Ulli Once 30 mg, filmomhulde tablet

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

ULIPRISTALACETAAT

Dostupno od:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC koda:

G03AD02

INN (International ime):

ULIPRISTALACETAAT

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

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

Administracija rute:

Oraal gebruik

Područje terapije:

Ulipristal

Datum autorizacije:

2019-01-28

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
ULLI ONCE 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 is and what it is used for
2. What you need to know before you use
3. How to use
4. Possible side effects
5. How to store
6. Contents of the pack and other information
- Useful information about contraception
1. WHAT IS AND WHAT IT IS USED FOR
is an emergency contraceptive
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.
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 doctor or other healthcare professional before
taking the tablet.
If

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ulli Once 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
can be made.
_ _
_Severe hepatic impairment _
In the absence of specific studies, is not recommended.
_ _
_Paediatric population _
There is no relevant use of ulipristal acetate for children of
prepubertal age in the indication
emergency contraception_. _
Adolescents: ulipristal acetate is suitable for any woman of
childbearing 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 the excipients
listed in section 6.1.