Ulipristal G.L. 5mg Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

ULIPRISTAL ACETATE

Dostupné z:

G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach, Austria

ATC kód:

G03XB02

INN (Medzinárodný Name):

ULIPRISTAL ACETATE 5 mg

Forma lieku:

TABLET

Zloženie:

ULIPRISTAL ACETATE 5 mg

Typ predpisu:

POM

Terapeutické oblasti:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2019-05-02

Príbalový leták

1
PACKAGE LEAFLET
Page
2
of
7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ULIPRISTAL G.L. 5MG 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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ulipristal G.L. 5mg tablets is and what it is used for
2.
What you need to know before you take Ulipristal G.L. 5mg tablets
3.
How to take Ulipristal G.L. 5mg tablets
4.
Possible side effects
5.
How to store Ulipristal G.L. 5mg tablets
6.
Contents of the pack and other information
1.
WHAT ULIPRISTAL G.L. 5MG TABLETS IS AND WHAT IT IS USED FOR
Ulipristal G.L. 5mg tablets 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 G.L. 5mg tablets 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 either before an operation of your fibroids or 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 G.L. 5MG TABLETS
You should know that most women have no menstrual bleeding (period)
during the treatment and for a
few weeks afterwards.
DO NOT TAKE ULI

Súhrn charakteristických

Page
1
of
14
SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
of
14
1.NAME OF THE MEDICINAL PRODUCT
Ulipristal G.L. 5mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of ulipristal acetate.
Excipient with known effect:
Each tablet contains 118 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White or almost white, round biconvex tablet of 7 mm, engraved with
“149” on one side and “LP” on
the other side.
4.
CLINICAL PARTICULARS
4.1
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
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ulipristal G.L. 5mg tablets 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 _
Page
3
of
14
No dose adjustment is recomm