TRANDATE 100mg tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

labetalol hydrochloride, Quantity: 100 mg

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: methyl hydroxybenzoate; lactose monohydrate; maize starch; propyl hydroxybenzoate; hypromellose; magnesium stearate; pregelatinised maize starch; titanium dioxide; sunset yellow FCF; purified water; sodium benzoate; industrial methylated spirit

Administration route:

Oral

Units in package:

25,000 Tablets (E), 100 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 24 OCT 1996 : Treatment of all grades of hypertension.

Product summary:

Visual Identification: Orange, film-coated biconvex tablets embossed "TRANDATE 100"; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

TRANDATE- Consumer Medicine Information
Page 1 of 4
TRANDATE
TM
_LABETALOL HYDROCHLORIDE_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TRANDATE
tablets. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TRANDATE
against the benefits he or she expects
it will have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT TRANDATE IS USED
FOR
The name of your medicine is
TRANDATE. The active ingredient
is called _labetalol hydrochloride_.
_Labetalol hydrochloride_ belongs to a
group of medicines called the beta-
blockers. The beta- blockers are
used for the treatment of high blood
pressure (hypertension).
TRANDATE is used for the
treatment of all degrees of
hypertension. Hypertension is a
condition marked by high blood
pressure.
TRANDATE is used to lower high
blood pressure. It works by changing
the body’s response to some nerve
impulses. Therefore, it widens the
blood vessels in the body, causing
the blood pressure to fall.
Your doctor may have prescribed
this medicine for another condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TRANDATE
HAS BEEN PRESCRIBED FOR YOU.
TRANDATE tablets are only
available with a doctor’s
prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TRANDATE IF YOU
ARE ALLERGIC TO:

labetalol hydrochloride or any
other agents used to treat
hypertension

any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction to TRANDATE may
include red, itchy skin rashes,
difficulty in breathing, swelling of
the face, lips, mouth or throat,
faintness or shortness of breath.
DO NOT USE TRANDATE AFTER THE
EXPIRY DATE (EXP.) PRINTED ON THE
PACK.
DO NOT TAKE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERIN

Summary of Product characteristics

TRANDATE- Product Information
Page 1 of 11
.
AUSTRALIAN PRODUCT INFORMATION – TRANDATE (LABETALOL
HYDROCHLORIDE)
1.NAME OF THE MEDICINE
Labetalol hydrochloride
2.&3.QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICAL FORM
Trandate 100 mg and 200 mg tablets contain labetalol, lactose, maize
starch, pregelatinized
maize
starch,
magnesium
stearate,
Pharmacoat
606,
Opaspray
M-1-3499D,
methyl
hydroxybenzoate and propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of excipients.
Trandate tablets 100 mg are circular biconvex tablets with orange film
coat, each containing
labetalol hydrochloride 100 mg, marked TRANDATE 100 on one face.
Trandate tablets 200 mg are circular biconvex tablets with orange film
coat, each containing
labetalol hydrochloride 200 mg, marked TRANDATE 200 on one face.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of all grades of hypertension.
4.2 DOSE AND METHOD OF ADMINISTRATION
Trandate tablets are to be taken orally, preferably after meals.
For all patients, the dosage of Trandate must be titrated against
blood pressure
response.
The recommended starting dose for all patients is 100-200 mg twice
daily. The
dosage should then be increased at weekly intervals until satisfactory
control of blood
pressure is attained. It is important to follow these dosage
instructions and to
increase the dosage gradually, in order to minimise side effects.
Effective daily doses vary between 200 and 2,400 mg. In those patients
on high
doses, a regime of 3 to 4 doses a day may be necessary.
Hypertension may be controlled by Trandate alone. If Trandate tablets
are prescribed
with diuretics, or other antihypertensive agents, an additive effect
can be expected.
When
transferring
patients
from
other
treatment
regimes,
Trandate
should
be
introduced in the manner described above and the dosage of other
treatments should
be reduced gradually.
4.3 CONTRAINDICATIONS
Beta-blockers are usually contraindicated in a variety of conditions
and as Trandate
has not yet been fully i