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Otsuka Pharmaceuticals (UK) Ltd
3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1EZ, UK
Telephone: +44 (0)20 8756 3100
Fax: +44 (0)20 8848 0529
WWW: http://www.otsuka-europe.com
Medical Information e-mail: otsuka@medinformation.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 01/05/2012
SPC Samsca 15 mg tablet

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 01/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The changes relate to managing the potential for too rapid correction of serum sodium when using Samsca - this includes more explicit monitoring precautions, acceptable rates of correction, warnings of which patients may be at greater risk of rapid correction, and concomitant medications which should be avoided to reduce this risk.

4.4       Special warnings and precautions for use

 

Fluid and electrolyte balance

- more detailed monitoring recommendations added

 

Too rapid correction of serum sodium

- new precaution added
- warning of caution when used with other treatment for hyponatraemia or medicinal products which increase serum sodium concentration. Co-administration of Samsca with other treatments for hyponatraemia, and medications that increase serum sodium concentration, is not recommended (see section 4.5).

 

4.5       Interaction with other medicinal products and other forms of interaction

 

Co-administration with other treatments for hyponatraemia and medicinal products that increase serum sodium concentration

- new interaction

 

 

Co-administration with vasopressin analogues

- new interaction

 

4.8          Undesirable effects

 - new addition

System Organ Class

Frequency

Surgical and medical procedures

Common: rapid correction of hyponatraemia, sometimes leading to neurological symptoms

 

 

7. MARKETING AUTHORISATION HOLDER

- Postcode amended
Updated on 14/09/2011 and displayed until 01/05/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.8 Undesirable effects
ADDED (for patients in other clinical trials/non-hyponatraemia):

Common: ... headache, malaise, diarrhoea, blood urine present.



5.2 Pharmacokinetic properties
ADDED:

In a population pharmacokinetic analysis in patients with hepatic edema, AUC of tolvaptan in severely (Child-Pugh class C) and mildly or moderately (Child-Pugh classes A and B) hepatic impaired patients were 3.1 and 2.3 times higher than that in healthy subjects.


10. DATE OF REVISION OF THE TEXT

{08/2011}
Updated on 20/08/2009 and displayed until 14/09/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  tolvaptan