Primolut N 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Norethisterone

Available from:

Bayer Plc

ATC code:

G03AC01

INN (International Name):

Norethisterone

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040102; GTIN: 5016703003762

Patient Information leaflet

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIMOLUT
 N
5 mg tablets
(norethisterone)
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:

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)
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
to treat premenstrual syndrome (also known as premenstrual tension,
PMS or PMT)

to delay periods
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIMOLUT N
_ _

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,

Summary of Product characteristics

OBJECT 1
PRIMOLUT N
Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc
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. Treatm