… th pre-existing bronchial hyper-reactivity. Cases have also been reported after dose increase. Patients should be monitored for signs and symptoms of respiratory impairment during diltiazem therapy.
Caution should be exercised when direct oral anticoagulants (DOACs) are administered concomitantly with diltiazem, a moderate CYP3A4 inhibitor and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5).
Sucrose
As Slozem contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medici …
Identical in both labels. Surrounding text shown from Zentiva.
… be monitored for signs and symptoms of respiratory impairment during diltiazem therapy.
This medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially 'sodium-free'.
Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with Diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see Interactions).
Identical in both labels. Surrounding text shown from SANOFI.
… em in considered unsafe in patients with acute porphyria.
Residues from slow-release formulations of the product may pass into the patient's stools; however, this finding has no clinical relevance.
Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with Diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5).
This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially 'sodium-free'.
… product contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5).
… al function be monitored, circulating ciclosporin levels be assayed and that the dose should be adjusted during combined therapy and after its discontinuation.
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.
General information to be taken into account:
Due to the potential for additive effects, caution and careful titration are necessary in patients receiving diltiazem concomitantly with other agent …
Identical in both labels. Surrounding text shown from Napp Pharmaceuticals Limited.