Elyoma 5 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ULIPRISTALACETAAT

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

G03XB02

INN (Algemene Internationale Benaming):

ULIPRISTALACETAAT

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ulipristal

Autorisatie datum:

2019-06-17

Bijsluiter

Sandoz B.V.
Page 1/7
Elyoma 5 mg, tabletten
RVG 122868
1311-v1
1.3.1.3 Bijsluiter
Mei 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ELYOMA 5 MG, TABLETTEN
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] 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).
[Product name] 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 [PRODUCT NAME]
You should know that most women have no menstrual bleeding (period)
during the treatment and for
a few weeks afterwards.
DO NOT TAKE [PRODUCT NAME]:
Sandoz B.V.
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Elyoma 5 mg, t

Productkenmerken

Sandoz B.V.
Page 1/15
Elyoma 5 mg, tabletten
RVG 122868
1311-v1
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2019
1.
NAME OF THE MEDICINAL PRODUCT
Elyoma 5 mg, tabletten
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
[Product name] 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.
Sandoz B.V.
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Elyoma 5 mg, tabletten
RVG 122868
1311-v1
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2019
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 sho