SPC Adverse Drug Reaction Reporting Form

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1. Patient Details:* This field is required.
Name
Please Select
Please Select
Male
Female
Gender
Age
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Are you Pregnant ?* This field is required.
YES
NO
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2. Adverse Drug Reaction* This field is required.What happened?
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Seriousness of the Adverse Drug Reaction?* This field is required.
Non-serious
Serious
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Type Seriousness of the Adverse Drug Reaction?* This field is required.
Patient died
Life threatening
Admitted to hospital or prolong hospitalization
Congenital anomaly
Other
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3. Suspected Medication:
SPC Medication Name
Dose, Frequency
Route of administration (e.g. Oral, IV or SC)
Indications
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Did medication stop because of side effect?
Please Select
Please Select
Yes
NO
If above is "YES", please specify the date?
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Action Taken for the medication
Drug Withdrawn
Dose Increased
Dose Reduced
Dose not changed
Unknown
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The Patient outcome:
Recovered
No Improvement
Fatal
Unknown
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Event subsided after stopping (dechallenge):
NO
YES
Unknown
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Event reappear after reintroducing (rechallenge):
NO
YES
Not Applicable
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Your Above answer is YES, please specify:
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4. Concomitant Medications and Medical History:Concomitant Medications (any other Medication that the patient is taking) and Medical History (any chronic diseases that the patient has. For example: Diabetes, Hypertension, etc
Concomitant Medications
Medical History
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5. Reporter’s Information:
Name
Please enter your email
Please enter your phone
Hospitals' Name
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Dear Healthcare Professional,

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
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