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Concise Prescribing Info
Manufacturer
Distributor
Contents
Norethisterone acetate
Indications / Uses
Dysfunctional uterine bleeding (DUB), premenstrual syndrome, menstruation postponement, endometriosis, mastodynia.
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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.
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Overdosage
View Normens overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food.
Contraindications
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.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... click to view detailed Normens Warnings
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.
Side Effects / Adverse Reactions
Uterine/vag bleeding, headache, nausea, oedema.
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Interactions
Accelerated metabolism w/ enzyme inducers.
X
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Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Storage
View Normens storage conditions for details to ensure optimal shelf-life.
Description
View Normens description for details of the chemical structure and excipients (inactive components).
Mechanism of Action
View Normens mechanism of action for pharmacodynamics and pharmacokinetics details.
ATC Classification
G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Presentation / Packing
FormPacking/Price
Normens tab 5 mg
3 × 10's



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