Norinyl-1 28 Day tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

norethisterone, Quantity: 1 mg; mestranol, Quantity: 51.5 microgram

Dostępny od:

Pfizer Australia Pty Ltd

Forma farmaceutyczna:

Tablet, uncoated

Skład:

Excipient Ingredients: povidone; lactose monohydrate; maize starch; magnesium stearate

Droga podania:

Oral

Sztuk w opakowaniu:

4 x 28 tablets (112 tablets)

Klasa:

Medicine Registered

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

INDICATIONS AS AT 23rd JANUARY 1998: Oral contraception. NORINYL-1 is an agent for conception control.

Podsumowanie produktu:

Visual Identification: White,round, flat tablets with bevelled edges, approximately 3/16 inch diameter, engraved Searle on one side and 1 on the other.;

Status autoryzacji:

Registered

Data autoryzacji:

1997-11-07

Ulotka dla pacjenta

NORINYL-1
® 28 DAY
_Mestranol and Norethisterone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Norinyl-1 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 Norinyl-1
against the benefits it is expected to
have for you.
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 NORINYL-1 IS USED
FOR
Norinyl-1 is a combined oral
contraceptive, commonly known as a
"birth control pill" or "the Pill". It
contains both an oestrogen
(mestranol) and progestogen
(norethisterone) hormone.
Oral contraceptives belonging to this
group produce their birth control (or
contraceptive) effect by preventing
ovulation (the release of an egg from
the ovary) during each menstrual
cycle. Combined oral contraceptives
also cause changes to the mucus of
the cervix and the lining of the
womb, which contribute to the
contraceptive action.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NORINYL-1 HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Norinyl-1 28 for another reason.
Norinyl-1 28 Day is only available
on a prescription from your doctor.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU START TO
TAKE NORINYL-1
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORINYL-1 IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
mestranol or norethisterone
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines (such
as other oral contraceptives).
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
_DO NOT TAKE NORINYL-1 IF YOU_
_HAVE OR HAVE HAD ANY OF T

Charakterystyka produktu

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Supersedes: pfpnoryt11018
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
NORINYL-1
® 28 DAY
(NORETHISTERONE AND MESTRANOL)
TABLETS
1. NAME OF THE MEDICINE
Norethisterone and Mestranol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white active tablet contains norethisterone 1 mg and mestranol 50

g.
Each orange tablet is a placebo tablet.
EXCIPIENTS WITH KNOWN EFFECT
White tablets: Lactose monohydrate
Orange tablets: Lactose, Lactose monohydrate
For the full list of excipients, see section 6.1, List of Excipients.
3. PHARMACEUTICAL FORM
Tablets.
Each NORINYL-1 28 Day blister pack contains 21 white active tablets
and 7 orange placebo
tablets.
The white active tablets are round, flat tablets with bevelled edges,
approximately 3/16 inches
diameter, engraved Searle on one side and 1 on the other. The orange
inert tablets are round flat
with bevelled edges, approximately 3/16 inches in diameter, engraved
Searle on one side and P on
the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral Contraception.
NORINYL-1 is an agent for conception control.
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Supersedes: pfpnoryt11018
Page 2 of 25
4.2 DOSE AND METHOD OF ADMINISTRATION
To achieve maximum contraceptive effectiveness, NORINYL-1 28 day must
be taken as directed
and at daily intervals not exceeding 24 hours. Women should be
instructed to take the tablets at
the same time every day, preferably at bedtime.
FIRST CYCLE:
On the first day of the menstrual cycle, i.e. the first day of
bleeding, the woman is
instructed to take a white active tablet corresponding to the day of
the week from the green area of
the NORINYL-1 28 day pack. Thereafter, one white active tablet is
taken daily, following the
arrows on the pack, until all 21 white tablets have been taken. The
woman should then be instructed
to take one orange inactive tablet daily for the next seven days.
Withdrawal bleeding should usually occur within two to four days after
the last white active tablet
has been taken. The woman should be advised that her firs