Trandate 100mg Film-Coated Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Labetalol hydrochloride

Dostupné z:

RPH Pharmaceuticals AB

ATC kód:

C07AG; C07AG01

INN (Medzinárodný Name):

Labetalol hydrochloride

Dávkovanie:

100 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Alpha and beta blocking agents; labetalol

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1993-07-19

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANDATE 100 MG FILM-COATED TABLETS AND TRANDATE 200 MG FILM-COATED
TABLETS
LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE
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. 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.
•
In this leaflet Trandate 100 mg film-coated Tablets and Trandate 200
mg film-coated Tablets
will be called Trandate.
IN THIS LEAFLET:
1.
What Trandate is and what it is used for
2.
What you need to know before you take Trandate
3.
How to take Trandate
4.
Possible side effects
5.
How to store Trandate
6.
Contents of the pack and further information
1.
WHAT TRANDATE IS AND WHAT IT IS USED FOR
Trandate belongs to a group of medicines called beta blockers.
Trandate works by causing the heart to beat more slowly and with less
force. It also widens the
arteries in the body. This helps to lower the pressure of the blood as
it travels around the body.
The result is a lower blood pressure and the prevention of angina
(chest pain).
Trandate are used to treat:
•
High blood pressure
•
High blood pressure in pregnant women
•
Angina (chest pains) with and without high blood pressure
•
Long term management of high blood pressure after a heart attack
High blood pressure often causes no obvious symptoms but if it is not
treated it can damage
blood vessels in the long-term. This can lead to heart attacks, kidney
failure, stroke or blindness.
This is why it is important not to stop taking this medicine without
talking to your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRANDATE
DO NOT TAKE TRANDATE:
•
if you ar

Súhrn charakteristických

Health Products Regulatory Authority
14 December 2023
CRN00DS7V
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trandate 100mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Labetalol hydrochloride
Excipients with known effect:
Lactose monohydrate 24.78 mg
Methyl hydroxybenzoate (E218) 2.8 micrograms
Propyl hydroxybenzoate (E216) 2.3 micrograms
Sunset yellow (E110)
Sodium benzoate (E211)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Circular, biconvex, orange-coloured, film-coated tablets engraved
‘Trandate 100’ on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of all forms of hypertension, including hypertension
of pregnancy.
In the treatment of patients with angina pectoris with and without
co-existing hypertension.
In the long term management of hypertensive episodes following acute
myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
_ _
HYPERTENSION
Treatment should start with 100mg 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 100mg twice daily should be made
at fortnightly intervals. Many patients' blood pressure is controlled
by 200mg twice daily and up to 800mg daily may be given
as a twice daily regimen. In severe, refractory hypertension, daily
doses up to 2400mg have been given. Such doses should be
divided into a three or four times a day regimen.
ELDERLY
Use of the 100 mg dosage in elderly is subject to the prescriber's
evaluation.
In elderly patients, reduced daily doses compared to adults.
IN THE HYPERTENSION OF PREGNANCY
Health Products Regulatory Authority
14 December 2023
CRN00DS7V
Page 2 of 8
The initial dose of 100mg twice daily may be increased, if necessary,
at weekly intervals by 100mg twice daily. During the
second and third trimester, the severity of the hypertension may