Tolvaptan Accord

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

Tolvaptan

Dostupné z:

Accord Healthcare S.L.U.

ATC kód:

C03XA01

INN (Medzinárodný Name):

tolvaptan

Terapeutické skupiny:

Diuretics,

Terapeutické oblasti:

Inappropriate ADH Syndrome

Terapeutické indikácie:

Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Stav Autorizácia:

Authorised

Príbalový leták

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOLVAPTAN ACCORD 7.5 MG TABLETS
TOLVAPTAN ACCORD 15 MG TABLETS
TOLVAPTAN ACCORD 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 Tolvaptan Accord is and what it is used for
2.
What you need to know before you take Tolvaptan Accord
3.
How to take Tolvaptan Accord
4.
Possible side effects
5.
How to store Tolvaptan Accord
6.
Contents of the pack and other information
1.
WHAT TOLVAPTAN ACCORD IS AND WHAT IT IS USED FOR
Tolvaptan Accord, 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.
Tolvaptan Accord 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,

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tolvaptan Accord 7.5 mg tablets
Tolvaptan Accord 15 mg tablets
Tolvaptan Accord 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolvaptan Accord 7.5 mg tablets
Each tablet contains 7.5 mg tolvaptan.
_Excipient with known effect_
_ _
17.5 mg lactose (as monohydrate) per tablet
Tolvaptan Accord 15 mg tablets
Each tablet contains 15 mg tolvaptan.
_Excipient with known effect_
_ _
35 mg lactose (as monohydrate) per tablet
Tolvaptan Accord 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
Tolvaptan Accord 7.5 mg tablets
Light blue to blue coloured, round, biconvex, uncoated tablets,
debossed with "MT" on one side and
"18" on other side with approximate dimension of 5.0 mm.
Tolvaptan Accord 15 mg tablets
Light blue to blue coloured, triangle, biconvex, uncoated tablets,
debossed with '"MT" on one side and
"7" on other side with approximate dimension of 6.7 x 6.3 x 3.3 mm.
Tolvaptan Accord 30 mg tablets
Light blue to blue coloured, round, biconvex, uncoated tablets,
debossed with "MT" on one side and
"8" on other side with approximate dimension of 8.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tolvaptan is indicated in adults for the treatment of hyponatremia
secondary to the syndrome of
inappropriate antidiuretic hormone secretion (SIADH).
3
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 tolvaptan has to be initiated in
hospital.
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