Samsca 15mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Tolvaptan

Disponible depuis:

Otsuka Pharmaceuticals (U.K.

Code ATC:

C03XA01

DCI (Dénomination commune internationale):

Tolvaptan

Dosage:

15mg

forme pharmaceutique:

Tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 06050200; GTIN: 5038256000036

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, please 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 symptoms 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.
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. Vasopression 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 Samsca 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 (hyponatraemia). 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 you are allergic to tolvaptan or any of the other ingredien

Résumé des caractéristiques du produit

SAMSCA 15 MG AND 30 MG TABLETS
Summary of Product Characteristics Updated 05-Aug-2014 | Otsuka
Pharmaceuticals (UK) Ltd
1. Name of the medicinal product
Samsca 15 mg tablets
Samsca 30 mg tablets
2. Qualitative and quantitative composition
Samsca 15 mg tablets: Each tablet contains 15 mg tolvaptan.
Excipient with known effect:
Each tablet contains approximately 35 mg lactose (as monohydrate).
Samsca 30 mg tablets: Each tablet contains 30 mg tolvaptan.
Excipients with known effect:
Each tablet contains approximately 70 mg (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Samsca 15 mg
tablets:
Tablet
Blue, triangular, shallow-convex, debossed with “OTSUKA“ and “15“
on one side.
Samsca 30 mg
tablets:
Tablet
Blue, round, shallow-convex, debossed with “OTSUKA“ and “30“ on
one side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of adult patients with hyponatraemia secondary to 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 should be initiated in hospital.
_Posology _
Treatment with tolvaptan should 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. During
titration, patients should be monitored for serum sodium and volume
status (see section 4.4). In case of
inadequate improvement in serum sodium levels, other treatment options
should be considered, either in
place of or in addition to tolvaptan. Use of tolvaptan in combination
with other options may increase the
risk of overly rapid correction of serum sodium (see sections 4.4 and
4.5). For patients with an
appropriate increase in serum sodium, the underlying disease and serum
sodium levels should be
monitored at regular intervals to evaluate further need of tolvaptan
treatment. In the setti