Erschöpfungssyndrom [ MedDRA 18.1 LLT (10015667): Exhaustion ] rezidivierende Infekte [ MedDRA 18.1 LLT (10021789): Infection ] chronische Übelkeit [ MedDRA 18.1 LLT (10028813): Nausea ]
starke Schleimbildung im Rachenraum [ MedDRA 18.1 LLT (10059004): Phlegm ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant information:
Bericht der Meldenden: Da ich unter hohem Blutdruck leide hat mir mein Hausarzt Candesartan 16mg verordnet und zwar morgens und abends je eine Tablette. Seitdem ist mein Blutdruck stabilisiert.
Seit Januar leide ich unter sehr starker Schleimbildung im Rachenraum. Er wechselt zwischen gelber und grüner Farbe. Selbst in den Nachtstunden habe ich Schwierigkeiten.
Diagnose HNO-Ärztin: rez. Infekte, Erschöfungssyndrom, chronische Übelkeit. Sie hat mir eine Vitalkurtherapie mit B 12 als Infusionen (10x) verordnet. Da diese keinen Erfolg brachten habe ich einen Facharzt für Bronchialkunde aufgesucht. Er hat mir eine Kur mit Ventolair 100 Easy Breathe verordnet. Bis heute habe ich keine Verbesserung verspürt. Ich leide nach wie vor an einer starken Verschleimung.
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH
DA MO YR
2a. AGE 3. SEX 4-6 REACTION ONSET
DA MO YR
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 INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION
II. SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG(S) (include generic name)
15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION
17. INDICATION(S) FOR USE
18. THERAPY DATES (from/to) 19. THERAPY DURATION
DID REACTION ABATE AFTER STOPPING DRUG?
DID REACTION REAPPEAR AFTER REINTRODUCTION?
III. CONCOMITANT DRUG(S) AND HISTORY
YES NO NA
YES NO NA
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.)
IV. SENDER INFORMATION
24a. NAME AND ADRESS OF SENDER
24b. MFR CONTROL NO.
DATE RECEIVED BY MANUFACTURER
24d. REPORT SOURCE
DATE OF THIS REPORT 25a. REPORT TYPE
20.
21.
24c.
STUDY LITERATURE
HEALTH PROFESSIONAL
INITIAL FOLLOW UP FINAL
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(Cont.) = Continuation on attached sheet(s)
DE
Female 01 2016
candesartan 16mg
"daily dose: 2 Df dosage form every Day" { 1 Df dosage form, 2 in 1 Day } Hypertension (cont.) (cont.) vitamin b12 10x gegeben ventolair 100 Easi-Breathe 21-APR-2016 15-APR-2016 BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE DE-BFARM-16131624 privacy
7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation ...)
Start date End date Duration
Time interval 1** Time interval 2*** Outcome*
Term highlighted Reaction text as reported
MedDRA coding
starke Schleimbildung im Rachenraum [MedDRA 18.1 PT (10036790): Productive cough ] [ MedDRA 18.1 LLT (10059004): Phlegm ] JAN-2016 not recovered/not resolved rezidivierende Infekte [MedDRA 18.1 PT (10021789): Infection ] [ MedDRA 18.1 LLT (10021789): Infection ] Unknown Erschöpfungssyndrom [MedDRA 18.1 PT (10016256): Fatigue ] [ MedDRA 18.1 LLT (10015667): Exhaustion ] Unknown chronische Übelkeit [MedDRA 18.1 PT (10028813): Nausea ] [ MedDRA 18.1 LLT (10028813): Nausea ] Unknown
* 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
Date Test Result Unit Normal low
range Normal high range More inform. available Results of tests
candesartan 16mg A: daily dose: 2 Df
dosage form every Day B: C: 1Df dosage form D: 2 E: 1Day Hypertension
Identification of the country where the drug was obtained
Deutschland
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
14. Suspect Drug(s) (including generic name) (... continuation ...) Suspect Drug
and batch no.
Start date End date Duration Route(s) of Administration Indication(s) Dose *
Report Page: 3 of 5
53175 Bonn, DE
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?
Active drug substance name candesartan
* 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
vitamin b12 A: 10x gegeben
B: C: D: E: Identification of the country
where the drug was obtained
Deutschland
Name of holder/applicant
Authorization/Application Number
Country of authorization/application Deutschland Pharmaceutical form (Dosage form) 293 (Infusion) 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?
Active drug substance name cyanocobalamin
* 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
22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation ...) Concomitant Drug
and batch no.
Start date
End date
Duration Dose * Route(s) of
Administration
Indication(s)
ventolair 100 Easi-Breathe A:
B: C:
22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation ...) Concomitant Drug
and batch no.
Start date
End date
Duration Dose * Route(s) of
Administration
D: E: Identification of the country
where the drug was obtained
Deutschland
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?
Active drug substance name beclometasone dipropionate * 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
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
20160415
Additional documents No
Does this case fulfill the local criteria for an expedited report?
No
Regulatory authority's case report number Other case identifiers in previous transmissions
Was the case medically confirmed, if not initially from health professional?
No List of documents held by sender
Primary source(s) of information
Literature reference(s) Reporter country Qualification
Reporter postcode
Study name
Sponsor study number
Study type in which the reaction(s)/event(s) were observed
Report Page: 5 of 5
53175 Bonn, DE
63 Deutschland Consumer or other
non health professional
SENDER INFORMATION (... continuation ...)
Type Regulatory Authority
Organisation BfArM
Department Pharmakovigilanz
Street address Kurt-Georg-Kiesinger-Allee 3
City Bonn
Country Deutschland
Fax Telephone
E-mail address [email protected]
Postcode 53175
PATIENT INFORMATION (... continuation ...)
Investigation number Gestation period Patient age group Weight (kg) Height (cm)
Text for relevant medical history and concurrent conditions
