Kliogest

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %);  ;  ;  ; Norethisterone acetate 1mg;  ;  ;  ; Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %); Norethisterone acetate 1mg

Available from:

Novo Nordisk Pharmaceuticals Ltd

INN (International Name):

Estradiol hemihydrate 2.07 mg (adjustment for water content 3.2 %)

Pharmaceutical form:

Film coated tablet

Composition:

Active: Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %)       Norethisterone acetate 1mg       Excipient: Hyprolose Hypromellose Lactose monohydrate Magnesium stearate Maize starch Purified talc Purified water Triacetin Active: Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %) Norethisterone acetate 1mg

Units in package:

Calendar pack, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Product summary:

Package - Contents - Shelf Life: Calendar pack, - 28 tablets - 48 months from date of manufacture stored at or below 25°C

Authorization date:

1990-12-06

Patient Information leaflet

Kliogest®
®
Tablets 23.02.2022
Page 1 of 11
PACKAGE LEAFLET
KLIOGEST
® 2
MG/1
MG FILM-COATED TABLETS
Estradiol/norethisterone acetate
READ THIS ENTIRE 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 Kliogest
®
is and what it is used for
2.
What you need to know before you take Kliogest
®
3.
How to take Kliogest
®
4.
Possible side effects
5.
How to store Kliogest
®
6.
Contents of the pack and other information
1
WHAT KLIOGEST
® IS AND WHAT IT IS USED FOR
Kliogest
®
is a
_ _
continuous combined Hormone Replacement Therapy (HRT) which is taken
every day
without interruption
_. _
Kliogest
®
is used in postmenopausal women with at least 1 year since their last
natural period.
The tablets contain 2 hormones: estradiol 2 mg (an oestrogen identical
to the one made in the ovaries)
and norethisterone acetate 1 mg (a progestagen that acts in a similar
way to the body’s own hormone
progesterone).
Kliogest
®
is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can
cause symptoms such as hot face, neck and chest (‘hot flushes’).
Kliogest
®
alleviates these symptoms
after menopause. You will only be prescribed Kliogest
®
if your symptoms seriously hinder your daily
life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all
available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medic

Summary of Product characteristics

0
NEW ZEALAND DATASHEET
1 PRODUCT NAME
KLIOGEST
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
17ß-oestradiol and Norethisterone acetate tablets
3 PHARMACEUTICAL FORM
Kliogest calendar dial pack contains 28 tablets as described below:
White, round, film coated tablets with diameter 6mm and stamped
“Novo 281" on one side.
The other side is plain. Each tablet contains 2mg of 17ß-oestradiol
and 1mg of norethisterone
acetate and weighs about 80mg.
Excipient with known effect: lactose monohydrate. Each white
film-coated tablet contains
lactose monohydrate 36.3 mg. For the full list of excipients, see
section 6.1.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Kliogest is indicated for treatment of oestrogen deficiency syndrome,
including prevention of
bone mineral content loss in postmenopausal women at increased risk of
developing fractures.
The experience of treating women older than 65 years is limited.
4.2 Dose and method of administration
Kliogest is a continuous combined oestrogen/progestogen HRT product
with a daily addition
of a low dose progestogen to the oestrogen, and is intended for use in
women with an intact
uterus.
This
regimen
is
intended
to
avoid
monthly
withdrawal
bleeding.
Kliogest
is
administered
orally,
one
tablet
daily,
preferably
at
the
same
time
each
day,
without
interruption.
Treatment with Kliogest should preferably be initiated not earlier
than one year after the
menopause.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective
dose for the shortest duration should be used (see section 4.4).
In women with amenorrhea and not taking HRT or women in transition
from another
continuous combined HRT product, treatment with Kliogest may be
started on any convenient
day. In women in transition from sequential HRT regimens, treatment
should start right after
their withdrawal bleeding has ended.
If the patient has forgotten to take a tablet, the tablet should be
taken as soon as possible
within the next 12 hours. If more than 12 hours have passed, the
forg