PROGYLUTON

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ESTRADIOL VALERATE; ESTRADIOL VALERATE; NORGESTREL

MAH:

BAYER ISRAEL LTD

ATC_code:

G03FB01

pharmaceutical_form:

TABLETS

composition:

ESTRADIOL VALERATE 2 MG; NORGESTREL 0.5 MG; ESTRADIOL VALERATE 2 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

therapeutic_group:

NORGESTREL AND ESTROGEN

therapeutic_area:

NORGESTREL AND ESTROGEN

therapeutic_indication:

Two phase preparation for climacteric and cycle disturbances.

authorization_date:

2023-11-30

PIL

PACKAGING TECHNOLOGY BERLIN SGQCL
page 1
Bayer AG
client: JS86
material-no.: 89262240
PZ: 2708B-3B
code-no.:
name: LF-INS PROGYLUTON TASC
country: IL/MULI/BAG
colors: BLACK
version: 17.08.2022/02
Restricted Document
dimension: 420 X 698 MM
89262240_02.indd 1
17.08.2022 13:18:04

SPC

1.
NAME OF THE MEDICINAL PRODUCT
Progyluton
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Calendar-pack containing 11 white tablets of 2 mg estradiol valerate
each, plus 10 light brown
tablets of 2 mg estradiol valerate and 0.5 mg norgestrel each.
Excipients:
Each white coated tablet contains 46.220 mg lactose monohydrate.
Each light brown coated tablets contain 45.720mg lactose monohydrate
3.
PHARMACEUTICAL FORM
Coated tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Two
phase
preparation for climacteric and cycle disturbances.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Progyluton is a cyclic HRT product. One tablet is to be taken orally
once a day for 21 days,
followed by a 7-day tablet free interval. Therefore each new pack is
started after a 28 day
cycle. The white tablets should be taken from days 1 to 11 followed by
the brown tablets from
days 12 to 21. It is recommended that the tablets are taken at the
same time every day.
For initiation and continuation of treatment of peri- and
post-menopausal symptoms the lowest
effective dose for the shortest duration (see also _'Special warnings
and special precautions for _
_use'_) should be used.
For women still having periods, the first tablet should be taken on
the 5th day of their menstrual
period. If menstruation has stopped, or is infrequent or sporadic,
then the first tablet can be
taken any time.
If the patient is being transferred from a continuous HRT product, the
patient may start
Progyluton on any convenient day. For those transferring from a cyclic
or sequential product,
Progyluton should be started following completion of the previous
regimen.
If a tablet is missed, it should be taken as soon as possible, unless
it is more than 12 hours
late. In this case the missed tablet should be left in the pack and
the next tablet taken at the
right time. Missing a dose may result in breakthrough bleeding or
spotting.
Unless there is a previous diagnosis of endometriosis, it is not
recommended that progestogen-
containing HRT be given t