LOCILAN 28 Day tablet 350 microgram

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

norethisterone

Available from:

Pfizer Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

LOCILAN
® 28 DAY
TABLETS
_Norethisterone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LOCILAN 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 LOCILAN
against the benefits it is expected to
have for you.
Use LOCILAN 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.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LOCILAN IS
USED FOR
LOCILAN is a birth control pill
commonly known as a "progestogen-
only" pill or "mini pill". LOCILAN
is usually given to women who are
unable to take other types of birth
control pills (oral contraceptives) or
use intrauterine devices (IUDs).
LOCILAN 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 the birth control
(contraceptive) action.
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
oestrogen and progestogen.
LOCILAN (like all oral
contraceptives) is intended to prevent
pregnancy. It does not protect against
HIV infection (AIDS) and other
sexually transmitted diseases.
LOCILAN 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 LOCILAN
_WHEN YOU MUST NOT TAKE IT_
LOCILAN 28 Day tablets are not
suitable for some women.
IF YOU HAVE OR HAVE HAD ANY OF
THESE PROBLEMS, DO NOT TAKE
LOCILAN UNTIL YOU HAVE TALKED TO
YOUR DOCTOR.
Do not take it if
•
you have

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
LOCILAN
®
28-DAY
(NORETHISTERONE)
TABLETS
1.
NAME OF THE MEDICINE
Norethisterone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LOCILAN tablet contains 0.35 mg norethisterone.
EXCIPIENTS WITH KNOWN EFFECT_ _
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets.
LOCILAN Tablets are are round, white, marked "SEARLE" on one side and
"NY" on the
reverse side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LOCILAN is an oral contraceptive for women who will not, or cannot
tolerate other oral
contraceptives or intrauterine devices.
ADVICE TO THE PATIENT
This product (like all oral contraceptives) is intended to prevent
pregnancy. It does not protect
against HIV infection (AIDS) and other sexually transmitted diseases.
4.2 DOSE AND METHOD OF ADMINISTRATION
One LOCILAN 0.35 mg tablet should be taken daily, at about the same
time each day starting
on the first day of menstruation. Tablets should be taken
continuously, without interruption,
whether bleeding occurs or not. This is especially important for
patients new to progestogen-
only oral contraception. Each subsequent pack is started on the day
after the previous pack is
finished.
If a tablet is missed and there is a delay of more than 3 hours after
the normal time of taking
the tablet, protection is reduced and additional means of
contraception should be used along
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with LOCILAN until menstrual bleeding occurs. The patient should be
advised that if
prolonged bleeding occurs, she should consult her physician.
If the patient has missed 1 or 2 tablets and does not have a period
within 6 weeks of the last
period,
she
should
stop
taking
LOCILAN
and
use
another
method
of
nonhormonal
contraception until pregnancy has been ruled out. If more than 2
tablets have been missed,
LOCILAN should be discontinued immediately and a method of nonhormonal
co