KLIOGEST estradiol 2mg and norethisterone acetate 1mg tablet dial dispenser pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol hemihydrate, Quantity: 2.07 mg (Equivalent: estradiol, Qty 2 mg); norethisterone acetate, Quantity: 1 mg

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

estradiol hemihydrate,Norethisterone acetate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short term symptomatic treatment of postmenopausal oestrogen deficiency (see DOSAGE AND ADMINISTRATION and CLINICAL TRIALS). For the prevention of postmenopausal bone mineral density loss. When prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. Life style modifications and the risk benefit profile of Kliogest should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. See PRECAUTIONS and DOSAGE AND ADMINISTRATION. Kliogest is for use in postmenopausal women with an intact uterus. In perimenopausal women treated with Kliogest the incidence of vaginal bleeding is unacceptably high and therefore therapy should not be initiated sooner than one year after the last menstrual period.

Product summary:

Visual Identification: 28 white tablets, 6 millimetres in diameter engraved 'Novo 281'.; Container Type: Dial Dispenser Pack; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-06-17

Patient Information leaflet

Kliogest
®
Tablets
Page 1 of 7
Kliogest cmi-v12
KLIOGEST
®
_Estradiol/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
® .................... 4
WHILE YOU ARE TAKING KLIOGEST
® ..... 4
SIDE EFFECTS ....................................... 4
STORAGE ............................................. 6
PRODUCT DESCRIPTION ....................... 6
FURTHER INFORMATION ....................... 6
USER INSTRUCTIONS ............................. 7
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
ESTROGENS, WITH OR WITHOUT A
PROGESTAGEN 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 estrogens
0.625 mg and the progestagen
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. The Women’s Health Initiative
Memory Study indicated increased risk
of dementia in women aged 65-79 years
taking conjugated estrogens and MPA.
There are no comparable data currently
available for other doses of conjugated
estrogens and MPA or other

Summary of Product characteristics

Kliogest-pi-v12
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
KLIOGEST
®
ESTRADIOL 2 MG (AS HEMIHYDRATE) AND NORETHISTERONE ACETATE 1 MG TABLET
DIAL DISPENSER
PACK.
WARNING
Estrogens and progestagens 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 estrogens
(0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative
to placebo (see
‘Section 5.1 Pharmacodynamic Properties’ – ‘Clinical Trials’
and ‘Section 4.4 Special
Warnings and Precautions for Use’).
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 estrogens
(0.625 mg) relative to placebo (see ‘Section 5.1 Pharmacodynamic
Properties’ – ‘Clinical
Trials’ and ‘Section 4.4 Special Warnings and Precautions for
Use’).
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
estrogens,
with
or
without
medroxyprogesterone acetate, relative to placebo. It is unknown
whether this finding applies
to younger postmenopausal women (see ‘Section 5.1 Pharmacodynamic
Properties’ – ‘Clinical
Trials’ and ‘Section 4.4 Special Warnings and Precautions for
Use’).
Other doses of conjugated estrogens and medroxyprogesterone acetate,
and other combinations
and dosage forms of estrogens and progestagens 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, estrogens with or without progestagens should be
prescribed at the lowest
effective doses and for the shortest du