doctor or pharmacist.

Missing a dose of Ezetimibe Aurovitas

The patient should not take a double dose to make up for a forgotten dose, they should just take their normal dose at the usual time the next day.

Stopping treatment with Ezetimibe Aurovitas

The patient should ask their doctor if they are considering stopping treatment, as their cholesterol levels may rise again.
If the patient has any further questions on the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezetimibe Aurovitas can cause side effects, although not everybody gets them.
The frequency of side effects is classified as follows:

• 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).

The patient should contact their doctor immediately if they experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems, including muscle breakdown, can be serious and life-threatening.

This can be a life-threatening condition.
After marketing, allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing (requiring immediate treatment), have been reported.
When used without other medicines, the following side effects have been reported:
Common:
abdominal pain; diarrhea; bloating; feeling tired.
Uncommon: increased levels of some liver function tests (aminotransferases) or muscle (CK); cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; flushing.
Additionally, when used in combination with a statin, the following side effects have been reported:
Common:
increased levels of some liver function tests (aminotransferases); headache; muscle pain, tenderness, or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in the arms and legs; unexplained tiredness or weakness; swelling, especially of the hands and feet.
Additionally, when used in combination with a statin or without, the following side effects are possible: abdominal pain.
Additionally, the following side effects have been reported during general use: dizziness; muscle pain, liver problems; allergic reactions, including rash and hives; difficulty breathing or swallowing with or without swelling of the face, lips, tongue, or throat, red, raised rash, sometimes with changes in shape (erythema multiforme); pain, tenderness, or weakness of the muscles; muscle breakdown; gallstones or inflammation of the gallbladder (may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased number of blood cells, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ezetimibe Aurovitas

The medicine should be stored out of the sight and reach of children.
The patient should not use this medicine after the expiry date which is stated on the label, carton, and bottle after EXP. The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This 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.
• The other ingredients are: lactose monohydrate, hypromellose (type 2910), croscarmellose sodium, sodium lauryl sulfate, 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 beveled edges, with the inscription 'E Z' on one side of the tablet and '10' on the other side. The size of the tablet is 8.1 mm x 4.1 mm.
Ezetimibe Aurovitas, tablets are available in blisters and HDPE bottles.
Blisters: 10, 14, 15, 28, 30, 50, 56, 90, 98, 100, and 300 tablets.
HDPE bottle: 28, 98, 100, and 500 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

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 authorized in the Member States of the European Economic Area under the following names:

Belgium:
Ezetimib AB 10 mg tablets
Czech Republic:
Ezetimib Aurovitas
France:
Ezétimibe Arrow 10 mg tablet
Germany:
Ezetimib PUREN 10 mg tablets
Netherlands:
Ezetimibe Aurobindo 10 mg, tablets
Poland:
Ezetimibe Aurovitas
Portugal:
Ezetimiba Aurovitas
Spain:
Ezetimiba Aurovitas 10 mg tablets EFG

Date of last revision of the leaflet: 03/2023