Package Insert: Information for the User

Oxitril 120 mg Hard Gastrorresistant Capsules

duloxetina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Oxitril 120 mg contains the active ingredient duloxetina. Oxitril 120 mg increases the levels of serotonina and noradrenalina in the nervous system.

Duloxetina is used in adults to treat:

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 this medication when you are feeling better to prevent your depression or anxiety from returning.

Do not take Oxitril 120 mg:

• you are allergic to duloxetine or any of the other ingredients in this medicine (listed in section 6)
• you have liver failure
• you have severe kidney failure
• you are taking or have taken in the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Other medicines and Oxitril 120 mg”)
• you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin or enoxacin, which are used in the treatment of some infections

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 “Other medicines and Oxitril”)
• you are taking St. John's Wort, a herbal remedy (Hypericum perforatum)
• you have any kidney disease
• you have had convulsions (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 bleeding problems, especially if you are pregnant (see “Pregnancy and breastfeeding”)
• 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 being treated with other medicines that can damage the liver
• you are taking other medicines that contain duloxetine (see “Other medicines and Oxitril 120 mg”)

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, diarrhea, coma, nausea, vomiting, as you may be suffering from a serotonin syndrome.

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

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

Some medicines in the same group as this medicine (called SSRIs/SNRIs) can 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 behavior in 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 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 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 behavior.

Children and adolescents under 18 years

This medicine is usually not 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 behavior, and hostility (mainly aggression, oppositional behavior, and irritability). Despite this, your doctor may prescribe this medicine to patients under 18 years old because they decide it may be beneficial for the patient. If your doctor has prescribed this medicine 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 worsen in patients under 18 years old who are taking this medicine. Additionally, in this age group, the long-term effects of this medicine on growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Other medicines and Oxitril 120 mg

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:

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, 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 putting your life at risk. 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 and amitriptyline), petidina, St. John's Wort, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you observe any unusual symptoms when using any of these medicines with this medicine, you should tell your doctor.

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

Taking Oxitril 120 mg with food, drinks, and alcohol

This medicine can be taken with or without food. You should be careful if you take alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 fetus 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 can include weak muscles, tremors, 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.

• If you take duloxetine towards the end of your pregnancy, there is a higher risk of excessive vaginal bleeding shortly after birth, especially if you have had bleeding problems. Your doctor or midwife should know that you are taking duloxetine so they can advise you. The available data on the use of duloxetine during the first three months of pregnancy do not show a general increase in the risk of birth defects in the baby. If you take duloxetine during the second half of pregnancy, there may be a higher risk of the baby being born prematurely (6 additional premature births per 100 women taking duloxetine in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

• 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.

Oxitril 120 mg contains saccharose

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

Oxitril 120 mg contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication 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 can be adjusted up to 120 mg per day depending on your response to duloxetine.

Oxitril 120 mg can be taken regardless of meals.

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 Oxitril 120 mg than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 stiffness) seizures, vomiting, and high heart rate.

If you forget to take Oxitril 120 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 Oxitril 120 mg:

Do not stop taking your capsules without your doctor's advice, 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 presented symptoms such as:

• dizziness, feeling of pins and needles or electric shock (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 have symptoms that are bothersome, ask your doctor for advice.

If you have any other doubts 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, 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
• 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 that causes 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
• enlarged pupils (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 levels of potassium, 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, 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)

Very 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.

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 that 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 that you no longer need. By doing so, you will help protect the environment.

Composition of Oxitril 120 mg

The active ingredient is duloxetine.

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

The other components are:

Capule content: hypromellose, talc, titanium dioxide (E171),copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (contains sodium lauryl sulfate and polysorbate 80),triethyl citrate, sugar spheres(contain cornstarch and sucrose), sucrose.

Capule coating: gelatin,brilliant blue FCF (E-133),and printing ink (iron oxide black [E-172], potassium hydroxide, shellac).

Appearance of the product and content of the container

Oxitril 120 mg hard-gastrorresistant capsules is a hard-gastrorresistant capsule.

Each capsule contains spherical granules of duloxetine hydrochloride with a coating to protect them from stomach acid.

Hard gelatin capsules with a blue clear cap/blue clear body, size 00 printed with black ink (cap “DU”/body “120”), approximately 23.2 mm.

Oxitril 120 mg hard-gastrorresistant capsules is available in containers of 28 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Responsible for manufacturing

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet: June 2024

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