Effexor
(Venlafaxine Hydrochloride)

What Effexor is and what it is used for

AlventaXLisan antidepressant thatbelongs toagroupof medicines calledserotonin and norepinephrinereuptakeinhibitors (SNRIs).Thisgroupof medicines isusedtotreatdepression andother conditions such asanxietydisorders.It is thought that people whoaredepressedand/oranxious havelower levelsof serotonin and noradrenalinein thebrain.It is not fullyunderstood how antidepressants work,but they may helpbyincreasingthelevelsof serotonin and noradrenalinein thebrain. AlventaXLisatreatment foradults with depression.AlventaXLisalsoatreatment foradults with thefollowinganxiety disorder:socialanxietydisorder (fearoravoidanceof social situations).Treatingdepression oranxietydisordersproperlyis important to helpyougetbetter.If it is not treated,your condition may notgoawayand maybecome moreseriousand more difficult totreat.

How to take Effexor

Always take AlventaXLexactlyasyourdoctor has toldyou.Youshouldcheck with yourdoctororpharmacist ifyouare not sure. Theusual recommendedstartingdosefor treatmentofdepression,socialanxietydisorder is75 mgperday.Thedosecan be raisedbyyourdoctorgradually,andif needed,even uptoa maximum doseof375 mgdailyfordepression.The maximum dose for socialanxietydisorder is225 mg/day. Take AlventaXLatapproximatelythesametimeeach day,either in the morningor in theevening. Capsules mustbeswallowed whole with fluidand notopened,crushed,chewedordissolved. AlventaXLshouldbetaken with food. Ifyou haveliverorkidneyproblems,talktoyourdoctor,sinceyourdoseof AlventaXL may needtobedifferent. Do not stoptaking AlventaXL without talkingtoyourdoctor (seethesection“Ifyoustoptaking AlventaXL”). PACKAGE LEAFLET: INFORMATION FOR THE USER Alventa XL 37.5 mg prolonged-release capsules, hard Alventa XL 75 mg prolonged-release capsules, hard Alventa XL 150 mg prolonged-release capsules, hard Venlafaxine If you take more Alventa XL than you should Callyourdoctororpharmacist immediatelyifyoutake morethan theamountof AlventaXLprescribedbyyourdoctor. Thesymptomsofapossibleoverdose mayincludearapid heartbeat,changes in levelofalertness (rangingfrom sleepiness to coma),blurredvision,seizuresor fits,andvomiting. If you forget to take Alventa XL Ifyou missadose,takeitas soon asyouremember.However, if it is timeforyour nextdose,skipthe misseddoseandtakeonlya singledoseasusual.Do not take morethan thedailyamountof AlventaXLthat hasbeen prescribedforyouin oneday. If you stop taking Alventa XL Do not stoptakingyour treatmentor reducethedose without theadviceofyourdoctoreven ifyoufeelbetter.Ifyourdoctor thinks thatyou nolonger need AlventaXL, he/she mayaskyoutoreduceyourdoseslowlybeforestoppingtreatmentaltogether. Sideeffectsareknown tooccur when peoplestopusing AlventaXL,especially when AlventaXLis stoppedsuddenlyor thedoseis reducedtooquickly.Somepatients mayexperiencesymptoms such as tiredness,dizziness, light-headedness, headache,sleeplessness, nightmares,dry mouth, lossofappetite, nausea,diarrhoea, nervousness,agitation,confusion,ringingin theears,tinglingor rarelyelectric shocksensations,weakness,sweating,seizures,or flu-likesymptoms. Yourdoctor willadviseyouon how youshouldgraduallydiscontinue AlventaXLtreatment.Ifyouexperienceanyof theseor other symptoms thataretroublesome,askyourdoctor for furtheradvice. Ifyou haveanyfurtherquestionson theuseof thisproduct,askyourdoctororpharmacist.

Possible side effects

Likeall medicines,AlventaXLcan causesideeffects,although noteverybodygets them. Allergic reactions Ifanyof thefollowing happen,do not take more AlventaXL.Tellyourdoctor immediately,orgotothecasualtydepartmentat your nearest hospital:
• Chest tightness,wheezing,troubleswallowingorbreathing
• Swellingof theface,throat, hands,or feet
• Feeling nervousoranxious,dizziness,throbbingsensations,sudden reddeningof theskin and/ora warm feeling
• Severerash, itching,or hives (elevatedpatchesof redorpaleskin thatoften itch) Serious side effects Ifyou noticeanysignsof thefollowing,you may needurgent medicalattention:
• Heartproblems,such as fastor irregular heart rate, increasedbloodpressure
• Eyeproblems,such asblurredvision,dilatedpupils
• Nerveproblems,such asdizziness,pinsand needles,movementdisorder,seizuresor fits
• Psychiatricproblems,such as hyperactivityandeuphoria
• Treatment withdrawal (seethesection“How totake AlventaXL, ifyoustoptaking AlventaXL”). Complete side effect listing Thefrequency(likelihoodofoccurring)of sideeffects is classifiedas follows: Verycommon Affects morethan 1user in 10

