LIVIAL TABLET 2.5 mg

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

TIBOLONE

Tilgjengelig fra:

ORGANON SINGAPORE PTE. LTD.

ATC-kode:

G03CX01

Dosering :

2.5 mg

Legemiddelform:

TABLET

Sammensetning:

TIBOLONE 2.5 mg

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

N V ORGANON

Autorisasjon status:

ACTIVE

Autorisasjon dato:

1991-02-18

Informasjon til brukeren

 
RA 1850 S9 REF 12.0  
1 

1. 
NAME OF THE MEDICINAL PRODUCT 
Livial 2.5 mg tablets. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 2.5 mg of tibolone. 
For excipients, see 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 
•
  Treatment of estrogen deficiency symptoms in
postmenopausal women, more 
than one year after menopause. 
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 
The dosage is one tablet per day. No
dose adjustment is necessary for the elderly. 
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 vaginal bleeding, either on
or off HRT, should be 
investigated to exclude malignancy before starting
Livial (see section 4.3). 
SWITCHING FROM A SEQUENTIAL OR CONTINUOUS COMBINED HRT PREPARATION 
If changing from a sequential HRT preparation, treatment with
Livial should start the 

RA 1

Preparatomtale

RA 1850 S9 REF 12.0
1.
NAME OF THE MEDICINAL PRODUCT
Livial® 2.5 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of tibolone.
For excipients, see 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
•
Treatment of estrogen deficiency symptoms in postmenopausal women,
more
than one year after menopause.
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
The dosage is one tablet per day. No dose adjustment is necessary for
the elderly.
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 progestagen 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 vaginal bleeding, either on or off HRT,
should be
investigated to exclude malignancy before starting Livial (see section
4.3).
Switching from a sequential or continuous combined HRT preparation
If changing from a sequential HRT preparation, treatment with Livial
should start the
day following completion of the prior regimen. If changing from a
continuous-combined
HRT preparation, treatment can start at any time.
Missed dose
A missed dose should be taken as soon as remembered, unless it is more
than 12
hours overdue. In the latter case, the missed dose should