PROGYNOVA 1 mg AND 2 mg TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

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Patient Information leaflet

                                PROGYNOVA 1 mg AND 2 mg TABLETS
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
PROGYNOVA 1 mg AND 2 mg TABLETS
For estrogen therapy of climacteric
complaints in the postmenopause
COMPOSITION
Progynova tablets contain 
estradiol 
valerate (estra-1,3,5(10)-triene-3,17beta-diol 17-valerate) 1,0 mg and 2,0 mg
respectively.
PHARMACOLOGICAL CLASSIFICATION
A. 21.8.1 Estrogens.
PHARMACOLOGICAL ACTION
Progynova contains estradiol valerate, an ester of the endogenous female estrogen, which following regular oral
administration eliminates the characteristic estrogen deficiency symptoms in the postmenopause or after oophorectomy
or radiological castration for non-carcinomatous diseases.
INDICATIONS
Climacteric complaints after the cessation of monthly bleeding or deficiency symptoms after oophorectomy or
radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances,
depressive moods, irritability, headaches, dizziness, bladder irritation, signs of muco-cutaneous involution.
CONTRA-INDICATIONS
Pregnancy; severe disturbances of liver function; jaundice or persistent itching during a previous pregnancy; Dubin-
Johnson syndrome; Rotor syndrome; previous or existing liver tumours; existing or previous thromboembolic processes
(eg stroke, myocardial infarction); sickle-cell anaemia; existing or suspected hormone-dependent tumours of the uterus or
mammae; endometriosis; severe diabetes with vascular changes; congenital disturbances of lipometabolism; otosclerosis
with deterioration in previous pregnancies.
DOSAGE AND DIRECTIONS FOR USE
Before starting Progynova a thorough general medical and gynaecological examination (including the breasts) should be
carried out.
Unless otherwise prescribed by the doctor, 1 tablet Progynova 2 mg is taken daily after a meal. The tablets ar
                                
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