Blissel 50 microgram/g, gel voor vaginaal gebruik

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ESTRIOL 50 µg/g

Beschikbaar vanaf:

Italfarmaco, S.A. C/ San Rafael, 3 Poligono Industrial 28108 ALCOBENDAS (SPANJE)

ATC-code:

G03CA04

INN (Algemene Internationale Benaming):

ESTRIOL 50 µg/g

farmaceutische vorm:

Gel voor vaginaal gebruik

Samenstelling:

CARBOMEER 971P ; GLYCEROL (E 422) ; NATRIUMHYDROXIDE (E 524) ; NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219) ; NATRIUMPROPYLPARAHYDROXYBENZOAAT ; POLYCARBOFIL ; WATER, GEZUIVERD ; ZOUTZUUR (E 507), CARBOMEER 971P ; GLYCEROL (E 422) ; NATRIUMHYDROXIDE (E 524) ; NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219) ; NATRIUMPROPYLPARAHYDROXYBENZOAAT (E 217) ; POLYCARBOFIL ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Toedieningsweg:

Vaginaal gebruik

Therapeutisch gebied:

Estriol

Product samenvatting:

Hulpstoffen: CARBOMEER 971P; GLYCEROL (E 422); NATRIUMHYDROXIDE (E 524); NATRIUMMETHYLPARAHYDROXYBENZOAAT (E 219); NATRIUMPROPYLPARAHYDROXYBENZOAAT (E 217); POLYCARBOFIL; WATER, GEZUIVERD; ZOUTZUUR (E 507);

Autorisatie datum:

2016-10-06

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR
THE USER
BLISSEL 50 MICROGRAM/G, GEL VOOR VAGINAAL GEBRUIK
Estriol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness 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 Blissel is and what it is used for
2.
What you need to know before you use Blissel
3.
How to use Blissel
4.
Possible side effects
5.
How to store Blissel
6.
Contents of the pack and other information
1.
WHAT BLISSEL IS AND WHAT IT IS USED FOR
Blissel belongs to a group of medicines called vaginal (local) Hormone
Replacement Therapy
(HRT).
It is used to relieve menopausal symptoms in the vagina such as
dryness or irritation. In medical
terms this is known as ‘vaginal atrophy’. It is caused by a drop
in the levels of oestrogen in your
body. This happens naturally after the menopause.
Blissel works by replacing the oestrogen which is normally produced in
the ovaries of women. It is
inserted into your vagina, so the hormone is released where it is
needed. This may relieve
discomfort in the vagina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BLISSEL
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.
Before you start (or restart) HRT, your doctor will ask about your own
and your family’s
medical history. Your doctor may decide to perform a physical
examination. This may
include an examination of your breasts and/or an internal examination,
if necessary.
Once you have started on Blissel you should see your doctor for
regular check

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Blissel 50 microgram/g, gel voor vaginaal gebruik
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g vaginal gel contains 50 micrograms estriol.
Excipients: 1 g vaginal gel contains 1.60 mg of sodium methyl
parahydroxybenzoate and 0.20 mg
of sodium propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vaginal gel
Gel homogeneous, colourless, clear to slightly translucent.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of symptoms of vaginal atrophy due to oestrogen deficiency
in postmenopausal women
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Blissel 50 micrograms/g vaginal gel is an estrogen-only product for
vaginal use.
Guidance on how to start therapy and maintenance
Blissel can be started any time after the manifestation of atrophic
vaginitis.
Initial treatment: One applicator-dose of vaginal gel per day for 3
weeks (suitably at bedtime).
As maintenance treatment one applicator-dose of vaginal gel twice a
week (suitably at bedtime) is
recommended. An evaluation of treatment continuation after 12 weeks
should be carried out by the
physician.
For initiation and continuation of treatment of post- menopausal
symptoms, the lowest effective
dose for the shortest duration (see also Section 4.4) should be used.
For oestrogen products for vaginal application of which the systemic
exposure to the
oestrogen remains within the normal postmenopausal range, it is not
recommended to add a
progestagen (but see section 4.4).
A missed dose should be administered as soon as remembered, unless it
is more than 12 hours
overdue. In the latter case the missed dose should be skipped and the
next dose should be
administered at the normal time.
Administration:
Blissel has to be applied into the vagina using a dose-marked
applicator, following carefully
“Instructions for use” included in the information leaflet, and
below.
One applicator-dose (applicator filled to the mark) delivers a dose of
1 g vaginal gel cont