Norethisterone 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Norethisterone

Available from:

Sigma Pharmaceuticals 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

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 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Norethisterone 5.0mg.
_ _
For the full list of_ _excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Norethisterone 5mg Tablets are 6.5mm, round, white, uncoated tablets
with
“NE 5” on one side and a break line on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_At low dose: _
Dysfuntional uterine bleeding
Polymenorrhoea
Menorrhagia
Metropathia
Haemorrhagia
Pre-menstrual syndrome
Postponement of menstruation
_At high dose: _
Disseminated carcinoma of the breast._ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Low dose _
DYSFUNCTIONAL UTERINE BLEEDING, POLYMENORRHOEA, MENORRHAGIA,
DYSMENORRHOEA AND METROPATHIA HAEMORRHAGIA: 1 tablet three times daily
for 10 days; bleeding usually stops within 48 hours. Withdrawal
bleeding
resembling true menstruation occurs a few days after the end of
treatment. One
tablet twice daily, from days 19 to 26 of the two subsequent cycles,
should be
given to prevent recurrence of the condition.
ENDOMETRIOSIS: 1 tablet three times daily for a minimum treatment
period of
six months. The dosage should be increased to 4 or 5 tablets a day if
spotting
occurs. The initial dosage should be resumed when bleeding or spotting
stops.
POSTPONEMENT OF MENSTRUATION: 1 tablet three times daily, starting
three days
before the expected onset of menstruation. Menstruation usually
follows
within three days of finishing the treatment.
PRE-MENSTRUAL SYNDROME: 1 tablet daily from days 16 to 25 of the
menstrual
cycle.
_ _
_High dose _
For disseminated breast carcinoma the starting dose is 8 tablets
(40mg) per day
increasing to 12 tablets (60mg) if no regression is noted._ _
Method of administration
Oral Administration
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1
Pregnancy
Previous idiopathic or current venous thromboembolism (deep vein
thrombosis,
pulmonary embolism)
Active or