Samsca
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
01-07-2022
Valmisteyhteenveto
(SPC)
01-07-2022
Julkisesta arviointikertomuksesta
(PAR)
07-08-2018
Aktiivinen ainesosa:
Tolvaptan
Saatavilla:
Otsuka Pharmaceutical Netherlands B.V.
ATC-koodi:
C03XA01
INN (Kansainvälinen yleisnimi):
tolvaptan
Terapeuttinen ryhmä:
Diuretics,
Terapeuttinen alue:
Inappropriate ADH Syndrome
Käyttöaiheet:
Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).,
Tuoteyhteenveto:
Revision: 15
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2009-08-02
Pakkausseloste
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
SAMSCA 7.5 MG TABLETS
SAMSCA 15 MG TABLETS
SAMSCA 30 MG TABLETS
tolvaptan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Samsca is and what it is used for
2.
What you need to know before you take Samsca
3.
How to take Samsca
4.
Possible side effects
5.
How to store Samsca
6.
Contents of the pack and other information
1.
WHAT SAMSCA IS AND WHAT IT IS USED FOR
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. Antagonist means that it prevents
vasopressin having its effect 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.
Samsca is used to treat low serum sodium levels in adults. You have
been prescribed this medicine
because you have a lowered sodium level in your blood as a result of a
disease called “syndrome of
inappropriate antidiuretic hormone secretion” (SIADH) where the
kidneys retain too much water. This
disease causes an inappropriate production of the hormone vasopressin
which has caused the sodium
levels in your blood to get too low (hyponatremia). That can lead to
difficulties in concentration and
memory, or in keeping your balance.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SAMSCA
DO NOT TAKE SAMSCA
•
if y
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Samsca 7.5 mg tablets
Samsca 15 mg tablets
Samsca 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Samsca 7.5 m
g tablets
Each tablet contains 7.5 mg tolvaptan.
Excipient with known effect
51 mg lactose (as monohydrate) per tablet
Samsca 15 mg
tablets
Each tablet contains 15 mg tolvaptan.
Excipient with known effect
35 mg lactose (as monohydrate) per tablet
Samsca 30 mg
tablets
Each tablet contains 30 mg tolvaptan.
Excipient with known effect
70 mg lactose (as monohydrate) per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Samsca 7.5
mg tablets
Blue, rectangular, shallow-convex tablets with dimensions of 7.7 ×
4.35 × 2.5 mm, debossed with
“OTSUKA” and “7.5” on one side.
Samsca 15 mg
tablets
Blue, triangular, shallow-convex tablets with dimensions of 6.58 ×
6.2 × 2.7 mm, debossed with
“OTSUKA” and “15” on one side.
Samsca 30 mg
tablets
Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm,
debossed with “OTSUKA” and
“30” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Samsca is indicated in adults for the treatment of hyponatremia
secondary to the syndrome of
inappropriate antidiuretic hormone secretion (SIADH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Due to the need for a dose titration phase with close monitoring of
serum sodium and volume status
(see section 4.4), treatment with Samsca has to be initiated in
hospital.
3
Posology
Tolvaptan has to be initiated at a dose of 15 mg once daily. The dose
may be increased to a maximum
of 60 mg once daily as tolerated to achieve the desired level of serum
sodium.
For patients at risk of overly rapid correction of sodium e.g.,
patients with oncological conditions, very
low baseline serum sodium, taking diuretics, or taking sodium
supplementation a dose of 7.5 mg
should be considered (see section 4.4).
During titration, patients must be monitored for serum sodium and
volume status (se
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