TIBOLONE LUPIN 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:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

84 Tablets, 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.

Product summary:

Visual Identification: White to off-white round uncoated tablets without any markings.; 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:

2018-04-03

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
TIBOLONE LUPIN
(TIBOLONE) TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Tibolone Lupin.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking Tibolone
Lupin against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to
read it again.
WHAT TIBOLONE LUPIN IS
USED FOR
Tibolone Lupin 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.
Tibolone Lupin contains
tibolone, a substance that has
favourable effects on different
tissues in the body, such as
brain, vagina and bone.
Tibolone Lupin is used in post-
menopausal women at least 12
months since their last natural
period.
Tibolone Lupin is used for the
following.
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”). Tibolone alleviates
these symptoms after
menopause.
You will only be prescribed
Tibolone Lupin 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
Tibolone Lupin to prevent
osteoporosis after menopause.
Tibolone Lupin is not a
contraceptive.
Tibolone Lupin has no effect on
alertness and concentration as
far as is known.
Tibolone Lupin is available only
with a doctor's prescription.
BEFORE YOU TAKE TIBOLONE
LUPIN
_WHEN YOU MUST NOT TAKE IT _
DO N

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – TIBOLONE LUPIN
(TIBOLONE) TABLETS
1
NAME OF THE MEDICINE
Tibolone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tibolone Lupin tablets contain 2.5 mg tibolone.
List of excipients with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tibolone Lupin 2.5 mg tablet is white to off-white, round, uncoated
tablets without any markings.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tibolone Lupin is indicated for:
•
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, Tibolone Lupin 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, see SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS
and SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE). Tibolone Lupin 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.
Tibolone Lupin v0.1
Page 2 of 15
(tibolone) tablets
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 contin