Carvedilol 3.125mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Carvedilol

Saatavilla:

DE Pharmaceuticals

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

Pakkausseloste

~CADILA
ANNEXURE-1
(Ref.
SOP.
No.:
DFD080)
--=-
PHARMACEUTICALS
ART
WORK
APPROVAL
FORM
LIMITED
_enogen _
_Healthcare _
PACKAGE
LEAFLET:
INFORMATION
FOR
THE
USER
CARVEDILOL
3.125
MG,
6.25
MG,
12.5
MG
&
25
MG
TABLETS
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
further
questions,
please
ask
your
doctor
or
your
pharmacist.
•
This
medicine
has
been
prescribed
for
you
only.
Do
not
pass
IT
on
to
others;
it
may
harm
them,
even
if
their
symptoms
are
the
same
as
yours.
If
you
get
any
side
effects,
talk
to
your
doctor
or
pharmacist.
This
includes
any
side
effects
not
listed
in
this
leaflet.
In
THIS
LEAFLET:
1.
What
Carvedilol
Tablets
are
and
what
they
are
used
for
2.
What
you
need
to
know
before
you
take
Carvedilol
Tablets
3.
How
to
take
Carvedilol
Tablets
4.
Possible
side
effects
5.
How
to
store
Carvedilol
Tablets
6.
Contents
of
the
pack
and
further
information
1.
WHAT
CARVEDILOL
TABLETS
ARE
AND
WHAT
THEY
ARE
USED
FOR
Carvedilol
is
a
type
of
medicine
called
a
beta
blocker
and
vasodilator.
Carvedilol
Tablets
are
used
for
the
treatment
of
angina
(pains
in
the
chest
caused
by
blockages
in
the
arteries
leading
to
the
heart)
and
mild
to
moderate
heart
failure
(when
the
heart
cannot
pump
blood
properly
to
the
rest
of
the
body).
Carvedilol
is
also
used
to
treat
hypertension
(high
blood
pressure).
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
CARVEDILOL
TABLETS
DO
NOT
TAKE
CARVEDILOL
TABLETS
IF
YOU:
•
are
ALLERGIC
(HYPERSENSITIVE)
to
CARVEDILOL,
other
BETA
BLOCKERS
or
any
of
the
other
ingredients
in
the
tablets
(these
are
listed
in
Section
6,
Further
Information)
•
have
a
history
of
WHEEZING
due
to
ASTHMA
or
other
LUNG
DISEASES
•
have
SEVERE
FLUID
RETENTION
(swelling
of
your
hands,
ankles
and
feet)
which
is
being
treated
by
medicines
given
into
your
veins
(intravenously}
•
have
very
SEVERE
HEART
FAILURE
and
are
breathless
even
when
sitting
•
have
LIVER
disease
•
suffer
from

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carvedilol 3.125 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Carvedilol 3.125 mg Tablet contains 3.125 mg carvedilol.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Uncoated tablet.
Cream coloured, circular, biconvex tablets marked '3' on one face and
plain on
reverse face
Your medicine is available in packs of 28 tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_SYMPTOMATIC CHRONIC HEART FAILURE (CHF) _
Carvedilol is indicated for the treatment of stable mild, moderate and
severe chronic
heart failure as adjunct to standard therapies e.g. diuretics, digoxin
and ACE
inhibitors in patients with euvolemia.
_HYPERTENSION _
Carvedilol is indicated for the treatment of hypertension.
_ANGINA _
Carvedilol is indicated for the prophylactic treatment of stable
angina.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. The tablets should be taken with fluid. For
CHF patients
carvedilol should be given with food.
_SYMPTOMATIC CHRONIC HEART FAILURE _
Initiation of therapy with carvedilol should only be under the
supervision of a hospital
physician, following a thorough assessment of the patients' condition.
Prior to any subsequent titration of the dose, the patient must be
clinically evaluated
on the day of up - titration by a health-care professional experienced
in the
management of heart failure to ensure that the clinical status has
remained stable. The
dose of carvedilol should not be increased in any patient with
deteriorating heart
failure since last visit or with signs of decompensated or unstable
chronic heart
failure.
The dosage must be titrated to individual requirements.
For those patients receiving diuretics and/or digoxin and/or ACE
inhibitors, dosing of
these other drugs should be stabilized prior to initiation of
carvedilol treatment.
_Adults _
The recommended dose for the initiation of therapy is 3.125mg twice a
day for two
weeks. If this dose is tolerated, the dosage should be increased
subsequently