LIVIAL tibolone 2.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tibolone, Quantity: 2.5 mg

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; potato starch; lactose monohydrate; ascorbyl palmitate

Administration route:

Oral

Units in package:

10 tablets Starter Pack, 28 tablets, 84 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. After careful selection of users, Livial should be prescribed for the shortest duration consistent with treatment goals. Review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at the moment (including cardiovascular disease and breast cancer, refer Clinical Trials and Precautions). Livial should only be continued for as long as the benefit outweighs the risks.

Product summary:

Visual Identification: 6mm diameter white, round, flat tablets with bevelled edge coded "MK" above "2" on one side and "Organon" and a star on the other.; Container Type: Blister Pack; Container Material: PVC; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-05-19

Patient Information leaflet

LIVIAL
® TABLETS
_Tibolone 2.5 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Livial. 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 taking Livial against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH THE
PACK.
You may wish to read it again.
WHAT LIVIAL IS USED FOR
Livial tablets contain the active
ingredient tibolone, which is a
synthetic steroid medicine used for
hormone replacement therapy (HRT).
It mimics the activity of the female
sex hormones in the body.
Livial contains tibolone, a substance
that has favourable effects on
different tissues in the body, such as
brain, vagina and bone. Livial is used
in postmenopausal women at least 12
months since their last natural period.
Livial is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER
MENOPAUSE
During the menopause, the amount of
estrogen produced by a woman's
body drops. This can cause
symptoms such as hot face, neck and
chest ("hot flushes"). Livial alleviates
these symptoms after menopause.
You will only be prescribed Livial 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 medicines are not suitable for
you, you can take Livial to prevent
osteoporosis after menopause.
Livial is not a contraceptive.
Livial has no effect on alertness and
concentration as far as is known.
A doctor's prescription is required to
obtain this medicine.
BEFORE YOU USE LIVIAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LIVIAL IF:
•
you are pregnant or think you
may be pregnant
•
you are breastfeeding
•
you have or have ever had breast

Summary of Product characteristics

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
LIVIAL
® (TIBOLONE) TABLETS
1
NAME OF THE MEDICINE
tibolone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet containing 2.5 mg of the steroid tibolone.
List of excipients with known effect: lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets.
LIVIAL (tibolone) tablets 2.5 mg are 6 mm in diameter, white, round
and flat with bevelled
edges, coded "MK" above "2" on one side and "Organon" and a star on
the reverse side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Short-term treatment of symptoms resulting from the natural or
surgical menopause in
postmenopausal women.
•
Second line therapy for the prevention of bone mineral density loss in
postmenopausal
women
at
high
risk
of
future
osteoporotic
fractures
who
are
intolerant
of,
or
contraindicated for, other medicinal products approved for the
prevention of bone
mineral density loss.
After careful selection of users, LIVIAL should be prescribed for the
shortest duration
consistent with treatment goals. Review the need for continuation of
treatment after 6 months,
taking into account the risk-benefit ratio for the individual user at
that moment (including
cardiovascular disease and breast cancer, see SECTION 5.1
PHARMACODYNAMIC PROPERTIES,
CLINICAL TRIALS and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE). LIVIAL should
only be continued for as long as the benefit outweighs the risks.
4.2
DOSE AND METHOD OF ADMINISTRATION
TREATMENT OF SYMPTOMS RESULTING FROM THE NATURAL OR SURGICAL
MENOPAUSE, MORE THAN
ONE YEAR AFTER MENOPAUSE:_ _
The recommended dose is 2.5 mg once daily.
PREVENTION OF POST-MENOPAUSAL BONE MINERAL DENSITY LOSS:_ _
The recommended dose is 2.5 mg once daily.
No dose adjustment is necessary for the elderly.
The tablets should be swallowed with some water or other drink,
preferably at the same time
of day. Improvement of symptoms generally occurs within a few weeks,
but optimal results are
obtained when therapy is continued for at