CRED SMPC 2024

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.

Very common

common Headache

Nervous system disorders Respiratory,thoracic and mediastinal disorders Gastrointestinal disorders

Cough

Constipation Nausea

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

4.9 Overdose

N/A 5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties N/A

5.2 Pharmacokinetic properties

N/A 5.3 Preclinical safety data N/A

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core

Microcrystalline cellulose Magnesium stearate

Tablet coating

TOPRAMAAX 10mg film-coated tablets Hypromellose 2910 Titanium dioxide

Macrogol 8000 Carnauba wax

TOPRAMAAX 50mg film-coated tablets Hypromellose 2910 Titanium dioxide

Macrogol 8000 Carnauba wax

4