Ulipristalacetaat Exeltis 30 mg, Filmomhulde tablet

Country: Holland

Tungumál: hollenska

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

Virkt innihaldsefni:

ULIPRISTALACETAAT 30 mg/stuk

Fáanlegur frá:

Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (SPANJE)

ATC númer:

G03AD02

INN (Alþjóðlegt nafn):

ULIPRISTALACETAAT 30 mg/stuk

Lyfjaform:

Filmomhulde tablet

Samsetning:

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

Stjórnsýsluleið:

Oraal gebruik

Lækningarsvæði:

Ulipristal

Leyfisdagur:

1900-01-01

Upplýsingar fylgiseðill

SPC-ULI-CC-NL.H.4229.001.IB.008-D0-cl
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ULIPRISTALACETAAT EXELTIS 30 MG FILM-COATED 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 Ulipristalacetaat Exeltis is and what it is used for
2.
What you need to know before you use Ulipristalacetaat Exeltis
3.
How to use Ulipristalacetaat Exeltis
4.
Possible side effects
5.
How to store Ulipristalacetaat Exeltis
6.
Contents of the pack and other information
- Useful information about contraception
1. WHAT ULIPRISTALACETAAT EXELTIS IS AND WHAT IT IS USED FOR
Ulipristalacetaat Exeltis is an emergency contraceptive
Ulipristalacetaat Exeltis is a contraceptive intended to prevent
pregnancy after unprotected sex or if
your contraceptive method has failed. For example:
•
if you had sex without protection;
•
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 should take the tablet as soon as possible after sex, and within a
maximum of 5 days (120
hours).
This is because the sperm can survive up to 5 days in your body after
intercourse.
This medicine is suitable for any woman of childbearing age, including
adolescents.
You can take this tablet at any time in the menstrual cycle.
Ulipristalacetaat Exeltis 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

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SPC-ULI-CC-NL.H.4229.001.IB.007-D0
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ulipristalacetaat Exeltis 30 mg, Filmomhulde tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg ulipristal acetate.
Excipients with known effect:
Each tablet contains 240.0 mg of lactose (as monohydrate) and 1.35 mg
sodium.
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.
This 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 Ulipristalacetaat Exeltis
can be made.
_Severe hepatic impairment _
In the absence of specific studies, Ulipristalacetaat Exeltis is not
recommended.
_Paediatric population _
There is no relevant use of ulipristal acetate for children of
prepubertal age in the indication
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SPC-ULI-CC-NL.H.4229.001.IB.007-D0
emergency contraception
_. _
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SPC-ULI-CC-NL.H.4229.001.IB.007-D0
Adolescents: ulipristal acetate 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 admi