Label: informationfortheuser

Apregia25mghardEFGcapsules

pregabalina

Readthelabelcarefullybeforestartingtotakethismedicine,becauseitcontainsimportantinformationforyou.

–Keepthislabel,asyoumayneedtorefertoitagain.

–Ifyouhaveanyquestions,consultyourdoctororpharmacist.

–Thismedicinehasbeenprescribedonlyforyou,andshouldnotbegiventootherswhomayhavethesamesymptomsasyou,asitmayharmthem.

–Ifyouexperienceadverseeffects,consultyourdoctororpharmacist,eveniftheyarenotlistedinthislabel.Seesection4.

Labelcontents

1.WhatisApregiaandwhatisitusedfor

2.WhatyouneedtoknowbeforestartingtotakeApregia

3.HowtotakeApregia

4.Adverseeffects

5.StorageofApregia

6.Contentsofthepackageandadditionalinformation

Apregiabelongstoagroupofmedicinesthatareusedfortreatmentofepilepsy, neuropathic painandgeneralizedanxietydisorder(TAG)inadults.

Peripheral and central neuropathic pain:Pregabalinaisusedfortreatmentofchronic pain caused by nerve damage. There are various diseases that can cause peripheral neuropathic pain, such as diabetes or herpes. The sensation of pain could be described as heat, burning, pulsating pain, flashing pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness and sensation of pinpricks. Peripheral and central neuropathic pain could also be associated with mood changes, sleep disturbances, fatigue (tiredness) and may affect physical and social activity and overall quality of life.

Epilepsy:Pregabalinaisusedintreatmentofcertainclassesofepilepsy(partial seizureswithorwithoutsecondary generalization)inadults.Yourdoctorwillprescribepregabalinatotreatepilepsywhenyourcurrenttreatmentdoesnotcontrolthedisease.Youmusttakepregabalinainadditiontoyourcurrenttreatment.Pregabalinashouldnotbeadministeredalone,butshouldalwaysbeusedincombinationwithotherantiepilepticmedicines.

Generalized anxiety disorder:Pregabalinaisusedintreatmentofgeneralized anxiety disorder(TAG).ThesymptomsofTAGareexcessiveandprolongedanxietyandworrythataredifficulttocontrol.TAGmayalsoproducerestlessnessorsensationofexcitementornervousness,feelfatigued(tired)easily,havedifficultyconcentratingorstayingwiththemindblank,irritability,musculartensionorsleepdisturbance.Thisisdifferentfromdailylifestressandtensions.

Do not take Apregia

If you are allergic to pregabalin or any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Apregia.

• Some patients treated with pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of a widespread skin rash. If you experience any of these symptoms, you should seek medical attention immediately.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should be cautious until you become familiar with the effects the medicine may have.
• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any alteration in your vision, you should inform your doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need a change in their diabetes medication.
• Certain adverse effects, such as somnolence, may be more frequent since patients with spinal cord injury may be taking other medications for treatment, for example, pain or spasticity (tense or rigid muscles), with similar adverse effects to pregabalin, so the intensity of these effects may increase when taken together.
• There have been reports of heart failure in some patients treated with pregabalin. Most of them were elderly patients with cardiovascular diseases. Before using this medicine, you should inform your doctor if you have a history of heart disease.
• There have been reports of kidney failure in some patients treated with pregabalin. If during pregabalin treatment you notice a decrease in your ability to urinate, you should inform your doctor, as interrupting treatment may improve this situation.
• Some patients treated with antiepileptic drugs such as pregabalin have had thoughts of self-harm or suicide or have shown suicidal behavior. If at any time you experience these thoughts or have shown such behavior, contact your doctor as soon as possible.
• When pregabalin is taken with other medications that may cause constipation (such as some types of pain medications), it is possible that gastrointestinal problems (such as constipation and intestinal blockage or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, inform your doctor if you have ever abused or had dependence on alcohol, prescription medications, or illegal drugs; it may mean you have a higher risk of becoming dependent on pregabalin.
• There have been reports of seizures during or shortly after stopping pregabalin treatment. If you experience seizures, contact your doctor immediately.
• There have been reports of reduced brain function (encephalopathy) in some patients taking pregabalin and who had other diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• There have been reports of difficulty breathing. If you have respiratory system disorders, kidney failure, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.

Dependence

Some people may become dependent on pregabalin (need to continue taking the medicine). They may experience withdrawal effects when they stop using pregabalin (see section 3 “How to take Apregia” and “If you interrupt treatment with Apregia”). If you are concerned that you may become dependent on pregabalin, it is essential to consult your doctor.

If you notice any of the following signs while taking pregabalin, it could be a sign that you have become dependent:

- You need to take the medicine for a longer time than recommended by your doctor.

- You feel the need to take more of the recommended dose.

- You are using the medicine for reasons other than those prescribed.

- You have made repeated and unsuccessful attempts to stop or control the use of the medicine.

- When you stop taking the medicine, you feel unwell and feel better once you take the medicine again.

If you notice any of these signs, talk to your doctor to analyze the best assistance plan for you, including when it is appropriate to stop treatment and how to do it safely.

