Label:Informationfortheuser

PregabalinaTAD25mghardcapsulesEFG

PregabalinaTAD50mghardcapsulesEFG

PregabalinaTAD75mghardcapsulesEFG

PregabalinaTAD100mghardcapsulesEFG

PregabalinaTAD150mghardcapsulesEFG

PregabalinaTAD200mghardcapsulesEFG

PregabalinaTAD300mghardcapsulesEFG

Readthelabelcarefullybeforestartingtotakethismedicine,becauseitcontainsimportantinformationforyou.

• Keepthislabel,asyoumayneedtoreaditagain.
• Ifyouhaveanyquestions,askyourdoctororpharmacist.
• Thismedicinehasbeenprescribedonlyforyou,andyoushouldnotgiveittootherseveniftheyhavethesamesymptomsasyou,asitmayharmthem.
• Ifyouexperienceanyadverseeffects,consultyourdoctororpharmacist,eveniftheyarenotlistedinthislabel.Seesection4.

Contentsofthelabel:

1. WhatisPregabalinaTADandwhatisitusedfor
2. WhatyouneedtoknowbeforestartingtotakePregabalinaTAD
3. HowtotakePregabalinaTAD
4. Possibleadverseeffects
5. StorageofPregabalinaTAD
6. Contentsofthecontainerandadditionalinformation

Pregabalinbelongstoagroupofmedicinesthatareusedfortreatmentofepilepsy, neuropathic painandgeneralizedanxietydisorder(GAD)inadults.

Peripheral and central neuropathic pain:Pregabalin is used for the treatment of chronic pain caused by nerve damage. There are various diseases that can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and a 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:Pregabalin is used in the treatment of certain classes of epilepsy (partial seizures with or without secondary generalization)inadults.Your doctor will prescribe Pregabalin TAD to treat epilepsy when your current treatment does not control the disease.You must take pregabalin in addition to your current treatment.Pregabalin should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Pregabalin is used in the treatment of generalized anxiety disorder (GAD).The symptoms of GAD are excessive and prolonged anxiety and worry that are difficult to control.GAD may also produce restlessness or a sensation of excitement or nervousness, feeling easily fatigued (tired), having difficulty concentrating or staying with your mind blank, irritability, muscle tension, or sleep disturbances.This is different from the stress and tensions of everyday life.

Do not take Pregabalina TAD

• if you are allergic to pregabalin or any of the other components of this medicine (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pregabalina TAD.

• Some patients treated with pregabalin have notified symptoms that point to an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of a diffuse 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 associated with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you observe any of these symptoms related to these severe skin reactions described in section 4.
• Pregabalina 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.
• Pregabalina 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.
• Cardiac insufficiency has been reported in some patients treated with this medicine. 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.
• Renal insufficiency has been reported in some patients treated with this medicine. If during pregabalin treatment you note a decrease in your ability to urinate, you should inform your doctor, as the interruption of treatment may improve this situation.
• Some patients treated with antiepileptic drugs such as pregabalin have had thoughts of self-harm 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.
• Pregabalin taken with other medications that may cause constipation (such as some types of pain medications) may lead to gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis). Inform your doctor if you suffer from 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, as this may mean you have a higher risk of becoming dependent on pregabalin.
• Seizures have been reported during or shortly after treatment with pregabalin. If you experience seizures, contact your doctor immediately.
• Reduced cerebral function (encephalopathy) has been reported 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.
• Difficulty breathing has been reported. If you have respiratory system disorders, kidney insufficiency, 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 Pregabalina TAD” and “If you interrupt treatment with Pregabalina TAD”). 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 experience discomfort 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 Pregabalina TAD

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

Pregabalina and certain medicines may interact with each other (interactions). When you take Pregabalina TAD with certain medicines that have a sedative effect (including opioids), these effects may be potentiated, and may lead to respiratory insufficiency, coma, and death.

