Dulotex 90 mg capsulas duras gastrorresistentes

Package Leaflet: Information for the User

Dulotex 90 mg Hard Capsules (Gastro-resistant)

Duloxetine (Hydrochloride)

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Dulotex 90 mg contains the active ingredient duloxetina. Dulotex 90 mg increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina is used in adults to treat:

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)

Duloxetina begins to act in most people with depression or anxiety within two weeks of starting treatment, but it may take between 2 and 4 weeks to start feeling better. Inform your doctor if you do not notice improvement after this time. Your doctor may continue giving you Dulotex 90 mg when you are feeling better to prevent your depression or anxiety from returning.

Do not take Dulotex 90 mg:

• if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
• if you have liver failure
• if you have severe kidney failure
• if you are taking or have taken in the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Taking Dulotex 90 mg 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 “Taking Dulotex 90 mg with other medicines”)

Consult your doctor if you have high blood pressure or a heart condition. Your doctor will tell you if you should take this medicine.

Warnings and precautions

This medicine may not be suitable for you for the following reasons.

Consult your doctor before taking this medicine if:

• you are taking other medicines to treat depression (see “Taking Dulotex 90 mg 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 had bleeding problems, especially if you are pregnant (see “Pregnancy and breast-feeding”)
• you are at risk of having low sodium levels (for example if you are taking diuretics, especially if you are an older person)
• you are taking other medicines that can damage the liver
• you are taking other medicines that contain duloxetine (see “Taking Dulotex 90 mg with other medicines”)

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

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).

Some medicines in the same group as Dulotex 90 mg (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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.

You are more likely to 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 who are being treated for a psychiatric disorder and taking 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.

Children and adolescents under 18 years

This medicine is usually not used in children and adolescents under 18 years. You should also know that patients under 18 years 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 this medicine for patients under 18 years because they decide it may be beneficial for the patient. If your doctor has prescribed this medicine for a patient under 18 years and you want to talk about it, please go back to the doctor. You should tell your doctor if any of the symptoms mentioned above appear or get worse in patients under 18 years who are taking this medicine. Additionally, in this age group, the long-term safety effects of this medicine related to growth, maturation and development of cognitive and behavioural functions have not yet been demonstrated.

Taking Dulotex 90 mg with other medicines

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

The main component of this medicine, duloxetine, is used in other medicines for other treatments:

•diabetic neuropathic 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 this medicine 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:

Monoamine oxidase inhibitors (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). 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. You should also 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 and 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 this medicine, 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication should be taken orally. Swallow the capsule whole with water.

For depression:

The recommended dose of duloxetine is 60 mg once a day, but your doctor will prescribe the dose that is best for you.

For generalized anxiety disorder:

The initial normal dose of duloxetine is 30 mg once a day, after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is best for you. The dose may be adjusted to 120 mg per day depending on your response to duloxetine.

If a dose of 30 mg or 60 mg has been prescribed, other medications containing duloxetine may be used at these doses.

To avoid forgetting to take duloxetine, it may be helpful to take it at the same time every day.

Discuss with your doctor for how long you should take duloxetine. Do not stop taking duloxetine, or change your dose without consulting your doctor. It is essential to treat your condition properly to help you improve. If you do not treat it, your condition may not disappear and may become more severe and harder to treat.

If you take more Dulotex 90 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested. Symptoms produced by an overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity) seizures, vomiting, and high heart rate.

If you forget to take Dulotex 90 mg

If you forget to take a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose and take a single dose as you normally do. Do not take a double dose to compensate for the missed doses. Do not take more of this medication than prescribed for you in a day.

If you interrupt treatment with Dulotex 90 mg

Do not stop taking your capsules without consulting your doctor, even if you feel better. If your doctor thinks you no longer need to take duloxetine, they will instruct you to reduce your dose for at least 2 weeks before stopping treatment.

Some patients who have stopped duloxetine treatment abruptly have experienced symptoms such as:

•dizziness, feeling of pins and needles or electric shock sensation (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling of restlessness or agitation, feeling of anxiety, nausea or vomiting, tremors, headaches, muscle pain, feeling of irritability, diarrhea, and excessive sweating or vertigo.

These symptoms are usually not significant and disappear within a few days, but if you experience bothersome symptoms, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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 sex drive, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling slow, tremor, 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 as other children and adolescents of the same age and sex.

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

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty sleeping, bruxism, feeling disoriented, lack of motivation
• muscle spasms and involuntary muscle 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
• 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
• liver inflammation that can cause abdominal pain and yellowing of the skin or white part of the eyes
• night sweats, 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
• Duloxetine 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 activity of the thyroid gland, 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, severe 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 happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), convulsions
• increased pressure in the eye (glaucoma)
• cough, wheezing, and shortness of breath, which may be accompanied by high fever
• inflammation of the mouth, bright red blood in the stool, bad breath, inflammation of the large intestine (leading to diarrhea)
• liver failure, yellowing of the skin or 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
• menopausal symptoms, abnormal milk production in men or women
• excessive vaginal bleeding shortly after birth (postpartum hemorrhage)

Rare side effects (may affect up to 1 in 10,000 patients)

• inflammation of the skin blood vessels (cutaneous vasculitis)

Frequency not known (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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.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.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Blister (PA/Al/PVC/Al):This medication does not require special storage conditions.

Blister (PVC/PE/PVDC//Al):Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dulotex 120 mg

Theactive principleis duloxetine.

Each capsule contains 120 mg of duloxetine (as hydrochloride).

Theothercomponents are:

Capule content: hypromellose, sugar spheres (sucrose and cornstarch), talc, sucrose, hypromellose phthalate, and triethyl citrate.

Capule body: gelatin, titanium dioxide (E171), carmine (E 132).

Appearance of the product and contents of the packaging

Dulotex 120 mg is a hard, gastro-resistant capsule.

The 120 mg capsules have a blue, opaque body and a blue opaque head. They are hard gelatin capsules of size 00.

Dulotex 120 mg is available in packaging of 28, 30, and 98 capsules.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí 08970

Barcelona – Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

Sant Joan Despí 08970

Barcelona – Spain

This medicine is authorized in:

Last reviewed date of this prospectus: July 2024

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