Ulipristal Aristo 30 mg filmomhulde tablet

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ULIPRISTALACETAAT 30 mg/stuk

Beschikbaar vanaf:

Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 BERLIJN (DUITSLAND)

ATC-code:

G03AD02

INN (Algemene Internationale Benaming):

ULIPRISTALACETAAT 30 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ulipristal

Autorisatie datum:

2019-01-28

Bijsluiter

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8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ULIPRISTAL ARISTO 30 MG FILMOMHULDE TABLET
Ulipristal acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your pharmacist, doctor or other
healthcare professional has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your pharmacist, doctor, or other
healthcare professional.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Ulipristal Aristo is and what it is us
ed for
2.
What you need to know before you take
Ulipristal Aristo
3.
How to take Ulipristal Aris
to
4.
Possible side effects
5.
How to store Ulipristal Aristo
6.
Contents of the pack and other information
- Useful information about contraception
1. WHAT ULIPRISTAL ARISTO IS AND WHAT IT IS USED FOR
Ulipristal Ari
sto is an emergency contraceptive
Ulipristal Aristo is a contraceptive intended to prevent pregnancy
after unprotected sex or if your
contraceptive method has failed. For example:
•
if you
had sex without prot
ection;
•
if your
or your partner’s condom tore, slipped or came off, or if you forgot
to
use one;
•
if you
did not
take your contraceptive pill as recommended.
You shoul
d take the tablet as soon as possible after sex, and within a maximum
of 5 days (120
hours).
This is because it is more effective if you take it as soon as
possible after unprotected sex.
This medicine is suitable for any woman of childbearing age, including
adolescents.
You can take the tablet at any time in the menstrual cycle.
Ulipristal Aristo does not work if you are already pregnant.
If your menstrual period is late, there is a possibility that you may
be pregnant. When your period is
late or when you have symptoms of pregnancy (heavy breasts, morning
sickness) you should consult
a d

Productkenmerken

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1.
NAME OF THE MEDICINAL PRODUCT
Ulipristal Aristo 30 mg filmomhulde tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg ulipristal acetate.
Excipients with known effect:
Each film-zoated tablet contains 227.99 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 9.0 – 9.2 mm diameter
embossed with
_“U30” _
on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emergency contraception within 120 hours (5 days) of unprotected
sexual intercourse or
contraceptive failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment consists of one tablet to be taken orally as soon as
possible, but no later than 120 hours
(5 days) after unprotected intercourse or contraceptive failure.
The tablet can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of the tablet intake, another tablet
should be taken.
If a woman’s menstrual period is late or in case of symptoms of
pregnancy, pregnancy should be
excluded before the tablet is administered.
Special populations
_Renal impairment _
No dose adjustment is necessary.
_Hepatic impairment _
In the absence of specific studies, no alternate dose recommendations
for ulipristal acetate can be
made.
_Severe hepatic impairment _
In the absence of specific studies, ulipristal acetate is not
recommended.
_Paediatric population _
There is no relevant use of ulipristal acetate for children of
prepubertal age in the indication
emergency contraception
_. _
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Adolescents: ulipristal acetate for emergency contraception is
suitable for any woman of child
bearing age, including adolescents. No differences in safety or
efficacy have been shown compared
to adult women aged 18 and older (see section 5.1).
Method of administration
Oral use.
The tablet can be taken with or without food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of th