HEM-SAT 250
Tablets

Antiaemorragic

  • Chemical Composition

    Etamsylate 250 mg / 1 tab

  • Packing

    20Tablets

  • Medical Id

    T80

  • License Number

    98/2010

  • License date

    2/5/2010

Mechanism Of Action When given P.O., etamsylate is slowly absorbed from the gastrointestinal tract. After oral administration of 500 mg etamsylate maximum plasma level, i.e. 15 µg/ml, is reached at 4 h, but bioavailability is not known . The binding rate to plasma proteins is about 95% . Plasma half-life is about 3.7 h. About 72 % of the administered dose are excreted in the first 24 h – urine , the molecule is excreted unchanged. Etamsylate crosses the placental barrier. Maternal and cord blood contains similar concentrations of etamsylate. It is not known if etamsylate is excreted in the maternal milk .
INDICATIONS In Surgery: Prevention and treatment of pre, per or postsurgical capillary haemorrhages in all delicate operations and in those affecting highly vascularised tissues: E.N.T., gynaecology, obstetrics, urology, odontostomatology, ophthalmology, plastic and reconstructive surgery. In internal medicine: Prevention and treatment of capillary haemorrhages of whatever origin or localization: haematuria, haematemesis, melaena, epistaxis, gingivorrhagia. In gynaecology: Metrorrhagia, primary or IUD-related menorrhagia in the absence of organic pathology.
CONTRAINDICATIONS Acute porphyria.
Side EFFECTS Rare: gastralgia, nausea, headache, skin rash. In most cases these symptoms disappear spontaneous. If they persist, the dosage should be reduced or the treatment withdrawn.
WARNINGS : Parenteral administration of etamsylate may induce a drop in blood pressure, but no data have been reported on such risk during oral administration. If HEM-SAT 500 is administered for a reduction of excessive and/or prolonged menstrual haemorrhages, and no improvement is observed, possible pathological causes should be looked for and excluded.
Pregnancy And lactations Pregnancy category C: studies in pregnant women or animals are not available. As a precaution, HEM-SAT 500 should not be administered during the first trimester of pregnancy, whereas the second and third trimesters, it should be administered only if expected therapeutic benefit is judged as superior to the potential risk for the foetus. In the absence of date regarding passage into maternal milk, lactation during treatment is not advisable or, if lactation is to continue, the treatment must be stopped.
Dosage And Administration Children: Half the adult dose of 250 mg tablet. Because of its high concentration of active principle, HEM-SAT 500 is not appropriate for children
Storage Conditions Keep out of reach of children Store in a cool dry place (20° – 25°C)