CIOMS FORM

SUSPECT ADVERSE REACTION REPORT

I. REACTION NFORMATION
1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET 8-12 CHECK ALL
(first, last) Portugal Day Month Year 7 M Day Month Year APPROPRIATE TO
--- 03 1995 ADVERSE
M. R. 07 12 1988
REACTION
7 + 1 3 DESCRIBE REACTION(S) (including relevant tests/lab data)
First episode – March - Generalized urticaria with angioedema of the face and distal extremities of the INVOLVED OR
limbs. PROLONGED
INPATIENT
Second episode – July - Generalized urticaria with labial angioedema HOSPITAUSATION

□ INVOLVED
This episodes occurred 2 hours after the third paracetamol 500 mg suppository administration. PERSISTENCE OR
SIGNIFICANT
Lab tests: DISABILITY OR
INCAPACITY
- Open oral challenge test with paracetamol with 40 mg/mL concentration – Positive result with localized
urticaria and angioedema behind the right ear. No systemic symptoms or respiratory reactions.
□ LIFE
THREATENING

□ OTHERS

II. SUSPECT DRUG(S) INFORMATION

14. SUSPECT DRUG(S) (include generic name) 20 DID REACTION
Paracetamol 500 mg suppositories ABATE AFTER
STOPPING DRUG?
□YES □ NO NA
15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 21. DID REACTION
REAPPEAR AFTER
1500 mg Rectal REINTRODUCTION?
17. INDICATION(S) FOR USE □YES □ NO NA
Pain and fever
18. THERAPY DATES (from/to) 19. THERAPY DURATION
March; July --------

III. CONCOMITANT DRUG(S) AND HISTORY

22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
------------

23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergies, pregnancy with last month of period, etc.)

April 1996 – Facial urticaria with labial and peri-orbital angioedema due to lysine acetylsalicylate.

IV. LOCAL GOVERNMENTAL HEALTH AUTHORITY INFORMATION

24a. NAME AND ADDRESS OF HEALTH AUTHORITY 26. MA HOLDER
ActivePharma, Lda.
INFARMED I.P. Quinta da Granja 
Edifício Tomé Pires, Avenida do Brasil 53 Pavilhão 21ª, 2829-511 Monte de Caparica, Almada 
Portugal 
Pavilhão 24, 1749-004 Lisboa Tel.: 212222222 
Email: activepharma@gmail.com 

24b. HEALTH AUTHORITY

INFARMED I.P. 26 a.COMMENTS
24c. DATE RECEIVED BY 24d. REPORT SOURCE
HEALTH AUTHORITY □ STUDY □ LITERATURE
08/1996 □ HEALTH PROFESSIONAL □
OTHERS
DATE OF THIS REPORT 25a. REPORT TYPE
07/1996 □ INITIAL □ FOLLOWUP
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ADDITIONAL INFORMATION

7 + 1 3 DESCRIBE REACTION(S)

22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION