Levonorgestrel Rowex 1.5mg Tablet

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Levonorgestrel

זמין מ:

Rowex Ltd

קוד ATC:

G03AD; G03AD01

INN (שם בינלאומי):

Levonorgestrel

כמות:

1.5 milligram(s)

טופס פרצבטיות:

Tablet

סוג מרשם:

Product not subject to medical prescription

איזור תרפויטי:

Emergency contraceptives; levonorgestrel

מצב אישור:

Marketed

תאריך אישור:

2016-05-26

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
LEVONORGESTREL ROWEX 1.5 MG TABLET
Levonorgestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This
medicine
is
available
without
prescription.
However,
you
still
need
to
take
Levonorgestrel Rowex
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What Levonorgestrel Rowex
is and what it is used for
2.
What you need to know before you take Levonorgestrel Rowex
3.
How to take Levonorgestrel Rowex
4.
Possible side effects
5.
How to store Levonorgestrel Rowex
6.
Content of the pack and other information
1.
WHAT LEVONORGESTREL ROWEX IS AND WHAT IT IS USED FOR
Levonorgestrel Rowex
is an emergency contraceptive that can be used within 72 hours
(3 days) of unprotected sex or if your usual contraceptive method has
failed.
When should emergency contraception be used?

No contraception was used during the sexual intercourse

The contraception measure was used incorrectly, for example as if a
condom was
penetrated, slipped away or used in a wrong way, if vaginal pessary or
diaphragm
changed position, burst, was broken or taken out ahead of time, in the
case of a failed
interruption during coitus interruptus (e.g. sperm ejaculated in
vagina or on external
genitalia).
Levonorgestrel
Rowex
contains
a
synthetic
hormone
like
active
substance
called
levonorgestrel. It prevents about 84% of expected pregnancies when you
take it within
72 hours of having unprotected sex. It will not prevent a pregnancy
every time and is more
effective if you take it as soon as possible after unprotected sex. It
is better to take it within
12 hours rather than delay until the third day.
Levonorgestrel is thought to work by:

stopping your ovaries f

מאפייני מוצר

Health Products Regulatory Authority
30 September 2019
CRN008TN3
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levonorgestrel Rowex 1.5mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.5 mg of levonorgestrel.
Excipient with known effect 43.3 mg of lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Levonorgestrel Rowex tablet is round and white, with approximate 6 mm
of diameter and marked “C” on one side and “1” on
the other
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency contraception within 72 hours of unprotected sexual
intercourse or failure of a contraception method.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet should be taken as soon as possible, preferably within 12
hours and no later than 72 hours after unprotected
intercourse (see section 5.1).
If vomiting occurs within three hours of taking the tablet, another
tablet should be taken immediately.
Women who have used enzyme-inducing drugs during the last 4 weeks and
need emergency contraception are recommended
to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of
levonorgestrel (i.e. 2 tablets taken together) for those women
unable or unwilling to use Cu-IUD (see section 4.5).
Levonorgestrel Rowex can be used at any time during the menstrual
cycle unless menstrual bleeding is overdue.
After using emergency contraception, it is recommended to use a local
barrier method (e.g. condom, diaphragm, spermicide,
cervical cap) until the next menstrual period starts. The use of
levonorgestrel does not contraindicate the continuation of
regular hormonal contraception.
_Paediatric population_
There is no relevant use of Levonorgestrel Rowex for children of
prepubertal age in the indication emergency contraception.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
30 Septemb