Children and adolescents

The safety and efficacy of pregabalin have not been established in children and adolescents (under 18 years old), so pregabalin should not be used in this age group.

Other medicines and Apregia

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Pregabalin and certain medicines may interact with each other. When pregabalin is taken with certain sedative medications (including opioids), the effects of these medications may be potentiated, and it may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medications that contain:

• Oxycodone (used as an analgesic).
• Lorazepam (used to treat anxiety).
• Alcohol.

Pregabalin can be taken with oral contraceptives.

Taking Apregia with food, drinks, and alcohol

The pregabalin capsules can be taken with and without food.

It is recommended not to drink alcohol during pregabalin treatment.

Pregnancy and breastfeeding

Do not take pregabalin during pregnancy or lactation, unless your doctor has told you to. The use of pregabalin during the first 3 months of pregnancy may cause congenital anomalies in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital anomalies. This contrasts with 4 out of 100 babies born to women not treated with pregabalin in the study. Congenital anomalies of the face (cleft palate), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

A reliable contraceptive method should be used in fertile women. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Pregabalin may cause dizziness, somnolence, and decreased concentration. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.

Followexactlytheinstructionsfortheadministrationofthismedicationasindicatedbyyourdoctor.Incaseofdoubt,consultyourdoctororpharmacistagain.Do not take more medication than prescribed.

Yourdoctorwilldeterminewhatdoseisadequateforyou.

Apregiaisavailableexclusivelyfororaluse.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Takethenumberofcapsulesindicatedbyyourdoctor.
• Thedose,whichhasbeenadjustedforyouandyourcondition,willgenerallybebetween150mgand600mgperday.
• Yourdoctorwillinformyoutotakepregabalinatwiceorthreetimesaday.Iftwiceaday,takepregabalinaonceinthemorningandonceintheevening,approximatelyatthesametimeeveryday.Ifthreetimesaday,takepregabalinainthemorning,atmidday,andintheevening,approximatelyatthesametimeeveryday.

Ifyouestimatethattheeffectofpregabalinaistoostrongorweak,informyourdoctororpharmacist.

Ifyouareanelderlypatient(over65yearsold),takepregabalinanormally,exceptifyouhavekidneyproblems.

Yourdoctormayprescribeadifferentdosingregimenordoseifyouhavekidneyproblems.

Swallowthecapsulewholewithwater.

Continuetakingpregabalinauntilyourdoctortellsyoutostop.

If you take more Apregia than you should

Incaseofoverdoseoraccidentalingestion,consultyourdoctororpharmacistimmediatelyorvisitthenearestemergencyservice.Bringthepackageorbottleofcapsuleswithyou.YoucanalsocalltheToxicologicalInformationService,phone915620420,indicatingthemedicationandtheamountingested.

AsaresultofhavingtakenmoreApregiathanyoushouldhave,youmayfeeldrowsy,confused,agitated,orrestless.Clinicalreportshavealsoincludedseizuresandlossofconsciousness(coma).

If you forget to take Apregia

Itisimportanttotakethecapsulesofpregabalinaregularlyatthesametimeeveryday.Ifyouforgettotakeadose,takeitassoonasyourememberunlessitisnearlytimeforthenextdose.Continuewiththenextdoseattheusualtime.Do nottakeadoubledosetocompensateforthemisseddoses.

If you interrupt the treatment with Apregia

Do notstoptakingpregabalinasuddenly.Ifyouwanttostoptakingpregabalina,talktoyourdoctorfirst.Hewilltellyouhowtodoit.Ifyouaregoingtostopthetreatment,itshouldbedonegraduallyoveraminimumofoneweek.

Onceyouhavefinishedthetreatmentwithpregabalinaforalongorshortperiod,youshouldknowthatyoumayexperiencecertainadverseeffects,calledwithdrawaleffects.Theseeffectsincludesleepproblems,headache,nausea,anxietysensations,diarrhea,flu-likesymptoms,seizures,nervousness,depression,thoughtsofself-harmorsuicide,pain,sweating,anddizziness.Theseeffectsmayappearmorefrequentlyormoreseverelyifyouhavebeentakingpregabalinaforalongerperiod.Ifyouexperiencewithdrawaleffects,visityourdoctor.

Ifyouhaveanyotherdoubtsabouttheuseofthismedication,askyourdoctororpharmacist.

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteveryonewillexperiencethem.

Verycommon:canaffectmorethan1in10people

• Dizziness, drowsiness, headache.

Common:canaffectupto1in10people

• Increasedappetite.
• Feelingofeuphoria,confusion,disorientation,decreasedlibido,irritability.
• Alterationofattention,clumsiness,difficultywithmovement,declineinmemory,memoryloss,shakiness,difficultyspeaking,feelingoftingling,numbness,sedation,drowsiness,insomnia,fatigue,abnormalfeeling.
• Blurredvision,doublevision.
• Dizziness,balanceproblems,falls.
• Drymouth,constipation,vomiting,flatulence,diarrhea,nausea,swollenabdomen.
• Difficultywitherection.
• Swellingofthebodyincludingtheextremities.
• Feelingofintoxication,abnormalgait.
• Weightgain.
• Musclespasms,jointpain,backpain,painintheextremities.
• Throatpain.

