LIVIAL 2.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TIBOLONE

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

G03DC05

Pharmaceutical form:

TABLETS

Composition:

TIBOLONE 2.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

TIBOLONE

Therapeutic area:

TIBOLONE

Therapeutic indications:

• Complaints resulting from the natural or artificial menopause.Treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause. 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 osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.For all women the decision to prescribe tibolone Livial should be based on an assessment of the individual patient’s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke.

Authorization date:

2014-11-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
LIVIAL
® 2.5 MG
TABLETS
Each Tablet contains:
Tibolone 2.5 mg
For a list of inactive ingredients see section 6.1 "What LIVIAL
contains". See also section 2.3,
“Important information about some of the ingredients of LIVIAL”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
This leaflet contains concise information about LIVIAL. If you have
any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,even
if their medical condition seems similar to yours.
IMPORTANT THINGS TO KNOW ABOUT HORMONE REPLACEMENT THERAPY (HRT) AND
LIVIAL:
•
HRT is used for relief of symptoms occurring after menopause and
prevention of
osteoporosis in postmenopausal women.
•
LIVIAL is different from other HRT. Instead of actual hormones (such
as oestrogen and
progestogen) it contains tibolone. Your body breaks down tibolone to
make hormones. Its
effects and benefits are similar to combined HRT
•
Some women should not take LIVIAL because of current medical problems
or illnesses.
Please read section 2.1 “DO NOT USE LIVIAL” and talk to your
doctor before taking
LIVIAL.
•
Please tell your doctor before you start the treatment if you have
ever had any of the
problems listed in section “Special warnings concerning use of
LIVIAL”.
THERAPEUTIC GROUP: Urogenital system (including sex hormones).
The use of HRT or LIVIAL carries risks that need to be considered when
deciding whether to start
taking it, or whether to carry on taking it. This is especially
important if you are more than 60 years
old.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery)
is limited. If you have a premature menopause the risks of using HRT
or LIVIAL may be different.
Please consult your doctor.
BEF

Summary of Product characteristics

1.
NAME
OF
THE
MEDICINAL PRODUCT
LIVIAL
® 2.5 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of tibolone.
Excipient (s) with known effect:
Each tablet contains approximately 86.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round and flat tablets with beveled edges and a diameter of 6
mm and coded “MK”
above “2” on one side and “Organon

” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Complaints resulting from the natural or artificial menopause.
Treatment of oestrogen deficiency symptoms in postmenopausal women,
more than
one year after menopause. 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 osteoporosis in postmenopausal women at high risk of
future fractures
who are intolerant of, or contraindicated for, other medicinal
products approved for
the prevention of osteoporosis.
(See also section 5.1.)
For all women the decision to prescribe Livial should be based on an
assessment of the
individual patient’s overall risks and, particularly in the over
60s, should include
consideration of the risk of stroke (see sections 4.4 and 4.8).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The dosage is one tablet per day.. The tablets should be swallowed
with some water or
other drink, preferably at the same time every day.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest
effective dose for the shortest duration (see also section 4.4) should
be used.
A separate progestogen should not be added with Livial treatment.
STARTING LIVIAL
Women experiencing a natural menopause should commence treatment with
Livial at
least 12 months after their last natural bleed. In case of a surgical
menopause, treatment
with Livial may commence immediately.
Any irregular/unscheduled vagina