Adizem-SR 120 mg capsules
*Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
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 08 May 2025
File name
IE_PIL_Adizem SR_CCDS update_PR 131586_clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 08 May 2025
File name
IE_SMPC_Adizem SR_120 mg PR Cap_CCDS v14.0 clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.5 Interaction with other medicinal products and other forms of interaction
Direct Oral Anticoagulants (DOACs):
Diltiazem (an inhibitor of CYP3A4 and P-gp) may increase the plasma concentrations of DOACs (i.e. apixaban, rivaroxaban, dabigatran) metabolized through these pathways with resulting increases in pharmacodynamic effects such as bleeding risk.
10 DATE OF REVISION OF THE TEXT
Updated on 26 May 2023
File name
Adizem SR 120 mg prolonged release capsules SPC- clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 May 2023
File name
Adizem SR 90,120.180 mg prolonged release capsules-PIL-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 29 March 2023
File name
Adizem SR 90,120.180 mg prolonged release capsules-PIL-clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
IE Address Change
Updated on 24 March 2023
File name
Adizem SR 120 mg prolonged release capsules SPC-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change in MAH address for Ireland
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Address:
United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, IrelandMedical Information E-mail:
medicalinformation@mundipharma.ieTelephone:
Medical Information Direct Line:
+44 174 882 8867