Primolut N

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Norethisterone 5mg;  

Available from:

Bayer New Zealand Limited

INN (International Name):

Norethisterone 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Norethisterone 5mg   Excipient: Lactose monohydrate Magnesium stearate Maize starch

Units in package:

Blister pack, PVC/Al, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Patient Information leaflet

1904 PRIMOLUT N
®
CMI
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
•
abnormally heavy and prolonged
menstrual bleeding
•
premenstrual complaints
(premenstrual syndrome)
•
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 IF YOU
ARE PREGNANT OR THINK YOU MIGHT
BE PREGNANT.
It may affect your developing baby
if you take it during pregnancy.
DO NOT BREASTFEED I

Summary of Product characteristics

1902 Primolut N- Data Sheet
Page 1 of 13
NEW ZEALAND DATA SHEET
1
PRIMOLUT N®
PRIMOLUT N ® 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet of PRIMOLUT N contains 5 mg of norethisterone.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Each round, white, flat, 7 mm tablet is impressed with an “AN” in
a regular hexagon on one side and
quarter-scored on the other and contains 5 mg norethisterone.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Dysfunctional
bleeding,
premenstrual
syndrome,
cyclical
mastopathy,
timing
of
menstruation,
endometriosis, menorrhagia.
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.
The following dosages are recommended:
_Dysfunctional uterine bleeding _
The administration of one tablet PRIMOLUT N three times daily over 10
days, in the majority of
cases, leads to the arrest of 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, withdrawal
bleeding will occur with the
intensity and duration of normal menstruation.
_Slight bleeding during tablet-taking _
Occasionally, slight bleeding may occur after the initial arrest of
bleeding. In these cases tablet-
taking must not be interrupted or stopped.
_Missing arrest of haemorrhage, heavy break-through bleeding _
If the 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,