Norethisterone 5mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Norethisterone

Fáanlegur frá:

DE Pharmaceuticals

ATC númer:

G03AC01

INN (Alþjóðlegt nafn):

Norethisterone

Skammtar:

5mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 06040102

Upplýsingar fylgiseðill

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

Vara einkenni

OBJECT 1
NORETHISTERONE 5MG TABLETS
Summary of Product Characteristics Updated 21-Feb-2017 | Wockhardt UK
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 res