TIBOLEEN 2.5MG TABLETS

Страна: Малайзия

Език: английски

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

Активна съставка:

TIBOLONE

Предлага се от:

EURODRUG LABORATORIES (M) SDN BHD

INN (Международно Name):

TIBOLONE

Броя в опаковка:

28tablet Tablets

Произведено от:

LABORATORIO LEON FARMA, S.A.

Листовка

Consumer Medication Information Leaflet (RiMUP)
1
TIBOLEEN
TIBOLONE 2.5 MG
IN THIS LEAFLET:
1.
WHAT TIBOLEEN IS USED
FOR
2.
HOW TIBOLEEN WORKS
3.
BEFORE YOU USE
TIBOLEEN
4.
HOW TO USE TIBOLEEN
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL
OF TIBOLEEN
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER
10.
PRODUCT REGISTRATION
HOLDER
1.
WHAT TIBOLEEN IS USED
FOR
TIBOLEEN belongs to the
group of medicines called hormone
replacement therapy (HRT).
It
is
used
for
problems
that
start
affecting women when their body
no
longer
produces
certain
hormones,
for
example
after
the
change of life (the menopauses). It is
also used to prevent bones becoming
brittle
(osteoporosis)
if
you
are
unable to use other treatments.
2.
HOW TIBOLEEN WORKS
TIBOLEEN
helps
restore
the
hormonal
balance
to
relieve
menopausal
symptoms
like
thinning, drying and inflammation
of the vagina, loss of bone density
and osteoporosis, as well as other
symptoms,
such
as
reducing
hot
flushes and improved libido.
3. BEFORE
YOU
TAKE
TIBOLEEN
WHEN YOU MUST NOT USE IT
Do not take TIBOLEEN
•
If
you
are,
or
think
you
are,
pregnant
•
If you have or have had breast
cancer,
or
if
breast
cancer
is
suspected
•
If you have a malignant tumour
sensitive to oestrogens or if one
is
suspected
(e.g.
endometrial
tumour)
•
If you have vaginal bleeding
of unknown cause
•
If you have abnormal growth
of
the
endometrium
(endometrial
hyperplasia)
and you are not yet receiving
treatment for this
•
If you have had in the past or
currently have a blood clot in
a vein (deep vein thrombosis
or
pulmonary
embolism)
of
which the cause is unknown
•
If you have recently had
or currently have a blocked
artery,
e.g.
angina
(heart
spasm
caused
by
lack
of
oxygen)
or
a
myocardial
infarction
•
If you have had in the past or
you
currently
have
liver
disease.
You
cannot
use
TIBOLEEN
until
liver
function has been restored.
•
If you have a blood pigment
production defect (porphyria)
•
If
you
are
allergic
(hypersensitive)
to
tibolone,
lactose or to any of the other
ingredient

Данни за продукта

222 x 340 1 mm
P030
100%
Dimensions:
Scale:
Material
type:
Leaflet
Drawing #:
Date:
Version:
A
xxxxx
29.04.19
-
PR TIB TIBOLEEN 2,5MG X28 EXELTIS MY
Laetus #:
Folded:
YES
NO
Substitutes
mat. #:
Material #/
Product :
LICONSA
LEON FARMA
X
Launch:
Internal change:
Customer change:
X
Pantones:
170 X 37 mm
die cut
black
0000
Signature:
Date:
With the signed proof of this file you commit to have had reviewed and
agreed with the following points as part of your
review:
- Keyline used.
- Free varnish areas.
- Colors.
- Text.
- Prefixes order for variable info (If the order is changed you
commint to clearly comunicate this change to
Chemo's artworks department, otherwise Chemo will not be responsible).
- Any other info included in the file.
DRAWED BY:
APPROVED BY CUSTOMER (Regulatory Affair or Quality Assurance)
FRONT SIDE / ANVERSO
EXAMPLE / EJEMPLO
Pharma Code
Read Directions
xxxxx
Pharma Code
Read Directions
Pharma Code
Read Directions
TIBOLEEN 2.5MG TABLETS
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each tablet contains 2.5mg Tibolone (I.N.N).
PHARMACEUTICAL FORM
White & round tablet.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
•
Treatment
of
complaints
resulting
from
the
natural
or
artificial
menopause. Women above 60 years of age should only start with
tibolone
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.
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage is one tablet per day. The tablets should be swallowed
without chewing.
Tablets must be taken in the order directed on the
package
every
day
at
about
the
same
time.
One
tablet
is
taken
consecutively for 28 days until the pack is empty. Each subsequent
pack is started after the completion of the previous pack.
Improvement
of symptoms generally occurs within a few w