The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medicines that contain:

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

Pregabalina TAD can be taken with oral contraceptives.

Taking Pregabalina TAD with food, drinks, and alcohol

The pregabalin TAD capsules can be taken with or without food.

It is recommended not to take alcohol during treatment with pregabalin.

Pregnancy, lactation, and fertility

Do not take pregabalin during pregnancy or lactation, unless your doctor has indicated otherwise. 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 use of machines

Pregabalina TAD may cause symptoms such as dizziness, somnolence, and decreased concentration. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor evaluates your response to this medicine.

Followexactlytheadministrationinstructionsforthismedicationasindicatedbyyourdoctor.Incaseofdoubt,consultyourdoctororpharmacistagain.Donottakemoremedicationthanprescribed.

Yourdoctorwilldeterminetheappropriatedoseforyou.

Pregabalinaisexclusivelyfororaluse.

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

• Takethenumberofcapsulesindicatedbyyourdoctor.
• Thedose,adjustedforyouandyourcondition,willgenerallybebetween150mgand600mgperday.
• Yourdoctorwillindicatethatyoutakepregabalinatwiceorthreetimesaday.Iftwiceaday,takepregabalinaonceinthemorningandonceintheevening,approximatelyatthesametimeeveryday.Ifthreetimesaday,takepregabalinainthemorning,atmidday,andintheevening,approximatelyatthesametimeeveryday.

Ifyouestimatethattheeffectofpregabalinaistoostrongorweak,informyourdoctororpharmacist.

Ifyouareanelderlypatient(over65yearsold),takepregabalinanormally,exceptifyouhavekidneyproblems.Yourdoctormayprescribeadifferentdosingregimenordoseifyouhavekidneyproblems.

Swallowthecapsulewholewithwater.

Continuetakingpregabalinauntilyourdoctortellsyoutostoptakingit.

IfyoutakemorePregabalinaTADthanyoushould

Incaseofoverdoseoraccidentalingestion,consultyourdoctororpharmacistimmediatelyorcalltheToxicologicalInformationService,phone915620420,indicatingthemedicationandtheamountingested.Bringthepackageorbottleofcapsuleswithyou.

Asaresultofhavingtakenmorepregabalinathanyoushould,youmayfeeldrowsy,confused,agitated,orrestless.Clinicalepisodesofepilepsyandlossofconsciousness(coma)havealsobeenreported.

IfyouforgettotakePregabalinaTAD

Itisimportanttotakethecapsulesofpregabalinaregularlyatthesametimeeveryday.Ifyouforgettotakeadose,takeitassoonasyouremember,unlessitisnearlytimeforthenextdose.Continuewiththenextdoseattheusualtime.Donottakeadoubledosetomakeupformisseddoses.

IfyouinterruptthetreatmentwithPregabalinaTAD

Donotstoptakingpregabalinasuddenly.Ifyouwanttostoptakingpregabalina,talktoyourdoctorfirst.Hewilltellyouhowtodoit.Ifyouaregoingtostopthetreatment,itshouldbedonegraduallyoveraminimumof1week.

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

Thesesymptomsmayappearmorefrequentlyorwithgreaterseverityifyouhavebeentakingpregabalinaforalongerperiodoftime.Ifyouexperiencewithdrawaleffects,seeyourdoctor.

Ifyouhaveanyotherdoubtsabouttheuseofthismedication,askyourdoctororpharmacist.

Like all medications, this medication can produce adverse effects, although not all people will experience them.

If you experience swelling in the face or tongue, or if your skin becomes red and presents blisters or peeling, you should seek medical assistance immediately.

