SUNOLUT TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

NORETHISTERONE

Available from:

SUNWARD PHARMACEUTICAL PRIVATE LIMITED

ATC code:

G03DC02

Dosage:

5 mg

Pharmaceutical form:

TABLET

Composition:

NORETHISTERONE 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SUNWARD PHARMACEUTICAL PRIVATE LIMITED

Authorization status:

ACTIVE

Authorization date:

1990-06-22

Patient Information leaflet

Checked by: Phoebe
Date: 04/05/2011
PROPOSED PACKAGE INSERT
SUNOLUT TABLET
Each tablet contains:-
Norethisterone
5 mg
THERAPEUTIC PROPERTIES:
Norethisterone transforms poliferative endometrium into secretary
endometrium.
It
inhibits the secretion of
pituitary gonadotropins,
which in turn prevents follicular
maturation and ovulation.
ADVERSE EFFECTS:
1.
Breakthrough bleeding
2.
Spotting
3.
Change in menstrual flow
4.
Amenorrhea
5.
Oedema
6.
Changes in weight
7.
Changes in cervical mucous and cervical secretion
8.
Cholestatic jaundice
9.
Rash (allergic) with and without pruritus
10.
Melasma or chloasma
11.
Mental depression
12.
Nausea
13.
Headache
14.
Visual disturbances
CONTRAINDICATIONS:
1.
Thrombophlebitis,
thromboembolic
disorders,
cerebral
apoplexy
or
patients with a past history of these conditions.
2.
Known or suspected carcinoma of the breast.
3.
Undiagnosed vaginal bleeding.
4.
Missed abortion.
5.
As a diagnostic test for pregnancy.
USAGE DURING PREGNANCY AND LACTATION:
It should be avoided during pregnancy and by nursing mothers.
DOSAGE:
This dosage schedule assumes the interval between menses to be 28
days.
Amenorrhea, abnormal
uterine bleeding due to hormonal
imbalance in the absence of
organic pathology:
5 to 20 mg norethisterone starting with the fifth day of the menstrual
cycle and ending
on the 25
th
day.
Endometriosis:
Initial
daily dosage of
10mg norethisterone for
two weeks with
increments of 5 mg per day of norethisterone every two weeks until 30
mg per day of
norethisterone is reached. Therapy may be held at this level
for six to nine months or
until annoying breakthrough bleeding demands temporary termination.
INCOMPATIBILITIES:
Reports of incompatibilities if any are not available.
INTERACTIONS:
The concomitant
use of
oestrogens with progestogens may rendered less effective
and an increased incidence of
breakthrough bleeding may occur
by virtue of
drug
interaction with rifampicin,
isoniazid,
ampicillin,
tetracycline,
neomycin,
penicillin,
chloramphenicol,
sulphonamides,
nitrofurantoin,
barbit