Ulipristal Acetate Rowex 30 mg Film-coated Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ulipristal acetate

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

G03AD; G03AD02

INN (International Name):

Ulipristal acetate

Dosering :

30 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Emergency contraceptives; ulipristal

Autorisasjon status:

Marketed

Autorisasjon dato:

2019-11-01

Informasjon til brukeren

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ULIPRISTAL ACETATE ROWEX 30 MG FILM-COATED TABLETS _ _
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 doctor or pharmacist 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 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 Acetate Rowex is and what it is used for
2. What you need to know before you take Ulipristal Acetate Rowex
3. How to take Ulipristal Acetate Rowex
4. Possible side effects
5. How to store Ulipristal Acetate Rowex
6. Contents of the pack and other information
- Useful information about contraception
1. WHAT ULIPRISTAL ACETATE ROWEX IS AND WHAT IT IS USED FOR
ULIPRISTAL ACETATE ROWEX IS AN EMERGENCY CONTRACEPTIVE
Ulipristal Acetate Rowex 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 the tablet at any time in the menstrual cycle.
ULIPRISTAL ACETATE ROWEX 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 ot

Preparatomtale

Health Products Regulatory Authority
12 July 2022
CRN00CTN3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ulipristal Acetate Rowex 30 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of ulipristal acetate.
Excipients with known effect
Each film-coated tablet contains 228 mg lactose.
Each film-coated tablet contains less than 1 mmol (23 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, white, biconvex, film-coated tablet, embossed with "U30" on one
side, with a diameter of approximately 9 mm and
thickness of 4.5 mm.
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 (see sections 4.4 and 4.6).
Special populations
_Renal impairment_
No dose adjustment is necessary.
_Hepatic impairment_
In the absence of specific studies, no alternate dose recommendations
for Ulipristal Acetate Rowex can be made.
_Severe hepatic impairment_
In the absence of specific studies, Ulipristal Acetate Rowex is not
recommended.
_Paediatric population_
There is no relevant use of Ulipristal Acetate Rowex for children of
prepubertal age in the indication emergency contraception.
Adolescents:
Ulipristal Acetate Rowex 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
wome