REPORT

A SIDE

EFFECT

Concomitant Medication
Adverse Drug Reaction (ADR) is a response to a medicinal product which is noxious and unintended. This includes side effects arising from use of a medicine within the terms of the marketing authorization (e.g. the authorized indications), as well as from use outside the terms of the marketing authorization, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure.

Confidentiality: Reporter's and patient's identity are held in strict confidence by Sudair Pharma and protected to the fullest extent of the law, information provided by the reporter will be strictly protected and will not be used in any way against him / her.

Please fill out the reporting form providing the most complete information. Use a separate form for each ADR. Attachment of additional documents (e.g. doctor's records, laboratory results, etc.) are highly appreciated as they would support Sudair Pharma assessment of the event. Kindly submit the completed form to:

- Pharmacovigilance and Drug Safety Department

- Tell phone: 920001432 (ex. 107)

- Fax: + (966) 11 466 8195

- Email: Pharmacovigilance@SudairPharma.com

- Website: www.sudairpharma.com

Sudair Pharmaceutical Company

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