DULOTEX 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Dulotex 120 mg Hard Gastro-Resistant Capsules

Duloxetine (hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Dulotex 120 mg is and what it is used for
2. What you need to know before you take Dulotex 120 mg
3. How to take Dulotex 120 mg
4. Possible side effects
5. Storing Dulotex 120 mg
6. Contents of the pack and other information

1. What Dulotex 120 mg is and what it is used for

Dulotex 120 mg contains the active substance duloxetine. Dulotex 120 mg increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetine is used in adults to treat:

• depression
• generalized anxiety disorder (a persistent feeling of anxiety or nervousness)

Duloxetine usually starts to work in most people with depression or anxiety within 2 weeks of starting treatment, but it may take between 2 and 4 weeks before you start to feel better. Tell your doctor if you do not feel better after this time. Your doctor may continue to give you Dulotex 120 mg when you are feeling better to prevent your depression or anxiety from returning.

2. What you need to know before you take Dulotex 120 mg

Do not take Dulotex 120 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 disease
• if you are taking or have taken within the last 14 days another medicinal product called a monoamine oxidase inhibitor (MAOI) (see "Using Dulotex 120 mg with other medicines")
• if you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin or enoxacin, which are used to treat some infections
• if you are taking other medicines that contain duloxetine (see "Using Dulotex 120 mg with other medicines")

Consult your doctor if you have high blood pressure or heart disease. Your doctor will decide if you can take this medicine. Warnings and precautions

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

Consult your doctor before taking this medicine if:

• you are using other medicines to treat depression (see "Using Dulotex 120 mg with other medicines")
• you are taking St. John's Wort, a herbal treatment (Hypericum perforatum)
• you have any kidney disease
• you have had seizures (epileptic fits)
• you have had mania
• you suffer from bipolar disorder
• you have eye problems, such as certain types of glaucoma (increased eye pressure)
• you have had bleeding problems (a tendency to develop bruises), 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 elderly person)
• you are being treated with other medicines that may harm your liver
• you are taking other medicines that contain duloxetine (see "Using Dulotex 120 mg with other medicines")

This medicine may cause a feeling of restlessness or an inability to sit or stand still. If this happens, you should 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, overactive reflexes, diarrhea, coma, nausea, vomiting, as you may be suffering from a condition called serotonin syndrome.

In its most severe form, serotonin syndrome can resemble a condition called 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 a blood test).

Some medicines of the same group as Dulotex 120 mg (called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These thoughts may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about 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. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents under 18 years

This medicine is not normally used in children and adolescents under 18 years. In addition, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior, and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 because they decide that it is in the patient's best interest. If your doctor has prescribed this medicine to a patient under 18 and you want to discuss this, please contact your doctor again. You should inform your doctor if any of the above symptoms occur or worsen in patients under 18 taking this medicine. Furthermore, the long-term safety of this medicine in terms of growth, maturation, and cognitive and behavioral development in this age group has not yet been established.

Using Dulotex 120 mg with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained 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 whether you can take this medicine with other medicines. Do not start or stop taking any medicine without consulting your doctor, including those obtained without a prescription and herbal remedies.

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

Monoamine oxidase inhibitors (MAOIs):you should not take duloxetine if you are taking, or have taken within the last 14 days, another antidepressant medicine called 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 or life-threatening side effects. You should wait at least 14 days after stopping an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping duloxetine before starting an MAOI.

Medicines that cause drowsiness:these include medicines prescribed by your doctor, such as benzodiazepines, strong painkillers, 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), pethidine, 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, you should tell your doctor.

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

Taking Dulotex 120 mg with food, drinks, and alcohol

This medicine can be taken with or without food. You should be cautious when drinking alcohol while being treated with this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you become pregnant or are planning to become pregnant while being treated with duloxetine. You should only use duloxetine after discussing the potential benefits and risks with your doctor.

• Make sure your midwife and/or doctor know 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 faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

• If you take duloxetine near 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 of your baby's life. These symptoms include weak muscles, trembling, restlessness, not feeding properly, breathing problems, and seizures. If your baby has any of these symptoms when it is born, or if you are worried about your baby's health, contact your doctor or midwife, who will be able to advise you.

• If you take duloxetine near the end of your pregnancy, there is a greater risk of heavy vaginal bleeding after giving birth, especially if you have had bleeding problems. Your doctor or midwife should know that you are taking duloxetine so that they can advise you.

