Carvedilol 3.125mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Carvedilol

Доступна з:

Genus Pharmaceuticals Ltd

Код атс:

C07AG02

ІПН (Міжнародна Ім'я):

Carvedilol

Дозування:

3.125mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 02040000

інформаційний буклет

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

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carvedilol 3.125 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.125 mg of carvedilol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Light peach, round flat tablet. Scored on one side, debossed on the
other side
with “CVL” on top and “T1” on bottom. The score line is only
to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
_CHRONIC HEART FAILURE_
Carvedilol is adjunctive therapy for the treatment of moderate to
severe stable chronic
heart failure.
_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
The tablets should be taken with fluid.
_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.
_Adults _
The recommended dose for initiation of therapy is 12.5 mg once a day
for the first
two days. Thereafter the recommended dosage is 25 mg once a day.
Although this is
an adequate dose in most patients, if necessary the dose may be
titrated up to a
recommended daily maximum dose of 50 mg given once a day or in divided
doses.
Dose titration should occur at intervals of at least two weeks.
_ _
_Elderly _
An initial dose of 12.5 mg daily is recommended. This has provided
satisfactory
control in some cases. If the response is inadequate the dose may be
titrated up to the
recommended daily maximum dose of 50 mg given once a day or in divided
doses.
_ _
_Paediatric population_
Safety and efficacy in children (under 18 years) has not been
established.
_ANGINA_
A twice-daily regimen is recommended.
_ _
_Adults_
The recommended dose for initiation of therapy is 12.5 mg twice a day
for the first
two days. Thereafter, the recommend