Hi-Pharm for Manufacturing Pharmaceuticals and Chemicals
Norethisterone acetate 5 mg.
Each tablet contains, as active ingredient. Norethisterone acetate 5 mg.
Excipients: Dibasic calcium phosphate, avicel PH102, povidone K25, crospovidone XL. magnesium stearate, talc, and aerosil 200.
Pharmaceutical Form :
Clinlcal Particulars :
Therapeutic indications :
Metropathla hemorrhaglca, premenstrual syndrome, postponement of menstruation, endometriosis, menorrhagia, dysmenorrhoea.
Posology and method of administration :
Oral administration :
Not intended for use in children.
Metropothio hemorrhogica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 13- days. A withdrawal bleeding resembling normal menstruation occurs within 24- days after discontinuing treatment.
Prophylaxis against recurrence of dysfunctional bleeding: If there are no signs of resumption of normal ovarian function (no rise in the second half of the cycle of the morning temperature, which should be measured daily), recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19″‘ to the 26’h day of the cycle.
Premenstrual Syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological
disturbances may be relieved by the administrations of 23- tablets daily from the 9′” to the 26″‘ day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped,
the patients may remain symptom-free for a number of months.
Postponement of menstruation: In cases of too frequent menstrual bleeding and in special circumstances (e.g. operations, travel, sports), the postponement of menstruation Is possible. 1 tablet of Steronate three times daily, starting 3 days before the expected onset of menstruation. A normal period should occur 23- days after the patient has stopped taking tablets.
Endometriosis (pseudo-pregnancy therapy ) : Long treatment is commenced on the 5th day of the cycle with 2 tablets of Steronate daUy for the first few weeks. In the event of spotting, the dosage is increased to 4, and if necessary,S tablets daily. After bleeding has ceased, the Initial dose is usually sufficient. Duration of treatment: 4-months continuously, or longer if necessary.
Menorrhagia (hypermenorrhoea): I tablet 23- times a day from the 19th to the 26″‘ day of the cycle
(counting the first day of menstruation as day 1).
Dysmenorrhoea : Functional or primary dysmenorrhea is almost invariably relieved by the suppression of ovulation. 1 tablet three times daily for 20 days, starting on the fifth day of the cycle (the first day of menstruation counting as day 1). Treatment shouldbe maintained for three to four cycles followed by treatment-free cycles. A further course of therapy may be employed if symptoms return.
– Severe disturbances of liver function,
– Dubin-Johnson syndrome
– Rotor Syndrome,
– Previous or existing liver tumors,
– History of Idiopathic jaundice during pregnancy, severe pruritus or herpes gestations,
– Current thromboembolic processes,
– Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use :
There is a general opinion, based on statistical evidence, that users of combined oral contraceptives experience, more often than non-users, venous thromboembolism, arterial thrombosis, including
cerebral and myocardial Infarction, and subarachnoid hemorrhage. Full recovery from such disorders does not always occur, and it should be realized that in a few cases they are fatal. Although Steronate does not contain estrogen, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic disease or in the presence of severe diabetes with vascular changes or sickle-cell anemia.
In rare cases benign, and In even rarer cases, ma1ignant liver turners leading in isolated cases to life-threatening Intra-abdominal hemorrhage have been observed after use of hormonal substance
such as the one contained in Steronate.lf severe upper abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.
Steronate can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Reasons for stopping Steronate immediately Occurrence for the first time of migralnous headaches or more frequent occurrence of unusually severe headaches.
Sudden perceptual disorders (e.g. disturbances of vision or hearing).
First signs o( thrombophlebitis or thromboembolic symptoms,fleeing of pain and tightness in the chest.
Pending operations (six week beforehand) Immobillzation (e.g. after accidents). Onset of jaundice, hepatltls, general pruritus.
Significant rise in blood pressure. Pregnancy.
lnteraction with other medicinal products and other forms of interaction :
Pregnancy and lactation :
The administration of Steronate during pregnancy iscontraindicated.
Effects on ability to drive and use machines :
Undesirable effects :
Side effects rarely occur In doses IS mg daily. Amongst those recorded are slight nausea, exacerbation of epilepsy, migraine and various skin disorders. With extremely high doses there may be cbolestanc liver changes.
There have been no reports of ill-effects from overdosage and treatment is generally unnecessary. There are no special antidotes, and treatment should be symptomatic.
PHARMACOLOGICAL PROPERTIES :
Norethisterone has progestational ecnons Similar to those of progesterone, u IS a more po en inhibitor of ovulation and has weak estrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle.
Pharmacokinatic properties :
Norethisterone is absorbed from the qastro-fntestlnal tract and its effects last for at least 24 hours. It is excreted in the urine.
Preclinical safety data :
There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.
PHARMACEUTICAL PARTICULARS :
Special precautions for storage :
Nature and contents of container :
Carton box of 2 (AI&PVC) strips and each strip contains 10 tablets with English & Arabic pamphlet.
Special precautions for disposal and other handling :
Keep out of reach of children
Store at temp. not exceeding 3Q’lC in a dry place.
Keep all medicaments out of reach of children
For Manufacturing :
Hi pharma for pharmaceuticals chemicals
Industrial Zone. EI-Obour Citv. Cairo – egypt