Prospect:Informationfortheuser

Duloxetina Alter60mgcapsulesustained-releasegastrorresistentesEFG

Leafletfortheprospectbeforeuseandaftereachuse,incaseofoverdose,andincaseofsideeffects

-Conservethisprospect,andfollowtheinstructionscarefullybeforeusingtheproduct.

-Storeinacool,dryplacefarfromchildren.

-Thismedicineshouldbeusedonlybythepatientforwhomithasbeenprescribed,andnotgiventootherpersonsasasubstitutefortheirownmedication,orincaseofemergency.

-Experiencehasshownthatthisproductiseffective,safeandwelltoleratedwhenusedasdirectedintheprospectversión4.

Contraindicationof:

1.WhatisDuloxetinaAlterandforwhatisitused

2.WhatarethecontraindicationsfortheuseofDuloxetinaAlter

3.HowtotakeDuloxetinaAlter

4.Whatarethepossiblesideeffects

5.ContraindicationofDuloxetinaAlter

6.Contraindicationoftheuseoftheproductincaseofallergicreactionorothercontraindications

Duloxetine Altercontieneelprincipioactivoduloxetina.Duloxetineaumentalosnivelesdeserotoninaynoradrenalinaenelsistemanervioso.

Duloxetineseempleaenadultosparatratar:

• depression
• generalized anxiety disorder (characterizedbyexcessiveworry,fear,oranxietythatisdifficulttocontrol).
• diabetic neuropathy (nervedamagethatcancausepain,numbness,ortinglinginthehandsandfeet).

Duloxetinecomenzaaactuarenlamayoríadepersonascondepresióno ansiedadalasdossemanastrashabercomenzadoeltratamiento,peropuedenpasarentre2 y 4semanashastaquecomiencea sentirsemejor.Informeasumédicosinonotamejoríatrasestetiempo.Sumédicopuedeseguirdándoleduloxetinecuandoseencuentramejorparaprevenirquesudepresiónoansiedadvelvaa aparecer.

Inthepersonascondolorneuropáticodiabéticopuedenpasaralgunassemanasantesdequecomience aencontrarsemejor.Consulteasumédicosinoseencuentramejoralos2meses.

Do not take Duloxetina Alter:

• if you are allergic to duloxetine or any of the other ingredients in this medicine

(listed in section6)

• if you have liver disease
• if you have severe kidney disease
• if you are taking or have taken in the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Use of Duloxetina Alter with other medicines”)
• if you are taking fluvoxamine, which is normally used to treat depression, ciprofloxacin or enoxacin, which are used in the treatment of some infections
• if you are taking other medicines that contain duloxetine (see “Use of Duloxetina Alter with other medicines”)

Consult your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take duloxetine.

Warnings and precautions

Duloxetine may not be suitable for you for the following reasons.

Some medicines in the group to which Duloxetina Alter belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Consult your doctor before starting to take this medicine if:

• you are using other medicines to treat depression (see “Use of Duloxetina Alter with other medicines”)
• you are taking St. John's Wort, a herbal remedy (Hypericum perforatum)
• you have any kidney disease
• you have had seizures (epileptic fits)
• you have had mania
• you have bipolar disorder
• you have eye problems, such as some types of glaucoma (increased eye pressure)
• you have a tendency to develop haematomas (bleeding under the skin)
• you are at risk of having low sodium levels (for example if you are taking diuretics, especially if you are elderly)
• you are being treated with other medicines that can damage the liver
• you are taking other medicines that contain duloxetine (see “Use of Duloxetina Alter with other medicines”)

Duloxetine may cause a feeling of restlessness or inability to sit or stay still. If this happens, tell your doctor.

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may occasionally have thoughts of self-harm or suicide. These thoughts may be increased at the beginning of treatment with antidepressants, as all these medicines take time to work, usually two weeks but sometimes longer.

It is more likely that you will have these thoughts if:

• you have had thoughts of self-harm or suicide before
• you are a young adult. There is information from clinical trials that has shown an increased risk of suicidal behaviour in young adults under 25 years old who have a psychiatric disorder and are being treated with antidepressants

Contact your doctor or go to the hospital immediately if you have any thoughts of self-harm or suicide.

