Noriday

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Norethisterone 0.35mg;  ;  

Disponibil de la:

Pfizer New Zealand Limited

INN (nume internaţional):

Norethisterone 0.35 mg

Dozare:

0.35 mg

Forma farmaceutică:

Tablet

Compoziție:

Active: Norethisterone 0.35mg     Excipient: Lactose monohydrate Magnesium stearate Maize starch Povidone

Unități în pachet:

Blister pack, 1 x 28 tablet physician sample, 28 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Bayer AG

Indicații terapeutice:

Noriday is indicated for oral contraception in women for whom oestrogens may not be appropriate.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, 1 x 28 tablet physician sample - 28 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, 3 x 28 tablet pack - 84 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, 4 x 28 tablet pack - 112 tablets - 60 months from date of manufacture stored at or below 25°C

Data de autorizare:

1972-07-06

Prospect

NORIDAY
 28 DAY TABLETS
NORETHISTERONE 350 MICROGRAMS
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NORIDAY 28 day
tablets.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking NORIDAY
against the benefits it is expected to
have for you.
Use NORIDAY as directed by your
doctor and follow advice given in
this leaflet.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT NORIDAY IS USED
FOR
NORIDAY is a birth control pill
commonly known as a
“progestogen-only” pill or “mini
pill”. NORIDAY is usually given
to women who are unable to take
other types of birth control pills
(combined oral contraceptives) or
use intrauterine devices (IUDs).
It is not known exactly how the
“progestogen-only” pill works.
However, NORIDAY causes
changes to the mucus of the cervix
and the lining of the womb and
affects the hormonal control system
of the body which may all
contribute to its effectiveness.
The effectiveness of the
“progestogen-only” pill is lower
than that of other birth control pills.
If taken according to directions it is
expected that if 100 women used
the progestogen-only pill for 1 year
approximately 4 pregnancies may
occur compared to less than 1
pregnancy in women using an oral
contraceptive containing an
estrogen and progestogen.
NORIDAY (like all oral
contraceptives) is intended to
prevent pregnancy. It does not
protect against HIV infection
(AIDS) and other sexually
transmitted diseases.
NORIDAY 28 day is only available
on a prescription from your doctor.
THIS MEDICINE IS PRESCRIBED FOR
YOU AND SHOULD NOT BE GIVEN TO
OTHERS.
BEFORE YOU START TO TAKE
NORIDAY
WHEN YOU MUST NOT TAKE IT
NORIDAY 28 Day tablets are not
suitable for some women.
IF YOU HAVE OR HAVE HAD ANY OF
THESE PROBLEMS, DO NOT TAKE
NORIDAY UNTIL YOU HAVE TALKED
TO YOUR DOCTOR:
DO NOT TAKE IT IF:
•
you have had a stroke

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
1. PRODUCT NAME
NORIDAY
®
28 DAY 0.35 mg tablets
.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.35
mg of norethisterone.
EXCIPIENTS WITH KNOWN EFFECT
•
Lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, round, flat with bevelled edges, 7/32” diameter, inscribed
“SEARLE” on one side and
“NY” on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For oral contraception in women for whom estrogens may not be
appropriate.
4.2 DOSE AND METHOD OF ADMINISTRATION
To achieve maximum contraceptive effectiveness, NORIDAY 28 DAY must be
taken exactly as
directed. One tablet is taken every day at the same time, with no
interruption, whether bleeding
occurs or not. Each subsequent pack is started on the day after the
previous pack is finished.
Contraceptive efficacy may be reduced if a tablet is taken more than 3
hours late.
To provide added protection during the first cycle only, the patient
should be instructed to use an
additional method of contraception (with the exception of rhythm,
temperature and cervical-
mucus methods).
HOW TO START NORIDAY 28 DAY
_No preceding hormonal contraceptive use (in the past month) _
Tablet-taking should start on the FIRST DAY of menstrual bleeding. If
starting on another day, a
non-hormonal back-up method of birth control (such as condoms and
spermicide) should be used
for the first 48 hours. Thereafter, one tablet is taken continuously
at the same time every day
preferably in the early evening even during menstrual bleeding.
Version: pfdnorit10118
Supercedes: pfdnorit10705
Page 1 of 12
_Changing from another type of progestin-only method (implant,
injection) _
Tablet-taking should start on the day of an implant removal or, if
using an injection, the day the
next injection would be due. In addition, a non-hormonal back-up
method of birth control should
be used for the first 48 hours.
_Changing from a combination oral contraceptive (COC) _
Tablet-taking should start on