Common Affects1to10users in 100

Uncommon Affects1to10users in 1,000

Rare Affects1to10users in 10,000 Notknown Frequencycannotbeestimatedfrom theavailabledata
• Blood disorders

Uncommon:bruising;blacktarrystools (faeces)orbloodin stools,which can beasign of internalbleeding

Not known: reduced numberofplatelets in yourblood, leadingtoan increasedriskofbruisingorbleeding;blooddisorders which mayleadtoan increasedriskof infection
• Metabolism/nutritional disorders

Common: weight loss; increasedcholesterol

Uncommon: weightgain

Not known: slight changes in bloodlevelsof liverenzymes;decreasein bloodsodium levels; itchiness,yellow skin oreyes,dark urine,or flu-likesymptoms,which aresymptomsof inflammation of theliver (hepatitis);confusion,excessive water intake (known asSIADH); abnormalbreast milkproduction
• Nervous system disorders

Very common:dry mouth; headache

Common:abnormaldreams;decreasedlibido;dizziness; increased muscletonus; insomnia; nervousness;pinsand needles; sedation;tremor;confusion;feelingseparated(ordetached) from yourselfandreality

Uncommon: lackof feelingoremotion; hallucinations; involuntary movementof the muscles;agitation; impairedcoordination andbalance

Rare: asensation of restlessnessoran inabilitytositor standstill;seizuresor fits;feelingoverexcitedoreuphoric

Not known: a high temperature with rigid muscles,confusion oragitation,andsweating,or ifyouexperiencejerky muscle movements which youcan’t control,these maybesymptomsof serious conditionsknown as neuroleptic malignant syndrome; euphoric feelings,drowsiness,sustainedrapideye movement,clumsiness,restlessness,feelingofbeingdrunk,sweatingor rigid muscles,which aresymptomsof serotonergic syndrome;disorientation andconfusion often accompaniedby hallucination (delirium);stiffness,spasmsandinvoluntary movementsof the muscles;thoughtsof harmingorkillingyourself, afeelingofdizzinessor“spinning”(vertigo);aggression
• Sight and hearing disorders

Common: blurredvision

Uncommon: alteredtastesensation;ringingin theears (tinnitus)

Not known: severeeyepain anddecreasedorblurredvision
• Heart or circulation disorders

Common: increasein bloodpressure;flushing;palpitations

Uncommon: feelingdizzy(particularly when standinguptooquickly),fainting,fast heartbeat

Not known: decreasein bloodpressure;abnormal,rapidor irregular heartbeat,which couldleadtofainting
• Breathing disorders

Common: yawning

Not known: coughing,wheezing,shortnessofbreath anda high temperature,which aresymptomsof inflammation of the lungsassociated with an increasein whitebloodcells (pulmonaryeosinophilia)
• Digestive disorders

Very common: nausea

Common: appetitedecreased;constipation;vomiting

Uncommon: grindingof theteeth;diarrhoea

Not known: severeabdominalorbackpains (which couldindicateaseriousproblem in thegut, liverorpancreas)
• Skin disorders

Very common: sweating(including night sweats)

Uncommon: rash;abnormal hair loss

Not known: skin rash,which mayleadtosevereblisteringandpeelingof theskin; itching;mildrash
• Muscle disorders

Not known: unexplained musclepain,tendernessor weakness (rhabdomyolysis)
• Urinary system disorders

Common: difficultiespassingurine; increasedfrequencyin urination

Uncommon: inabilitytopassurine

Rare: inabilitytocontrolurination
• Reproductive and sexual disorders

Common:abnormalejaculation/orgasm (males); lackoforgasm;erectiledysfunction (impotence);menstrual irregularities such as increasedbleedingor increasedirregularbleeding

Uncommon:abnormalorgasm (females)
• General

Common: weakness (asthenia);chills

Uncommon: sensitivitytosunlight

Not known: swollen faceor tongue,shortnessofbreath ordifficultybreathing,often with skin rashes (this maybeaserious allergic reaction) AlventaXLsometimes causesunwantedeffects thatyou may notbeawareof,such as increases in bloodpressureorabnormal heartbeat;slight changes in bloodlevelsor liverenzymes,sodium or cholesterol.Morerarely,AlventaXL mayreducethefunction ofplatelets in yourblood, leadingtoan increasedriskofbruisingorbleeding.Therefore,yourdoctor may wish todobloodtests occasionally,particularlyifyou havebeen taking AlventaXLforalongtime. Ifanyof thesideeffectsgets serious,or ifyou noticeanysideeffects not listedin this leaflet,pleasetellyourdoctoror pharmacist.

How to Store Effexor

Keepoutof thereach andsightof children. Do notuse AlventaXLafter theexpirydate which is statedon thepackage.Theexpirydaterefers tothelastdayof that month. This medicinalproductdoes not requireanyspecial storageconditions. Medicines should notbedisposedofvia wastewateror household waste.Askyourpharmacist how todisposeof medicines no longer required.These measures will helptoprotect theenvironment