Bromocriptin-Richter tablets

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

bromcriptine (bromocriptine mesilate)

Disponible depuis:

Gedeon Richter PLC

Code ATC:

G02CB01

DCI (Dénomination commune internationale):

bromcriptine (bromocriptine mesilate)

Dosage:

2,5mg

forme pharmaceutique:

tablets

Unités en paquet:

(30) glass bottle

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2019-10-11

Résumé des caractéristiques du produit

OGYÉI/56403/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BROMOCRIPTIN-RICHTER
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg bromocriptine as 2.87 mg bromocriptine
mesilate.
Excipient with known effect: each tablet contains 41.0 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Almost white, flat-faced, diameter about 7 mm, bevel-edged bisect
tablets
with an inscription of “2.5” on the plain side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inhibition or suppression of lactation for medical reasons
Prevention or suppression of post-partum physiological lactation only
where medically indicated (such
as in case of intrapartum loss, neonatal death, HIV infection of the
mother).
Bromocriptine is not recommended for the routine suppression of
lactation or for the relief of
symptoms of post-partum pain and breast engorgement which can be
adequately treated with non-
pharmacological intervention (such as firm breast support, ice
application) and/or analgesics.
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 female
infertility 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 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