PACKAGE LEAFLET. Page 1 of 10

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1 PACKAGE LEAFLET Page 1 f 10

2 Package leaflet: Infrmatin fr the user Ireven 75 mg prlnged-release capsules, hard Ireven 150 mg prlnged-release capsules, hard Venlafaxine Read all f this leaflet carefully befre yu start taking this medicine because it cntains imprtant infrmatin fr yu. 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 nly. D nt pass it n t thers. It may harm them, even if their signs f illness are the same as yurs. If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. See sectin 4. What is in this leaflet 1 What Ireven is and what it is used fr 2 What yu need t knw befre yu take Ireven 3 Hw t take Ireven 4 Pssible side effects 5 Hw t stre Ireven 6 Cntents f the pack and ther infrmatin 1. What Ireven is and what it is used fr Ireven cntains the active substance venlafaxine. Ireven 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. Ireven 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. What yu need t knw befre yu take Ireven D nt take Ireven If yu are allergic t venlafaxine r any f the ther ingredients f this medicine (listed in sectin 6). 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 Ireven, can cause serius r even life-threatening side effects. Als, yu must wait at least 7 days after yu stp taking Ireven befre yu take any MAOI (see als the sectin entitled Other medicines and Ireven and the infrmatin in that sectin abut Sertnin syndrme ). Warnings and precautins Page 2 f 10

3 Talk t yur dctr r pharmacist befre taking Ireven: If yu use ther medicines that taken tgether with Ireven culd increase the risk f develping sertnin syndrme (see the sectin Other medicines and Ireven ). 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 been tld yu have an abnrmal heart rhythm. 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. Ireven 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 behavir. 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 Ireven. Therefre, the dsages f yur diabetes medicines may need t be adjusted. Children and adlescents Ireven 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 Ireven. Als, the lng-term Page 3 f 10

4 safety effects cncerning grwth, maturatin and cgnitive and behaviural develpment f this medicine in this age grup has nt yet been demnstrated. Other medicines and Ireven Tell yur dctr r pharmacist if yu are taking, have recently taken r might take any ther medicines. Yur dctr shuld decide whether yu can take Ireven 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 Ireven. Tell yur dctr if yu have taken these medicines within the last 14 days. (MAOIs: see the sectin What yu need t knw befre yu take Ireven ). 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) 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. Yu must tell yur dctr if yu are taking medicines that can affect yur heart rhythm. Examples f these medicines include: Antiarrhythmics such as quinidine, amidarne, stall r dfetilide (used t treat abnrmal heart rhythm) Page 4 f 10

5 Antipsychtics such as thiridazine (see als Sertnin syndrme abve) Antibitics such as erythrmycin r mxiflxacin (used t treat bacterial infectins) Antihistamines (used t treat allergy) The fllwing medicines may als interact with Ireven 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) Ireven with fd, drink and alchl Ireven shuld be taken with fd (see sectin 3 Hw t take Ireven ). Yu shuld avid alchl while yu are taking Ireven. Pregnancy and breast-feeding If yu are pregnant r breast-feeding, think yu may be pregnant r are planning t have a baby, ask yur dctr r pharmacist fr advice befre taking this medicine. Yu shuld use Ireven 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 Ireven. 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, in additin t having truble breathing, anther symptm yur baby might have when it is brn is nt feeding prperly. 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. Ireven 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. Hw t take Ireven Always take this medicine exactly as yur dctr has tld yu. 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 Ireven 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. Ireven shuld be taken with fd. Page 5 f 10

6 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 Ireven ). If yu take mre Ireven 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 Ireven 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 a duble dse t make up fr a frgtten dse. D nt take mre than the daily amunt f Ireven that has been prescribed fr yu in ne day. If yu stp taking Ireven 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 Ireven, 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 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 Ireven 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 medicine, ask yur dctr r pharmacist. 4. Pssible side effects Like all medicines, this medicine can cause side effects, althugh nt everybdy gets them. If any f the fllwing happen, d nt take mre Ireven. Tell yur dctr immediately, r g t the casualty department at yur nearest hspital: Uncmmn (may affect up t 1 in 100 peple) Swelling f the face, muth, tngue, thrat, hands, r feet, and/r a raised itchy rash (hives), truble swallwing r breathing Rare (may affect up t 1 in 1,000 peple) Chest tightness, wheezing, truble swallwing r breathing Severe skin 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). Page 6 f 10

