Rosuvastatin/amlodipine Billev Coated Tablets 20mg/5mg

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

ROSUVASTATIN, AMLODIPINE

Disponible desde:

Billev farmacija vzhod d.o.o. Parmova ulica 14, 1000 Ljubljana, Slovenia

Código ATC:

C10BX09

Designación común internacional (DCI):

ROSUVASTATIN 20 mg AMLODIPINE 5 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

ROSUVASTATIN 20 mg AMLODIPINE 5 mg

tipo de receta:

POM

Área terapéutica:

LIPID MODIFYING AGENTS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2016-01-12

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATIN/AMLODIPINE BILLEV 10 MG/5 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE BILLEV 10 MG/10 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE BILLEV 20 MG/5 MG FILM-COATED TABLETS
ROSUVASTATIN/AMLODIPINE BILLEV 20 MG/10 MG FILM-COATED TABLETS
Rosuvastatin/amlodipine
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 Billev is and what it is used for
2.
What you need to know before you take Rosuvastatin/amlodipine Billev
3.
How to take Rosuvastatin/amlodipine Billev
4.
Possible side effects
5.
How to store Rosuvastatin/amlodipine Billev
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATIN/AMLODIPINE BILLEV IS AND WHAT IT IS USED FOR
Rosuvastatin/amlodipine Billev is a combination product that contains
two active substances called
rosuvastatin and amlodipine.
Rosuvastatin belongs to a group of medicines known as statins, which
are lipid (fat) regulating
medicines.
Amlodipine belongs to a group of medicines called calcium antagonists,
they work by relaxing blood
vessels.
Rosuvastatin/amlodipine Billev is indicated as substitution therapy
for those patients who are
adequately controlled with amlodipine and rosuvastatin given
concurrently, at the same dose level as
in the combination for the treatment of hypertension (with or without
chronic stable coronary artery
disease and/or Prinzmetal’s angina) in adult patients with one of
the following coincident conditions:
-
elevated cholesterol levels (called primary hy

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin/amlodipine Billev 10 mg/5 mg film-coated tablets
Rosuvastatin/amlodipine Billev 10 mg/10 mg film-coated tablets
Rosuvastatin/amlodipine Billev 20 mg/5 mg film-coated tablets
Rosuvastatin/amlodipine Billev 20 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg/5 mg: Each film-coated tablet contains 10 mg rosuvastatin (as
rosuvastatin calcium)
and 5 mg amlodipine (as amlodipine besylate).
10 mg/10 mg: Each film-coated tablet contains 10 mg rosuvastatin (as
rosuvastatin calcium)
and 10 mg amlodipine (as amlodipine besylate).
20 mg/5 mg: Each film-coated tablet contains 20 mg rosuvastatin (as
rosuvastatin calcium)
and 5 mg amlodipine (as amlodipine besylate).
20 mg/10 mg: Each film-coated tablet contains 20 mg rosuvastatin (as
rosuvastatin calcium)
and 10 mg amlodipine (as amlodipine besylate).
Excipients with known effect:
Each 10 mg/5 mg film-coated tablet contains 56 mg anhydrous lactose.
Each 10 mg/10 mg film-coated tablet contains 112 mg anhydrous lactose.
Each 20 mg/5 mg film-coated tablet contains 112 mg anhydrous lactose.
Each 20 mg/10 mg film-coated tablet contains 112 mg anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
10 mg/5 mg: yellowish brown, round, slightly biconvex, film-coated
tablets with bevelled
edges, engraved with mark 10-5 on one side of the tablet with a
diameter of approx. 8.6mm.
10 mg/10 mg: light pink, round, slightly biconvex, film-coated tablets
with bevelled edges,
engraved with mark 10-10 on one side of the tablet with a diameter of
approx. 11mm.
20 mg/5 mg: light yellow, round, slightly biconvex, film-coated
tablets with bevelled edges,
engraved with mark 20-5 on one side of the tablet with a diameter of
approx. 11mm.
20 mg/10 mg: white, round, slightly biconvex, film-coated tablets with
bevelled edges,
engraved with mark 20-10 on one side of the tablet with a diameter of
approx. 11mm.
_ _
4.
CLINICAL PARTICULARS
4.1