Primolut N 5 mg Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Norethisterone

Disponibil de la:

Bayer Limited

Codul ATC:

G03DC; G03DC02

INN (nume internaţional):

Norethisterone

Dozare:

5 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Estren derivatives; norethisterone

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1978-04-01

Prospect

18153
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 medical
conditio

Caracteristicilor produsului

Health Products Regulatory Authority
01 August 2019
CRN00970K
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Primolut N 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg norethisterone.
Excipients: also includes Lactose Monohydrate 70.0mg per tablet.
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Tablet.
Round, white, flat 7 mm 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