Trandate 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Labetalol hydrochloride

Available from:

RPH Pharmaceuticals AB

ATC code:

C07AG01

INN (International Name):

Labetalol hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5015313011648 5015313011655

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
• 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 symptoms are
the same as yours.
• In this leaflet Trandate 50mg film-coated
Tablets, Trandate 100mg film-coated
Tablets, Trandate 200mg film-coated
Tablets and Trandate 400mg film-coated
Tablets will be called Trandate.
IN THIS LEAFLET:
1. What Trandate is for
2. Before you take Trandate
3. How to take Trandate
4. Possible side effects
5. How to store Trandate
6. Further information
1. WHAT TRANDATE IS 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) if you already have
high blood pressure
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. BEFORE YOU TAKE TRANDATE
DO NOT TAKE TRANDATE IF:
• You are allergic to labetalol hydrochloride
• You are allergic to any of the other
ingredients of Trandate (see section 6)
• You suffer from wheezing, obstructive
airways disease or asthma – taking
Trandate can make your breathing worse
• You have a problem that is common in
the elderly, related to poor control of the
working of your heart (sick sinus
syndrome)
•
You have a heart defect that leads to a
decreased function of the heart (heart block)
• Your heart cannot mainta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trandate
®
100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Labetalol hydrochloride
3
PHARMACEUTICAL FORM
Orange coloured, circular, biconvex film-coated tablets engraved
Trandate 100
on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trandate Tablets are indicated for the treatment of:
1.
Mild, moderate or severe hypertension
2.
Hypertension in pregnancy
3.
Angina pectoris with existing hypertension
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Trandate tablets should be taken orally with food.
_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
In elderly patients, an initial dose of 50mg twice daily is
recommended. This
has provided satisfactory control in some cases.
IN THE HYPERTENSION OF PREGNANCY
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 require further dose titration to
a three
times daily regimen, ranging from 100mg tds to 400mg tds. A total
daily dose
of
2400mg
should
not
be
exceeded.
Hospital
in-patients
with
severe
hypertension, particularly of pregnancy, may have daily increases in
dosage.
GENERAL
If rapid reduction of blood pressure is necessary, see the SPC for
Trandate
Injection. If long-term control of hypertension following the use of
Trandate
Injection is required, oral therapy with Trandate tablets shoul