ESTINOR TABLET 0.75MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LEVONORGESTREL

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

LEVONORGESTREL

Units in package:

10 Tablets; 10 Tablet Tablets

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Patient Information leaflet

_Consumer Medication Information Leaflet (RIMUP) _
1
ESTINOR TABLET
Levonorgestrel (0.75mg)
WHAT IS IN THE LEAFLET?
1.
What ESTINOR is used for
2.
How ESTINOR works
3.
Before you use ESTINOR
4.
How to use ESTINOR
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ESTINOR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ESTINOR IS USED FOR
ESTINOR
is
an
emergency
contraceptive
only.
It
is
not
intended as a regular method of
contraception.
HOW ESTINOR WORKS
ESTINOR
contain
the
active
ingredient
of
levonorgestrel.
Levonorgestrel
reduces
the
chance
of
pregnancy
by
inhibiting the ovulation.
BEFORE YOU USE ESTINOR
-
_When you must not take it _
Do not take ESTINOR Tablet if
you have an allergy to:
•
Levonorgestrel,
the
active
ingredient in ESTINOR Tablet
• any of the ingredients listed at
the end of this leaflet.
Do not take this medicine:
if you are pregnant.
if you suffer or have suffered
from a severe liver disease
if you have breast cancer
-
_Before you start to use it _
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have had any of the following
medical conditions:
you have diabetes
you have high blood pressure
you have liver disease or a
liver tumour
you
have
or
have
had
yellowish-brown
pigmentation
patches on the skin, particularly
of
the
face;
if
so,
avoid
too
much exposure to the sun or
ultraviolet radiation
If any of these conditions apply
to you it may not be suitable for
you to take ESTINOR

you have a disease of your
gastro-intestinal tract (such
as
Crohn's
disease)
that
interferes with the digestion
and absorption of your food;

you are vomiting or have
severe diarrhoea
-
_Taking other medicines _
Tell your doctor or pharmacist
if
you
are
taking
any
other
medicines, including any that
you get without a prescription
from
your
pharmacy,
supermarket
or
health
food
shop.
If you have used any of the
medicines below during the last
4 weeks, Estinor may work le

Summary of Product characteristics

[DUOPHARMA (M) SDN BHD]
ESTINOR TABLET 0.75 MG
DESCRIPTION: ESTINOR TABLET 0.75 MG: A round, green tablet, 7 mm in
diameter with marking ‘DUO 861’ & ‘flower’.
COMPOSITION: Each tablet contains d-Norgestrel 0.75 mg.
PHARMACODYNAMICS:
Levonorgestrel is progestogen derived from nortestosterone. It is more
potent inhibitors of ovulation than norethisterone and have androgenic
activity.
PHARMACOKINETICS:
Levonorgestrel is rapidly and almost completely absorbed after
administration by mouth and undergoes little first pass hepatic
metabolism. It is highly bound to plasma proteins; 42 to 68%
to sex hormone binding globulin and 30 to 56% to albumin. The
proportion bound to sex hormone binding globulin is higher when it is
administered with an oestrogen. Levonorgestrel is
metabolised in the liver to sulphate and glucuronide conjugates, which
are excreted in the urine and to a lesser extent in the faeces.
INDICATIONS:
Oral contraception. The preparation is an oral contraceptive indicated
for females having sexual intercourse occasionally. No more than 4
tablets can be taken monthly at 2 to 4 occasions.
To females having sexual intercourse more frequently combined oral
contraceptive / or other contraceptive methods are recommended.
RECOMMENDED DOSAGE:
In case of one or once repeated intercourse, one tablet should be
taken after the first intercourse. In case intercourse is repeated
several times, one tablet should be taken after the first
intercourse and one tablet 8 hours later. In this case, 2 tablets are
taken at one occasion.
Women who have used enzyme-inducing drugs during the last 4 weeks and
need emergency contraception are recommended to use a non-hormonal
emergency contraceptive, i.e. Cu-
IUD or take a double dose of levonorgestrel (i.e. No more than 4
tablets monthly taken together) for those women unable or unwilling to
use Cu-IUD.
ROUTE OF ADMINISTRATION : For oral use
CONTRAINDICATIONS: Disease of the liver and the biliary tract,
pregnancy jaundice in the history.
WARNINGS AND PRECAUTIONS:
A thorough per