TIBOLONE SANDOZ tibolone 2.5 mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

tibolone, Quantity: 2.5 mg

Tilgjengelig fra:

Southern Cross Pharma Pty Ltd

Legemiddelform:

Tablet, uncoated

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

84 Tablets, 28 Tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

- 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.

Produkt oppsummering:

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

Autorisasjon status:

Registered

Autorisasjon dato:

2018-04-03

Informasjon til brukeren

TIBOLONE SCP/032017/CMI-00
1
TIBOLONE SANDOZ
_contains the active ingredient tibolone _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about TIBOLONE SANDOZ.
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
SANDOZ 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 SANDOZ is
used for
TIBOLONE SANDOZ 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 SANDOZ contains
tibolone, a substance that has a
favourable effects on different
tissues in the body, such as brain,
vagina and bone. TIBOLONE
SANDOZ is used in postmenopausal
women at least 12 months since
their last natural period.
TIBOLONE SANDOZ 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”). Tibolone
alleviates these symptoms after
menopause. You will only be
prescribed TIBOLONE SANDOZ 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
SANDOZ to prevent osteoporosis
after menopause.
TIBOLONE SANDOZ is not a
contraceptive.
TIBOLONE SANDOZ has no effect on
alertness and concentration as far
as is known.
TIBOLONE SANDOZ is available only
with a doctor's prescription.
Before you us

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
TIBOLONE SANDOZ, (TIBOLONE), TABLETS
_ _
1. NAME OF THE MEDICINE
Tibolone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tibolone SANDOZ tablets contain the active tibolone.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Tibolone SANDOZ 2.5 mg tablet is white to off-white round uncoated
tablets without any markings.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
TIBOLONE SANODZ is indicated for:
• 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 SANDOZ 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 SANDOZ 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 least 3 months.
For initiation and