Livial

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tibolone 2.5mg;  

Available from:

Organon (New Zealand) Limited

INN (International Name):

Tibolone 2.5 mg

Dosage:

2.5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Tibolone 2.5mg   Excipient: Ascorbyl palmitate Lactose monohydrate Magnesium stearate Potato starch

Units in package:

Blister pack, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

· Treatment of symptoms resulting from the natural or surgical menopause in post-menopausal women. Women above 60 years of age should only start with LIVIAL treatment when they are intolerant of or contraindicated for other medicinal products approved for the treatment of oestrogen deficiency symptoms. · 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:

Package - Contents - Shelf Life: Blister pack, - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 84 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1988-11-08

Patient Information leaflet

LIVIAL
®
TABLETS
1
LIVIAL
® TABLETS
_Tibolone 2.5 mg _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Livial. 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 Livial 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 LIVIAL IS USED FOR
Livial tablets contain the active
these symptoms after menopause.
You will only be prescribed Livial 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 Livial to prevent
osteoporosis after menopause.
Livial is not a contraceptive.
Livial 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 LIVIAL
•
you have excessive thickening of
the womb lining (endometrial
hyperplasia) that is not being
treated
•
you have or have ever had a
blood clot in a vein (thrombosis),
such as in the legs (deep venous
thrombosis) or the lungs
(pulmonary embolism)
•
you have a blood clotting disorder
(such as protein C, protein S, or
antithrombin deficiency)
•
you have or recently have had a
disease caused by blood clots in
the arteries, such as a heart attack,
stroke or angina
•
you have or have ever had liver
disease and your liver function
tests have not returned to normal
•
you have a rare blood problem
called porphyria which is passed
down in families (inherited)
•
you are allergic (hypersensitive)
to tibolone or any of the
ingredient tibolone, which is a

Summary of Product characteristics

Page 1 of 14
NEW ZEALAND DATA SHEET
1
LIVIAL
® 2.5 MG TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of the steroid tibolone.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
LIVIAL 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
•
Treatment
of
symptoms
resulting from the
natural
or
surgical menopause
in
post
menopausal women. Women above 60 years of age should only start with
LIVIAL
treatment when they are intolerant of or contraindicated for other
medicinal products
approved for the treatment of oestrogen deficiency symptoms.
•
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, LIVIAL 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
SAFETY AND EFFICACY
and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). LIVIAL
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
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.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective
dose for the shortest duration (see SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE)
should be used