Carvedilol 3.125mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Carvedilol

Saatavilla:

Phoenix Healthcare Distribution 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

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARVEDILOL 3.125, 6.25, 12.5 AND 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 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 drugs called beta-blockers.
Beta-blockers make your blood vessels relax
and widen and slows your heart rate, thus causing the heart to beat
more calmly and lower blood pressure.
Carvedilol is used to:
treat angina
control high blood pressure.
Carvedilol can also be used in combination with other therapies to
treat heart failure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL
DO NOT TAKE CARVEDILOL IF YOU:
are allergic (hypersensitive) to Carvedilol or any of the other
ingredients of this medicine
(listed in
section 6).
have a history of asthma or other lung diseases unless you have
consulted your doctor or pharmacist first
have problems with your heart (for example „heart block‟ or
unstable heart failure), as Carvedilol is not
suitable for some people with certain types of heart problem
have an unusually slow heart beat
(<50 bpm)
or very low blood pressure
(systolic blood pressure
below 85 mmHg)
sometimes causing dizziness, faintness or lightheadness on standing
are receiving verapamil or diltiazem by injection or as an infusion
(with a drip)
have a problem with the a

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