Primolut N

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NORETHISTERONE

Available from:

Bayer PLC

ATC code:

G03DC02

INN (International Name):

NORETHISTERONE

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

PACKAGING TECHNOLOGY BERLIN SGQWX
page 1
Bayer AG
client: JS86
material-no.: 85996428
PZ: 2598F-4
code-no.: 36
name: LF-PRIMOLUT N 5MG TAB GB
country: GB/-/BAG
colors: BLACK
version: 21.07.2017/01
Restricted Document
dimension: 420 X 160 MM
THIS AREA MUST BE IDENTICAL ON BOTH SIDES!
J PLEASE TURN OVER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT PRIMOLUT N IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIMOLUT N
3.
HOW TO TAKE PRIMOLUT N
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PRIMOLUT N
6.
CONTENTS OF THE PACK AND OTHER 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 in several different circumstances:
R to treat irregular, painful or heavy periods
R to treat endometriosis (where tissue from the lining of the womb is
present in places
where it is not normally found)
R to treat premenstrual syndrome (also known as premenstrual tension,
PMS or PMT)
R to delay periods
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIMOLUT N
R Your doctor will discuss your medical and family history with you.
Your doctor will also
need to check your blood pressure and make sure you are not pregnant.
You may also
need additional checks, such as a breast examination, that will be
specific to your medical
needs and/or concerns.
DO NOT TAKE PRIMOLUT N:
R IF YOU ARE ALLERGIC to norethisterone or any of the other
ingredients of this medicine
(listed in s

Summary of Product characteristics

1.3.1
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Primolut N
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 milligrams of norethisterone BP.
Excipient with known effect
Lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM.
Tablet.
White, uncoated tablets impressed with ‘AN’ in a regular hexagon
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metropathia haemorrhagica.
Premenstrual syndrome.
Postponement of menstruation.
Endometriosis. Menorrhagia. Dysmenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Not intended for use in children.
_Metropathia haemorrhagica (dysfunctional uterine bleeding): _1 tablet
3 times daily for 10 days.
Bleeding
is
arrested
usually
within
1-3
days.
A
withdrawal
bleeding
resembling
normal
menstruation occurs within 2-4 days after discontinuing treatment. One
tablet twice daily from
the 19
th
to the 26
th
day of the two subsequent cycles should be given to prevent recurrence
of
the condition.
To ensure treatment success, Primolut N must be taken for the full 10
days. Occasionally, slight
bleeding may occur after the initial suspension of bleeding. Treatment
should not be interrupted
or suspended in these cases.
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 suspension
of bleeding, fairly heavy bleeding reoccurs during tablet intake.
_Premenstrual syndrome (including premenstrual mastalgia): _
Premenstrual symptoms such as
headache,
migraine,
breast
discomfort,
water
retention,
tachycardia,
and
psychological
disturbances may be relieved by the administration of 1-3 tablets
daily from the 19
th
to the 26
th
day of the cycle. Treatment should be repe