Primolut N 5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

norethisterone, Quantity: 5 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Norethisterone

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets, 100 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, delay of menstrual period, endometriosis, adjunct to estrogen hormone replacement therapy.

Product summary:

Visual Identification: Round and white tablet, quarter scored on one side with the letters "AN" in a regular hexagon on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2007-04-04

Patient Information leaflet

1805 PRIMOLUT N
®
dCMI
1
PRIMOLUT
® N
(PREE·MOE·LOOT)
_Norethisterone _
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Primolut N. 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 Primolut N
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST FOR MORE
ADVICE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT PRIMOLUT N IS
USED FOR
Primolut N contains a hormone,
norethisterone. This type of
hormone is similar to the natural
female hormone progesterone.
Some of the information in this
leaflet is based on experience with
estrogen containing oral
contraceptives as some of the active
ingredient in Primolut N is
converted to estrogen in the body.
However, Primolut N is not to be
used as a contraceptive
Primolut N is used to treat
•
irregular menstrual periods with
heavy and/or persistent bleeding
that has no identified cause
•
lack of menstrual bleeding
•
premenstrual complaints
(premenstrual syndrome)
•
menopausal complaints in
combination with estrogen as part
of hormone replacement therapy,
•
endometriosis (a disease caused
by womb-lining tissue growing
outside the womb)
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
PRIMOLUT N
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PRIMOLUT N IF YOU
HAVE AN ALLERGY TO:
• norethisterone, the active
ingredient in Primolut N
• any of the ingredients listed at the
end of this leaflet.
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 THIS MEDICINE

Summary of Product characteristics

-1-
PRODUCT INFORMATION
DECA-DURABOLIN
®
_(nandrolone decanoate) _
NAME OF THE MEDICINE
_ _
DECA-DURABOLIN
® 50 MG/ML (Solution for injection of nandrolone decanoate) _ _
_ _
_ _
_ _
_ _
_Molecular Formula: C_
_28_
_H_
_44_
_O_
_3 _
_Molecular mass: 428.7 _
_Cas. No: 360-70-3 _
_Chemical Name: 3-oxo-estr-4-en-17_

_-yl decanoate _
Deca-Durabolin is an androgenic oily preparation for intramuscular
administration.
DESCRIPTION
Nandrolone decanoate is a white to creamy white, crystalline powder.
It is practically insoluble in water
but is freely soluble in chloroform, ethanol, ether, fixed oils and
esters.
Deca-Durabolin comes in 1 mL pre-filled syringes containing 1 mL of
light yellow oily liquid.
Each pre-filled syringe contains 1 ml of 50 mg/mL nandrolone
decanoate.
COMPOSITION
Each ml of Deca-Durabolin contains 50 mg of the active ingredient
nandrolone decanoate. The
product also contains the inactive ingredients benzyl alcohol (0.1 mL)
and arachis (peanut) oil making
up the volume.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Deca-Durabolin is an injectable anabolic preparation. The
pharmacologically active substance is
nandrolone. The decanoate ester gives the preparation a duration of
action of about three weeks after
injection.
Nandrolone is chemically related to the male hormone. Compared to
testosterone, it has an enhanced
anabolic and a reduced androgenic activity. This has been demonstrated
in animal bioassays and
explained by receptor binding studies. The low androgenicity of
nandrolone is confirmed in clinical
use. In the human, Deca-Durabolin has been shown to positively
influence calcium metabolism and to
increase bone mass in osteoporosis. In women with disseminated mammary
carcinoma, Deca-
Durabolin has been reported to produce objective regressions for many
months. Furthermore, Deca-
Durabolin has a nitrogen-saving action. This effect on protein
metabolism has been established by
-2-
metabolic studies and is utilised therapeutically in conditions where
a protein deficiency exists such as
during chr

Summary of Product characteristics

1901PRIMOLUT N dPI
Page 1
AUSTRALIAN PRODUCT INFORMATION
PRIMOLUT
®
N (NORETHISTERONE) TABLET
1
NAME OF THE MEDICINE
Primolut N
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Primolut N contains 5 mg norethisterone.
LIST OF EXCIPIENTS WITH KNOWN EFFECT: LACTOSE MONOHYDRATE
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TABLET
Tablets are round and white, quarter scored on one side, with the
letters ‘AN’ in a
regular hexagon on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dysfunctional bleeding, primary and secondary amenorrhoea,
premenstrual
syndrome, delay of menstrual period, endometriosis, adjunct to
estrogen hormone
replacement therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The tablets are to be swallowed whole with some liquid.
The efficacy of Primolut N could be reduced if the user forgets to
take a tablet as
directed. The woman should take only the last missed tablet as soon as
she
remembers and then continue tablet intake at her usual time on the
next day.
If contraceptive protection is required, additional non-hormonal
contraceptive
methods should be used.
DYSFUNCTIONAL BLEEDING
Primolut N 1 tablet is to be taken 3 times daily for 10 days. In the
majority of
cases this will arrest uterine bleeding that is not associated with
organic lesions
within 1 to 3 days, nevertheless to ensure treatment success Primolut
N must be
taken for the full 10 days. About 2 to 4 days after completion of the
treatment,
1901PRIMOLUT N dPI
Page 2
withdrawal bleeding will occur with the intensity and duration of
normal
menstruation. Occasionally, slight bleeding may occur after the
initial suspension
of bleeding. Also in these cases tablet intake should not be
interrupted or
stopped.
If vaginal bleeding does not stop, despite correct tablet intake, an
organic cause or
an extra-genital factor (e.g. polyps, carcinoma of the cervix uteri or
endometrium,
myoma, residua of abortion, extra-uterine pregnancy, or coagulation
disorders)
must be considered