Asacolon 1600 mg modified-release tablets
- Name:
Asacolon 1600 mg modified-release tablets
- Company:
Tillotts Pharma GmbH
- Active Ingredients:
- 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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Tillotts Pharma GmbH
Company Products
| Medicine Name | Active 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 DIFICLIR 200 mg film-coated tablets | Active Ingredients Fidaxomicin |
| 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 |
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)