Intrarosa
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-01-2024
Charakterystyka produktu
(SPC)
15-01-2024
Sprawozdanie z oceny publicznego
(PAR)
14-02-2018
Składnik aktywny:
Prasterone
Dostępny od:
Endoceutics S.A.
Kod ATC:
G03XX01
INN (International Nazwa):
prasterone
Grupa terapeutyczna:
Other sex hormones and modulators of the genital system
Dziedzina terapeutyczna:
Postmenopause
Wskazania:
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,
Podsumowanie produktu:
Revision: 6
Status autoryzacji:
Authorised
Data autoryzacji:
2018-01-08
Ulotka dla pacjenta
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
INTRAROSA 6.5 MG PESSARY
prasterone
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 Intrarosa is and what it is used for
2.
What you need to know before you use Intrarosa
3.
How to use Intrarosa
4.
Possible side effects
5.
How to store Intrarosa
6.
Contents of the pack and other information
1.
WHAT INTRAROSA IS AND WHAT IT IS USED FOR
Intrarosa contains the active substance prasterone.
What Intrarosa is used for
Intrarosa is used to treat postmenopausal women having moderate to
severe symptoms of vulvar and
vaginal atrophy. It is used to relieve menopausal symptoms in the
vagina such as dryness or irritation.
It is caused by a drop in the levels of oestrogen in your body. This
happens naturally after the
menopause.
How Intrarosa works
Prasterone corrects the symptoms and signs of vulvar and vaginal
atrophy by replacing the oestrogens
which are normally produced before menopause by 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 INTRAROSA
The use of Hormone Replacement Therapy (HRT) carries risks which need
to be considered when
deciding whether to start taking it, or 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 HRT may
be different. Please talk to
your
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Intrarosa 6.5 mg pessary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 6.5 mg of prasterone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pessary
White to off-white, bullet-shaped pessary approximately 28 mm long and
9 mm in diameter at its
widest end.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy
in postmenopausal women
having moderate to severe symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 6.5 mg prasterone (one pessary) administered
once daily, at bedtime.
For the treatment of postmenopausal symptoms, Intrarosa should only be
initiated for symptoms that
adversely affect quality of life. In all cases, a careful appraisal of
the risks and benefits should be
reassessed at least every 6 months and Intrarosa should only be
continued as long as the benefit
outweighs the risk.
If a dose is forgotten, it should be taken as soon as the patient
remembers. However, if the next dose is
due in less than 8 hours, the patient should skip the missed pessary.
Two pessaries should not be used
to make up for a forgotten dose.
_ _
_Special populations _
_ _
_Elderly _
No dose adjustment is considered necessary in elderly women.
_ _
_Patients with renal and/or hepatic impairment _
Since Intrarosa acts locally in the vagina, no dose adjustment is
needed for postmenopausal women
having renal or hepatic impairment or any other systemic anomaly or
disease.
_ _
_Paediatric population _
There is no relevant use of Intrarosa in female children of any age
group for the indication of vulvar
and vaginal atrophy due to menopause.
3
Method of administration
Vaginal use
Intrarosa can be inserted in the vagina with the finger or with an
applicator provided within the
identified pack.
The pessary should be inserted in the vagina as far as it can
comfortably go without force.
If inserted with an applicator,
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