Norethisterone 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Norethisterone

Available from:

Mawdsley-Brooks & Company Ltd

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

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
PACKAGE LEAFLET: INFORMATION FOR
THE USER
NORETHISTERONE 5MG TABLETS
NORETHISTERONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING 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.
The name of your medicine is
Norethisterone 5mg Tablets. In the rest of
this leaflet it is called Norethisterone Tablets.
WHAT IS IN THIS LEAFLET:
1. What Norethisterone Tablets are and
what they are used for
2. What you need to know before you take
Norethisterone Tablets
3. How to take Norethisterone Tablets
4. Possible side effects
5. How to store Norethisterone Tablets
6. Contents of the pack and other
information
1. WHAT NORETHISTERONE TABLETS ARE
AND WHAT THEY ARE USED FOR
Norethisterone Tablets is one of a group of
medicines called ‘Progestogens’.
Progestogens are similar to the natural
female hormone progesterone.
Norethisterone Tablets contains the
progestogen called norethisterone as the
active ingredient. Norethisterone Tablets
has many uses.
You can take Norethisterone Tablets to
treat or manage:
• Heavy periods
• Painful periods
• Irregular periods or periods that are
more frequent than normal
• Premenstrual tension (PMT)
• Endometriosis (where tissue from your
womb is found outside your womb)
• Breast cancer.
Your doctor may also prescribe
Norethisterone Tablets if you want to delay
your next period.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NORETHISTERONE TABLETS
Norethisterone Tablets may not be suitable
for all women. Please read t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
NORETHISTERONE TABLETS BP 5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of Norethisterone.
Excipients with known effect
Each tablet contains 70.52mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
• Metropathia haemorrhagica.
• Premenstrual syndrome.
• Postponement of menstruation.
• Dysmenorrhoea.
• Endometriosis.
• Menorrhagia.
• Disseminated Carcinoma of the breast.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Prophylaxis against recurrence of dysfunctional bleeding: If there are
no signs of
resumption of normal ovarian function (no rise of morning temperature
in the second
half of the cycle), recurrence must be anticipated. Cyclical bleeding
can be
established with 1 tablet twice daily from the 19th to the 26th day of
the cycle.
Premenstrual syndrome (including premenstrual mastalgia): Premenstrual
symptoms
such as headache, migraine, breast discomfort, water retention,
tachycardia and
psychic disturbances may be relieved by the administration of 2-3
tablets daily from
the 19th to the 26th day of the cycle. Treatment should be repeated
for several cycles.
When treatment is stopped, the patient may remain symptom-free for a
number of
months.
Postponement of menstruation: In cases of too frequent menstrual
bleeding, and in
special circumstances (eg operations, travel, sports) Dosage: 1 tablet
three times
daily, starting 3 days before the expected onset of menstruation. A
normal period
should occur 2-3 days after the patient has stopped taking tablets.
Dysmenorrhoea: functional or primary dysmenorrhoea is almost
invariably relieved
by the suppression of ovulation.