NORIMIN 28 Day tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

ethinylestradiol, Quantity: 36 microgram; norethisterone, Quantity: 500 microgram

Disponibil de la:

Pfizer Australia Pty Ltd

Forma farmaceutică:

Tablet, uncoated

Compoziție:

Excipient Ingredients: lactose monohydrate; sunset yellow FCF; magnesium stearate; microcrystalline cellulose; lactose

Calea de administrare:

Oral

Unități în pachet:

4 x 28 tablets (112 tablets), 2 x 28 tablets (56 tablets)

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

INDICATIONS AS AT 31 AUGUST 1998 : Contraception

Rezumat produs:

Visual Identification: Orange, round, flat tablet with bevelled edges, approximately 3/16 inch diameter, engraved "Searle" on one side and "P" on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Registered

Data de autorizare:

1998-01-08

Prospect

NORIMIN
® 28 DAY
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NORIMIN 28 DAY?
Norimin 28 Day contains the active ingredients ethinylestradiol and
norethisterone. Norimin 28 Day is used to prevent pregnancy.
For more information, see Section 1. Why am I using Norimin 28 Day? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NORIMIN 28 DAY?
Do not use if you have ever had an allergic reaction to
ethinylestradiol or norethisterone, or any other similar oral
contraceptives, or
any of the ingredients listed in Section 7. Product Details in the
full CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
Norimin 28 Day? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interact with Norimin 28 Day and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NORIMIN 28 DAY?
•
Take one tablet at the same time every day, regardless of how often
you have sex.
•
See the full CMI for instructions on how to start taking Norimin 28
Day for the first time or how to change to Norimin 28 Day from
a different contraceptive.
More instructions can be found in Section 4. How do I use Norimin 28
Day? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NORIMIN 28 DAY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
Norimin 28 Day.
•
Tell your doctor immediately if you become pregnant while taking
Norimin 28 Day.
•
See your doctor if you have not taken your tablets correctly and have
missed a period.
•
Have regular check ups from your doctor, including a Pap smear.
•
Perform regular breast self-examination
THINGS YOU
SHOULD NOT DO
•
D

Caracteristicilor produsului

Version: pfpnorpt10120
Supersedes: pfpnorpt11018
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
NORIMIN
 28 DAY TABLETS
NORIMIN-1
 28 DAY TABLETS
(NORETHISTERONE AND ETHINYLESTRADIOL)
1. NAME OF THE MEDICINE
Norethisterone and Ethinylestradiol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NORIMIN 28 day tablets
Each blue active tablet contains norethisterone 500

g and ethinylestradiol 35

g.
Each orange tablet is a placebo tablet.
NORIMIN-1 28 day
Each white active tablet contains norethisterone 1 mg and
ethinylestradiol 35

g.
Each orange tablet is a placebo tablet.
EXCIPIENTS WITH KNOWN EFFECT
NORIMIN 28 day tablets
Blue tablets: Lactose monohydrate.
Orange tablets: Lactose, Lactose monohydrate
NORIMIN-1 28 day
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
Tablet
NORIMIN 28 day: Each blister contains 21 blue active tablets and 7
orange placebo tablets.
NORIMIN-1 28 day: Each blister contains 21 white active tablets and 7
orange placebo tablets.
Version: pfpnorpt10120
Supersedes: pfpnorpt11018
Page 2 of 26
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception.
4.2 DOSE AND METHOD OF ADMINISTRATION
NORIMIN 28 DAY PACK
To achieve maximum contraceptive effectiveness, NORIMIN 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 blue active tablet corresponding to the day of
the week from the silver area of the
NORIMIN 28 day pack. Thereafter one blue active tablet is taken daily,
following the arrows on the
pack, until all 21 blue 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 t