Ulipristal Helm 5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ULIPRISTALACETAAT

Beschikbaar vanaf:

Helm AG Nordkanalstrasse 28 20097 HAMBURG (DUITSLAND)

ATC-code:

G03XB02

INN (Algemene Internationale Benaming):

ULIPRISTALACETAAT

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ulipristal

Autorisatie datum:

2019-12-11

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ULIPRISTAL HELM 5 MG FILMOMHULDE TABLETTEN
Ulipristal acetate
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 Ulipristal Helm is and what it is used for
2.
What you need to know before you take Ulipristal Helm
3.
How to take Ulipristal Helm
4.
Possible side effects
5.
How to store Ulipristal Helm
6.
Contents of the pack and other information
1. WHAT ULIPRISTAL HELM IS AND WHAT IT IS USED FOR
Ulipristal Helm 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 Helm 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 HELM
You should know that most women have no menstrual bleeding (period)
during the treatment and for
a few weeks afterwards.
DO NOT TAKE ULIPRISTAL HELM
•
if you are allergic to ulipristal acetate or any of the other
ingredients of this medicine (listed
in section 6).
•
if you have an und

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1. NAME OF THE MEDICINAL PRODUCT
Ulipristal Helm 5 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg ulipristal acetate.
Excipients with known effect:
Each tablet contains 130.0 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex, film-coated tablet of 7.00 – 7.2 mm diameter
embossed with
_“U5” _
on one
side.
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 Helm 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 populations
_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