POSTINOR

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

LEVONORGESTREL

Saadav alates:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC kood:

G03AC03

Ravimvorm:

TABLETS

Koostis:

LEVONORGESTREL 1.5 MG

Manustamisviis:

PER OS

Retsepti tüüp:

Not required

Valmistatud:

GEDEON RICHTER PLC, HUNGARY

Terapeutiline rühm:

LEVONORGESTREL

Terapeutiline ala:

LEVONORGESTREL

Näidustused:

Emergency contraseptive.

Loa andmise kuupäev:

2021-05-31

Infovoldik

K-00000-0.0
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
A ‘MORNING AFTER PILL’ FOR PREVENTING PREGNANCY AFTER
HAVING UNPROTECTED INTERCOURSE
This medicine is to be dispensed without a doctor’s prescription
POSTINOR
®
Each pill contains: Levonorgestrel 1.5 mg.
Inactive ingredients and allergens in the medicine: see section 2
under ‘Important information about some of the ingredients of the
medicine’ and section 6 ‘Additional information’.
THE MEDICINE IS MARKETED TO WOMEN AND GIRLS OVER 14 YEARS
OF AGE WITHOUT A PRESCRIPTION. THE MEDICINE IS MARKETED
ONLY WITH A PRESCRIPTION TO GIRLS UNDER 14 YEARS OF AGE. IF
YOU HAVE STARTED TREATMENT WITHOUT ASKING A DOCTOR, SEE
YOUR DOCTOR AS SOON AS POSSIBLE.
Patient Safety Information Card:
In
addition
to
the
patient
information
leaflet,
Postinor
has a patient safety information card. This card contains
important safety information that you should be aware of
and follow before and after taking Postinor.
Read the patient safety information card and the patient
information leaflet before using this medicine. Keep the
card and leaflet so you can read them again if you need to.
READ
THE
ENTIRE
LEAFLET
CAREFULLY
BEFORE
USING
THIS
MEDICINE. This leaflet contains concise information about
this medicine. If you have further questions, refer to your
doctor or pharmacist. You must take this medicine according
to all the instructions in the section about dosage in this
leaflet. Consult the pharmacist if you need more information.
1) WHAT IS THIS MEDICINE INTENDED FOR?
Postinor
is
an
emergency
contraceptive
for
preventing
pregnancy up to 72 hours (3 days) after having unplanned,
unprotected intercourse, or after rape, or if there is reason to
believe that the contraceptive you used is insufficient.
THERAPEUTIC GROUP: Progestogens (female hormones).
Postinor is an emergency contraceptive when taken up to
72 hours (3 days) after having unprotected intercourse, or if
your usual contraceptive method has failed.
Postinor contains a sy

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Postinor
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1500 micrograms of levonorgestrel.
Excipient with known effect: 142.5 mg lactose monohydrate. For the
full list of
excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Almost white, flat, rimmed tablet of about 8 mm diameter with an
impressed mark of “G00” on
one side.
PATIENT SAFETY INFORMATION CARD
The marketing of Postinor is subject to a risk management plan (RMP)
including a 'Patient
safety information card'. The 'Patient safety information card',
emphasizes important safety
information that the patient should be aware of before and during
treatment. Please explain to
the patient the need to review the card before starting treatment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emergency contraception.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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).
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).
If vomiting occurs within three hours of taking the tablet another
tablet should be taken
immediately.
Postinor 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 Postinor does not contraindicate the continuation of regular
hormonal contraception.
_Paediatric population_
:
There is no relevant use of Postinor for children of prepubertal age
in the indication
emergency contraception.
Method of administration:
For oral administration.
4.3
CONTRAINDICATIONS
Hyper