Very common: may affect more than 1 in 10 people

• Dizziness, somnolence, headache

Common: may affect up to 1 in 10 people

• Increased appetite
• Sensation of euphoria, confusion, disorientation, decreased sexual appetite, irritability
• Alteration of attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation of numbness, tingling, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen
• Difficulty with erection
• Swelling of the body including extremities
• Sensation of intoxication, alterations in the way of walking
• Weight gain
• Muscle cramp, pain in joints, back pain, pain in extremities
• Throat pain

Rare: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Change in perception of oneself, anxiety, depression, agitation, changes in mood, difficulty finding words, hallucinations, strange dreams, anxiety crisis, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation
• Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, sensation of burning, tremor when moving, decreased consciousness, loss of knowledge, fainting, increased sensitivity to sounds, general discomfort
• Dry eyes, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation
• Alterations in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Flush, heat rash
• Difficulty breathing, dry nasal passages, nasal congestion
• Increased saliva production, pain, numbness around the mouth
• Sweating, rash, chills, fever
• Muscle spasms, swollen joints, muscle stiffness, pain including muscle pain, neck pain
• Breast pain
• Difficulty or pain when urinating, inability to hold urine
• Weakness, thirst, chest oppression
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nasal bleeding, cough, sneezing
• Painful menstruation
• Sensation of cold in hands and feet

Very rare: may affect up to 1 in 10,000 people

• Altered sense of smell, oscillating vision, alteration of depth perception, visual brightness, loss of vision
• Dilated pupils, strabismus
• Cold sweat, throat oppression, swollen tongue
• Pancreatitis inflammation
• Difficulty swallowing
• Slow or reduced body mobility
• Difficulty writing correctly
• Fluid accumulation in the abdominal area
• Fluid in the lungs
• Convulsions
• Changes in ECG corresponding to heart rhythm alterations
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual cycle interruption
• Renal problems, reduced urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts

• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by flat, non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Jaundice (yellow skin and eyes)
• Parkinsonism, Parkinson's disease-like symptoms, such as tremor, bradykinesia (decreased ability to move), and muscle stiffness

Very rare: may affect up to 1 in 10,000 people

• Liver failure
• Hepatitis (liver inflammation)

Frequency unknown: the frequency cannot be estimated from available data

• Becoming dependent on pregabalin ("drug dependence").

After completing short- and long-term treatment with pregabalin, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop taking Pregabalin TAD")

Certain adverse effects, such as drowsiness, may be more frequent since patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (tense or rigid muscles), with adverse effects similar to those of pregabalin, so the intensity of these effects may increase when taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Communication of adverse effects

Siexperimentacualquieriptodeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv.Tambienpuedecomunicarlosdirectamenteatravésdeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv.Tambienpuedecomunicarlosdirectamenteatravésdeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv.Tambienpuedecomunicarlosdirectamenteatravésdeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv.Tambienpuedecomunicarlosdirectamenteatravésdeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv.

Si experimentacualquieriptodeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv,Tambienpuedecomunicarlosdirectamenteatravésdeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv,puedecomunicarlosdirectamenteatravésdeefectoadverso,consulteasumédicoofarmacetico,inclusosisetratamentdeposiblesefectosadversosquenoaparecenenesteprospectiv.

Keepthismedicationoutofsightandreachofchildren.

DonotusethismedicationaftertheexpirationdatethatappearsonthecontainerafterCAD.Theexpirationdateisthelastdayofthemonthindicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and unused medications. This will help protect the environment.