7 Signs f infectin, such as high temperature, chills, shivering, headaches, sweating, flu-like symptms. This may be the result f a bld disrder which leads t an increased risk f infectin. Severe rash, which may lead t severe blistering and peeling f the skin. Unexplained muscle pain, tenderness r weakness. This may be a sign f rhabdmylysis. Other side effects that yu shuld tell yur dctr abut include (The frequency f these side effects are included in the list Other side effects that may ccur belw): Cughing, wheezing and shrtness f breath which may be accmpanied by a high temperature Black (tarry) stls r bld in stls Itchiness, yellw skin r eyes, 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, (muscle spasms r stiffness), seizures r fits Psychiatric prblems, such as hyperactivity and feeling unusually verexcited Withdrawal effects (see the sectin Hw t take Ireven, if yu stp taking Ireven ). Prlnged bleeding - if yu cut r injure yurself, it may take slightly lnger than usual fr bleeding t stp. Other side effects that may ccur Very cmmn (may affect mre than 1 in 10 peple) Dizziness; headache; drwsiness Insmnia Nausea; dry muth; cnstipatin Sweating (including night sweats) Cmmn (may affect up t 1 in 10 peple) Appetite decreased Cnfusin; feeling separated (r detached) frm yurself; lack f rgasm; decreased libid; agitatin; nervusness; abnrmal dreams Tremr; a sensatin f restlessness r an inability t sit r stand still; pins and needles; altered taste sensatin; 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) Fast heartbeat; palpitatins Increase in bld pressure; flushing Shrtness f breath; yawning Vmiting; diarrhea Mild rash; itching Increased frequency in urinatin; inability t pass urine; difficulties passing urine Menstrual irregularities such as increased bleeding r increased irregular bleeding; abnrmal ejaculatin/rgasm (males); erectile dysfunctin (imptence) Weakness (asthenia); fatigue; chills Weight gain; weight lss Increased chlesterl Uncmmn (may affect up t 1 in 100 peple) Over activity, racing thughts and decreased need fr sleep (mania) Hallucinatins; feeling separated (r detached) frm reality; abnrmal rgasm; lack f feeling r emtin; feeling ver-excited; grinding f the teeth Fainting; invluntary mvements f the muscles; impaired crdinatin and balance Feeling dizzy (particularly when standing up t quickly); decrease in bld pressure Vmiting bld, black tarry stls (faeces) r bld in stls, which can be a sign f internal Page 7 f 10

8 bleeding Sensitivity t sunlight; bruising; abnrmal hair lss Inability t cntrl urinatin Stiffness, spasms and invluntary mvements f the muscles Slight changes in bld levels f liver enzymes Rare (may affect up t 1 in 1,000 peple) Seizures r fits Cughing, wheezing and shrtness f breath which may be accmpanied by a high temperature Disrientatin and cnfusin ften accmpanied by hallucinatin (delirium) Excessive water intake (knwn as SIADH) Decrease in bld sdium levels Severe eye pain and decreased r blurred visin Abnrmal, rapid r irregular heartbeat, which culd lead t fainting 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) Very rare (may affect up t 1 in 10,000 peple) Prlnged bleeding, which may be a sign f reduced number f platelets in yur bld, leading t an increased risk f bruising r bleeding Abnrmal breast milk prductin 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) Frequency nt knwn (cannt be estimated frm the available data) 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, What yu need t knw befre yu take Ireven) Aggressin Vertig Ireven 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 f liver enzymes, sdium r chlesterl. Mre rarely, Ireven 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 Ireven fr a lng time. Reprting f side effects If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via HPRA Pharmacvigilance, Earlsfrt Terrace, IRL - Dublin 2; Tel: ; Fax: ; Website: medsafety@hpra.ie. By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. Hw t stre Ireven Keep this medicine ut f the sight and reach f children. D nt use this medicine after the expiry date which is stated n the packaging after EXP. The expiry date refers t the last day f that mnth. Stre belw 30ºC. D nt thrw away any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw Page 8 f 10

