SUSPECT ADVERSE REACTION REPORT

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1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM 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 ( ): Allergic exanthema ] 56 DA MO YR (Year) Male Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Unter erhöhten RR-Werten erfolgte die HA-Vorstellung mit Neueinstellung auf Amlodipin ab Es trat ein Palmarerythem neu auf- Annahme unsererseits dies kam vom Amlodipin, daher wurde dies wieder abgesetzt. Zeitgleich Cipralex-Eindosierung seit 11.5., weiter anhaltende Rötung der Hände, Cipralex wurde pausiert ab , das Erythem war abgeklungen. Reexposition am , erneute Rötung UA bds., Juckreiz und kl.pustelartige, nicht eitrige Erhebungen. Weiterbehandlung: Neueinstellung auf Venlafaxin ret. und Mirtazapin, depressive Symptomatik deutlich gebessert. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT Sender's comment: 14. SUSPECT DRUG(S) (include generic name) cipralex II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 5 Mg milligram(s),1 Day 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 11-MAY-2016 to 22-MAY Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) doxepin from 2012 galvus (cont.) þ 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.) [ MedDRA 20.0 ( ): Depression ] Continuing: Unknown [ MedDRA 20.0 ( ): Hypertension arterial ] Continuing: Unknown [ MedDRA 20.0 ( ): Type 2 diabetes mellitus ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 13-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Ungewöhnliche Nebenwirkung: Benkert Hippius: Hautausschlag gelegentlich, aber Palmarerythem als solches nicht erwähnt, ggfs. Rückfrage beim Hersteller nötig, ob solches bekannt. Zusammenhang sicher, da Reexposition positiv => für Cipralex. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT ( ): Dermatitis allergic ] 9 Day recovered/resolved 18-MAY MAY-2016 [ MedDRA 20.0 LLT ( ): Allergic exanthema ] * 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 Normal low range Normal high range More inform. available 11-MAY-2016 GFR 2.64 ml/min 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of cipralex 11-MAY- 22-MAY- 12 Day A: C: 5Mg milligram(s) 8 Day 5 Day Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages

3 Report Page: 3 of 7 escitalopram oxalate Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Allergic exanthema ] AMSP certain 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of cipralex 25-MAY- 26-MAY- 2 Day A: C: 5Mg milligram(s) 8 Day 9 Day Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages escitalopram oxalate Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Allergic exanthema ] AMSP certain 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of doxepin 2012 A: C: 50Mg milligram(s)

4 Report Page: 4 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages doxepin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of galvus A: C: 50Mg milligram(s) Diabetes seit längerem

5 Report Page: 5 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages vildagliptin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of amlodipin 18-MAY A: C: 5Mg milligram(s) Drug withdrawn Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages amlodipine 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Depression ] Unknown rezidivierend [ MedDRA 20.0 ( ): Hypertension arterial ] Unknown [ MedDRA 20.0 ( ): Type 2 diabetes mellitus ] Unknown [ MedDRA 20.0 ( ): Gambling addiction ] Unknown

6 Report Page: 6 of 7 Report duplicates Duplicate source AMSP - Institut für Arzneimittelsicherheit in der Duplicate number RUD 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 No 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? No 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 15 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address PATIENT INFORMATION (... continuation...)

7 Report Page: 7 of 7 Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions

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