Norethisterone 5mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Norethisterone

Διαθέσιμο από:

Wockhardt UK Ltd

Φαρμακολογική κατηγορία (ATC):

G03AC01

INN (Διεθνής Όνομα):

Norethisterone

Δοσολογία:

5mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 06040102; GTIN: 5012727903132

Φύλλο οδηγιών χρήσης

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 the following list carefully to
see if any of these apply to you.
Consult your doctor if you are not
sure.
DO NOT TAKE NORETHISTERONE

Αρχείο Π.Χ.Π.

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