Carvedilol 3.125mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Carvedilol

Saatavilla:

Milpharm Ltd

ATC-koodi:

C07AG02

INN (Kansainvälinen yleisnimi):

Carvedilol

Annos:

3.125mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02040000; GTIN: 8901175014019

Pakkausseloste

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
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.
DO NOT TAKE CARVEDILOL:
•
if you are ALLERGIC (hypersensitive) 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 being treated with injections of
medicines into your veins (intravenously),
•
if you

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carvedilol 3.125 mg tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.125 mg carvedilol.
Excipient with known effect: Each tablet contains 12.5mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White, oval, smooth on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
Chronic stable angina pectoris
Adjunctive treatment in moderate to severe stable heart failure._ _
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
Carvedilol is available in 4 strengths: 3.125 mg, 6.25 mg, 12.5 mg and
25 mg
_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 _
_Adults_
The recommended initial dose is 12.5 mg twice daily for two days.
Thereafter, the
treatment is continued at the dose 25 mg twice daily. If necessary,
the dose may be
further increased gradually at intervals of two weeks or more rarely.
The
recommended maximum daily dose is 100 mg in divided doses (50mg twice
daily).
_Elderly_
The recommended initial dose is 12.5 mg twice daily for two days.
Thereafter, the
treatment is continued at the dose 25 mg twice daily, which