Sevelamer Carbonate 800mg film-coated tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 December 2024
File name
ie-combined-dk2249-MAT- clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 02 December 2024
File name
ie-combined-dk2249-MAT- clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 September 2024
File name
ie-combined-dk2249-clean-v026.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 17 September 2023
File name
ie-pl-dk2249-clean-v023.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 03 July 2023
File name
ie-pl-dk2249-clean-v022.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to name of medicinal product
Updated on 02 September 2022
File name
ie-PIL-dk2249-clean-v022.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 10 December 2019
File name
ie-pil-dk2249-clean-v017v018.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 December 2019
File name
ie-spc-dk2249-clean-v017v018.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 October 2019
File name
ie-spc-dk2249-clean-v018.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 October 2019
File name
ie-pil-dk2249-clean-v018.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 January 2019
File name
PIL Eczibet ie-combined-ie0631-mahtransfer-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 18 January 2019
File name
ie-combined-dk2249-clean-r001.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2018
File name
PIL Eczibet ie-combined-ie0631-mahtransfer-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 20 December 2018
File name
SPC Eczibet ie-combined-ie0631-mahtransfer-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 October 2018
File name
Package leaflet sevelamer.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
Updated on 02 October 2018
File name
SUMMARY OF PRODUCT CHARACTERISTICS sevelamer.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 September 2018
File name
PACKAGE LEAFLET Sevelamer.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
Updated on 28 September 2018
File name
SUMMARY OF PRODUCT CHARACTERISTICS Sevelamer.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 July 2018
File name
ie-combined-dk2249-clean-v015.docx
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
The safety and efficacy of Sevelamer Carbonate have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Therefore Sevelamer Carbonate is currently not recommended for use in these patients.
The safety and efficacy of Sevelamer Carbonate have not been established in patients with the following disorders:
• Dysphagia
• swallowing disorders
• severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion
• active inflammatory bowel disease
• major gastrointestinal tract surgery
Therefore caution should be exercised when Sevelamer Carbonate is used in these patients.
Inflammatory gastrointestinal disorders
Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis …) associated with the presence of sevelamer crystals have been reported in literature. However, the causality of the sevelamer crystals in initiating such disorders has not been demonstrated. Sevelamer hydrochloride/carbonate treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Updated on 17 August 2016
File name
PIL_16833_578.pdf
Reasons for updating
- New PIL for new product
Updated on 17 August 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1