PRIMOLUT N TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

NORETHISTERONE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

G03DC02

Dosage:

5 mg

Pharmaceutical form:

TABLET

Composition:

NORETHISTERONE 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

BAYER WEIMAR GMBH UND CO. KG

Authorization status:

ACTIVE

Authorization date:

1990-05-04

Patient Information leaflet

*
NAME OF THE MEDICINAL PRODUCT
PRIMOLUT N 5MG TABLETS *
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet Primolut N contains 5mg norethisterone.
For excipients, see section 6.1 *
PHARMACEUTICAL FORM
Tablets *
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
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 other wise prescribed by the doctor, the following dosages are
recommended: *
DYSFUNCTIONAL BLEEDING
The administration of 1 tablet Primolut N 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, Primolut N 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 must be considered. This applies also in cases where
after initial arrest of haemorrhage, fairly heavy bleedings still
occur during tablet-taking.
PREVENTION OF RECURRENCE
To prevent recurrence of dysfunctional bleeding, it is recommended to
administer Primo

Summary of Product characteristics

Primolut N PI_SG_CCDS 10_01 June 2018
1.
NAME OF THE MEDICINAL PRODUCT
PRIMOLUT N 5MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet Primolut N contains 5mg norethisterone.
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets
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 other wise prescribed by the doctor, the following dosages are
recommended:
4.2.2.1
DYSFUNCTIONAL BLEEDING
The administration of 1 tablet Primolut N 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, Primolut N
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.
Primolut N PI_SG_CCDS 10_01 June 2018
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 must be
considered. This applies also in cases where after initial arrest of
haemorrhage, fairly
heavy bleeding