PROGYLUTON TABLETS

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

ESTRADIOL VALERATE; ESTRADIOL VALERATE; NORGESTREL

Disponible des:

BAYER CO. (MALAYSIA) SDN. BHD.

Designació comuna internacional (DCI):

ESTRADIOL VALERATE; ESTRADIOL VALERATE; NORGESTREL

Unidades en paquete:

21Tablet Tablets

Fabricat per:

Bayer Weimar GmbH und Co. KG

Fitxa tècnica

Reference : Progyluton / coated tablets / CCDS / Version 14 / 14 Jul 2015, Indications
Progyluton ®
Coated Tablets
1. NAME OF THE MEDICINAL PRODUCT
Progyluton Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white sugar -coated tablet contains estradiol valerate 2.0 mg
Each light brown sugar -coated tablet contains estradi ol valerate 2.0 mg and norgestrel 0.5 mg
For a full list of excipient(s) see section “list of excipients”
3. PHARMACEUTICAL FORM
Sugar -coated tablet
4. CLINICAL PARTICULARS
4.1 Indication (s)
Hormone replacement therapy (HRT) for the treatment of si gns and symptoms of estrogen deficiency due to menopause or
hypogonadism, castration or primary ovarian failure in women with an intact uterus.
Prevention of postmenopausal osteoporosis.
Control of irregular menstrual cycles.
Treatment of primary or sec ondary amenorrhea.
4.2 Dosage and method of administration
4.2.1 Method of administration
Oral Use
4.2.2 Dosage regimen
► How to start Progyluton
If the patient is still menstruating, treatment should begin on the 5th day of the cycle (1st day of menstru al bleeding = 1st
day of the cycle).
Patients with amenorrhea or very infrequent periods or who are postmenopausal may start at any time, provided pregnancy
has been excluded (see section ‘ Pregnancy and lactation’).
► Dosage
One white tablet is taken daily for the first 11 days, followed by one light brown tablet daily for 10 days.
Following the 21 days of tablet -taking there will be a tablet-free interval of 7 days.
► Administration
Each pack covers 21 days of treatment. A new pack of Progyluton should be started after the 7-day tablet-free interval on
the same day of the week as the previous one.
The tablets are to be swallowed whole with some liquid.
The tablets should preferably be taken at the same time every day.
► Missed tablets
In case a tablet is f orgotten, it should be taken as soon as possible. If more than 24 hours have elapsed, no extra tablet
needs to be taken. If several tablets are forgotten, bleeding may