Blissel 50 micrograms/g vaginal gel

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Estriol

Tillgänglig från:

Italfarmaco S.A.

ATC-kod:

G03CA; G03CA04

INN (International namn):

Estriol

Dos:

50 Micrograms/g

Läkemedelsform:

Vaginal gel

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Natural and semisynthetic estrogens, plain; estriol

Bemyndigande status:

Not marketed

Tillstånd datum:

2016-09-09

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
BLISSEL 50 MICROGRAMS/G VAGINAL GEL
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-ups (at least

Produktens egenskaper

Health Products Regulatory Authority
09 August 2022
CRN00CG7G
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blissel 50 micrograms/g vaginal gel
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 f