Carvedilol 12.5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Carvedilol

Disponibil de la:

Genus Pharmaceuticals Ltd

Codul ATC:

C07AG02

INN (nume internaţional):

Carvedilol

Dozare:

12.5mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02040000

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARVEDILOL 3.125 MG, 6.25 MG, 12.5 MG & 25 MG TABLETS
CARVEDILOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINEBECAUSE 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 of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
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
works 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 asthmatic or other lung
diseases.
-
if you have been told you have very severe fluid retention (swelling)
which is being treated
with injections of medicines into one of your veins (intravenously).
-
if you have liver disease.
-
if you have been told th

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carvedilol 12.5 mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.5 mg of Carvedilol
Excipient(s) with known effect: Each tablet contains 62.94 mg of
lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Carvedilol Tablets are cream coloured, circular, biconvex tablets,
8.30 mm-8.70 mm
in diameter, marked ‘C12’ on one face and plain on the reverse
face.
SUMMARY OF PRODUCT CHARACTERISTICS
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension
Chronic stable angina pectoris
Adjunctive treatment of moderate to severe stable chronic heart
failure.
SUMMARY OF PRODUCT CHARACTERISTICS
4
CLINICAL PARTICULARS
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ESSENTIAL HYPERTENSION
Carvedilol
may
be
used
for
the
treatment
of
hypertension
alone
or
in
combination with other antihypertensives, especially thiazide
diuretics. Once
daily dosing is recommended, however the recommended maximum single
dose is 25 mg and the recommended maximum daily dose is 50 mg.
_ _
_Adults:_
The recommended initial dose is 12.5 mg once a day for the first two
days.
Thereafter the treatment is continued at the dose 25 mg/day. If
necessary, the
dose may be further increased gradually at intervals of two weeks or
more
rarely.
_Elderly:_
The recommended initial dose in hypertension is 12.5 mg once a day
which
may also be sufficient for continued treatment.
However, if the therapeutic response is inadequate at this dose, the
dose may
be further increased gradually at intervals of two weeks or more
rarely.
CHRONIC STABLE ANGINA PECTORIS:
A twice-daily regimen is recommended.
_Adults:_
The recommended initial dosage is 12.5 mg twice a day for the first
two days.
Thereafter, the treatment is continued at the dose 25 mg twice a day.
If
necessary, the dose may be further increased gradually at intervals of
two
weeks or more rarely to the recommended maximum dose of 100 mg