Labetalol 400mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Labetalol hydrochloride

Disponível em:

Viatris UK Healthcare Ltd

Código ATC:

C07AG01

DCI (Denominação Comum Internacional):

Labetalol hydrochloride

Dosagem:

400mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02040000; GTIN: 5016695640136

Folheto informativo - Bula

21 Apr 2021
14:06
II/II
Braille
Varnish
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labeta-
lol
#400 mg
tablets
labeta-
lol
#400 mg
tablets
1
PEEL HERE BUT DO NOT REMOVE
400
MG
LABETALOL 400 MG
FILM-COATED TABLETS
56 film-coated tablets
Each film-coated tablet contains labetalol
hydrochloride 400 mg. Contains sucrose
.
For Oral use as directed by a doctor.
Read the package leaflet before use.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
WARNING: Do not take this medicine
if you have wheezing or asthma.
Store in a dry place below 25 °C. Store in the
original package in order to protect from light.
PL 04569/0063
POM
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
LL0427AJ
2438862
21 Apr 2021
14:06
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2
Each film-coated tablet contains labetalol
hydrochloride 400 mg. Contains sucrose.
For Oral use as directed by a doctor.
Read the package leaflet before use.
Keep out of the sight and reach of children.
WARNING: Do not take this medicine if you
have wheezing or asthma.
Store in a dry place below 25 °C. Store in the
original package in order to protect from light.
PL 04569/0063
POM
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
400
MG
LABETALOL 400 MG
FILM-COATED TABLETS
56 film-coated tablets
LL0427AJ
2438862
3/32
3
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LABETALOL 100 MG FILM-COATED TABLETS
LABETALOL 200 MG FILM-COATED TABLETS
LABETALOL 400 MG FILM-COATED TABLETS
(labetalol hydrochloride)
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14:06
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4
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.
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5
IN THIS LEAFLET:
1. What Labetalol is and what it i

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Labetalol 400 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg labetalol hydrochloride
Excipients with known effect
Each film-coated tablet contains 15.0 mg sucrose.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Round orange biconvex film-coated tablets marked “LL 100” on one
side and blank
on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Labetalol is a combined alpha and beta-adrenoceptor blocker indicated
for:
-
Hypertension, including hypertension in pregnancy.
-
Angina pectoris with existing hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Labetalol tablets should be taken with food.
Adults:
Hypertension:
Initially, 100 mg twice daily. In patients already being treated with
antihypertensives and in those of low body weight this may be
sufficient to control
blood pressure. In others, increases in dose of 100 mg twice daily
should be made at
intervals of 14 days. Many patients blood pressure is controlled by
200 mg twice
daily. If necessary up to 800 mg daily may be given, as a twice daily
regimen. In
severe refractory hypertension, daily doses of up to 2400 mg have been
given,
divided into three or four times a day regimens.
Hypertension in Pregnancy:
An initial dosage of 100 mg twice daily may be
increased, if necessary at weekly intervals by 100 mg twice daily.
During the second
and third trimesters, the severity of hypertension may necessitate a
further dose
titration to a three times daily regimen ranging from 100 mg – 400
mg three times a
day. The total daily dosage should not exceed 2400 mg.
Hospital in-patients with severe hypertension, particularly in
pregnancy, may have
daily increases in dosage.
Angina Co-Existing with Hypertension: The recommended dose is that
which is
necessary to control the hypertension.
Paediatric population
:
Labetalol is not recommended for use in children due to a lack of d