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 DA MO YR Unterleibskrämpfe ( ): Cramp in lower abdomen ] Migräne ( ): Migraine ] Depressionen ( ): Depression ] Stimmungsschwankungen ( ): Mood swings ] Heulkrämpfe ( ): Weeping ] Aggressionen ( ): Aggression ] Müdigkeit ( ): Tiredness ] DA MO YR Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden Ich habe mir die Spirale legen lassen, das tat sehr weh. Anschließend hatte ich bei jeder "Periode" so starke Krämpfe, dass ich teilweise nicht mehr stehen konnte. Außerdem war meine Stimmung extrem schwankend und ich hatte immer depressive Phasen. Teilweise jeden Abend Heulkrämpfe und starke Aggressionen. Ich habe auch starke Migräne bekommen, welche ich davor noch nie hatte. Meine Frauenärztin meinte es könne nicht an der Spirale liegen und hat mir wegen den Unterleibskrämpfen zu einer Bauchspiegelung geraten, die ich aber abgelehnt habe. Sie hatte den Verdacht auf Endometriose. Dennoch habe ich mich letztendlich dafür entschieden die Spirale II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) Jaydess Hormonspirale 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE Contraception DE 25 (Year) Female 18. THERAPY DATES (from/to) 19. THERAPY DURATION (cont.) þ 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 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 07-JUN-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE 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...) ziehen zu lassen und siehe da: Keinerlei Unterleibskrämpfe mehr. Die Stimmungsschwankungen werden sicherlich auch bald besser. Die Migräne ist schon besser geworden, aber noch nicht vollständig weg. Mir geht es seit der Entfernung der Spirale sehr viel besser. Mein Stresshormonlevel hat sich fühlbar gesenkt (denke ich jedenfalls, eine Kortisolspiegel-Überprüfung habe ich nicht machen lassen). Seit der Entfernung der Spirale nehme ich keinerlei Hormone mehr zu mir. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date Depressionen [MedDRA 20.0 PT ( ): Depression ] ( ): Depression ] Unterleibskrämpfe [MedDRA 20.0 PT ( ): Abdominal pain lower ] 11 Month recovered/resolved ( ): Cramp in lower abdomen ] Stimmungsschwankungen [MedDRA 20.0 PT ( ): Mood swings ] ( ): Mood swings ] Heulkrämpfe [MedDRA 20.0 PT ( ): Crying ] ( ): Weeping ] Aggressionen [MedDRA 20.0 PT ( ): Aggression ] ( ): Aggression ] Müdigkeit [MedDRA 20.0 PT ( ): Fatigue ] ( ): Tiredness ] Migräne [MedDRA 20.0 PT ( ): Migraine ] 10 Month recovering/resolving ( ): Migraine ] * 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

3 Report Page: 3 of 5 Results of tests Date Test Result Unit Normal low range Normal 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) Jaydess Hormonspirale A: B: C: D: E: Contraception 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 E: Number of units in the interval Active drug substance name levonorgestrel Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION

4 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 Deutschland 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? DE-CADRBFARM 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 91 Deutschland Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Deutschland Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 85 Height (cm) 162

5 Report Page: 5 of 5 Last menstrual periode date Text for relevant medical history and concurrent conditions