Uncommon:canaffectupto1in100people

• Lossofappetite,weightloss,lowbloodsugar,highbloodsugar.
• Changeinself-perception,anxiety,depression,agitation,moodswings,difficultyfindingwords,hallucinations,strangedreams,anxietyattacks,apathy,aggressiveness,elevatedmood,mentaldecline,difficultythinking,increasedlibido,sexualproblemsincludinginabilitytoachieveorgasm,delayedejaculation.
• Changesinvision,unusualeyemovements,changesinvisionincludingtunnelvision,flashesoflight,spasmodicmovements,diminishedreflexes,hyperactivity,dizzinesswhenstanding,sensitiveskin,lossoftaste,burningfeeling,shakinesswhenmoving,diminishedconsciousness,lossofconsciousness,syncope,increasedsensitivitytonoise,generalmalaise.
• Eyedryness,swolleneyes,eyepain,fatiguedeyes,tearfuleyes,eyeirritation.
• Changesinheartrate,increasedheartrate,lowbloodpressure,highbloodpressure,changesinheartrate,heartfailure.
• Flushes,hotflashes.
• Difficultybreathing,drynose,stuffynose.
• Increasedsalivaproduction,burning,numbnessaroundthemouth.
• Sweating,eruption,chills,fever.
• Musclespasms,swollenjoints,musclestiffness,painincludingmusclepain,backpain.
• Breastpain.
• Difficultyorpainwhenurinating,inabilitytoholdurine.
• Weakness,thirst,chestoppression.
• Changesinbloodtestresultsandliverfunctiontests(elevatedcreatininephosphokinaseinblood,alanineaminotransferaseelevated,aspartateaminotransferaseelevated,decreasedplateletcount,neutropenia,elevatedcreatinineinblood,decreasedpotassiuminblood).
• Hypersensitivity,swollenface,itching,urticaria,runnynose,nasalbleeding,cough,snoring.
• Painfulmenstruation.
• Feelingofcoldnessinhandsandfeet.

Rare:canaffectupto1in1000people

• Alteredsenseofsmell,oscillatingvision,distortionofdepthperception,glare,lossofvision.
• Dilatedpupils,strabismus.
• Coldsweat,throatconstriction,swollentongue.
• Pancreatitis.
• Difficultyswallowing.
• Slowedorreducedmovementofthebody.
• Difficultywritingcorrectly.
• Fluidaccumulationintheabdomen.
• Fluidinthelungs.
• Seizures.
• Changesintheelectrocardiogram(ECG)correspondingtochangesinheartrate.
• Muscledamage.
• Milksecretion,abnormalbreastgrowth,enlargedbreastsinmen.
• Disruptedmenstruation.
• Renalinsufficiency,reducedurineoutput,urineretention.
• Decreasedwhitebloodcellcount.
• Inappropriatebehavior,suicidalbehavior,suicidalthoughts.
• Allergicreactionsthatmayincludedifficultybreathing,inflammationoftheeyes(keratitis),andasevereskinreactioncharacterizedbyflatredpatchesthatarenotelevated,orroundorcoin-shapedpatchesonthechest,oftenwithcentralvesicles,peelingoftheskin,ulcersinthemouth,throat,nose,genitals,andeyes.Thesesevereskinreactionsmaybeprecededbyfeverandflu-likesymptoms(Stevens-Johnsonsyndrome,toxicepidermalnecrolysis).
• Jaundice(yellowskinandeyes).
• Parkinsonism,symptomssimilartoParkinson'sdisease,suchasshakiness,bradykinesia(decreasedabilitytomove),andmusclestiffness.

Veryrare:canaffectupto1in10,000people

• Liverfailure.
• Hepatitis(inflammationoftheliver).

Frequencynotknown:cannotbeestimatedfromavailabledata

• Becomingdependentonpregabalin(“drugdependence”).

Onceyouhavefinishedashort-termtreatmentwithpregabalin,youshouldknowthatyoumayexperiencecertainsideeffects,calledwithdrawaleffects(see“IfyoustoptakingApregia”).

Ifyouexperienceswellinginthefaceoronthetongue,orifyourskinturnsredandyougetblisterorpeel,youshouldimmediatelyseekmedicalattention.

Certainsideeffects,suchasdrowsiness,maybemorecommonbecausepatientswithspinalcordinjurymaybetakingothermedicinestotreat,forexample,painorspasticity(muscletensionorrigidity),withsideeffectssimilartopregabalinthatmaybeintensifiedwhentakentogether.

Thefollowingadversereactionhasbeenreportedinpost-marketingexperience:difficultybreathing,shallowbreathing.

Reportingofadversereactions

Sincerintemedicalationtoreportanyadverseeffects,consultyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuticantonlyyourphysicianorpharmaceuti5. Conservation of Apregia

6. Contents of the packaging and additional information