Esmya
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
03-02-2021
Karatteristiċi tal-prodott
(SPC)
03-02-2021
Rapport ta 'Valutazzjoni Pubblika
(PAR)
03-02-2021
Ingredjent attiv:
ulipristal acetate
Disponibbli minn:
Gedeon Richter Ltd
Kodiċi ATC:
G03XB02
INN (Isem Internazzjonali):
ulipristal
Grupp terapewtiku:
Sex hormones and modulators of the genital system,
Żona terapewtika:
Leiomyoma
Indikazzjonijiet terapewtiċi:
Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Sommarju tal-prodott:
Revision: 16
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2012-02-22
Fuljett ta 'informazzjoni
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ESMYA 5 MG TABLETS
Ulipristal acetate
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 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 Esmya is and what it is used for
2.
What you need to know before you take Esmya
3.
How to take Esmya
4.
Possible side effects
5.
How to store Esmya
6.
Contents of the pack and other information
1.
WHAT ESMYA IS AND WHAT IT IS USED FOR
Esmya contains the active substance ulipristal acetate. It is used to
treat moderate to severe symptoms
of uterine fibroids (commonly known as myomas), which are
non-cancerous tumours of the uterus
(womb).
Esmya is used in adult women (over 18 years of age) before they reach
the menopause.
In some women, uterine fibroids may cause heavy menstrual bleeding
(your ‘period’), pelvic pain
(discomfort in the belly) and create pressure on other organs.
This medicine acts by modifying the activity of progesterone, a
naturally occuring hormone in the
body. It is used for long term treatment of your fibroids to reduce
their size, to stop or reduce bleeding
and to increase your red blood cell count.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESMYA
_ _
You should know that most women have no menstrual bleeding (period)
during the treatment and for a
few weeks afterwards.
_ _
DO NOT TAKE ESMYA
-
if you are allergic to ulipristal acetate or any of the other
ingredients of Esmya (listed in
section 6).
-
if you have an underlying hepatic disorder.
-
if you are pregnant or if you are breastfeeding.
-
if you have vaginal bleed
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Esmya 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of ulipristal acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round biconvex tablet of 7 mm engraved with
“ES5” on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ulipristal acetate is indicated for intermittent treatment of moderate
to severe symptoms of uterine
fibroids in adult women who have not reached menopause when uterine
fibroid embolisation and/or
surgical treatment options are not suitable or have failed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Esmya treatment is to be initiated and supervised by physicians
experienced in the diagnosis and
treatment of uterine fibroids.
Posology
The treatment consists of one tablet of 5 mg to be taken once daily
for treatment courses of up to
3 months each. Tablets may be taken with or without food.
Treatments should only be initiated when menstruation has occurred:
- The first treatment course should start during the first week of
menstruation.
- Re-treatment courses should start at the earliest during the first
week of the second menstruation
_ _
following the previous treatment course completion.
The treating physician should explain to the patient the requirement
for treatment free intervals.
Repeated intermittent treatment has been studied up to 4 intermittent
courses.
If a patient misses a dose, the patient should take ulipristal acetate
as soon as possible. If the dose was
missed by more than 12 hours, the patient should not take the missed
dose and simply resume the
usual dosing schedule.
_Special population_
_Renal impairment _
No dose adjustment is recommended in patients with mild or moderate
renal impairment. In the
absence of specific studies, ulipristal acetate is not recommended in
patients with severe renal
impairment unless the patient is closely monitored
_ _
(see sections 4.4 and 5.2).
_Paediatric popula
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