CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17051756 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR (10011942): Debility ] (10013781): Dry mouth ] (10010300): Confusion ] (10042112): Stomach pain ] (10043890): Tiredness ] (10015667): Exhaustion ] (10012805): Difficulty thinking ] (10009197): Circulatory instability ] (10010249): Concentration impaired ] (10058911): General physical condition abnormal ] 71 DA MO YR (Year) Female 19 12 2016 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Das Vorkommnis zog sich mehr und mehr schleichend vom 19.12.2016 bis 04.02.2017 hin. Zu diesem Zeitpunkt setzte ich das Medikament wieder ab und fühlte mich nach ca. einer Woche wieder viel leichter, aktiver, kreativer und lebensfroh. Abgesehen von den üblichen Beschwerden: körperliche Schwäche, Mundtrockenheit, Verwirrtheit, Magenschmerzen, Müdigkeit und schnelle 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) mictonorm 15 mg 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 15 Mg milligram(s) every Day" [ 15 Mg Oral 17. INDICATION(S) FOR USE Bladder discomfort DE milligram(s) { 15 Mg milligram(s), 1 in 1 Day } ] 18. THERAPY DATES (from/to) 19. THERAPY DURATION from to III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) (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 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10007864): Celiac disease ] Continuing: Unknown [ MedDRA 20.0 (10019167): Hashimoto's thyroiditis ] Continuing: Unknown [ MedDRA 20.0 (10016296): Fecal incontinence ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 02-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17051756 24d. REPORT SOURCE þ 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...) Erschöpfung usw. belastete mich sehr, dass mein Denzprozess nicht mehr gut funktionierte. Schon geringste Aufgaben konnte ich nur sehr schwierig einordnen, bzw. lösen. Bildlich gesprochen fühlte ich mich, als ob mein Gehirn aus Puffreis bestand, ein logischer Denkprozess nur gering möglich war, mich äußerst überanstrengte und das Leben so nicht mehr lebenswert für mich war. Außerdem hatte das Medikament nur eine sehr geringe positive Wirkung. Bericht des Meldenden Arztes: Verlauf: Kaum positive Wirkung,sehr schlechtes Allgemeinbefinden,Gefühl wie vergiftet; Magen-Darmprobleme Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date [MedDRA 20.0 PT (10003549): Asthenia ] (10011942): Debility ] recovered/resolved 1 Day [MedDRA 20.0 PT (10013781): Dry mouth ] (10013781): Dry mouth ] recovered/resolved 1 Day [MedDRA 20.0 PT (10010305): Confusional state ] (10010300): Confusion ] recovered/resolved 1 Day [MedDRA 20.0 PT (10000087): Abdominal pain upper ] (10042112): Stomach pain ] recovered/resolved 1 Day [MedDRA 20.0 PT (10016256): Fatigue ] (10043890): Tiredness ] recovered/resolved 1 Day [MedDRA 20.0 PT (10016256): Fatigue ] (10015667): Exhaustion ] recovered/resolved 1 Day [MedDRA 20.0 PT (10027374): Mental impairment ] (10012805): Difficulty thinking ] recovered/resolved 1 Day [MedDRA 20.0 PT (10007649): Cardiovascular disorder ] (10009197): Circulatory instability ] recovered/resolved 1 Day [MedDRA 20.0 PT (10013496): Disturbance in attention ] (10010249): Concentration impaired ] recovered/resolved 1 Day
Report Page: 3 of 5 [MedDRA 20.0 PT (10058911): General physical condition abnormal ] recovered/resolved 1 Day (10058911): General physical condition abnormal ] * 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 date End date Duration Dose * Route(s) of Administration Indication(s) mictonorm 15 mg 19-DEC- 2016 04-FEB- 2017 A: daily dose: 15 Mg milligram(s) every Day B: 15Mg milligram(s) C: 15Mg milligram(s) D: 1 E: 1Day Oral Bladder discomfort Identification of the country where the drug was obtained Name of holder/applicant Apogepha Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) 245 (Tablet) 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 Drug withdrawn 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 E: Number of units in the interval Active drug substance name propiverine hydrochloride
Report Page: 4 of 5 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 20.0 (10007864): Celiac disease ] Unknown [ MedDRA 20.0 (10019167): Hashimoto's thyroiditis ] Unknown [ MedDRA 20.0 (10016296): Fecal incontinence ] Unknown [ MedDRA 20.0 (10047862): Weakness ] Unknown [ MedDRA 20.0 (10010250): Concentration impairment ] Unknown [ MedDRA 20.0 (10076493): Gluten sensitivity ] Unknown [ MedDRA 20.0 (10023682): Lactose intolerant ] Unknown [ MedDRA 20.0 (10029399): Nickel sensitivity ] Unknown [ MedDRA 20.0 (10061626): Allergy to chemicals ] Unknown 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 20170502 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 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 12 Consumer or other non health professional 10 Physician SENDER INFORMATION (... continuation...) Type Organisation Regulatory Authority
Report Page: 5 of 5 Department 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 Elderly >65.Lj. Weight (kg) 68 Height (cm) 173 Last menstrual periode date Text for relevant medical history and concurrent conditions