Borg pharmaceutical industries

Suspected Adverse Drug Reaction Reporting Form ( Individual Case )

Reporting date: 09 / 04 / 2017

A. Patient Information

Name / Initials: N
Date of Birth: 05/10/1959
Age: 58
Sex: Female
Weight: 90 kg kg.
Patient Contact details: contact with patient's son in saudia arabia dr/ mohamed abdou 00966582037722
Country / City: Egypt , kafreldawar

B. Suspected Drug(s) Information

Drug Name

Trade name: healsec 20 mg

Active Material(s): omeprazole

Concentration / Strength: 20 mg
Manufacturer: borg
Batch Number: 048223
Expiry Date: 2019 / 7
Indication for Use: gastritis and peptic ulcer
Daily Dose: once
Role of Administration: oral
Date Started: 04/08/2014
Date Stopped: 03/23/2017
Duration of Use: 3 years

C. Suspected Reaction(s) Information

Description of Adverse Reaction: severe gastric upset
Date Reaction Started: 03/13/2017
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: gastric upset
Other Information: the capsule color is pale and is not like the original one also the shape of the ingredients inside the capsule is different
Any Lab Tests/ Date:
Allergy / Pregnancy / Others:

E. Concomitant Drug(s)

Name Concentration Route Dose & Frequency Used For Date Started Date Stopped Batch Number

F. Reporter Details

Name: mohamed abdou
Job: anesthisiologist
Telephone/Mobile No.: 00966582037722
Address: Saudia, gizan
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