Estradiol Valeraat 1 mg / Dienogest 2 mg Laboratorios León Farma, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

DIENOGEST 2 mg/stuk ; ESTRADIOLVALERAAT 1 mg/stuk SAMENSTELLING overeenkomend met ; ESTRADIOL 0,76 mg/stuk

Beschikbaar vanaf:

Laboratorios Leon Farma, S.A. C/La Vallina s/n, Pol. Ind. 24008 NAVATEJERA (SPANJE)

ATC-code:

G03FA15

INN (Algemene Internationale Benaming):

DIENOGEST 2 mg/stuk ; ESTRADIOLVALERAAT 1 mg/stuk SAMENSTELLING overeenkomend met ; ESTRADIOL 0,76 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Dienogest And Estrogen

Product samenvatting:

Hulpstoffen: IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2014-09-26

Bijsluiter

9
LF-DIE-EV-NL/H/2949/002/IB/021
PACKAGE LEAFLET: INFORMATION FOR THE USER
Estradiol Valeraat 1 mg / Dienogest 2 mg Laboratorios Léon Farma,
filmomhulde tabletten
estradiol valerate and dienogest
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What
<
Invented Name
>
is and what it is used for
2.
What you need to know before you take
<
Invented Name
>
3.
How to take
<
Invented Name
>
4.
Possible side effects
5.
How to store
<
Invented Name
>
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
<
Invented Name
>
is a Hormone Replacement Therapy (HRT). It contains two types of
female
hormones, an oestrogen and a progestogen. is used in
postmenopausal women with
at least 12 months since their last natural period.
<
Invented Name
>
is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This can cause
symptoms such as hot
face, neck and chest
(“hot flushes”). alleviates these
symptoms
after
menopause.
You
will
only be
prescribed
if
your symptoms
seriously hinder your daily life.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, or
whether to carry on taking it.
10
LF-DIE-EV-NL/H/2949/002/IB/021
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is
limited. If

Productkenmerken

1
SPC-DIE-EV-NL/H/2949/002/I
B/021
SUMMARY OF PRODUCT CHARACTERISTICS
ESTRADIOL VALERAAT 1 MG / DIENOGEST 2 MG LABORATORIOS LÉON FARMA,
FILMOMHULDE TABLETTEN
ESTRADIOL VALERATE / DIENOGEST
1.
NAME OF THE MEDICINAL PRODUCT
Estradiol Valeraat 1 mg / Dienogest 2 mg Laboratorios Léon Farma,
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains: estradiol valerate 1.0 mg
(equivalent to 0.764 mg estradiol) and dienogest
2.0 mg
Excipients with know effect: each tablet contains 58.22 mg of lactose
monohydrate.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Tablets are light pink and rounded with a diameter of 6 mm approx.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
I
NDICATIONS
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in
postmenopausal women more
than one year post menopause.
Experience of treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
How to start

1 mg/2 mg
Women who do not take hormone replacement therapy (HRT) or women who
change from another
continuous combined HRT product may start treatment at any time.
Women changing from a continuous sequential HRT regimen should begin
the day following completion of
the prior regimen.
Women changing from a cyclic HRT regimen should begin the day after
the treatment-free period.
One tablet is taken daily. Each blister pack contains tablets for 28
days of treatment.
Method of Aadministration
For oral use.
2
SPC-DIE-EV-NL/H/2949/002/I
B/021
The tablets are to be swallowed whole with some liquid. Treatment is
continuous, which means that the
next pack follows immediately without a break. The tablets should
preferably be taken at the same time
every day. In case a tablet is forgotten 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 occur.
For initiation and continuation of treatment of postmenopausal
sym