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
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
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)
F. Reporter Details
Name: mohamed abdou
Job: anesthisiologist
Telephone/Mobile No.: 00966582037722
Address: Saudia, gizan
Email: d_mas2010@yahoo.com
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
TF/IC/001 Rev. (1/1) 04/12/ 2014
TF/IC/001 Rev. (1/1) 04/12/ 2014