It may be helpful to tell a close friend or family member that you are depressed or have anxiety disorders, and ask them to read this leaflet. They may be able to tell if your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

You should also contact your doctor:

if you experience signs and symptoms of restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, vomiting, as you may be suffering from a serotonin syndrome.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS can include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by blood test).

Children and adolescents

Duloxetine should not normally be used in children and adolescents under 18 years old. You should also know that patients under 18 years old who take this class of medicines have an increased risk of side effects such as suicidal thoughts, suicidal behaviour and hostility (mainly aggression, oppositional behaviour and irritability). Despite this, your doctor may prescribe duloxetine to patients under 18 years old because they decide it may be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 years old and you want to talk about it, please go back to your doctor. You should tell your doctor if any of the symptoms above appear or get worse in patients under 18 years old who are taking duloxetine. Also, in this age group, the long-term safety effects of duloxetine related to growth, maturation and development of cognitive and behavioural functions have not yet been demonstrated.

Use of Duloxetina Alter with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may have to take any other medicine, including those bought without a prescription.

The main component of Duloxetina Alter, duloxetine, is used in other medicines for other treatments:

• dyspeptic pain, depression, anxiety and urinary incontinence.

You should avoid using more than one of these medicines at the same time. Check with your doctor if you are already using other medicines that contain duloxetine.

Your doctor will decide if you can take duloxetine with other medicines.Do not start or stop taking any medicine, including those bought without a prescription and herbal remedies, without first consulting your doctor.

You should also tell your doctor if you are taking any of the following medicines:

MAOIs (monoamine oxidase inhibitors):do not take duloxetine if you are taking, or have taken recently (in the last 14 days), another antidepressant known as a monoamine oxidase inhibitor (MAOI). As examples of MAOIs, moclobemide (an antidepressant) and linezolid (an antibiotic) are included. Taking an MAOI with many prescription medicines, including duloxetine, can cause serious side effects, even life-threatening. You should wait at least 14 days after stopping treatment with an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping treatment with duloxetine before starting treatment with an MAOI.

Medicines that cause drowsiness:including prescription medicines such as benzodiazepines, powerful analgesics, antipsychotics, phenobarbital and antihistamines.

Medicines that increase serotonin levels:Triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (SSRIs, such as paroxetine and fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs, such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), petidin, St. John's Wort and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you notice any unusual symptoms when using any of these medicines with duloxetine, you should tell your doctor.

Oral anticoagulants or antiplatelet agents:medicines that thin the blood or prevent the formation of blood clots. These medicines may increase the risk of bleeding.

Taking Duloxetina Alter with food, drink and alcohol

Duloxetine can be taken with or without food. You should be careful if you take alcohol while taking duloxetine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

• Inform your doctor if you become pregnant or are trying to become pregnant while taking duloxetine. You should only use duloxetine after discussing the potential benefits and any potential risks to the foetus with your doctor.

Make sure your midwife and/or doctor know that you are taking duloxetine. Other similar medicines (SSRIs), taken during pregnancy, may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe more rapidly and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take duloxetine towards the end of your pregnancy, your baby may have some symptoms when it is born. These usually start at birth or within the first few days after the baby's birth. These symptoms may include weak muscles, trembling, nervousness, the baby not feeding properly, breathing problems and convulsions. If your baby has any of these symptoms when it is born or if you are concerned about your baby's health, contact your doctor or midwife, who can advise you.

• Inform your doctor if you are breastfeeding. Duloxetine is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and operating machinery

During treatment with duloxetine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how duloxetine affects you.

Duloxetina Alter contains saccharose

Duloxetine containssaccharose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Ifyouareunsureaboutthedosageofduloxetina,consultyourdoctororpharmacistagainforguidanceonthecorrectdosageforyou.

Duloxetinaisavailableinoralform.Itisusuallytakenonceaday.

