CRED SMPC 2024

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)

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

4.4 Special warnings and precautions for use

During treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period.

QT prolongation In clinical trials of toprexate, the incidence of QT prolongation was comparable to placebo. Toprexate should be used with caution in patients with a family history of QT prolongation (see section 4.8).

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of toprexate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). TOPRAMAAX is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether toprexate is excreted in human breast milk. There is insufficient information on the excretion of toprexate /metabolites in animal milk. A risk to the newborns/infants cannot be excluded. TOPRAMAAX should not be used during breast-feeding. Fertility Studies in animals showed no effects on fertility (see section 5.3). The potential risk for humans is unknown.

4.7 Effects on ability to drive and use machines

TOPRAMAAX has no or negligible influence on the ability to drive and use machines.

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.

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