XYVION tibolone 2.5mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

tibolone, Quantity: 2.5 mg

Inapatikana kutoka:

ORGANON PHARMA PTY LTD

INN (Jina la Kimataifa):

Tibolone

Dawa fomu:

Tablet, uncoated

Tungo:

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

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

84 tablets, 10 tablets, 28 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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, Xyvion 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). Xyvion should only be continued for as long as the benefit outweighs the risks.

Bidhaa muhtasari:

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/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Registered

Idhini ya tarehe:

2007-03-22

Taarifa za kipeperushi

XYVION
® TABLETS
_tibolone 2.5 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xyvion. 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 Xyvion
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 XYVION IS USED
FOR
Xyvion 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.
Xyvion contains tibolone, a
substance that has favourable effects
on different tissues in the body, such
as brain, vagina and bone. Xyvion is
used in postmenopausal women at
least 12 months since their last
natural period.
Xyvion 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"). Xyvion
alleviates these symptoms after
menopause. You will only be
prescribed Xyvion 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 Xyvion to prevent
osteoporosis after menopause.
Xyvion is not a contraceptive.
Xyvion 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 XYVION
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE XYVION IF:
•
you are pregnant or think you
may be pregnant
•
you are breastfeeding
•
you have or have ever had breast

Tabia za bidhaa

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
XYVION

(TIBOLONE) TABLETS
1
NAME OF THE MEDICINE
tibolone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet containing 2.5mg 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.
XYVION (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, XYVION 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). XYVION
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