Velbienne 1 mg/2 mg, filmomhulde tabletten
Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
Bijsluiter
(PIL)
15-11-2023
Productkenmerken
(SPC)
15-11-2023
Werkstoffen:
DIENOGEST 2 mg/stuk ; ESTRADIOLVALERAAT 1 mg/stuk
Beschikbaar vanaf:
Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (SPANJE)
ATC-code:
G03FA15
INN (Algemene Internationale Benaming):
DIENOGEST 2 mg/stuk ; ESTRADIOLVALERAAT 1 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:
2018-06-21
Bijsluiter
1
PL.DIEEV.CC.NL.H.3591.001.IB.015
PACKAGE LEAFLET: INFORMATION FOR THE USER
VELBIENNE 1 MG/2 MG, 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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What
is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.
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
2
PL.DIEEV.CC.NL.H.3591.001.IB.015
whether to carry on taking it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is
limited. If you have a premature menopause the risks of using H
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Productkenmerken
1
SPC.DIEEV.CC.NL.H.3591.001.IB.0015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Velbienne 1 mg/2 mg, 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 known 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 with
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.
Dosage
One tablet is taken daily. Each blister pack contains tablets for 28
days of treatment.
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SPC.DIEEV.CC.NL.H.3591.001.IB.0015
Method of Administration
For oral use.
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
symptoms, the lowest effective dose for the
shortest duration (see also Section 4.4) should be used.
Additional information on special populations
Paedia
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