NORCOLUT TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Norethisterone

Available from:

PHARMLINE MARKETING PTE. LTD.

ATC code:

G03DC02

Dosage:

5 mg

Pharmaceutical form:

TABLET

Composition:

Norethisterone 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

CHEMICAL WORKS OF GEDEON RICHTER PLC

Authorization status:

ACTIVE

Authorization date:

1991-11-19

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Norcolut
®
tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg norethisterone
Excipients with known effect: lactose monohydrate (92.50 mg per
tablet).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Almost white, flat, bevelled edged tablets, debossed with “+” on
one side, “NORCOLUT” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dysfunctional bleeding, primary and secondary amenorrhoea,
premenstrual syndrome, mastopathy,
timing of menstruation, endometriosis.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF ADMINISTRATION
Oral use
4.2.2
DOSAGE REGIMEN
The tablets are to be swallowed whole with some liquid.
If you forget a dose, wait until it is time to take the next
prescribed dose. Do not take the missed dose. If
you are worried, contact your doctor or pharmacist.
If contraceptive protection is required, additional non-hormonal
(barrier) contraceptive methods should
be used.
Unless otherwise prescribed by the doctor, the following dosages are
recommended:
4.2.2.1
DYSFUNCTIONAL BLEEDING
The administration of 1 tablet Norcolut 3 times daily over 10 days
leads to the arrest of uterine bleeding
not associated with organic lesions within 1-3 days. In individual
cases, bleeding diminishes during the
first few days after the commencement of tablet-taking and does not
stop until about 5 days later. For the
treatment to be successful, Norcolut administration should be
continued regularly even after arrest of
bleeding (up to a total of 30 tablets).
About 2-4 days after discontinuation of treatment a withdrawal
bleeding will occur resembling a normal
menstruation in intensity and duration.
Slight bleeding during tablet-taking
Occasionally, slight bleeding may occur after initial arrest of
bleeding. In these cases tablet-taking must not
be interrupted.
Missing arrest of haemorrhage. Heavy break through bleeding
If the bleeding does not stop in spite of regular tablet taking, an
organic cause mu