Primolut-Nor 5 mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC code:

G03DC02

INN (International Name):

NORETHISTERONE ACETATE 5 mg/5ml

Pharmaceutical form:

TABLET

Composition:

NORETHISTERONE ACETATE 5 mg/5ml

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Product summary:

Licence number in the source country: Spain - 39927, 724247

Authorization status:

Authorised

Authorization date:

2024-01-19

Patient Information leaflet

PACKAGE LEAFLET – INFORMATION FOR THE USER
PRIMOLUT-NOR 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-Nor is and what it is used for
2.
Before you take Primolut-Nor
3.
How you take Primolut-Nor
4.
Possible side effects
5.
How to store Primolut-Nor
6.
Further information
1.WHAT PRIMOLUT-NOR IS AND WHAT IT IS USED FOR
Primolut-Nor contains norethisterone, which belongs to a group of
medicines called
progestogens, which are female hormones.
Primolut-Nor 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-NOR
Before you can begin taking Primolut-Nor, 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-Nor 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-Nor 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 m

Summary of Product characteristics

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BP22036_REC30610
S
UMMARY
O
F
P
RODUCT
C
HARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Primolut-Nor 5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Primolut-Nor 5 mg contains 5 mg of norethisterone
acetate.
Excipient with known effect: 67,375 mg lactose monohydrate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Compressed.
Primolut-Nor 5 mg: white tablet with a cross groove on one side and
engraved on the other side
with the letters "AP" enclosed in a regular hexagon.
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-Nor 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-Nor 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-Nor 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