Kliogest

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oestradiol hemihydrate; Norethisterone acetate; Oestradiol

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

 
Kliogest
®
 Tablets   

Page 1 of 6 
Klicmi7.doc 
KLIOGEST
®

_Oestradiol/Norethisterone acetate _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
WHEN YOU MUST NOT USE KLIOGEST
®
. 1

WHAT KLIOGEST
®
 IS USED FOR............. 1

BEFORE YOU TAKE KLIOGEST
®
.............. 1

HOW TO TAKE KLIOGEST
®
.................... 3

WHILE YOU ARE TAKING KLIOGEST
®
..... 3

SIDE EFFECTS....................................... 3

STORAGE............................................. 5

PRODUCT DESCRIPTION ....................... 5

FURTHER INFORMATION....................... 5

DIRECTIONS FOR USE ........................... 6

This leaflet answers some common 
questions about Kliogest
®
, the 
menopause (the ‘change of life’), and 
hormone therapy.  It does not contain all 
the available information.  It does not 
take the place of talking to your doctor 
or pharmacist. 
All medicines have risks and benefits.  
Your doctor has weighed the risks of 
you using Kliogest
® 
against the benefits 
they expect it will have for you. 
ASK YOUR DOCTOR OR PHARMACIST IF YOU 
HAVE ANY CONCERNS ABOUT USING THIS 
MEDICINE. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
YOU MAY NEED TO READ IT AGAIN. 
Kliogest
®
 is available only by 
prescription at pharmacies. 
WHEN YOU MUST NOT USE 
KLIOGEST
®

Do not use Kliogest
®
 or other 
oestrogens, with or without a 
progestogen to prevent heart attacks, 
stroke or dementia.  
A study called the Women’s Health 
Initiative indicated increased risk of 
heart attack, stroke, breast cancer, and 
blood clots in the legs or lungs in 
women receiving treatment with a 
product containing conjugated 
oestrogens 0.625 mg and the 
progestogen medroxyprogesterone 
acetate (MPA). The researchers stopped 
the study after 5 years when it was 
determined the risks were greater than 
the benefits in this group.

Summary of Product characteristics

Product Information 
Klipi7.doc 

Page 1 of 17 

PRODUCT INFORMATION 

KLIOGEST
®  

WARNING 

Oestrogens and progestogens should not be used for the prevention of
cardiovascular disease or 
dementia. 

The Women’s Health Initiative (WHI) study reported increased risks
of myocardial infarction, 
stroke, invasive breast cancer, pulmonary emboli, and deep vein
thrombosis in postmenopausal 
women (50 to 79 years of age) during 5 years of treatment with
conjugated oestrogens (0.625 mg) 
combined with medroxyprogesterone acetate (2.5 mg) relative to
placebo.  (See ‘Clinical Trials’and 
‘Precautions.’) 

The WHI study reported increased risks of stroke and deep vein
thrombosis in postmenopausal 
women (50 to 79 years of age) during 6.8 years of treatment with
conjugated oestrogens (0.625 mg) 
relative to placebo.  (See ‘Clinical Trials’and
‘Precautions.’) 

The Women’s Health Initiative Memory Study (WHIMS), a substudy of
WHI, reported increased 
risk of developing probable dementia in postmenopausal women 65 years
of age or older during 4 
to 5.2 years of treatment with conjugated oestrogens, with or without
medroxyprogesterone acetate, 
relative to placebo. It is unknown whether this finding applies to
younger postmenopausal women.  
(See ‘Clinical Trials’and ‘Precautions.’) 

Other doses of conjugated oestrogens and medroxyprogesterone acetate,
and other combinations 
and dosage forms of oestrogens and progestogens were not studied in
the WHI clinical trials and, in 
the absence of comparable data, these risks should be assumed to be
similar. Because of these risks, 
oestrogens with or without progestogens should be prescribed at the
lowest effective doses and for 
the shortest duration consistent with treatment goals and risks for
the individual woman. 

NAME OF THE MEDICINE 

Oestradiol (as hemihydrate) 
Norethisterone acetate 

DESCRIPTION 

Kliogest is a continuous combined oestrogen/progestogen preparatio