LIVIAL TABLET 2.5MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TIBOLONE

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

TIBOLONE

Unit dalam pakej:

28Tablet Tablets; 28 Tablets

Dikeluarkan oleh:

N.V. ORGANON

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LIVIAL TABLET
®
Tibolone (2.5 mg)
1
Copyright 2022 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET:
1.
What
_LIVIAL _
is used for
2.
How
_LIVIAL _
works
3.
Before you take
_LIVIAL _
4.
How to take
_LIVIAL _
5.
While you are taking
_LIVIAL _
6.
Side effects
7.
Storage and Disposal of
_LIVIAL _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _LIVIAL _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”).
_LIVIAL _
alleviates these symptoms after
menopause. You will only be prescribed
_LIVIAL _
if your symptoms seriously
hinder your daily life.
PREVENTION OF OSTEOPOROSIS
To prevent osteoporosis (fragile bones)
in women who are at high risk of
fractures after menopause.
You can take
_LIVIAL _
if other medicines
are not suitable for you.
HOW _LIVIAL _WORKS
_LIVIAL _
is a Hormone Replacement
Therapy (HRT).
_LIVIAL _
contains
tibolone, a substance that has favorable
effects on different tissues in the body,
such as brain, vagina and bone.
_LIVIAL _
is used in postmenopausal women with
at least 12 months since their last natural
period. This results in the relief of
climacteric symptoms such as hot
flushes and night sweats, a beneficial
effect on the lining of the vagina and a
favorable effect on mood and sexual
desire.
_LIVIAL _
can also stop the process
of bone loss that occurs after the
menopause in your spine, hip and wrists.
Unlike some hormone replacement
therapies,
_LIVIAL _
does not stimulate the
lining of the womb. Treatment with
_LIVIAL _
therefore does not lead to
monthly vaginal bleeding.
BEFORE YOU TAKE _LIVIAL _
_ _
_-_
_ _
_When you must not take it _
DO NOT TAKE _LIVIAL _
If any of the following applies to you. If
you are not sure about any of the points
below,
TALK TO YOUR DOCTOR
before
taking
_LIVIAL_
.
Do not take
_LIVIA

Ciri produk

LOCAL PRODUCT CIRCULAR
LIVIAL
RA 1850 CCDS 1850 12 (12.0A)
TIBOLONE, 2.5 MG
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 complaints resulting from the natural or artificial
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 estrogen 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.
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.
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
over