PACKAGE LEAFLET: INFORMATION FOR THE USER. Efexor XL 75 mg prolonged-release capsules, hard Efexor XL 150 mg prolonged-release capsules, hard

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER Efexr XL 75 mg prlnged-release capsules, hard Efexr XL 150 mg prlnged-release capsules, hard Venlafaxine IMPORTANT THINGS YOU SHOULD KNOW ABOUT EFEXOR XL Please read all f this leaflet befre yu start t take yur medicine as it cntains imprtant infrmatin abut Efexr XL Efexr XL is used t treat depressin, severe and persistent anxiety knwn as generalised anxiety disrder (GAD), scial anxiety disrder (als knwn as scial phbia) and panic disrder (panic attacks) Efexr XL is nt fr use in children and adlescents see in sectin 2 Use in children and adlescents If yu have any cncerns abut hw yu feel, r abut this medicatin, it is imprtant that yu talk t yur dctr - even if yu feel anxius r wrried abut ding s. Yu may find it helpful t tell a friend r relative that yu are depressed r suffering frm an anxiety disrder, and that yu have been prescribed this medicatin; it might be useful t shw them this leaflet. Efexr XL may nt start t wrk immediately. Sme peple taking antidepressants may feel wrse befre feeling better. Yur dctr may ask t see yu again a cuple f weeks after yu start treatment and then regularly until yu start t feel well again. Tell yur dctr if yu d nt start t feel better. Sme peple wh are depressed may think f harming r killing themself. If this happens yu shuld see yur dctr r g t a hspital straight away see in sectin 2 Thughts f suicide and wrsening f yur depressin r anxiety disrder If yu take t many capsules it is imprtant t seek immediate medical attentin, even if yu feel well, because f the risk f serius side effects D nt stp taking Efexr XL r change yur dse withut the advice f yur dctr even if yu feel better. If yu stp taking Efexr XL abruptly yu may get withdrawal reactins see in sectin 3 If yu stp taking Efexr XL If yu have heart prblems such as fast r irregular heart rate r high bld pressure yu shuld talk t yur dctr befre taking Efexr XL see in sectin 2 Befre yu take Efexr XL Taking certain ther medicines with Efexr XL may cause prblems. Yu shuld tell yur dctr if yu are taking any ther medicines see in sectin 2 Befre yu take Efexr XL See yur dctr withut delay if yu feel restless and feel like yu can t keep still, feel high r very ver-excited, have jerky muscle mvements which yu can t cntrl. See sectin 4 Pssible side effects fr ther imprtant infrmatin Page 1 f 12

2 If yu are pregnant, r intend t becme pregnant, r breast-feeding, yu shuld talk t yur dctr see in sectin 2 Pregnancy, breast-feeding and Efexr XL Mre infrmatin n all f these pints is prvided in the rest f this leaflet. Read all f this leaflet carefully befre yu start taking this medicine. Keep this leaflet. Yu may need t read it again. If yu have any further questins, ask yur dctr r pharmacist. This medicine has been prescribed fr yu. D nt pass it n t thers. It may harm them, even if their symptms are the same as yurs. If any f the side effects gets serius, r if yu ntice any side effects nt listed in this leaflet, please tell yur dctr r pharmacist. In this leaflet: 1. What Efexr XL is and what it is used fr 2. Befre yu take Efexr XL 3. Hw t take Efexr XL 4. Pssible side effects 5. Hw t stre Efexr XL 6. Further infrmatin 1. WHAT EFEXOR XL IS AND WHAT IT IS USED FOR Efexr XL is an antidepressant that belngs t a grup f medicines called sertnin and nrepinephrine reuptake inhibitrs (SNRIs). This grup f medicines is used t treat depressin and ther cnditins such as anxiety disrders. It is thught that peple wh are depressed and/r anxius have lwer levels f sertnin and nradrenaline in the brain. It is nt fully understd hw antidepressants wrk, but they may help by increasing the levels f sertnin and nradrenaline in the brain. Efexr XL is a treatment fr adults with depressin. It is als a treatment fr adults with the fllwing anxiety disrders: generalised anxiety disrder, scial anxiety disrder (fear r avidance f scial situatins) and panic disrder (panic attacks). Treating depressin r anxiety disrders prperly is imprtant t help yu get better. If it is nt treated, yur cnditin may nt g away and may becme mre serius and mre difficult t treat. 2. BEFORE YOU TAKE EFEXOR XL D nt take Efexr XL If yu are allergic t venlafaxine r any f the ther ingredients f this medicine (Sectin 6 cntains a full list). If yu are als taking, r have taken within the last 14 days, any medicines knwn as irreversible mnamine xidase inhibitrs (MAOIs), used t treat depressin r Parkinsn s disease. Taking an irreversible MAOI tgether with Efexr XL, can cause serius r even life-threatening side effects. Als, yu must wait at least 7 days after yu stp taking Efexr XL befre yu take any MAOI (see als the sectin entitled Taking ther medicines and the infrmatin in that sectin abut Sertnin Syndrme ). Page 2 f 12

