Asacolon 1600 mg modified-release tablets *

  • Company:

    Tillotts Pharma GmbH
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 03 June 2021

File name

SPC_1622709516.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 03 June 2021

File name

PIL_1622709477.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 15 November 2019

File name

ie-spc-2_1573826120.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

PRAC update on Nephrolithiasis

Section 4.4

Nephrolithiasis
Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content. It is recommended to ensure adequate fluid intake during treatment.

Section 4.8 under frequency not known

Nephrolithiasis**

** see section 4.4 for further information


 

Updated on 15 November 2019

File name

ie-pl-2_1573825917.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

PRAC update on kidney stones in section 2 and 4

Section 2

Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with mesalazine.


Section 4

  • kidney stones and associated kidney pain (see also section 2)

 

Updated on 09 May 2019

File name

Asacolon PIL Aug 2018 n_1557324471.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 May 2019

File name

Asacolon SmPC Aug 2018_1557324511.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)