ADIZEM-XL 300 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_SMPC_Adizem XL_300 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 08 May 2025
File name
IE_PIL_Adizem XL_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
Free text change information supplied by the pharmaceutical company
2. What you need to know before you take Adizem-XL capsules
Other medicines and Adizem-XL capsules
Diltiazem may lead to increased risk of bleeding if taken along with blood thinners known as direct acting oral anti-coagulants (example apixaban, rivaroxaban, dabigatran). This leaflet was last revised in January 2025.
This leaflet was last revised in January 2025
Updated on 26 May 2023
File name
Adizem XL 300 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 XL 120 180 240 300 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 24 March 2023
File name
Adizem XL 300 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
IE MAH Address Change
Updated on 24 March 2023
File name
Adizem XL 120 180 240 300 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 MAH Address Change
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