CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16131624 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR DA MO YR Female 01 2016 Erschöpfungssyndrom (10015667): Exhaustion ] rezidivierende Infekte (10021789): Infection ] chronische Übelkeit (10028813): Nausea ] starke Schleimbildung im Rachenraum (10059004): Phlegm ] 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht der Meldenden: Da ich unter hohem Blutdruck leide hat mir mein Hausarzt Candesartan 16mg verordnet und zwar morgens und abends je eine Tablette. Seitdem ist mein Blutdruck stabilisiert. Seit Januar leide ich unter sehr starker Schleimbildung im Rachenraum. Er wechselt zwischen gelber und grüner Farbe. Selbst in den Nachtstunden habe ich Schwierigkeiten. Diagnose HNO-Ärztin: rez. Infekte, Erschöfungssyndrom, chronische Übelkeit. Sie hat mir eine Vitalkurtherapie mit B 12 als Infusionen (10x) verordnet. Da diese keinen Erfolg brachten habe ich einen Facharzt für Bronchialkunde aufgesucht. Er hat mir eine Kur mit Ventolair 100 Easy Breathe verordnet. Bis heute habe ich keine Verbesserung verspürt. Ich leide nach wie vor an einer starken Verschleimung. 14. SUSPECT DRUG(S) (include generic name) candesartan 16mg II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 2 Df dosage form every Day" { 1 Df dosage form, 2 in 1 Day } 17. INDICATION(S) FOR USE Hypertension 18. THERAPY DATES (from/to) 19. THERAPY DURATION (cont.) 20. 21. INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) vitamin b12 10x gegeben ventolair 100 Easi-Breathe (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 15-APR-2016 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16131624 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 5 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** starke Schleimbildung im Rachenraum [MedDRA 18.1 PT (10036790): Productive cough ] not recovered/not resolved JAN-2016 (10059004): Phlegm ] rezidivierende Infekte [MedDRA 18.1 PT (10021789): Infection ] (10021789): Infection ] Erschöpfungssyndrom [MedDRA 18.1 PT (10016256): Fatigue ] (10015667): Exhaustion ] chronische Übelkeit [MedDRA 18.1 PT (10028813): Nausea ] (10028813): Nausea ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** and start of reaction/event Results of tests Date Test Result Unit rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of candesartan 16mg A: daily dose: 2 Df dosage form every Day C: 1Df dosage form D: 2 E: 1Day Hypertension
Report Page: 3 of 5 Cumulative dose number (to first reaction) C: Structure dosages number candesartan 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of vitamin b12 A: 10x gegeben C: D: E: 293 (Infusion) Cululative dose number (to first reaction) C: Structure of separate dosages cyanocobalamin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of ventolair 100 Easi-Breathe A: C:
Report Page: 4 of 5 D: E: Cululative dose number (to first reaction) C: Structure of separate dosages beclometasone dipropionate ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 20160415 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed
Report Page: 5 of 5 63 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions