Ulipristal Acetate Gedeon Richter

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ulipristal acetate

Available from:

Gedeon Richter Plc.

ATC code:

G03XB02

INN (International Name):

ulipristal acetate

Therapeutic group:

Sex hormones and modulators of the genital system,

Therapeutic area:

Leiomyoma

Therapeutic indications:

Ulipristal acetate is indicated for one treatment course of 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 who are not eligible for surgery.

Product summary:

Revision: 1

Authorization status:

Withdrawn

Authorization date:

2018-08-27

Patient Information leaflet

26
B. PACKAGE LEAFLET
Medicinal product no longer authorised
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ULIPRISTAL ACETATE GEDEON RICHTER 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 Ulipristal Acetate Gedeon Richter is and what it is used for
2.
What you need to know before you take Ulipristal Acetate Gedeon
Richter
3.
How to take Ulipristal Acetate Gedeon Richter
4.
Possible side effects
5.
How to store Ulipristal Acetate Gedeon Richter
6.
Contents of the pack and other information
1.
WHAT ULIPRISTAL ACETATE GEDEON RICHTER IS AND WHAT IT IS USED FOR
Ulipristal Acetate Gedeon Richter 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).
Ulipristal Acetate Gedeon Richter 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 ULIPRISTAL ACETATE GEDEON
RICHTER
_ _
You should know that most women have no menstrual bleeding (period)
during the treat

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Ulipristal Acetate Gedeon Richter 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
Ulipristal Acetate Gedeon Richter 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
impair