Rosuvastatin/Ezetimibe KRKA 10 mg/10 mg Film-Coated Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Rosuvastatin calcium; Ezetimibe

Dostupné s:

KRKA, d.d., Novo mesto

ATC kód:

C10BA06

INN (Mezinárodní Name):

Rosuvastatin calcium; Ezetimibe

Léková forma:

Film-coated tablet

Terapeutické oblasti:

rosuvastatin and ezetimibe

Stav Autorizace:

Marketed

Datum autorizace:

2023-01-06

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN/EZETIMIBE KRKA 10 MG/10 MG FILM-COATED TABLETS
ROSUVASTATIN/EZETIMIBE KRKA 20 MG/10 MG FILM-COATED TABLETS
rosuvastatin/ezetimibe
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 Rosuvastatin/Ezetimibe KRKA is and what it is used for
2.
What you need to know before you take Rosuvastatin/Ezetimibe KRKA
3.
How to take Rosuvastatin/Ezetimibe KRKA
4.
Possible side effects
5.
How to store Rosuvastatin/Ezetimibe KRKA
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN/EZETIMIBE KRKA IS AND WHAT IT IS USED FOR
Rosuvastatin/Ezetimibe KRKA contains two different active substances.
One of the active substances
is rosuvastatin, which belongs to the group of so called statins, the
other active substance is ezetimibe.
Rosuvastatin/Ezetimibe KRKA lowers levels of total cholesterol,
“bad” cholesterol (LDL cholesterol),
and fatty substances called triglycerides in the blood. In addition,
Rosuvastatin/Ezetimibe KRKA
raises levels of “good” cholesterol (HDL cholesterol). HDL
cholesterol is often called “good”
cholesterol because it helps keep the bad cholesterol from building up
in the arteries and protects
against heart disease.
Rosuvastatin/Ezetimibe KRKA 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.
Rosuvastatin/Ezetimibe KRKA is used for patients who cannot control
their cholesterol levels by
cholesterol lowering d

Charakteristika produktu

Health Products Regulatory Authority
24 May 2023
CRN00DH24
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin/Ezetimibe KRKA 10 mg/10 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium) and 10 mg ezetimibe.
Excipients with known effect:
Each 10 mg/10 mg film-coated tablet contains 62.85 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pale brownish-yellow to pale brown-yellow round, slightly biconvex
film-coated tablets with bevelled edges, engraved with
mark R2 on one side of the tablet. Tablet diameter: approximately 10
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia/Homozygous Familial
Hypercholesterolaemia
Rosuvastatin/Ezetimibe KRKA is indicated as substitution therapy
adjunctive to diet and other non-pharmacological treatments
(e.g. exercise, weight reduction) for use in adult patients with
primary hypercholesterolaemia (heterozygous familial and
nonfamilial) or homozygous familial hypercholesterolaemia, who are
adequately controlled with the individual substances
given concurrently at same dose level as in the fixed dose
combination, but as separate products.
Prevention of Cardiovascular Events
Rosuvastatin/Ezetimibe KRKA 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
_ _
Before treatment initiation the patient should be placed on a standard
cholesterol-lowering diet that should continue during
treatment.
The recommended dose of Rosuvastatin/Ezetimibe KRKA is one tablet per
day.
Before switching to Rosuvastatin/Ezetimibe