Renata Limited


Concise Prescribing Info
Norethisterone acetate
Dysfunctional uterine bleeding (DUB), premenstrual syndrome, menstruation postponement, endometriosis, mastodynia.
Dosage/Direction for Use
DUB 1 tab tds for 10 days. Premenstrual syndrome including menstrual mastopathy 2-3 tab daily from 19th-26th day of cycle, treatment may be repeated for several cycles. Menstruation postponement 1 tab tds 3 days before expected onset of menstruation. Duration: Not >10-14 days. Endometriosis 1 tab bd on 5th day of cycle for 1st few wk, may be increased to 2 tab bd in the event of spotting. Duration: 4-6 mth.
May be taken with or without food.
Discontinue use if frequent occurrence of unusually severe headache or 1st time migrainous headache occurs. Dubin-Johnson & Rotor syndromes; history of idiopathic jaundice, severe pruritus or herpes gestationis; current thromboembolic processes. Vision or hearing disturbance, thrombophlebitis or thromboembolic symptoms; feeling of chest pain & tightness; pending operations (6 wk beforehand); immobilization, onset of jaundice, hepatitis, general pruritus, significant rise of BP. Severe liver function disturbances; previous or existing liver tumours. Pregnancy & lactation.
Special Precautions
Discontinue use if thromboembolic complications develops. Hypertriglyceridemia, pancreatitis; benign or malignant liver tumours; history of chloasma gravidum & depression. Epilepsy, migraine, asthma, cardiac dysfunction. Exclude papilloedema or retinal lesions before continuing medication. Examine carbohydrate metabolism parameters in diabetic patients prior & regularly during treatment. Minimize sun or UV radiation exposure. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Renal dysfunction.
Adverse Reactions
Uterine/vag bleeding, headache, nausea, oedema.
Drug Interactions
Accelerated metabolism w/ enzyme inducers.
ATC Classification
G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Normens tab 5 mg
3 × 10's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in