Primolut N 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NORETHISTERONE

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

G03DC02

INN (International Name):

NORETHISTERONE 5 mg

Pharmaceutical form:

TABLET

Composition:

NORETHISTERONE 5 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2007-04-19

Patient Information leaflet

BP22036_REC30610
PACKAGE LEAFLET – INFORMATION
FOR THE USER
PRIMOLUT N
5 mg Tablets
NORETHISTERONE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to
read it again.
If you have more questions, ask your
doctor or pharmacist.
This medicine has been prescribed
for you. Do not pass it on to others. It
may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious,
or if you notice any side effect not
listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT PRIMOLUT N IS AND WHAT IT
IS USED FOR
2.
BEFORE YOU TAKE PRIMOLUT N
3.
HOW YOU TAKE PRIMOLUT N
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PRIMOLUT N
6.
FURTHER INFORMATION
1.
WHAT PRIMOLUT N IS AND WHAT IT
IS USED FOR
Primolut N contains norethisterone,
which belongs to a group of
medicines called _progestogens_, which
are female hormones.
Primolut N can be used:
•
to treat irregular, painful or heavy
periods
•
to treat endometriosis (where
tissue from the lining of the womb
is present in places where it is
not normally found)
2.
BEFORE YOU TAKE PRIMOLUT N
Before you can begin taking Primolut
N, your doctor will ask you some
questions about your personal health
history and that of your close
relatives. The doctor will also
measure your blood pressure, and
depending upon your personal
situation, may also carry out some
other tests.
DO NOT TAKE PRIMOLUT N IF YOU ARE:
•
ALLERGIC to norethisterone or any
of the other ingredients. The
ingredients are listed in section 6
•
PREGNANT or if you think you
might be pregnant
•
BREASTFEEDING
OR IF YOU HAVE:
•
any UNEXPLAINED BLEEDING FROM
THE VAGINA
•
(or are recovering from ) a LIVER
DISEASE and the blood tests
show that your liver is not yet
working normally.
•
(or have ever had) LIVER CANCER.
DO NOT TAKE PRIMOLUT N IF YOU HAVE:
•
(or ever have had) BLOOD CLOTS
in the legs or lungs, a heart
attack or stroke (see also “Other
things you should know”)
•
(or ever have had) any medi

Summary of Product characteristics

1 of 11
BP22036_REC30610
S
UMMARY
O
F
P
RODUCT
C
HARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Primolut N 5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg norethisterone
Excipients: also includes Lactose Monohydrate 70.0mg per tablet.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets
Round, white, flat 7mm tablet, impressed with ‘AN’ in a regular
hexagon on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dysfunctional bleeding, endometriosis
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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,
barrier 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, 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 suspension
of bleeding. Also in these
cases tablet intake should not be interrupted or stopped.
•
Missing arrest of haemorrhage, heavy breakthrough bleeding
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 so that other
measures are then mostly required. This also applies to cases where
after an initial