3 Take special care with Efexr XL If any f the fllwing apply t yu, please tell yur dctr befre taking Efexr XL: If yu use ther medicines that taken tgether with Efexr XL culd increase the risk f develping sertnin syndrme (see the sectin Taking ther medicines ). If yu have eye prblems, such as certain kinds f glaucma (increased pressure in the eye). If yu have a histry f high bld pressure. If yu have a histry f heart prblems. If yu have a histry f fits (seizures). If yu have a histry f lw sdium levels in yur bld (hypnatraemia). If yu have a tendency t develp bruises r a tendency t bleed easily (histry f bleeding disrders), r if yu are taking ther medicines that may increase the risk f bleeding e.g., warfarin (used t prevent bld clts). If yu have a histry f, r if smene in yur family has had, mania r biplar disrder (feeling ver-excited r euphric). If yu have a histry f aggressive behaviur. Efexr XL may cause a sensatin f restlessness r an inability t sit r stand still during the first few weeks f treatment. Yu shuld tell yur dctr if this happens t yu. Thughts f suicide and wrsening f yur depressin r anxiety disrder If yu are depressed and/r have anxiety disrders, yu can smetimes have thughts f harming r killing yurself. These may be increased when yu first start taking antidepressants, since these medicines all take time t wrk, usually abut tw weeks, but smetimes lnger. Yu may be mre likely t think like this: If yu have previusly had thughts abut killing yurself r harming yurself. If yu are a yung adult. Infrmatin frm clinical trials has shwn an increased risk f suicidal behaviur in yung adults (less than 25 years ld) with psychiatric cnditins wh were treated with an antidepressant. If yu have thughts f harming r killing yurself at any time, cntact yur dctr r g t a hspital straight away. Yu may find it helpful t tell a relative r clse friend that yu are depressed r have an anxiety disrder, and ask them t read this leaflet. Yu might ask them t tell yu if they think yur depressin r anxiety is getting wrse, r if they are wrried abut changes in yur behaviur. Page 3 f 12

4 Dry muth Dry muth is reprted in 10% f patients treated with venlafaxine. This may increase the risk f tth decay (caries). Therefre, yu shuld take special care in yur dental hygiene. Diabetes Yur bld glucse levels may be altered due t Efexr XL. Therefre, the dsage f yur diabetes medicines may need t be adjusted. Use in children and adlescents under 18 years f age Efexr XL shuld nrmally nt be used fr children and adlescents under 18 years. Als, yu shuld knw that patients under 18 have an increased risk f side effects, such as suicide attempt, suicidal thughts and hstility (predminantly aggressin, ppsitinal behaviur and anger) when they take this class f medicines. Despite this, yur dctr may prescribe this medicine fr patients under 18 because he/she decides that this is in their best interests. If yur dctr has prescribed this medicine fr a patient under 18, and yu want t discuss this, please g back t yur dctr. Yu shuld infrm yur dctr if any f the symptms listed abve develp r wrsen when patients under 18 are taking Efexr XL. Als, the lng-term safety effects cncerning grwth, maturatin and cgnitive and behaviural develpment f this medicine in this age grup has nt yet been demnstrated. Taking ther medicines Please tell yur dctr r pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut a prescriptin. Yur dctr shuld decide whether yu can take Efexr XL with ther medicines. D nt start r stp taking any medicines, including thse bught withut a prescriptin, natural and herbal remedies, befre checking with yur dctr r pharmacist. Mnamine xidase inhibitrs which are used t treat depressin r Parkinsn s disease must nt be taken with Efexr XL. Tell yur dctr if yu have taken these medicines within the last 14 days. (MAOIs: see the sectin Befre yu take Efexr XL ). Sertnin syndrme: A ptentially life-threatening cnditin r Neurleptic Malignant Syndrme (NMS)-like reactins (see the sectin Pssible Side Effects ), may ccur with venlafaxine treatment, particularly when taken with ther medicines. Examples f these medicines include: Triptans (used fr migraine) Other medicines t treat depressin, fr instance SNRIs, SSRIs, tricyclics, r medicines cntaining lithium Medicines cntaining linezlid, an antibitic (used t treat infectins) Medicines cntaining mclbemide, a MAOI (used t treat depressin) Medicines cntaining sibutramine (used fr weight lss) Medicines cntaining tramadl, fentanyl, tapentadl, pethidine, r pentazcine (used t treat severe pain) Medicines cntaining dextrmethrphan (used t treat cughing) Page 4 f 12

