CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17342269 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 [ MedDRA 20.0 LLT (10050471): Achilles tendon pain ] Achillessehnenriss re. [ MedDRA 20.0 LLT (10000439): Achilles tendon rupture ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Meldung aus der Bevölkerung: 64-jähriger, männlicher Patient berichtet über sehr starke Schmerzen in beiden Achillessehnen nach der Einnahme von Levofloxacin-ratiopharm 500 mg Filmtabletten. Schmerzfreies Laufen war über eine Dauer von ca. 4 Wochen nicht möglich. Er sei noch heute wegen der Beschwerden in Behandlung. Dauer und Indikation der Einnahme von Levofloxacin sind nicht bekannt. Weitere Informationen wurden angefordert. Ergänzende Meldung des Initial-Berichtenden (Bevölkerung): Verlauf der Therapie der UAW: Hepathrombin 60.000 Gel, Ibuprofen 600 mg 64 DA MO YR (Year) Male 23 07 2017 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 INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) Levofloxacin-ratiopharm 500 mg Filmtabletten (batch: 1632290) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 500 Mg " [ 3500 Mg { 500 Mg, 1 in 1 Day } ] 17. INDICATION(S) FOR USE Prostatitis 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 17-JUL-2017 to 25-JUL-2017 9 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) ramipril 2,5 mg (batch: GF2970) from 2014 daily dose: 2.5 Mg pantoprazol 20 mg (batch: G04092) from 2014 daily dose: 20 Mg 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10036978): Prostatitis ] Continuing: 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 26-OCT-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17342269 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*** [MedDRA 20.0 PT (10066371): Tendon pain ] [ MedDRA 20.0 LLT (10050471): Achilles tendon pain ] 7 Day 3 Day 23-JUL-2017 Achillessehnenriss re. [MedDRA 20.0 PT (10043248): Tendon rupture ] [ MedDRA 20.0 LLT (10000439): Achilles tendon rupture ] 89 Day 81 Day 13-OCT-2017 * 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 Levofloxacin-ratiopharm 500 mg Filmtabletten (batch: 1632290) 17-JUL- 2017 25-JUL- 2017 9 Day A: daily dose: 500 Mg B: 3500Mg C: 500Mg Prostatitis ratiopharm GmbH
Report Page: 3 of 5 B: Cumulative dose number (to first reaction) C: Structure dosages number levofloxacin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of ramipril 2,5 mg (batch: GF2970) 2014 A: daily dose: 2.5 Mg B: C: 2.5Mg Hypertension B: Cululative dose number (to first reaction) C: Structure of separate dosages ramipril 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of pantoprazol 20 mg (batch: G04092) 2014 A: daily dose: 20 Mg B: C: 20Mg Heartburn
Report Page: 4 of 5 B: Cululative dose number (to first reaction) C: Structure of separate dosages pantoprazole 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10036978): Prostatitis ] leichte Entzündung der Prostata 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 20171026 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? Yes
Report Page: 5 of 5 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 30 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 uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 105 Height (cm) 185 Last menstrual periode Text for relevant medical history and concurrent conditions