TIBOGEN 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:

Actor Pharmaceuticals Pty Ltd

INN (International Name):

Tibolone

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

1 x 28 film coated tablets (1 blister strip per carton 28 tablets per blister strip)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: The formulation is presented as white to whitish round tablet, 6.0 mm +/- 0.2 mm in diameter.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-02-09

Patient Information leaflet

TIBOGEN® TABLETS
1
TIBOGEN
®
_tibolone 2.5mg tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tibogen. 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 Tibogen
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 IS TIBOGEN USED
FOR
Tibogen contains tibolone, a
substance that can replace the
natural sex hormones after
menopause.
The production of sex hormones by
the body decreases during and after
menopause. Women may then suffer
from complaints such as hot flushes,
night sweats, vaginal irritation,
depression and loss of sexual desire.
In addition, menopause may cause
thinning of the bones (osteoporosis).
Tibogen is used in postmenopausal
women at least 12 months since
their last natural period.
Tibogen is used for:
RELIEF OF SYMPTOMS OCCURRING
AFTER MENOPAUSE
During menopause, the amount of
oestrogen produced by a woman's
body drops. This can cause
symptoms such as hot face, neck
and chest ("hot flushes"). Tibogen
alleviates these symptoms after
menopause.
You will only be prescribed
Tibogen 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 Tibogen to
prevent osteoporosis after
menopause.
Tibogen is not a contraceptive.
Tibogen has no effect on alertness
and concentration as far as is known.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU

Summary of Product characteristics

TIBOGEN (tibolone 2.5mg) PI (29-Aug-2014)
Page 1 of 11
PRODUCT INFORMATION
TRADE NAME
TIBOGEN®
NAME OF THE MEDICINE
TIBOGEN (tibolone) 2.5 mg tablets
TIBOLONE
_ _
_Molecular formula: C_
_21_
_H_
_28_
_O_
_2_
_ _
_Molecular Weight:_
_312.45_
_[CAS No. 5630-53-5] _
CHEMICAL NAME:
17β-Hydroxy-7α-methyl-19 nor-17α pregn-5(10)-en-20-yn-3-one
OTHER NAME:
17α‐ethynyl‐17‐hydroxy‐7α‐methyl‐5(10)‐estren‐3‐one.
PHARMACEUTICAL FORM
Tablets, each containing 2.5 mg of the steroid tibolone.
DESCRIPTION
Tibolone exists as white to almost white crystals or crystalline
powder. Tibolone is related to and
derived from naturally occurring steroids. It is optically pure and
has the D-configuration. It is
practically insoluble in water, aqueous acid or alkali at 20°C.
LIST OF EXCIPIENTS
TIBOGEN tablets 2.5 mg contain potato starch, magnesium stearate,
ascorbyl palmitate and lactose.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
ATC code: G03CX01
After oral administration tibolone is rapidly metabolised into three
compounds which contribute to
the pharmacological effects of tibolone. Two of these metabolites (the
3αOH and 3βOH metabolite)
have predominantly oestrogenic activity, a third metabolite (Δ
4
-isomer of tibolone) and the parent
compound have predominantly progestagenic and androgenic activities.
Tibolone substitutes for the loss of oestrogen production in
postmenopausal women and alleviates
menopausal symptoms. Tibolone prevents bone loss following menopause
or ovariectomy.
Tibolone has various tissue-specific effects. It has oestrogenic
effects on the vagina, on bone and on
the thermoregulatory centres in the brain (hot flushes). Based on _in
vitro_ data, tibolone inhibits the
TIBOGEN (tibolone 2.5mg) PI (29-Aug-2014)
Page 2 of 11
sulphatase enzyme in cultured breast cancer cells thereby reducing the
levels of active oestrogens
produced in those cells. Due to local conversion to the Δ
4
-isomer, the endometrial findings have
been mainly atrophic or in some cases weakly proliferative, which can,
in thems