Paraleladosingoisonlyornuopatico:

Therecommendeddoseofduloxetinais60mgonceaday.However,yourdoctormayprescribeadifferentdoseforyou.

Paraeltrastornondeansieda:

Therecommendeddoseofduloxetinaforpatientswhohavedifficultyswallowingis30mgonceaday,takenindivideddosesevery12hours.However,yourdoctormayprescribeadifferentdoseforyou.

Tohelpyouremembertotakeduloxetina,takeitatthesametimeeveryday.

Donottakeduloxetinawithothermedicationswithoutconsultingyourdoctororpharmacistfirst.Donotstoptakingduloxetinawithoutconsultingyourdoctororpharmacistfirst.Ifyoustoptakingduloxetina,yoursymptomsmaynotimproveormayevenworsen.

SitomamásDuloxetina Alterdelquedebe

Incaseofoverdoseoraccidentalingestion,consultyourdoctororpharmacistimmediatelyorcalltheToxicologicalInformationService,phone:91.562.04.20,indicatingthemedicationandtheamountingested.

Someofthesymptomsofanoverdoseincludedrowsiness,coma,serotoninsyndrome(ararereactionthatcancausefeelingsofintensehappiness,drowsiness,clumsiness,restlessness,feelingdrunk,fever,sweating,ormusclestiffness),seizures,vomiting,andrapidheartrate.

SiolvidótomarDuloxetina Alter

Ifyouorsomeoneelsehastakenanoverdose,seekmedicalattentionimmediately.Donotdelayinseekinghelp.Ifyouareunsureaboutwhattodo,callyourdoctororpharmacistforguidance.

SiinterrumpeeltratamientoconDuloxetina Alter

DONOTSTOPTAKINGDULOXETINAWITHOUTCONSULTINGYOURDOCTORORPHARMACISTFIRST.Ifyoustoptakingduloxetina,yoursymptomsmaynotimproveormayevenworsen.

Somepatientsmayexperiencesideeffectssuchasdizziness,lightheadedness,nausea,vomiting,diarrhea,abdominalpain,fatigue,insomnia,anxiety,agitation,irritability,restlessness,tremors,seizures,ormuscleweakness.

Thesesideeffectsareusuallymildandtemporary,butinsomecases,theycanbesevereandpersistent.

Somepatientsmayexperiencemoreseveresideeffects,suchasserotoninsyndrome,whichcancausefeelingsofintensehappiness,drowsiness,clumsiness,restlessness,feelingdrunk,fever,sweating,ormusclestiffness).

Estossíntomasnormalmentenosonimportantesydesaparecenenunospocosdías,perosiustedtiene síntomasqueseanmolestospidaconsejoasumédico.

Sitienecualquierotradudasobreelusodeestemedicamento,pregunteasumédicoo farmacéutico.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

These side effects are usually mild to moderate and often disappear within a few weeks.

Very common side effects (may affect more than 1 in 10 patients)

• headache, drowsiness.
• unpleasantness (nausea), dry mouth.

Common side effects (may affect up to 1 in 10 patients)

• loss of appetite.
• difficulty sleeping, feeling agitated, decreased libido, anxiety, difficulty or inability to have an orgasm, unusual dreams.
• dizziness, feeling of slowness, tremors, numbness, including numbness, itching, or tingling in the skin.
• blurred vision.
• tinnitus (perception of sounds in the ear when there is no sound outside).
• feeling palpitations in the chest.
• increased blood pressure, flushing.
• increased yawning.
• constipation, diarrhea, stomach pain, vomiting, heartburn, or indigestion, gas.
• increased sweating, rash (itching).
• muscle pain, muscle spasms.
• painful urination, frequent urination.
• difficulty achieving an erection, changes in ejaculation.
• falls (mainly in older adults), fatigue.
• weight loss.

Children and adolescents under 18 years of age with depression treated with this medicine experienced a decrease in weight when they started taking this medicine. After 6 months of treatment, the weight increased to similar levels of other children and adolescents of the same age and sex.

