Rosuvastatin/amlodipine Krka 15mg/5mg Film-coated Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Rosuvastatin calcium; Amlodipine besilate

Tilgængelig fra:

Krka d.d., Novo mesto

ATC-kode:

C10BX; C10BX09

INN (International Name):

Rosuvastatin calcium; Amlodipine besilate

Dosering:

15 mg/5 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

HMG CoA reductase inhibitors, other combinations; ZZZ rosuvastatin and amlodipine

Autorisation status:

Not marketed

Autorisation dato:

2016-01-22

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN/AMLODIPINE KRKA 10 MG/5 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE KRKA 10 MG/10 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE KRKA 15 MG/5 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE KRKA 15 MG/10 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE KRKA 20 MG/5 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE KRKA 20 MG/10 MG FILM-COATED TABLETS
Rosuvastatin/amlodipine Krka
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/amlodipine Krka is and what it is used for
2.
What you need to know before you take Rosuvastatin/amlodipine Krka
3.
How to take Rosuvastatin/amlodipine Krka
4.
Possible side effects
5.
How to store Rosuvastatin/amlodipine Krka
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN/AMLODIPINE KRKA IS AND WHAT IT IS USED FOR
Rosuvastatin/amlodipine Krka contains two active substances –
rosuvastatin and amlodipine.
Rosuvastatin/amlodipine Krka is indicated in adults for treatment of
increased blood pressure and
concomitant high cholesterol level when changing diet and taking more
exercise were not enough to
correct cholesterol levels and/or for prevention of cardiovascular
events if you have other factors that
increase your risk of having a heart attack, stroke or related health
problems.
Rosuvastatin/amlodipine Krka is indicated in patients who are already
taking rosuvastatin and
amlodipine at these doses. Instead of taking rosuvastatin and
amlodipine as separate tablets you will
receive one tab

Produktets egenskaber

Health Products Regulatory Authority
10 October 2019
CRN009D7X
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin/amlodipine Krka 15mg/5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rosuvastatin (as rosuvastatin
calcium) and 5 mg amlodipine (as amlodipine besylate).
Excipient with known effect:
Each 15 mg/5 mg film-coated tablet contains 84 mg anhydrous lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pale pinkish-brown, round, slightly biconvex, film-coated tablets with
bevelled edges, engraved with mark 15-5 on one side of
the tablet with a diameter of approx. 10 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rosuvastatin/amlodipine Krka is indicated as substitution therapy for
those patients who are adequately controlled with
rosuvastatin and amlodipine given concurrently, at the same dose level
as in the combination for the treatment of
hypertension in adult patients who are estimated to have a high risk
for a first cardiovascular event (for prevention of major
cardiovascular events) as an adjunct to correction of other risk
factors or with one of the following coincident conditions:
- primary hypercholesterolaemia (type IIa including heterozygous
familial hypercholesterolaemia) or mixed dyslipidaemia (type
IIb) as an adjunct to diet when response to diet and other
non-pharmacological treatments (e.g. exercise, weight reduction) is
inadequate
- homozygous familial hypercholesterolaemia as an adjunct to diet and
other lipid lowering treatments (e.g. LDL apheresis) or
if such treatments are not appropriate.
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/amlodipine Krka is one tablet per
day.
The fixed dose combination is not suitable for initial therapy.
Before switching to Rosuv