5 Medicines cntaining methadne (used t treat piid drug addictin r severe pain) Medicines cntaining methylene blue (used t treat high levels f methaemglbin in the bld) Prducts cntaining St. Jhn s Wrt (als called Hypericum perfratum, a natural r herbal remedy used t treat mild depressin) Prducts cntaining tryptphan (used fr prblems such as sleep and depressin) Antipsychtics (used t treat a disease with symptms such as hearing, seeing r sensing things which are nt there, mistaken beliefs, unusual suspiciusness, unclear reasning and becming withdrawn) Signs and symptms f sertnin syndrme may include a cmbinatin f the fllwing: restlessness, hallucinatins, lss f crdinatin, fast heart beat, increased bdy temperature, fast changes in bld pressure, veractive reflexes, diarrhea, cma, nausea, vmiting. In its mst severe frm, sertnin syndrme can resemble Neurleptic Malignant Syndrme (NMS). Signs and symptms f NMS may include a cmbinatin f fever, fast heart beat, sweating, severe muscle stiffness, cnfusin, increased muscle enzymes (determined by a bld test). Tell yur dctr immediately, r g t the casualty department at yur nearest hspital if yu think sertnin syndrme is happening t yu. The fllwing medicines may als interact with Efexr XL and shuld be used with cautin. It is especially imprtant t mentin t yur dctr r pharmacist if yu are taking medicines cntaining: Ketcnazle (an antifungal medicine) Halperidl r risperidne (t treat psychiatric cnditins) Metprll (a beta blcker t treat high bld pressure and heart prblems) Taking Efexr XL with fd and drink Efexr XL shuld be taken with fd (see sectin 3 HOW TO TAKE EFEXOR XL ). Yu shuld avid alchl while yu are taking Efexr XL. Pregnancy and breast-feeding Tell yur dctr if yu becme pregnant, r yu are trying t becme pregnant. Yu shuld use Efexr XL nly after discussing the ptential benefits and the ptential risks t yur unbrn child with yur dctr. Make sure yur midwife and/r dctr knws yu are n Efexr XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk f a serius cnditin in babies, called persistent pulmnary hypertensin f the newbrn (PPHN), making the baby breathe faster and appear bluish. These symptms usually begin during the first 24 hurs after the baby is brn. If this happens t yur baby yu shuld cntact yur midwife and/r dctr immediately. If yu are taking this medicine during pregnancy, ther symptms yur baby might have when it is brn is nt feeding prperly, in additin t having truble breathing. If yur baby has these symptms when it is brn and yu are cncerned, cntact yur dctr and/r midwife wh will be able t advise yu. Page 5 f 12

