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Astellas Pharma Ltd
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH
Telephone: +44 (0)1784 419615
Fax: +44 (0)1784 419583
Medical Information Direct Line: 0800 783 5018
Medical Information e-mail: medinfo@gb.astellas.com

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: 13/04/2011
SPC De-Noltab

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 13/04/2011 and displayed until Current
Reasons for adding or updating:
  • 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:   13-Dec-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises.  This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.

 

In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7.  This date is updated to 13th December 2010.
Updated on 15/08/2008 and displayed until 13/04/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   18-Jul-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.5 Interaction with other Medicinal products and other forms of Interaction

The following sentence has been added -

No other medicines, food or drink, in particular antacids, milk, fruit or fruit juices, should be consumed within half an hour before or after a dose of De-Nol as they may influence its effect. 

4.8 Undesirable Effects

The original paragraph has been deleted and the following table has been added.

 

System Organ Class

Common

>1/100,

<1/10

Uncommon

>1/1000,

1/100

Very rare

<1/10,000, Not known (cannot be estimated from the available data)

Immune system disorders

 

 

anaphylactic reaction

Gastrointestinal disorders

blackening of the stool

nausea, vomiting, constipation, diarrhoea

 

Skin and subcutaneous tissue disorders

 

rash, pruritus

 

 
Updated on 09/07/2007 and displayed until 15/08/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.3 Contraindications
The following sentence has been added:
Hypersensitivity to the active substance(s) or to any of the excipients.
 
4.4 Special warnings and special precautions for use
The following has been added:
Prolonged use of high doses of bismuth compounds is not recommended because this has occasionally led to reversible encephalopathy.  It is, not advisable to take other bismuth-containing drugs concomitantly.
Contains approximately 2 mmol (approximately 40 mg) potassium per tablet.  To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
 
 
4.8 Undesirable effects
This has been added to and now reads
Blackening of the stool usually occurs; nausea, vomiting, constipation, diarrhoea, anaphylaxis, rash and pruritis have been reported.
 
Updated on 06/01/2006 and displayed until 09/07/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/07/2004 and displayed until 06/01/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
Updated on 30/12/2003 and displayed until 22/07/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/07/2002 and displayed until 30/12/2003
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.3 - Contra-indications
  • Change to section 6. 4 - Special Precautions for Storage
  • Addition of Legal Category
Updated on 07/08/2001 and displayed until 25/07/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/01/2000 and displayed until 07/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 28/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  tri-potassium di-citrato bismuthate