Duloxetine Altercontieneelprincipioactivoduloxetina.Duloxetineaumentalosnivelesdeserotoninaynoradrenalinaenelsistemanervioso.

Duloxetineempleaenadultosparatratar:

• depression
• generalized anxiety disorder (notowritedbymedicationorothertreatmentsorifsymptomsaresevereorpersistent).
• diabetic neuropathic pain (nervepainthatiscausedbydiabetesandisnotwellcontrolledbyothertreatmentsorifsymptomsaresevereorpersistent).

Duloxetinecomenzaaactuarenlamayoríadepersonascondepresióno ansiedadalasdossemanas trashabercomenzadoeltratamiento,peropuedenpasarentre2 y 4semanashastaquecomiencea sentirsemejor.Ifyoudonotimproveafter2to4weeks,yourdoctormayincreaseyourdoseorswitchyoutoadifferentmedicationforyourconditionorpainsymptomsthataresevereorpersistent).

In people with diabetic neuropathic pain, duloxetine may help you feel better after a few weeks. If you do not feel better after a few weeks, your doctor may increase your dose or switch you to a different medication for your condition or pain symptoms that are severe or persistent.

Some people with diabetic neuropathic pain may feel better after a few weeks. If you do not feel better after a few weeks, your doctor may increase your dose or switch you to a different medication for your condition or pain symptoms that are severe or persistent.

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 usually 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 an elderly person)
• 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 still. If this happens, tell your doctor.

Thoughts of suicide and worsening of your 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 directly to the hospital as soon as 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 an anxiety disorder, 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 may resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may 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. Also, you should 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 mentioned 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:

• dyspnoea, 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:do not take duloxetine if you are taking, or have taken in the last 14 days, another antidepressant known as a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). 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:This includes prescription medicines prescribed by your doctor, 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), petidina, 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, 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, drinks 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 if you 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.

Ifyoutaketoomuchduloxetina,consultyourdoctororpharmacistimmediately.Incaseofdoubt,consultyourdoctororpharmacistagain.

Duloxetinaisavailablebyoralroute.Takethecapsulewithaglassofwater.

Paralosquehanprescritoduloxetina,ladosisrecomendadaes60mgperday,perosumédicoleprescribiráladosismásapropiadaparausted.

Paralosquehanprescritoduloxetina,ladosisnodebeserreducidainicialmentea30mgperday,yluegoseincrementaráa60mgperday,perosumédicoleprescribiráladosismásapropiadaparausted.Sinosesigueeltratamiento,nosedebetomarduloxetinahasta12hoursafterthelastdoseofduloxetinathatday.

Toremembertotakeduloxetina,itmaybehelpfultotakeitatthesametimeeveryday.

Informyourdoctorifyoumissadoseofduloxetinaorifyoutaketoomuchduloxetinaatonetimeorifyoustoptakingduloxetinawithoutconsultingyourdoctorfirst.Itisimportanttofollowtheinstructionsgivenbyyourdoctortogetthebestresultsfromduloxetina.

Ifyoutaketoomuchduloxetina,consultyourdoctororpharmacistimmediately.

Incaseofsobredosis,ingestiónaccidental,consulteinmediatamenteasumédicoofarmacéuticoollamealServiciodeInformaciónToxicológica,teléfono:91.562.04.20,indicandoelmedicamentoylacantidadingerida.

Amongthesymptomsproducedbyasobredosis,includesomnolencia,coma,síndromeserotoninérgico,convulsiones,vómitos,yaltafrecuenciacardíaca.

Ifyouaccidentallytakeduloxetina,pleasecontactyourdoctororpharmacistimmediately.

Donottakeanotherdoseofduloxetinauntilyouhavecontactedyourdoctororpharmacistagain.

Ifyoustoptakingduloxetina,donotstoptakingduloxetinawithoutconsultingyourdoctorfirstandfollowtheinstructionsgivenbyyourdoctortogetthebestresultsfromduloxetinaforatleast2weeksbeforestoppingduloxetinacompletelyandconsultyourdoctorbeforestoppingduloxetinacompletelyifyouarenotsurewhattodoorifyouareexperiencinganysideeffectsthatarebotheringyouorifyouarenotgettingtheresultsyouwantfromduloxetinaorifyouareexperiencinganysideeffectsthatarebotheringyouorifyouarenotgettingtheresultsyouwantfromduloxetinaorifyouareexperiencinganysideeffectsthatarebotheringyouorifyouarenotgettingtheresultsyouwantfromduloxetinaorifyouareexperiencinganysideeffectsthatarebotheringyouorifyouarenotgettingtheresultsyouwantfromduloxetinaorifyouareexperiencinganysideeffectsthatarebotheringyouorifyouarenotgettingtheresultsyouwantfromduloxetinaorifyouareexperiencinganysideeffectsthatarebotheringyouorifyouarenotgettingtheresultsyouwantfromduloxetinaorifyouareexperiencinganysideeffectsthatarebotheringyouorifyouarenot

4. Possible Adverse Effects

5. Conservation of Duloxetina Alter

6. Contents of the packaging and additional information