6 Efexr XL passes int breast milk. There is a risk f an effect n the baby. Therefre, yu shuld discuss the matter with yur dctr, and he/she will decide whether yu shuld stp breast-feeding r stp the therapy with this medicine. Driving and using machines D nt drive r use any tls r machines until yu knw hw this medicine affects yu. 3. HOW TO TAKE EFEXOR XL Always take Efexr XL exactly as yur dctr has tld yu. Yu shuld check with yur dctr r pharmacist if yu are nt sure. The usual recmmended starting dse fr treatment f depressin, generalised anxiety disrder and scial anxiety disrder is 75 mg per day. The dse can be raised by yur dctr gradually, and if needed, even up t a maximum dse f 375 mg daily fr depressin. If yu are being treated fr panic disrder, yur dctr will start with a lwer dse (37.5 mg) and then increase the dse gradually. The maximum dse fr generalised anxiety disrder, scial anxiety disrder and panic disrder is 225 mg/day. Take Efexr XL at apprximately the same time each day, either in the mrning r in the evening. Capsules must be swallwed whle with fluid and nt pened, crushed, chewed r disslved. Efexr XL shuld be taken with fd. If yu have liver r kidney prblems, talk t yur dctr, since yur dse f this medicine may need t be different. D nt stp taking this medicine withut talking t yur dctr (see the sectin If yu stp taking Efexr XL ). If yu take mre Efexr XL than yu shuld Call yur dctr r pharmacist immediately if yu take mre f this medicine than the amunt prescribed by yur dctr. The symptms f a pssible verdse may include a rapid heart beat, changes in level f alertness (ranging frm sleepiness t cma), blurred visin, seizures r fits, and vmiting. If yu frget t take Efexr XL If yu miss a dse, take it as sn as yu remember. Hwever, if it is time fr yur next dse, skip the missed dse and take nly a single dse as usual. D nt take mre than the daily amunt f Efexr XL that has been prescribed fr yu in ne day. If yu stp taking Efexr XL D nt stp taking yur treatment r reduce the dse withut the advice f yur dctr even if yu feel better. If yur dctr thinks that yu n lnger need Efexr XL, he/she may ask yu t reduce yur dse slwly befre stpping treatment altgether. Side effects are knwn t ccur when peple stp using this medicine, especially when it is stpped suddenly r the dse is reduced t quickly. Sme patients may Page 6 f 12

7 experience symptms such as tiredness, dizziness, light-headedness, headache, sleeplessness, nightmares, dry muth, lss f appetite, nausea, diarrhea, nervusness, agitatin, cnfusin, ringing in the ears, tingling r rarely electric shck sensatins, weakness, sweating, seizures, r flu-like symptms. Yur dctr will advise yu n hw yu shuld gradually discntinue Efexr XL treatment. If yu experience any f these r ther symptms that are trublesme, ask yur dctr fr further advice. If yu have any further questins n the use f this prduct, ask yur dctr r pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Efexr XL can cause side effects, althugh nt everybdy gets them. If any f the fllwing happen, d nt take mre Efexr XL. Tell yur dctr immediately, r g t the casualty department at yur nearest hspital: Chest tightness, wheezing, truble swallwing r breathing Swelling f the face, thrat, hands, r feet Feeling nervus r anxius, dizziness, thrbbing sensatins, sudden reddening f the skin and/r a warm feeling Severe rash, itching, r hives (elevated patches f red r pale skin that ften itch) Signs and symptms f sertnin syndrme which may include restlessness, hallucinatins, lss f crdinatin, fast heart beat, increased bdy temperature, fast changes in bld pressure, veractive reflexes, diarrhea, cma, nausea, vmiting. In its mst severe frm, sertnin syndrme can resemble Neurleptic Malignant Syndrme (NMS). Signs and symptms f NMS may include a cmbinatin f fever, fast heart beat, sweating, severe muscle stiffness, cnfusin, increased muscle enzymes (determined by a bld test). Other side effects that yu shuld tell yur dctr abut include: Cughing, wheezing, shrtness f breath and a high temperature Black (tarry) stls r bld in stls Yellw skin r eyes, itchiness r dark urine, which may be symptms f inflammatin f the liver (hepatitis) Heart prblems, such as fast r irregular heart rate, increased bld pressure Eye prblems, such as blurred visin, dilated pupils Nerve prblems, such as dizziness, pins and needles, mvement disrder, seizures r fits Psychiatric prblems, such as hyperactivity and euphria (feeling unusually verexcited). Withdrawal effects (see the sectin HOW TO TAKE EFEXOR XL, if yu stp taking Efexr XL ). Prlnged bleeding - if yu cut r injure yurself, it may take slightly lnger than usual fr bleeding t stp. D nt be cncerned if yu see small white balls r granules in yur stls after taking this medicine. Inside Efexr XL capsules are spherids (small white balls) that cntain the active ingredient (venlafaxine). These spherids are released frm the capsule int yur stmach. As they Page 7 f 12

