Suvezen 20 mg/10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rosuvastatin; Ezetimibe

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

C10BA06

INN (International Name):

Rosuvastatin; Ezetimibe

Dosage:

20/10 mg/mg

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

rosuvastatin and ezetimibe

Authorization status:

Marketed

Authorization date:

2019-06-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUVEZEN 10 MG/10 MG FILM-COATED TABLETS
SUVEZEN 20 MG/10 MG FILM-COATED TABLETS
SUVEZEN 40 MG/10 MG FILM-COATED TABLETS
rosuvastatin/ezetimibe
SANOFI
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 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 signs of
illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Suvezen is and what it is used for
2.
What you need to know before you take Suvezen
3.
How to take Suvezen
4.
Possible side effects
5.
How to store Suvezen
6.
Contents of the pack and other information
1. WHAT SUVEZEN IS AND WHAT IT IS USED FOR
Suvezen contains two different active substances in one tablet. One of
the active substances is rosuvastatin, belonging to
the group of so called statins, the other active substance is
ezetimibe. Suvezen is a medicine used to lower levels of total
cholesterol, “bad“ cholesterol (LDL cholesterol), and fatty
substances called triglycerides in the blood. In addition, Suvezen
raises levels of “good” cholesterol (HDL cholesterol).
Suvezen works to reduce your cholesterol in two ways. It reduces the
cholesterol absorbed in your digestive tract, as well
as the cholesterol your body makes by itself.
Cholesterol is one of several fatty substances found in the
bloodstream. Your total cholesterol is made up mainly of LDL
and HDL cholesterol.
It is used for patients who cannot control their cholesterol levels by
diet alone. You should
always stay on a cholesterol-lowering diet while taking this medicine.
Suvezen is used in addition to your cholesterol lowering diet if you
have a raised cholesterol level in your b

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2023
CRN00DV9R
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suvezen 20 mg/10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Suvezen 20 mg/10 mg: Each film-coated tablet contains 20 mg of
rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe.
Excipients with known effect:
Suvezen 20 mg/10 mg: Each film-coated tablet contains 268.9 mg of
lactose (as lactose monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Suvezen 20 mg/10 mg: yellow to light yellow, round, biconvex,
film-coated tablets with a diameter about 9.9 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia/Homozygous Familial
Hypercholesterolaemia (HoFH)
Suvezen is indicated as adjunct to diet for treatment of primary
hypercholesterolaemia (heterozygous familial and non-familial)
or homozygous familial hypercholesterolaemia in adult patients

who are not appropriately controlled with statin alone,

who are adequately controlled with rosuvastatin and ezetimibe given
concurrently at the same dose level as in the
fixed combination, but as separate products
Prevention of Cardiovascular Events
Suvezen is indicated as substitution therapy in adult patients who are
adequately controlled with rosuvastatin and ezetimibe
given concurrently, at the same dose level as in the fixed dose
combination, but as separate products to reduce the risk of
cardiovascular events in patients with coronary heart disease (CHD)
and a history of acute coronary syndrome (ACS).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during treatment with Suvezen.
Suvezen is not suitable for initial therapy.
When Suvezen is indicated for patients not controlled by statin alone,
the dose of Suvezen should be individualized according
to the target lipid levels and the patient's response.
When Suvezen