Asacolon 1600 mg modified-release tablets

  • Name:

    Asacolon 1600 mg modified-release tablets

  • Company:
    info
  • Active Ingredients:

    Mesalazine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/11/19

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Summary of Product Characteristics last updated on medicines.ie: 15/11/2019

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Tillotts Pharma GmbH

Tillotts Pharma GmbH

Company Products

Medicine NameActive Ingredients
Medicine Name Asacolon 1600 mg modified-release tablets Active Ingredients Mesalazine
Medicine Name Asacolon 400 mg Gastro-Resistant Tablet Active Ingredients Mesalazine
Medicine Name Asacolon 500 mg Suppositories Active Ingredients Mesalazine
Medicine Name Asacolon 800 mg Gastro-Resistant Tablets Active Ingredients Mesalazine
Medicine Name Entocort CR 3mg Capsules Active Ingredients Budesonide
Medicine Name Vistaprep Powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
1 - 0 of 6 items.Total: Infinity pages

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 15 November 2019 SmPC

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 PIL

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 9 May 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 May 2019 SmPC

Reasons for updating

  • New SmPC for new product

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