• Tell your doctor if you are breast-feeding. Duloxetine is not recommended during breast-feeding. Ask your doctor or pharmacist for advice.

Driving and using machines

While being treated with duloxetine, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment affects you.

Dulotex 120 mg contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Dulotex 120 mg

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

This medicine is taken by mouth. You should 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 usual starting 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 up to 120 mg a day depending on your response to duloxetine.

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

To help you remember to take duloxetine, it may be helpful to take it at the same times every day.

Discuss with your doctor how long you should take duloxetine. Do not stop taking duloxetine, or change your dose, without consulting your doctor. It is important to treat your condition effectively to help you improve. If you do not treat your condition, it may not get better and may become more serious and more difficult to treat.

If you take more Dulotex 120 mg than you should

If you have taken more duloxetine than you should, contact your doctor or pharmacist immediately or go to the hospital. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

If you forget to take Dulotex 120 mg

If you forget to take a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more of this medicine than prescribed for you in one day.

If you stop taking Dulotex 120 mg

Do not stop taking your capsules without the advice of your doctor, even if you feel better. If your doctor thinks you do not need to take duloxetine anymore, they will tell you how to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who stop taking duloxetine have experienced symptoms such as:

• dizziness, sensations like pins and needles or electric shock-like sensations

(especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, and excessive sweating or dizziness.

These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome, you should ask your doctor for advice.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild to moderate and often disappear after a few weeks.

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

• headache, drowsiness
• nausea, dry mouth

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

• loss of appetite
• difficulty sleeping, feeling agitated, decreased sexual desire, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling sluggish, tremor, numbness, including numbness, tingling, or prickling of the skin
• blurred vision
• tinnitus (ringing in the ears)
• feeling your heartbeat
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhea, stomach pain, vomiting, heartburn or indigestion, gas
• increased sweating, rash
• muscle pain, muscle spasms
• difficulty urinating, frequent urination
• difficulty getting an erection, changes in ejaculation
• falls (mainly in elderly people), fatigue
• weight loss

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

Adverse effects infrequently encountered (may affect up to 1 in 100 patients)

• inflammation of the throat that causes hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding, feeling of disorientation, lack of motivation
• muscle spasms and involuntary movements, feeling of restlessness or inability to sit 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
• dilation of the pupils (the black dot in the center of the eye), vision problems
• feeling of dizziness or vertigo, ear pain
• rapid and/or irregular heartbeats
• fainting, dizziness, feeling of dizziness or fainting when standing up, coldness in the fingers of the hands and/or feet
• throat spasms, nosebleeds
• vomiting blood, or black stools, gastroenteritis, belching, difficulty swallowing
• liver inflammation that can cause abdominal pain and yellowing of the skin or the 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 menstruation, exceptionally light or absent menstruation, pain in the testicles or scrotum
• chest pain, feeling of cold, thirst, chills, feeling of heat, alteration in gait
• weight gain
• Duloxetine may cause effects that you may not be aware of, such as increased liver enzymes or potassium levels in the blood, creatine phosphokinase, sugar, or cholesterol.

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

• severe allergic reactions, which can 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 elderly people; symptoms may include feeling of dizziness, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting, the most serious symptoms are fainting, convulsions, or falls), syndrome of inadequate secretion of antidiuretic hormone (SIADH)
• suicidal behavior, mania (hyperactivity, accelerated thinking, and decreased need for sleep), hallucinations, aggression, and anger
• "Serotonin syndrome" (a rare reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling of being 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 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 urine odor
• menopausal symptoms, abnormal milk production in men or women
• excessive vaginal bleeding shortly after birth (postpartum hemorrhage)

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• inflammation of the blood vessels in the skin (cutaneous vasculitis)

Frequency not known (cannot be estimated from the available data)

• signs and symptoms of a condition called "stress cardiomyopathy", which may include chest pain, difficulty breathing, dizziness, fainting, and irregular heartbeats

Reporting of adverse effects

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

5. Storage of Dulotex 120 mg

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

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Dulotex 120 mg

The active ingredient is duloxetine.

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

The other ingredients are:

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

Capsule body: gelatin, titanium dioxide (E171), carmine indigo (E132).

Appearance of the product and package contents

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, size 00.

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí 08970

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

Sant Joan Despí 08970

Barcelona – Spain

This medicine is authorized in:

Date of the last revision of this leaflet: July 2024

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