Norethisterone 5mg Tablets

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

NORETHISTERONE

Prieinama:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC kodas:

L02AB

INN (Tarptautinis Pavadinimas):

NORETHISTERONE 5 mg

Vaisto forma:

TABLET

Sudėtis:

NORETHISTERONE 5 mg

Recepto tipas:

POM

Gydymo sritis:

ENDOCRINE THERAPY

Autorizacija statusas:

Withdrawn

Leidimo data:

2019-05-13

Pakuotės lapelis

Page 1 of 7
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 TABLETS

Prekės savybės

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1
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6
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.
Page
2
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6
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, pu