CIOMS FORM

DE-BFARM-17015718

SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS

1a. COUNTRY

DE

privacy

2. DATE OF BIRTH DA MO YR

2a. AGE

66 (Year)

3. SEX

Female

4-6 REACTION ONSET DA MO YR

01

01

8-1

CHECK ALL APPROPRIATE TO ADVERSE REACTION

2017

¨ PATIENT DIED

7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)

nach Genuss von Lindenblütentee aus Gran Canaria Blutdruck erhöht [ MedDRA 19.1 LLT (10005750): Blood pressure increased ]

¨

INVOLVED OR PROLONGED INPATIENT HOSPITALISATION

¨

INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY

Reporter's comments: Sonstiges: die UAW sei lt. Patientin schon einmal unter der Einnahme von Lindenblütentee aufgetreten.

¨ LIFE THREATENING ¨

CONGENITAL ANOMALY / BIRTH DEFECT

¨

OTHER MEDICALLY IMPORTANT CONDITION

II. SUSPECT DRUG(S) INFORMATION (cont.) 20. DID REACTION ABATE

14. SUSPECT DRUG(S) (include generic name)

AFTER STOPPING DRUG?

valsartan dura 15. DAILY DOSE(S)

16. ROUTE(S) OF ADMINISTRATION

"as needed" { 160 Mg milligram(s) }

¨ YES ¨ NO ¨ NA 21. DID REACTION REAPPEAR AFTER REINTRODUCTION?

17. INDICATION(S) FOR USE

¨ YES ¨ NO ¨ NA

18. THERAPY DATES (from/to)

19. THERAPY DURATION

III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)

(cont.)

pradaxa pradaxa

23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.)

(cont.)

[ MedDRA 19.1 (10028596): Myocardial infarction ] Continuing: No [ MedDRA 19.1 (10007515): Cardiac arrest ] Continuing: No

IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER

Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE 24b. MFR CONTROL NO.

DE-BFARM-17015718 24c. DATE RECEIVED BY MANUFACTURER

02-JAN-2017 DATE OF THIS REPORT

17-JAN-2017

24d. REPORT SOURCE

¨ STUDY ¨ LITERATURE þ HEALTH PROFESSIONAL 25a. REPORT TYPE

þ INITIAL ¨FOLLOW UP ¨ FINAL (Cont.) = Continuation on attached sheet(s)

Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17015718

7. + 13. Describe Reaction(s) (including relevant tests/lab data)

Reaction text as reported MedDRA coding

(... continuation ...)

Outcome* Term highlighted

Duration

17-JAN-2017 2 of 7

Time interval 1** Time interval 2*** Start date

End date

nach Genuss von Lindenblütentee aus Gran Canaria Blutdruck erhöht [MedDRA 19.1 PT (10005750): 4 Hour Blood pressure increased ]

recovered/resolved

01-JAN-2017

[ MedDRA 19.1 LLT (10005750): Blood pressure increased ] * 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

Blood pressure

120/80

mmHg

162/108

mmHg

01-JAN-2017 Blood pressure 14. Suspect Drug(s) (including generic name) Suspect Drug and batch no.

Start date

Normal high range

More inform. available

(... continuation ...)

End date

valsartan dura

Identification of the country where the drug was obtained

Duration

Dose * A: as needed B: C: 160Mg milligram(s) D: E:

Deutschland

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

Normal low range

Dose not changed

Route(s) of Administration

Indication(s)

Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17015718

17-JAN-2017 3 of 7

Active drug substance name valsartan Causality assessment Reaction

Source

Method

[ MedDRA 19.1 (10005750): Blood pressure increased ]

AkdÄ

Global Introspection (WHO GI)

14. Suspect Drug(s) (including generic name) Suspect Drug and batch no.

Start date

Result

(... continuation ...)

End date

Duration

lindenblütentee

Dose *

Route(s) of Administration

Indication(s)

A: B: C: D: E: Deutschland

Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application

Deutschland

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 lindenblueten 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.

Start date

pradaxa

End date

Duration

Dose * A: B: C: 150Mg milligram(s) D: E:

Identification of the country where the drug was obtained Name of holder/applicant

Deutschland

(... continuation ...)

Route(s) of Administration

Indication(s)

Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17015718

17-JAN-2017 4 of 7

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 Active drug substance name dabigatran etexilate 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.

Start date

End date

amlodipin

Duration

Dose * 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

Deutschland

(... continuation ...)

Route(s) of Administration

Indication(s)

Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17015718

17-JAN-2017 5 of 7

Active drug substance name amlodipine 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.

Start date

End date

Duration

atozet 40mg/10 mg

Dose *

(... continuation ...)

Route(s) of Administration

Indication(s)

A: B: C: D: E: Deutschland

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 Active drug substance name

atorvastatin calcium ezetimibe 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.

Start date

End date

pantoprazol

Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form)

Duration

Dose * A: B: C: 40Mg milligram(s) D: E:

Deutschland

(... continuation ...)

Route(s) of Administration

Indication(s)

Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17015718

17-JAN-2017 6 of 7

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 Active drug substance name pantoprazole 23. Other relevant history

(... continuation ...)

Reactions, Symptoms and Events

Start date End date Continuing Comments

[ MedDRA 19.1 (10028596): Myocardial infarction ]

No

Z.n. Herzinfarkt

[ MedDRA 19.1 (10007515): Cardiac arrest ]

No

Z.n. Herzstillstand

Report duplicates Duplicate source

Duplicate number

Drug Commission of the German Medical Association

DE-DCGMA-17172278

Parent Parent identification Date of birth

Age

LMP date

Weight(kg) Height(cm) Sex

0

ADMINISTRATIVE AND IDENTIFICATION INFORMATION

Safetyreportversion

1

Identification of the country where the reaction/event occur

Deutschland

Serious

No

Date Format of receipt of the most recent information for this report

20170102

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

No

Text for relevant medical history and concurrent conditions

Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17015718

17-JAN-2017 7 of 7

Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional?

Yes

Primary source(s) of information Study name Reporter postcode Reporter country

Qualification

74

Physician

Deutschland

Literature reference(s)

Sponsor study number

SENDER INFORMATION (... continuation ...) Type

Health professional

Organisation

Drug Commission of the German Medical Association

Department Street address

Herbert-Lewin-Platz 1

City

Berlin

Postcode

10623

Country

Deutschland

Fax

+49 / (0)30 4004 / 56555

Telephone

+49 / (0)30 4004 / 56500

E-mail address

[email protected]

PATIENT INFORMATION (... continuation ...) Investigation number Gestation period Patient age group Weight (kg) Height (cm) Last menstrual periode date Text for relevant medical history and concurrent conditions

Elderly

>65.Lj.

Study type in which the reaction(s)/event(s) were observed