8 travel thrugh yur stmach and intestines, venlafaxine is slwly released. The spherid shell des nt disslve and is passed ut in yur stls. S, even thugh yu may see spherids in yur stls, yur dse f medicine has been absrbed. Cmplete side effect listing Very cmmn (affects mre than 1 in 10 users) Dizziness; headache Nausea; dry muth Sweating (including night sweats) Cmmn (affects 1 t 10 users in 100) Appetite decreased Cnfusin;feeling separated (r detached) frm yurself; lack f rgasm; decreased libid; nervusness; insmnia; abnrmal dreams Drwsiness; tremr; pins and needles; increased muscle tnus Visual disturbance including blurred visin; dilated pupils; inability f the eye t autmatically change fcus frm distant t near bjects Ringing in the ears (tinnitus) Palpitatins Increase in bld pressure; flushing; Yawning Vmiting; cnstipatin; diarrhea Increased frequency in urinatin; difficulties passing urine Menstrual irregularities such as increased bleeding r increased irregular bleeding; abnrmal ejaculatin/rgasm (males); erectile dysfunctin (imptence) Weakness (asthenia); fatigue; chills Increased chlesterl Uncmmn (affects 1 t 10 users in 1,000) Hallucinatins; feeling separated (r detached) frm reality; agitatin; abnrmal rgasm (females); lack f feeling r emtin; feeling ver-excited; grinding f the teeth A sensatin f restlessness r an inability t sit r stand still; fainting; invluntary mvements f the muscles; impaired crdinatin and balance; altered taste sensatin Fast heartbeat; feeling dizzy (particularly when standing up t quickly) Shrtness f breath Vmiting bld, black tarry stls (faeces) r bld in stls; which can be a sign f internal bleeding General swelling f the skin especially the face, muth, tngue, thrat area r hands and feet and/r a raised itchy rash (hives) may be present; sensitivity t sunlight; bruising; rash; abnrmal hair lss Inability t pass urine; Weight gain; weight lss Rare (affects 1 t 10 users in 10,000) Seizures r fits Page 8 f 12

9 Inability t cntrl urinatin Over activity, racing thughts and decreased need fr sleep (mania) Frequency nt knwn Reduced number f platelets in yur bld, leading t an increased risk f bruising r bleeding; bld disrders which may lead t an increased risk f infectin Swllen face r tngue, shrtness f breath r difficulty breathing, ften with skin rashes (this may be a serius allergic reactin) Excessive water intake (knwn as SIADH) Decrease in bld sdium levels Suicidal ideatin and suicidal behaviurs; cases f suicidal ideatin and suicidal behaviurs have been reprted during venlafaxine therapy r early after treatment discntinuatin (see sectin 2, Befre yu take Efexr XL) Disrientatin and cnfusin ften accmpanied by hallucinatin (delirium); aggressin A high temperature with rigid muscles, cnfusin r agitatin, and sweating, r if yu experience jerky muscle mvements which yu can't cntrl, these may be symptms f serius cnditins knwn as neurleptic malignant syndrme; euphric feelings, drwsiness, sustained rapid eye mvement, clumsiness, restlessness, feeling f being drunk, sweating r rigid muscles, which are symptms f sertnin syndrme; stiffness, spasms and invluntary mvements f the muscles Severe eye pain and decreased r blurred visin Vertig Decrease in bld pressure; abnrmal, rapid r irregular heart beat, which culd lead t fainting; unexpected bleeding, e.g. bleeding gums, bld in the urine r in vmit, r the appearance f unexpected bruises r brken bld vessels (brken veins) Cughing, wheezing, shrtness f breath and a high temperature, which are symptms f inflammatin f the lungs assciated with an increase in white bld cells (pulmnary esinphilia) Severe abdminal r back pains (which culd indicate a serius prblem in the gut, liver r pancreas) Itchiness, yellw skin r eyes, dark urine, r flu-like symptms, which are symptms f inflammatin f the liver (hepatitis); slight changes in bld levels f liver enzymes Skin rash, which may lead t severe blistering and peeling f the skin; itching; mild rash Unexplained muscle pain, tenderness r weakness (rhabdmylysis) Abnrmal breast milk prductin Efexr XL smetimes causes unwanted effects that yu may nt be aware f, such as increases in bld pressure r abnrmal heart beat; slight changes in bld levels r liver enzymes, sdium r chlesterl. Mre rarely, Efexr XL may reduce the functin f platelets in yur bld, leading t an increased risk f bruising r bleeding. Therefre, yur dctr may wish t d bld tests ccasinally, particularly if yu have been taking Efexr XL fr a lng time. If any f the side effects gets serius, r if yu ntice any side effects nt listed in this leaflet, please tell yur dctr r pharmacist. 5. HOW TO STORE EFEXOR XL Keep ut f the reach and sight f children. D nt use Efexr XL after the expiry date, which is stated n the packaging. Page 9 f 12

