CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16415004 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10007031): Calf pain ] (10043127): Taste bitter ] (10043890): Tiredness ] (10016785): Floppy ] (10023197): Joint ache ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DA MO YR 46 DA MO YR (Year) Female 29 11 2016 Das Medikament sollte ich morgens um 7.00Uhr und abends um 19.00Uhr einnehmen. Am darauffolgenden Tag hatte ich in der rechten Wade Schmerzen, die zwar auszuhalten waren aber lästig. Mein Arzt verordnete mir Magnesium Verla 1 Brausetablette morgens und der Schmerz wurde weniger, war aber bis zur letzten Einnahme der Tablette da. Am nächsten Tag nach dem Aufstehen war der Wadenschmerz ganz weg. Ausserdem hatte ich den ganzen Tag einen bitteren Geschmack im Mund, der nach Absetzen der Tablette verschwand. II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) clarithromycin Basics 500mg (batch: 3003) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 1000 Mg milligram(s) every Day" [ 2000 Mg Oral 17. INDICATION(S) FOR USE Bronchitis DE milligram(s) { 500 Mg milligram(s), 2 in 1 Day } ] 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 28-NOV-2016 1 Week III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) MetoHexal Succ 47,5 mg (cont.) 20. 21. INVOLVED OR PROLONGED INPATIENT HOSPITALISATION 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 (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 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16415004 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...) Müdigkeit, Schlappheit und allg. Gelenkschmerz war der Beigeschmack des Antibiotikum. Hautausschläge blieben weg. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End [MedDRA 19.1 PT (10033425): Pain in extremity ] (10007031): Calf pain ] [MedDRA 19.1 PT (10013911): Dysgeusia ] (10043127): Taste bitter ] [MedDRA 19.1 PT (10016256): Fatigue ] (10043890): Tiredness ] [MedDRA 19.1 PT (10021118): Hypotonia ] (10016785): Floppy ] [MedDRA 19.1 PT (10003239): Arthralgia ] (10023197): Joint ache ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose 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 and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) clarithromycin Basics 500mg (batch: 3003) 28-NOV- 2016 1 Week A: daily dose: 1000 Mg milligram(s) every Day B: 2000Mg milligram(s) C: 500Mg milligram(s) D: 2 E: 1Day Oral Bronchitis Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number
Report Page: 3 of 5 Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Additional information on drug Einnhame: 1-0-1 Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name clarithromycin 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) MetoHexal Succ 47,5 mg A: B: C: D: E: Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name
Report Page: 4 of 5 metoprolol succinate Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2016014636 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 20161207 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? DE-CADRBFARM-2016014636 Yes 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 45 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country
Report Page: 5 of 5 Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 62 Height (cm) 165 Last menstrual periode Text for relevant medical history and concurrent conditions