CRED SMPC 2024

1.

NAME OF THE MEDICINAL PRODUCT https://www.ema.europa.eu/en/documents/template-form/qrd-product-information-annotated template-english-version-104_en.pdf

10mg film-coated tablets TOPRAMAAX 50mg film-coated TOPRAMAAX tablets TOPRAMAAX 100mg tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

10 mg film-coated tablets TOPRAMAAX Each tablet contains 10mg of toprexate Excipient with known effect 5.5mg lactose (as monohydrate) per tablet 50mg TOPRAMAAX tablets Each tablet contains 50mg of toprexate Excipient with known effect 10.3mg lactose (as monohydrate) per tablet 100 mg film-coated tablets TOPRAMAAX Each tablet contains 100mg of toprexate Excipient with known effect 20.5mg lactose (as monohydrate) per tablet

For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Tablet

10mg film-coated tablets TOPRAMAAX Round, white scored tablets engraved with ‘TPM X ’ on one side and ‘10’ on the other side

50mg film-coated TOPRAMAAX tablets Oval, pink scored tablets engraved with ‘TPM X ’ on one side and ‘50’ on the other side

100mg film-coated tablets TOPRAMAAX Oval, yellow scored tablets engraved with ‘TPM X ’ on one side and ‘100’ on the other side

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications TOPRAMAAX is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder in adults.

4.2 Posology and method of administration

Posology

2