SUNOLUT TABLET 5MG

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

NORETHISTERONE

Beschikbaar vanaf:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Algemene Internationale Benaming):

NORETHISTERONE

Eenheden in pakket:

100 Tablet Tablets; 500 Tablet Tablets; 1000 Tablet Tablets

Geproduceerd door:

SUNWARD PHARM PTE LTD

Bijsluiter

NONE

Productkenmerken

SUNOLUT TABLET
Each tablet contains:-
Norethisterone 5 mg
PHARMACOLOGY:
Norethisterone has pharmacological properties similar to progesterone.
Norethisterone is absorbed from the gastrointestinal tract and its
effect last for at least 24 hours.
When injected, it is detectable in the plasma after 2 days and is not
completely excreted in the
urine after 5 days.
Norethisterone has progestational actions similar to those of
progesterone. It acts on the
endometrium by converting the proliferative phase induced by oestrogen
to a secretory phase. It
inhibits the secretion of pituitary gonadotropins, which in turn
presents follicular maturation and
ovulation. Norethisterone is a more potent inhibitor of ovulation to
progesterone and in addition it
has weak oestrogenic and androgenic properties.
INDICATIONS:
It is indicated in amenorrhea, in abnormal uterine bleeding due to
hormonal imbalance in the
absence of organic pathology, such as submucous fibroids or uterine
cancer, and in endometriosis.
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
PRECAUTIONS:
Because of occasional occurrence of thrombophlebitis and pulmonary
embolism in patients taking
progestogens, the physician should be alerted to the earliest
manifestations of the disease. This
drug may cause some degree of fluid retention, conditions which might
be influenced by this factor,
such as epilepsy, migraine, asthma, cardiac or renal dysfunction,
require careful observation.
In cases of breakthrough bleedi