Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10183234serious1Date Last Updated27/05/2014receiptdateformat102companynumbAU-MYLANLABS-2014S1010694occurcountryAUseriousnessother1duplicate1Date Received20/05/2014transmissiondate12/12/2014primarysourcecountryAU

Primary Source

reportercountryAUqualification5

Patient

Onset Age43Unit of Onset AgeyearsSexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
- 12)
- 13)
- 14)
- 15)
- 16)
- 17)
- 18)
- 19)
- 20)
- 21)
- 22)
Drug

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug withdrawal syndromeOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionVision blurredOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionHypokinesiaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionMemory impairmentOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionLibido disorderOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionDepressionOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionTremorOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.0ReactionWeight increasedOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt17.0ReactionNasal drynessOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt17.0ReactionDry mouthOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt17.0ReactionHyporeflexiaOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt17.0ReactionHypopnoeaOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt17.0ReactionYellow skinOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt17.0ReactionChange of bowel habitOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

21)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductKALMAdrugauthorizationnumb074215drugstructuredosagenumb3drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPANIC DISORDERactiondrug2

2)

drugcharacterization1medicinalproductKALMAdrugauthorizationnumb074215drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPANIC DISORDERactiondrug2

3)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 TABLETS OF 100MG AT NIGHTdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductCAVSTATdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TABLET AT NIGHTdrugindicationBLOOD CHOLESTEROL

5)

drugcharacterization2medicinalproductMINAXdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 TABLET IN THE MORNING AND 1 AT THE NIGHTdrugindicationHYPERTENSION

Report Duplicate

duplicatesourceMYLANduplicatenumbAU-MYLANLABS-2014S1010694

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use

Adverse Event Report

Report

Primary Source

Patient

Reaction

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

12)

13)

14)

15)

16)

17)

18)

19)

20)

21)

22)

Drug

1)

2)

3)

openFDA Info on Medication

4)

5)

Report Duplicate

Receiver

Sender

Media

Newsletter

Follow us

Connect with us