Samsca Tolvaptan Tablet 15mg

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

Tolvaptan

Доступна с:

OTSUKA PHARMACEUTICALS (MALAYSIA) SDN. BHD.

ИНН (Международная Имя):

Tolvaptan

Штук в упаковке:

10 Tablets

Производитель:

KOREA OTSUKA PHARMACEUTICAL CO LTD

тонкая брошюра

SAMSCA
_® _
TABLET
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
Tolvaptan 15 mg
Page 1
WHAT IS IN THIS LEAFLET
1.
What Samsca is used for
2.
How Samsca works
3.
Before you use Samsca
4.
How to use Samsca
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Samsca
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SAMSCA IS USED FOR
Samsca can be used to treat low blood
sodium
levels
in
adults
(hyponatraemia). Hyponatraemia may
be
a
result
of
a
disease
called
“syndrome
of
inappropriate
antidiuretic
hormone
secretion”
(SIADH), where the kidneys retain too
much
water,
or
a
heart
condition
known
as
congestive
heart
failure
where
it
is
a
chronic
progressive
condition
that
affects
the
pumping
power
of
your
heart
muscles.
Both
conditions
cause
an
inappropriate
production of the hormone vasopressin
which can cause the sodium levels in
your blood to get too low, leading to
difficulties
in
concentration
and
memory, or in keeping your balance.
It can also be used to add on to other
diuretics to treat volume overload in
heart failure when adequate response is
not obtained with other diuretics (e.g.
loop diuretics, etc.).
HOW SAMSCA WORKS
Samsca,
which
contains
the
active
substance tolvaptan, belongs to a group
of
medicines
called
vasopressin
antagonists. Vasopressin is a hormone
that helps prevent the loss of water
from
the
body
by
reducing
urine
output.
An
antagonist
prevents
the
effect
of
vasopressin
on
water
retention. This leads to a reduction in
the amount of water in the body by
increasing urine production and as a
result
it
increases
the
level
or
concentration of sodium in your blood.
BEFORE YOU USE SAMSCA
_-When you must not use it _
Do not take Samsca if:
•
you are allergic to tolvaptan or any
of
the other ingredients of this
medicine
(see
_Product _
_description_
)
•
your sodium level in your blood
must be increased right away
•
your
kidneys
do
not
work
(no
urine production)
•
you
have
a
condition
which
increases the salt in your

Характеристики продукта

Page 1 of 27 (TOLVAPTAN)
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
SAMSCA
®
TABLETS 15 MG
WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR
SERUM SODIUM
(B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY
DISEASE (ADPKD)
(A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM
SAMSCA SHOULD BE INITIATED AND RE-INITIATED IN PATIENTS ONLY IN A
HOSPITAL WHERE SERUM SODIUM CAN BE MONITORED CLOSELY.
TOO RAPID CORRECTION OF HYPONATREMIA (e.g., >12 mEq/L/24 hours) can
cause osmotic demyelination resulting in dysarthria, mutism,
dysphagia,
lethargy, affective changes, spastic quadriparesis, seizures, coma and
death. In susceptible patients including those with severe
malnutrition,
alcoholism or advanced liver disease, slower rates of correction may
be
advisable.
For volume overload in heart failure, administration of SAMSCA should
be
initiated
or
re-initiated
only
under
hospitalization,
as
occurrence
of
consciousness disturbance has been reported as a result of dehydration
and
hypernatremia associated with rapid water diuresis and rapid increase
in
serum sodium concentration may induce osmotic demyelination syndrome
(ODS). On the first day of treatment initiation or re-initiation,
serum sodium
concentration should be frequently monitored.
(B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
(ADPKD)
Because of the
risk of hepatotoxicity, SAMSCA
should not be used for
ADPKD_ [see Contraindications (4.1)]_.
Page 2 of 27
1.1
HYPONATREMIA
The treatment of clinically significant hypervolemic and euvolemic
hyponatremia
[serum sodium < 125 mEq/L or hyponatremia that is symptomatic and has
resisted
correction with fluid restriction], including patients with heart
failure, and Syndrome of
Inappropriate Antidiuretic Hormone (SIADH).
IMPORTANT LIMITATIONS
Patients requiring intervention to raise serum sodium urgently to
prevent or to treat
serious neurological symptoms should not be treated with SAMSCA.
It has not been established that raising serum sodium with SAMSCA
provides a