CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16151679 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 21 DA MO YR (Year) Female 13 04 2016 Magenkrämpfe die so stark wurden, dass eine Bewegung unmöglich war [ MedDRA 19.0 LLT (10049901): Stomach cramps ] Geschmack von Kräutern im Mund bis hin zur Unerträglichkeit [ MedDRA 19.0 LLT (10013911): Dysgeusia ] 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 des Meldenden: Zunächst der Geschmack von Kräutern im Mund bis zu Unerträglichkeit, mit einhergehend anfängliche Magenkrämpfe bis hin zur so starken Krämpfen, dass eine Bewegung unmöglich war. Durch Aussitzen der Schmerzen, da ich auf einen angegriffenen Magen keine Schmerztabletten nehmen kann, sind die Beschwerden nach etwa 5 Stunden vollkommen verschwunden. Ergänzende Informationen der Patientin: Ich nahm das Medikament Soledum Kapseln forte, einmalige Einnahme am 13.04.2016. Die Nebenwirkungen traten von 14. Uhr bis ca. 18. Uhr auf. Ich nahm das Medikament wegen Erkältung mit anfänglicher Sinusitis. Begleiterkrankungen: Reizmagen. 14. SUSPECT DRUG(S) (include generic name) soledum kapseln forte II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION Oral 17. INDICATION(S) FOR USE Sinusitis 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 13-APR-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) Kontrazeptiva 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 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.0 (10023009): Irritable stomach ] Continuing: Unknown [ MedDRA 19.0 (10009851): Cold ] Continuing: Unknown 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-16151679 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...) Zusätzlich nehme ich noch die Anti-Baby-Pille Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Geschmack von Kräutern im Mund bis hin zur Unerträglichkeit [MedDRA 19.0 PT (10013911): Dysgeusia ] [ MedDRA 19.0 LLT (10013911): Dysgeusia ] 5 Hour recovered/resolved 1 Day Magenkrämpfe die so stark wurden, dass eine Bewegung unmöglich war [MedDRA 19.0 PT (10000087): Abdominal pain upper ] [ MedDRA 19.0 LLT (10049901): Stomach cramps ] 5 Hour recovered/resolved 1 Day Time interval 1** Time interval 2*** * 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 Start 13-APR-2016 13-APR-2016 End 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) soledum kapseln forte 13-APR- 2016 A: B: C: D: E: Oral Sinusitis 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: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages
Report Page: 3 of 5 E: Number of units in the interval Active drug substance name cineole 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) Kontrazeptiva 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 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.0 (10023009): Irritable stomach ] Unknown Reizmagen [ MedDRA 19.0 (10009851): Cold ] Unknown Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2016012473 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
Report Page: 4 of 5 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 20160511 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-2016012473 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 49 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 Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 52 Height (cm) 170 Last menstrual periode
Report Page: 5 of 5 Text for relevant medical history and concurrent conditions