Utovlan 5mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Norethisterone

Հասանելի է:

Pfizer Ltd

ATC կոդը:

G03AC01

INN (Միջազգային անվանումը):

Norethisterone

Դոզան:

5mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 06040102; GTIN: 5012882007652 5012882007669

Տեղեկատվական թերթիկ

Package Leaflet: Information for the user
Utovlan
®
5 mg Tablets
norethisterone
Read all of this leaflet carefully before you start taking 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.
What is in this leaflet
1.
What Utovlan is and what it is used for
2.
What you need to know before you take Utovlan
3.
How to take Utovlan
4.
Possible side effects
5.
How to store Utovlan
6.
Contents of the pack and other information
1.
What Utovlan is and what it is used for
Utovlan is one of a group of medicines called ‘Progestogens’.
Progestogens
are similar to the natural female hormone progesterone. Utovlan
contains the
progestogen called norethisterone as the active ingredient. Utovlan
has many uses.
You can take Utovlan 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 Utovlan if you want to delay your next
period.
2.
What you need to know before you take Utovlan
Utovlan 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 Utovlan:
-
if you are allergic to norethisterone or other similar hormone
medicines, or any
of the other ingredients of this medicine ( listed in section 6).
-
if you are pregnant, or think you might be pregnant. Your doctor may
give
you a pregnancy test before starting treatment or if you miss a period
during
treatment.
-
if you have n

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Utovlan 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg norethisterone.
Excipient(s) with known effect
Each tablet contains 62.25 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, flat, circular, bevel-edged tablet inscribed 'SEARLE' on one
side and
‘U’ on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
At low dose:
Dysfunctional uterine bleeding, endometriosis, polymenorrhoea,
menorrhagia, metropathia, haemorrhagia, postponement of
menstruation and premenstrual syndrome.
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 curr