10 D nt stre abve 30 C. Medicines shuld nt be dispsed f via wastewater r husehld waste. Ask yur pharmacist hw t dispse f medicines n lnger required. These measures will help t prtect the envirnment. 6. FURTHER INFORMATION What Efexr XL cntains The active substance is venlafaxine. Efexr XL75 mg: Each prlnged-release capsule cntains mg f venlafaxine hydrchlride, equivalent t 75 mg f venlafaxine free base. The ther ingredients are: Capsule cntents: micrcrystalline cellulse, ethylcellulse, hyprmellse, talc Capsule shell: gelatin, red and yellw irn xides (E172), titanium dixide (E171) Capsule printing ink: shellac, red irn xide (E172), ammnium hydrxide, simethicne, prpylene glycl Efexr XL 150 mg: Each prlnged-release capsule cntains mg f venlafaxine hydrchlride, equivalent t 150 mg f venlafaxine free base. The ther ingredients are: Capsule cntents: micrcrystalline cellulse, ethylcellulse, hyprmellse, talc Capsule shell: gelatin, red and yellw irn xides (E172), titanium dixide (E171) Capsule printing ink: shellac, sdium hydrxide, pvidne, titanium dixide (E171), prpylene glycl What Efexr XL lks like and cntents f the pack Efexr 75 mg are paque peach capsules with a W and strength 75 printed in red. Efexr 75 mg is available in pack sizes f 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100 and hspital packs f 500 (10x50) and 1000 (10x100) r as bttles f 14, 20, 50, 100 and hspital packs f 500 and Efexr 150 mg are paque dark range capsules with a W and 150 printed in white. Efexr 150 mg is available in pack sizes f 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100 and hspital packs f 500 (10x50) and 1000 (10x100) r as bttles f 14, 20, 50, 100 and hspital packs f 500 and Nt all pack sizes may be available in all cuntries. Page 10 f 12

11 Prlnged-release capsule, hard Marketing Authrisatin Hlder and Manufacturer The Marketing Authrisatin Hlder is: Pfizer Limited Ramsgate Rad Sandwich Kent CT13 9NJ United Kingdm Manufacturer: Pfizer Ireland Pharmaceuticals Little Cnnell Newbridge Cunty Kildare Republic f Ireland This medicinal prduct is authrised in the Member States f the EEA under the fllwing names: Austria Efectin ER 37,5 mg Kapseln Efectin ER 75 mg Kapseln Efectin ER 150 mg Kapseln Belgium, Luxemburg Efexr-Exel 37,5 Efexr-Exel 75 Efexr-Exel 150 Bulgaria Czech Republic, Rmania Cyprus, Greece, Estnia, Lithuania, Prtugal Latvia Denmark, Finland, Iceland, Nrway, Sweden France Efectin ER 75 mg Efectin ER 150 mg Efectin ER 37.5 mg Efectin ER 75 mg Efectin ER 150 mg Efexr XR Efexr XR Efexr XR 75 Efexr XR 150 Efexr Dept Effexr L.P. Page 11 f 12

12 Germany Ireland, Malta, United Kingdm Trevilr retard 37,5 mg Trevilr retard 75 mg Trevilr retard 150 mg Efexr XL The Netherlands Efexr XR 37,5 Efexr XR 75 Efexr XR 150 Italy Efexr Faxine Pland Efectin ER 37,5 Efectin ER 75 Efectin ER 150 Slvenia Spain Efectin ER 37,5 mg trde kapsule s pdaljšanim sprščanjem Efectin ER 75 mg trde kapsule s pdaljšanim sprščanjem Efectin ER 150 mg trde kapsule s pdaljšanim sprščanjem Vandral Retard 75 mg cápsulas de liberación prlgada Vandral Retard 150 mg cápsulas de liberación prlgada *[Please nte that nt all listed prducts and strengths may be available.] This leaflet was last revised in 08/2013 Ref: EF 5_0 This leaflet can be made available in large print, audi r Braille n request. Cntact t request this, quting the fllwing numbers: 00057/1280 r 00057/1281. Page 12 f 12