9 away medicines yu n lnger use. These measures will help prtect the envirnment. 6. Cntents f the pack and ther infrmatin What Ireven cntains The active substance is venlafaxine. Each prlnged-release capsule, hard cntains 37.5 mg, 75 mg and 150 mg f venlafaxine as venlafaxine hydrchlride. The ther ingredients are: 37.5 mg prlnged-release capsules, hard: Capsule cntent: Hyprmellse, ammni methacrylate cplymer (type B), sdium larilsulfate, magnesium stearate Cating:Basic butylated methacrylate cplymer 12.5% Capsuleshell: Gelatin, titanium dixide (E 171) Printing ink: Shellac, black irn xide (E172), prpylene glycl (E1520) 75 mg prlnged-release capsules, hard: Capsule cntent: Hyprmellse, ammni methacrylate cplymer (type B), sdium larilsulfate, magnesium stearate Cating: Basic butylated methacrylate cplymer 12.5% Capsule shell: Gelatin, titanium dixide (E 171), red irn xide (E172) Printing ink: Shellac, black irn xide (E172), prpylene glycl (E1520) 150 mg prlnged-release capsules, hard: Capsule cntent: Hyprmellse, ammni methacrylate cplymer (type B), sdium larilsulfate, magnesium stearate Cating: Basic butylated methacrylate cplymer 12.5% Capsule shell: Gelatin, titanium dixide (E 171), erythrsine (E127), indigtin I (E 132) Printing ink: Shellac, black irn xide (E172), prpylene glycl (E1520) What Ireven lks like and cntents f the pack 37.5 mg prlnged-release capsules, hard: white paque white paque size 0 hard gelatin capsules cntaining ne rund, bivnvex film-cated tablet, with imprint VEN n cap and 37.5 n bdy. 75 mg prlnged-release capsules, hard: flesh paque flesh paque size 0 hard gelatin capsules cntaining tw rund, bivnvex film-cated tablets, with imprint VEN n cap and 75 n bdy 150 mg prlnged-release capsules, hard: scarlet paque scarlet paque size 00 hard gelatin capsules cntaining three rund, bivnvex film-cated tablets, with imprint VEN n cap and 150 n bdy mg: 10, 14, 28, 30 and 98 prlnged-release capsules, hard 75 mg: 10, 14, 28, 30, 60 and 98 prlnged-release capsules, hard 150 mg: 10, 14, 28, 30, 60 and 98 prlnged-release capsules, hard Marketing Authrisatin Hlder Pharmathen S.A., 6 Dervenakin str., Pallini Attikis, Greece tel: (+30) fax: (+30) inf@pharmathen.cm Page 9 f 10

10 Manufacturer Pharmathen S.A. Dervenakin 6 Pallini Attikis Greece Pharmathen Internatinal S.A. Sapes Industrial Park Blck Rdpi Greece One Pharma industrial pharmaceutical cmpany S.A. 60th km N.N.R. Athinn-Lamias, Sximatari Vitias, 32009, Greece This medicinal prduct is authrised in the Member States f the EEA under the fllwing names: Denmark: Venlafaxine Pharmathen 37,5 mg, 75 mg, 150 mg deptkapsler, hårde Greece: Nrafexine 75 mg, 150 mg σκληρά καψάκια παρατεταμένης αποδέσμευσης Spain: Venlafaxina retard Mab 75 mg, 150 mg Cápsulas duras de liberación prlngada Ireland: Ireven 75 mg, 150 mg prlnged released capsules This leaflet was last revised in Page 10 f 10