APO-TIBOLONE tibolone 2.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tibolone, Quantity: 2.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

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, <> (tibolone tablets) 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 CLINICAL TRIALS and PRECAUTIONS). <> (tibolone tablets) should only be continued for as long as the benefit outweighs the risks.

Product summary:

Visual Identification: White to off white, circular with flat face beveled edge, uncoated tablet debossed with TO above 2 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-03-28

Patient Information leaflet

APO-TIBOLONE
1
APO-TIBOLONE TABLETS
_tibolone _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
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 LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
APO-Tibolone 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.
APO-Tibolone contains tibolone, a
substance that has favourable effects
on different tissues in the body, such
as brain, vagina and bone. APO-
Tibolone is used in postmenopausal
women at least 12 months since their
last natural period.
APO-Tibolone 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"). APO-Tibolone
alleviates these symptoms after
menopause. You will only be
prescribed APO-Tibolone 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 APO-Tibolone to
prevent osteoporosis after
menopause.
APO-Tibolone is not a contraceptive.
APO-Tibolone has no effect on
alertness and concentration as far as
is known.
A doctor's prescription is required to
obtain this medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS A

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – APO-TIBOLONE (TIBOLONE)
TABLET, UNCOATED
1
NAME OF THE MEDICINE
Tibolone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg tibolone.
List of excipients with known effect: Lactose and lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, uncoated.
APO-Tibolone 2.5 mg are white to off white, circular with flat face
beveled edge, uncoated tablet
debossed with ‘TO’ above ‘2’ on one side and plain on other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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, APO-Tibolone 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). APO-Tibolone should only be continued for as
long as the benefit
outweighs the risks.
4.2
D
OSE 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 co