Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
bromcriptine (bromocriptine mesilate)
Gedeon Richter OJSC
bromcriptine (bromocriptine mesilate)
2,5mg
tablets
Prescription
OGYI/3076/2013 1. NAME OF THE MEDICINAL PRODUCT BROMOCRIPTIN-RICHTER 2.5 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 2.5 mg bromocriptine as 2.87 mg bromocriptine mesilate in each tablet. Excipient with known effect: 41.0 mg lactose monohydrate in each tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Almost white, flat-faced, bevel-edged bisect tablets with an inscription of “2.5” on the plain side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inhibition or suppression of lactation for medical reasons This preparation is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement of the breasts. Hyperprolactinaemia Treatment of hyperprolactinaemia in men and women (with and/or without galactorrhoea). Infertility Treatment of hyperprolactinaemic infertility. Bromocriptine has been used successfully in the treatment of a number of infertile women without demonstrable hyperprolactinaemia. Prolactinomas Bromocriptine can be a first choice of treatment in case of macroadenomas and an alternative to the surgical procedure (transsphenoidal hypophysectomy) in patients with microadenomas. Acromegaly Bromocriptine is an appropriate adjunct to surgery and/or radiotherapy in reducing the level of growth hormone in the systemic circulation of acromegalic patients. Parkinson's disease In the treatment of idiopathic Parkinson's disease, bromocriptine has been used both as monotherapy and in combination with levodopa in the management of previously untreated patients and those disabled by 'on-off' phenomena. Treatment is of benefit in patients who do not respond to or are unable to tolerate levodopa, as well as in those whose response to levodopa is declining. Treatment of cyclical benign breast disease; premenstrual syndrome (see section 4.4 “Special warnings and precautions for use”). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 2 T Soma hati kamili