CRED SMPC 2024

18/09/2024

Task - Section 4.2

4.2 Posology and method of administration

Posology

Adults The recommended starting dose is 10mg once daily. Thereafter the dose can be increased slowly in 10 mg increments to a maximum dose of 200mg/day, if needed. Renal impairment No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80ml/min). TOPRAMAAX must not be used in patients with severe renal impairment (creatinine clearance< 30ml/min)

The Organisation for Professionals in Regulatory Affairs

9

Task - Section 4.8 4.8 Undesirable effects [MedDRA frequency convention and system organ class database, see Appendix II.]

Summary of the safety profile The most commonly reported adverse reactions possibly related to toprexate were constipation and nausea.

Tabulated list of adverse reactions The incidences of the Adverse Drug Reactions (ADRs) associated with toprexate are tabulated below. The table is based on adverse events reported during clinical trials and/or post-marketing use.

Paediatric population No safety data available for children below 18years of age. TOPRAMAAX is not recommended in this population (see section 4.2)

The Organisation for Professionals in Regulatory Affairs

10