Uncommon side effects (may affect up to 1 in 100 patients)

• pharyngitis that causes hoarseness.
• suicidal thoughts, difficulty sleeping, bruxism, feeling disoriented, lack of motivation.
• muscle spasms and involuntary movements, feeling restless or inability to remain seated or still, nervousness, difficulty concentrating, changes in taste, difficulty controlling movements, e.g., lack of coordination or involuntary muscle movements, restless legs syndrome, poor-quality sleep.

difficulty controlling movements, e.g., lack of coordination or involuntary muscle movements, restless legs syndrome, poor-quality sleep.

• pupil dilation (the black center of the eye), vision problems.
• feeling dizzy or vertigo, ear pain.
• rapid or irregular heartbeat.
• syncope, dizziness, feeling dizzy or syncope when standing up, cold hands and/or feet.
• throat spasms, nasal bleeding.
• vomiting blood, or black stools, gastroenteritis, belching, difficulty swallowing.
• inflammation of the liver that can cause abdominal pain and yellowing of the skin or the white part of the eyes.
• nocturnal sweating, rashes, cold sweats, sensitivity to sunlight, increased tendency to bruise.
• muscle stiffness, muscle spasms.
• difficulty or inability to urinate, difficulty starting urination, need to urinate at night, need to urinate more than usual, decreased urine flow.
• abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular, or prolonged periods, occasionally light or absent periods, testicular or scrotal pain.
• chest pain, feeling cold, thirst, chills, feeling hot, gait disturbance.
• weight gain.
• This medicine may cause effects that you may not be aware of, such as increased liver enzymes or blood potassium levels, creatine phosphokinase, sugar, or cholesterol.

Rare side effects (may affect up to 1 in 1,000 patients)

• severe allergic reactions, which cause difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions.
• decreased thyroid gland activity, which can cause fatigue or weight gain.
• dehydration, low sodium levels in the blood (mainly in older adults; symptoms may include dizziness, weakness, confusion, sleepiness, or excessive fatigue, nausea, or vomiting, and more serious symptoms are syncope, convulsions, or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• suicidal behavior, mania (hyperactivity, accelerated thinking, and decreased need for sleep), hallucinations, aggression, and anger.
• “serotonin syndrome” (a rare reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), convulsions.
• increased intraocular pressure (glaucoma).
• inflammation of the mouth, bright red blood in the stool, bad breath.
• liver failure, yellowing of the skin or the white part of the eyes (jaundice).
• Stevens-Johnson syndrome (a severe disease with blistering of the skin, mouth, eyes, and genitals), severe allergic reactions that cause swelling of the face or throat (angioedema).
• jaw muscle contractions.
• unusual odor of urine.
• cough, wheezing, and shortness of breath, which may be accompanied by high fever.
• menopausal symptoms, abnormal milk production in men or women.

Unknown frequency (cannot be estimated from available data)

• Signs and symptoms of a condition called “stress cardiomyopathy,” which may include chest pain, difficulty breathing, dizziness, syncope, and irregular heartbeat

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Maintainstemedicamentofueradelavisitaydelacancedelnins.

Donousethismedicamentonpersonaladulaythathasbeenladed.Theexpirationddateofexpirationisthelastdayofthemonthhasbeenlabeled.

Conservarintheoriginalpackage.Donoconservaratperaperaturasuperiorto30°C.

Donodisposeofthismedicamentinthedrain.Insteadofthemedicament,placeinthePointSIGREofthepharmacy.Ifyouhaveanydoubts,pleasecontactyourpharmaceutic.

Composition of Duloxetina Alter

-Theactive principleis duloxetina. Each capsule contains 60mg of duloxetina (as hydrochloride).

-Theothercomponents are:

Content of the capsule: hypromellose, sugar spheres (cornstarch and sucrose), talc, sucrose, hypromellose phthalate, and triethyl citrate.

Capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and indigotin.

Appearance of the product and content of the packaging

Duloxetina Alter 60 mg is a hard, gastro-resistant capsule. The capsules are blue and green.

Duloxetina Alter 60 mg is available in packaging of 28 and 56 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid - Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Last review date of this leaflet:

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.