Carvedilol 12.5mg film-coated Tablets

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

CARVEDILOL

Disponible des:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Codi ATC:

C07AG02

Designació comuna internacional (DCI):

CARVEDILOL 12.5 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

CARVEDILOL 12.5 mg

tipo de receta:

POM

Área terapéutica:

BETA BLOCKING AGENTS

Estat d'Autorització:

Authorised

Data d'autorització:

2012-12-24

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARVEDILOL 3.125 MG FILM-COATED TABLETS
CARVEDILOL 6.25 MG FILM-COATED TABLETS
CARVEDILOL 12.5 MG FILM-COATED TABLETS
CARVEDILOL 25 MG FILM-COATED TABLETS
Carvedilol
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 Carvedilol is and what it is used for
2.
What you need to know before you take Carvedilol
3.
How to take Carvedilol
4.
Possible side effects
5.
How to store Carvedilol
6.
Contents of the pack and other information
1.
WHAT CARVEDILOL IS AND WHAT IT IS USED FOR
Carvedilol belongs to a group of medicines called beta-blockers that
work by relaxing and widening
the blood vessels. This makes it easier for your heart to pump blood
around the body and reduces
blood pressure and strain on your heart.
CARVEDILOL IS USED: -
•
for the treatment of high blood pressure (hypertension),
•
for the treatment of chest pain that occurs when the arteries that
supply your heart with blood
carrying oxygen are narrowed which results in less oxygen reaching
your heart muscles (angina),
•
for the treatment of weakening of the heart muscle (heart failure), in
combination with other
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL
DO NOT TAKE CARVEDILOL:
•
if you are
ALLERGIC
to carvedilol or any of the other ingredients of this medicine (listed
in section
6).
•
if you have a history of wheezing due to asthma or other lung
diseases,
•
if you have been told you have very severe heart failure and you have
fluid retention (swelling)
which is b

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carvedilol 3.125 mg film-coated tablets
Carvedilol 6.25 mg film-coated tablets
Carvedilol 12.5 mg film-coated tablets
Carvedilol 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Carvedilol 3.125 mg film-coated tablets: _
Each tablet contains 3.125 mg of carvedilol.
Excipient(s) with known effect: Each tablet contains 28.625 mg of
lactose monohydrate and 0.625 mg
of sucrose.
_Carvedilol 6.25 mg film-coated tablets: _
Each tablet contains 6.25 mg of carvedilol.
Excipient(s) with known effect: Each tablet contains 57.25 mg lactose
monohydrate and 1.250 mg of
sucrose.
_Carvedilol 12.5 mg film-coated tablets: _
Each tablet contains 12.5 mg of carvedilol.
Excipient(s) with known effect: Each tablet contains 114.5 mg lactose
monohydrate and 2.5 mg of
sucrose.
_Carvedilol 25 mg film-coated tablets: _
Each tablet contains 25 mg carvedilol.
Excipient(s) with known effect: Each tablet contains 229 mg lactose
monohydrate and 5 mg of
sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Carvedilol 3.125 mg film-coated tablets _
Film-coated tablets white to off-white, oval, engraved with "E" on one
side and "01" on the other.
_Carvedilol 6.25 mg film-coated tablets _
Film-coated tablets white to off-white, oval, engraved with "F57" on
one side and scored on the other
side. The tablet can be divided into equal doses.
_Carvedilol 12.5 mg film-coated tablets _
Film-coated tablets white to off-white, oval, engraved with "F58" on
one side and scored on the other
side. The tablet can be divided into equal doses.
_Carvedilol 25 mg film-coated tablets _
Film-coated tablets white to off-white, oval, engraved with "F59" on
one side and scored on the other
side. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension
Chronic stable angina pectoris
Adjunctive treatment of moderate to severe stable chronic heart
failure
4.2
POSOLOGY AND