Borg pharmaceutical industries

Suspected Adverse Drug Reaction Reporting Form ( Individual Case )

Reporting date: 09 / 04 / 2017

A. Patient Information

Name / Initials: Mohammed
Date of Birth: 02/01/1983
Age: 34
Sex: Male
Weight: 93 kg.
Patient Contact details: d_mas2010@yahooncom
Country / City: Egypt , Kafreldawar

B. Suspected Drug(s) Information

Drug Name

Trade name: Healsec 20

Active Material(s): Omeprazole 20 ,mg

Concentration / Strength: 20 mg
Manufacturer: Borg
Batch Number: 048223
Expiry Date: 2019 / 7
Indication for Use: Gastritis
Daily Dose: Once
Role of Administration: Oral
Date Started: 04/02/2014
Date Stopped: 04/01/2017
Duration of Use: 3 years

C. Suspected Reaction(s) Information

Description of Adverse Reaction: The product material is different from before
Date Reaction Started: 03/15/2017
Did the reaction stop after stopping the drug ? Yes
Did the reaction reappear after retaking the drug ? No

D. Seriousness

Seriousness to adverse drug reaction: Other Specify
Other Specify: Severe gastric upset
Other Information:
Any Lab Tests/ Date:
Allergy / Pregnancy / Others:

E. Concomitant Drug(s)

Name Concentration Route Dose & Frequency Used For Date Started Date Stopped Batch Number
Omeprazole 20 Oral Once Gastritis 2014 2017 048223

F. Reporter Details

Name: Dr mohammed abdou
Job: Anesthesit
Telephone/Mobile No.: 00966582037722
Address: Ksa
Any more comments:
This form should be delivered to Pharmacovigilance Department as soon as possible (not exceeding 48 hours)
Received by:
Receiver Job Tile:
Receiving Date:
Report No.:
QPPV Evaluation: Valid Needs follow up

Address of the factory

District 17-Area 3-Industrial Zone 3-Borg El Arab New City- Alexandria - Egypt

Tel: (+203) 4622152/3/4 - Fax.: (203) 4622155


TF/IC/001 Rev. (1/1) 04/12/ 2014
TF/IC/001 Rev. (1/1) 04/12/ 2014