NORIDAY TABLET

Country: Malaysia

Language: English

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

Active ingredient:

NORETHISTERONE

Available from:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

NORETHISTERONE

Units in package:

84Tablet Tablets

Manufactured by:

Piramal Healthcare UK Limited

Patient Information leaflet

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NORIDAY
®
TABLET
Norethisterone (350 mcg)
PLD Title
: Norethisterone (Noriday
®
)
PLD Date
: 19 July 2021
Country
: Malaysia
Reference Document
: Noriday Malaysia LPD dated 21 June 2021
Reason for change
: PfLEET 2021-0070602 (M) - To update the storage condition as per BOH
request
: To update serial number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NORIDAY
®
TABLET
Norethisterone (350 mcg)
2
WHAT IS IN THIS LEAFLET
1.
What Noriday is used for
2.
How Noriday works
3.
Before you use Noriday
4.
How to use Noriday
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Noriday
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT NORIDAY IS USED FOR
Noriday is a progestogen-only
contraceptive pill, or ‘POP’ for short.
Noriday contains the active ingredient
norethisterone. Noriday helps to prevent
you becoming pregnant.
HOW NORIDAY WORKS
Noriday prevents pregnancy in several
ways.

It thickens the fluid at the entrance to
your womb and this makes it hard for
sperm to travel through and enter the
womb.

It also changes the lining of your
womb so that a fertilised egg cannot
grow there.

By changing the lining of the
fallopian tubes (allows transport of
egg(s) to the womb), transport of the
egg to the womb could be slowed.
BEFORE YOU USE NORIDAY
-
_When you must not use it_
Do not take Noriday if you have had:
•
An allergic (hypersensitivity)
reaction to the active ingredient,
norethisterone, or any other
ingredients present in Noriday.
•
Blood clots in the legs, blood clots in
varicose veins, the lungs, the brain or
elsewhere (coronary and cerebral
thrombotic disorders).
•
A heart attack or angina.
•
Disorders of body fats.
•
Cancer of the breast, cervix, vagina
or uterus.
•
Known, suspected or a past history
of cancer responsive to female
hormones.
•
The following during previous
pregnancy:
-
Severe pruritus (itching of

Summary of Product characteristics

Pfizer Confidential
CLD TITLE
: Norethisterone (Noriday)
CLD DATE
: 21 June 2021
COUNTRY
: Malaysia
REFERENCE DOCUMENT
: UK SmPC, dated 18 September 2019
REASON FOR CHANGE
: PfLEET 2021-0070603 (M) - To update the storage condition as per BOH
request
Pfizer Confidential
1
PFIZER
NORIDAY
*
Norethisterone
1.
NAME OF THE MEDICINAL PRODUCT
Noriday 350 microgram tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 350 micrograms norethisterone.
Excipient(s) with known effect
Each tablet contains 62.25 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, flat, circular, bevel-edged, tablet inscribed ‘SEARLE’ on
one side and ‘NY’ on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Starting on the first day of menstruation, one pill every day without
a break in medication for
as long as contraception is required. Additional contraceptive
precautions (such as a condom)
should be taken for the first 7 days of the first pack. Pills should
be taken at the same time
each day.
Missed pills
If a pill is missed within 3 hours of the correct dosage time then the
missed pill should be
taken as soon as possible; this will ensure that contraceptive
protection is maintained. If a pill
is taken 3 or more hours late it is recommended that the woman takes
the last missed pill as
soon as possible and then continues to take the rest of the pills in
the normal manner.
However, to provide continued contraceptive protection it is
recommended that an alternative
method of contraception, such as a condom, is used for the next 7
days.
Changing from another oral contraceptive
In order to ensure that contraception is maintained it is advised that
the first pill is taken on
the day immediately after the patient has finished the previous pack.
Pfizer Confidential
2
Use after childbirth, miscarriage or abortion
The first pill should be taken on the 21
st
day after childbirth. Th