CompositionofPregabalinaTAD

• Theactiveingredientispregabalina.Eachhardcapsulecontains25mg,50mg, 75mg, 100mg, 150mg, 200mg or 300mgofpregabalina.
• Theothercomponentsarepregelatinizedcornstarchandtalc(E553b)inthecapsulecontent.
• Theothercomponentsofthehardcapsulesof25mgaredioxideoftitanium(E171),gelatinandblackinkforprinting(shellac(E904),ironoxideblack(E172),propyleneglycol(E1520))inthecapsulecoat.
• Theothercomponentsofthehardcapsulesof50mgand75mgaredioxideoftitanium(E171),gelatin,yellowironoxide(E172)andblackinkforprinting(shellac(E904),ironoxideblack(E172),propyleneglycol(E1520))inthecapsulecoat.
• Theothercomponentsofthehardcapsulesof100mgaredioxideoftitanium(E171),gelatin,redironoxide(E172)andwhiteinkforprinting(shellac(E904),propyleneglycol(E1520),potassiumhydroxide(E525),dioxideoftitanium(E171))inthecapsulecoat.
• Theothercomponentsofthehardcapsulesof150mgaredioxideoftitanium(E171),gelatin,redironoxide(E172),yellowironoxide(E172)andblackinkforprinting(shellac(E904),ironoxideblack(E172),propyleneglycol(E1520))inthecapsulecoat.
• Theothercomponentsofthehardcapsulesof200mgaredioxideoftitanium(E171),gelatin,redironoxide(E172),yellowironoxide(E172),ironoxideblack(E172)andblackinkforprinting(shellac(E904),ironoxideblack(E172),propyleneglycol(E1520))inthecapsulecoat.
• Theothercomponentsofthehardcapsulesof300mgaredioxideoftitanium(E171),gelatin,redironoxide(E172),yellowironoxide(E172),ironoxideblack(E172)andwhiteinkforprinting(shellac(E904),propyleneglycol(E1520),potassiumhydroxide(E525),dioxideoftitanium(E171))inthecapsulecoat.

Appearanceoftheproductandcontentsofthepackaging

Hardcapsule.

PregabalinaTAD25mgarehardcapsuleswithawhitebodyandawhitecapwithablackimprintP25.Thecontentsofthecapsuleareawhiteoralmostwhitepowder.Thelengthofthecapsuleis13.8–14.8mm.

PregabalinaTAD50mgarehardcapsuleswithawhitebodyandayellowshinycapwithablackimprintP50.Thecontentsofthecapsuleareawhiteoralmostwhitepowder.Thelengthofthecapsuleis15.3–16.2mm.

PregabalinaTAD75mgarehardcapsuleswithayellowishbrowncolourandayellowishbrowncapwithablackimprintP75.Thecontentsofthecapsuleareawhiteoralmostwhitepowder.Thelengthofthecapsuleis13.8–14.8mm.

PregabalinaTAD100mgarehardcapsuleswithabrownishredcolourandabrownishredcapwithawhiteimprintP100.Thecontentsofthecapsuleareawhiteoralmostwhitepowder.Thelengthofthecapsuleis15.3–16.2mm.

PregabalinaTAD150mgarehardcapsuleswithawhitebodyandayellowishbrowncapwithablackimprintP150.Thecontentsofthecapsuleareawhiteoralmostwhitepowder.Thelengthofthecapsuleis17.2–18.3mm.

PregabalinaTAD200mgarehardcapsuleswithabrowncolourandabrowncapwithablackimprintP200.Thecontentsofthecapsuleareawhiteoralmostwhitepowder.Thelengthofthecapsuleis18.7–19.8mm.

PregabalinaTAD300mgarehardcapsuleswithawhitebodyandabrownishdarkcapwithawhiteimprintP300.Thecontentsofthecapsuleareawhiteoralmostwhitepowder.Thelengthofthecapsuleis20.0–22.1mm.

PregabalinaTADispresentedinblisterpackscontaining14,56or84hardcapsules.

Onlysomepacksizesmaybemarketed.

MarketingAuthorisationHolder

TAD Pharma GmbH, Heinz‑Lohmann‑Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz‑Lohmann‑Straße 5, 27472 Cuxhaven, Germany

FurtherinformationcanbeobtainedfromthelocalrepresentativeoftheMarketingAuthorisationHolder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

ThismedicineisauthorisedintheMemberStatesoftheEEAunderthefollowingnames:

Lastreviewdateofthisleaflet:March 2024

FurtherinformationisavailableonthewebsiteoftheSpanishAgencyforMedicinesandMedicalDevices(AEMPS)http://www.aemps.gob.es/