Last Updated on eMC 18-09-2012 View medicine  | Astellas Pharma Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Change to MA holder contact details

Date of revision of text on the SPC:17-09-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to MA holder contact details

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:13-12-2010

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.

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:18-07-2008

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

 

 

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:01-07-2007

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.
 

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients

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

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

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied