Asacolon 1600 mg modified-release tablets * Pharmacy Only: Prescription
Company:
Tillotts Pharma GmbHStatus:
UpdatedLegal 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
Updated on 24 March 2023
File name
641daf1e9b764.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 March 2023
File name
641dae3570ef1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 March 2023
File name
641dadfe8f716.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 January 2023
File name
63d2e782cde1f.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 26 January 2023
File name
63d2e764d4c87.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
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)