Samsca

tolvaptan

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This is a summary of the European public assessment report (EPAR) for Samsca. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Samsca.

For practical information about using Samsca, patients should read the package leaflet or contact their doctor or pharmacist.

What is Samsca and what is it used for?

Samsca is a medicine for treating abnormally low levels of sodium in the blood in adults with a condition called ‘syndrome of inappropriate antidiuretic hormone secretion’ (SIADH).

In SIADH, an excessive amount of the hormone vasopressin makes the patient produce less urine and thereby retain more water in the body, which dilutes the concentration of sodium in the blood.

Samsca contains the active substance tolvaptan.

How is Samsca used?

Samsca is available as tablets (7.5, 15 and 30 mg). The starting dose is 15 mg once a day. This may be increased to a maximum of 60 mg once a day to achieve an appropriate level of blood sodium and blood volume. A dose of 7.5 mg once a day can be used for patients at risk of excessively quick rise in blood sodium.

The medicine can only be obtained with a prescription. Treatment with Samsca should be started in hospital so that healthcare professionals can determine the most appropriate dose and monitor the patient’s level of blood sodium and blood volume. For further information, see the package leaflet.

How does Samsca work?

People with SIADH have an excessive amount of vasopressin, leading to decreased urine production and dilution of the blood. The active substance in Samsca, tolvaptan, is a ‘vasopressin‑2 receptor antagonist’. This means that it blocks one type of receptor (a target) to which the hormone vasopressin normally attaches itself. By blocking this receptor, Samsca prevents vasopressin’s effect. This increases urine production, so decreasing the amount of water in the blood and increasing the blood sodium level.

What benefits of Samsca have been shown in studies?

Two studies involving 424 adults showed that Samsca is effective at increasing sodium levels in patients with low sodium levels caused by SIADH and other conditions such as liver and heart problems. However, Samsca was more effective in patients with SIADH than in those with liver or heart problems. Normal sodium levels are between 135 and 145 mmol/l.

In patients with SIADH, sodium levels, which were around 129 mmol/l at the start of treatment, rose by an average of 4.8 mmol/l by day 4 in those who took Samsca, compared with 0.2 mmol/l in those who took placebo. By day 30, sodium had increased by an average of 7.4 mmol/l in patients who took Samsca, compared with 1.5 mmol/l in patients receiving placebo.

What are the risks associated with Samsca?

The most common side effects with Samsca (seen in more than 1 patient in 10) are thirst, nausea (feeling sick) and sodium levels rising too quickly. For the full list of all side effects reported with Samsca, see the Package Leaflet.

Samsca must not be used in patients with anuria (an inability to pass urine), very low blood volume, low blood sodium levels with low blood volume, hypernatremia (abnormally high levels of sodium in the blood) or in patients who cannot perceive thirst. It must also not be used in women who are pregnant or breast-feeding.

Why is Samsca approved?

Samsca has been shown to be effective at increasing sodium levels, particularly in patients with SIADH. The only major safety concerns seen with this medicine came from animal studies suggesting it could be harmful to unborn babies. This medicine must therefore not be used in women who are pregnant or breastfeeding.

The European Medicines Agency concluded that Samsca’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Samsca?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Samsca have been included in the summary of product characteristics and the package leaflet.

Other information about Samsca

The European Commission granted a marketing authorisation valid throughout the European Union for Samsca on 3 August 2009.

For more information about treatment with Samsca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Samsca : EPAR - Summary for the public BG = bălgarski 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public ES = español 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public CS = čeština 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public DA = dansk 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public DE = Deutsch 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public ET = eesti keel 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public EL = elliniká 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public EN = English 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public FR = français 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public IT = italiano 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public LV = latviešu valoda 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public LT = lietuvių kalba 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public HU = magyar 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public MT = Malti 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public NL = Nederlands 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public PL = polski 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public PT = português 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public RO = română 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public SK = slovenčina 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public SL = slovenščina 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public FI = suomi 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public SV = svenska 2009-08-18 2017-12-21
Samsca : EPAR - Summary for the public HR = Hrvatski 2009-08-18 2017-12-21

This EPAR was last updated on 21/12/2017 .

Authorisation details

Product details

Product details for Samsca
NameSamsca
Agency product numberEMEA/H/C/000980
Active substance

tolvaptan

International non-proprietary name (INN) or common name

tolvaptan

Therapeutic area Inappropriate ADH Syndrome
Anatomical therapeutic chemical (ATC) code C03XA01

Publication details

Publication details for Samsca
Marketing-authorisation holder

Otsuka Pharmaceutical Europe Ltd

Revision6
Date of issue of marketing authorisation valid throughout the European Union03/08/2009

Contact address:

Otsuka Pharmaceutical Europe Ltd
Gallions Wexham Springs
Framewood Road
Wexham, Slough
Berkshire
SL3 6PJ
Unied Kingdom

Product information

Product information

18/09/2017  Samsca -EMEA/H/C/000980 -X/0024

Name Language First published Last updated
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21
Samsca : EPAR - Product Information HR = Hrvatski 2009-08-18 2017-12-21

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  
Samsca : EPAR - All Authorised presentations HR = Hrvatski 2009-08-18  

Pharmacotherapeutic group

Diuretics

Therapeutic indication

Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Samsca : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2010-11-09 2017-12-21

Initial marketing-authorisation documents

Name Language First published Last updated
Samsca : EPAR - Public assessment report HR = Hrvatski 2009-08-18  
Committee for medicinal products for human use, summary of positive opinion for Samsca HR = Hrvatski 2009-05-29  

Authorised

This medicine is approved for use in the European Union