Dulotex 120 mg gastro-resistant hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dulotex 120 mg gastro-resistant hard capsules

Duloxetine (hydrochloride)

Read this entire leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Dulotex 120 mg is and what it is used for
2. What you need to know before taking Dulotex 120 mg
3. How to take Dulotex 120 mg
4. Possible adverse effects
5. How to store 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 levels of serotonin and noradrenaline in the nervous system.

Duloxetine is used in adults to treat:

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

Duloxetine begins to work in most people with depression or anxiety within two weeks of starting treatment, but it may take between 2 and 4 weeks before you start to feel better. Inform your doctor if you do not notice improvement within this time. Your doctor may continue prescribing Dulotex 120 mg once you feel better in order to prevent your depression or anxiety from returning.

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

Do NOT take Dulotex 120 mg if:

• you are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)
• you have hepatic impairment
• you have severe renal impairment
• you are taking or have taken within the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Use of Dulotex 120 mg with other medicines”)
• you are taking fluvoxamine, which is normally used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections
• you are taking other medicines containing duloxetine (see “Use of Dulotex 120 mg with other medicines”)

Consult your doctor if you have high blood pressure or a heart condition. Your doctor will advise whether 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 using other medicines to treat depression (see “Use of Dulotex 120 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 experienced mania
• you suffer from bipolar disorder
• you have eye problems, such as certain types of glaucoma (increased eye pressure)
• you have had bleeding problems (tendency to bruise easily), especially if you are pregnant (see “Pregnancy and breastfeeding”)
• you are at risk of low sodium levels (for example, if you are taking diuretics, particularly if you are elderly)
• you are receiving treatment with other medicines that may cause liver damage
• you are taking other medicines containing duloxetine (see “Use of Dulotex 120 mg with other medicines”)

This medicine may cause a feeling of restlessness or inability to sit still. If this occurs, inform your doctor.

You should also contact your doctor:

If you experience signs and symptoms such as 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 experiencing serotonin syndrome.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).

Some medicines in the same class as Dulotex 120 mg (known as SSRIs/SNRIs) can cause sexual dysfunction symptoms (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 suffer from anxiety disorders, you may occasionally have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as all these medicines take time to take effect, usually about two weeks, but sometimes longer.

You are more likely to have such thoughts if:

• you have previously had thoughts of self-harm or suicide
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age being treated with antidepressants.

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

It may be helpful to inform a close family member or friend that you are depressed or suffer from an anxiety disorder, and ask them to read this leaflet. You may ask them to let you know if they notice your depression or anxiety getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents under 18 years of age

This medicine should normally not be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age taking this type of medicine have an increased risk of experiencing side effects such as suicidal behaviour, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger). Despite this, your doctor may prescribe this medicine to patients under 18 years of age if they decide it may be beneficial for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss it, please return to the doctor. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age taking this medicine. Furthermore, in this age group, the long-term effects of this medicine on growth, puberty, and cognitive and behavioural development have not yet been established.

Use of Dulotex 120 mg with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

• diabetic neuropathic pain, depression, anxiety, and urinary incontinence

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

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

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

Monoamine oxidase inhibitors (MAOIs): You must not take duloxetine if you are currently taking, or have recently taken (within the last 14 days), another antidepressant medicine known as a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI together with many prescription medicines, including duloxetine, can cause serious adverse effects, even life-threatening reactions. You must wait at least 14 days after stopping treatment with an MAOI before starting duloxetine. Likewise, you must wait at least 5 days after stopping duloxetine before starting treatment with an MAOI.

Medicines that cause drowsiness: This includes 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, amitriptyline), meperidine, St. John's wort, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of adverse effects; if you notice any unusual symptoms while taking any of these medicines together with this medicine, you must inform your doctor.

Oral anticoagulants or antiplatelet agents: Medicines that thin the blood or prevent blood clots from forming. 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 exercise caution when consuming alcohol during treatment with this medicine.

Pregnancy and breastfeeding

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

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

• Make sure your midwife and/or your doctor know that you are taking duloxetine. Other similar medicines (SSRIs), when taken during pregnancy, may increase the risk of causing a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and develop a bluish coloration. These symptoms usually begin within the first 24 hours after the baby's birth. If this occurs in your baby, you should contact your midwife and/or doctor immediately.

• If you take duloxetine near the end of your pregnancy, your baby may experience certain symptoms at birth. These symptoms usually begin at the time of birth or during the first few days after birth. They may include weak muscles, tremors, irritability, poor feeding, breathing difficulties, and seizures. If your baby shows any of these symptoms after birth or if you are concerned about your baby's health, contact your doctor or midwife, who can provide advice.

• If you take duloxetine near the end of your pregnancy, there is an increased risk of excessive vaginal bleeding shortly after delivery, especially if you have had bleeding problems. Your doctor or midwife should be aware that you are taking duloxetine so they can advise you appropriately.

• Inform your doctor if you are breastfeeding. The use of duloxetine during breastfeeding is not recommended. Seek advice from your doctor or pharmacist.

Driving and using machines

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

Dulotex 120 mg contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Dulotex 120 mg

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is to be taken orally. You must swallow the capsule whole with water.

For depression:

The recommended dose of duloxetine is 60 mg once daily, 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 daily, after which most patients will receive 60 mg once daily, but your doctor will prescribe the dose that is best for you. The dose may be increased up to 120 mg daily depending on your response to duloxetine.

If a dose of 30 mg or 60 mg has been prescribed, 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 time each 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 properly to help you improve. If left untreated, your condition may not resolve and may become worse and more difficult to treat.

If you take more Dulotex 120 mg than you should

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

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 almost time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for the missed one. Do not take more of this medicine than prescribed for you in one day.

If treatment with Dulotex 120 mg is interrupted

Do not stop taking your capsules without consulting your doctor, even if you feel better. If your doctor considers that you no longer need to continue taking duloxetine, he or she will instruct you to gradually reduce your dose over at least 2 weeks before stopping treatment.

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

• dizziness, tingling sensations like electric shocks or pricking sensations
  (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, somnolence, feeling restless or agitated, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or vertigo.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. These effects are usually mild to moderate and frequently disappear within a few weeks.

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

• headache, drowsiness
• discomfort (nausea), dry mouth

Frequent adverse effects (may affect up to 1 in every 10 patients)

• loss of appetite
• difficulty sleeping, feeling restless, decreased sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling slowed down, tremor, numbness, including numbness, itching, or tingling of the skin
• blurred vision
• tinnitus (perception of sounds in the ear when there is no external sound)
• sensation of 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
• pain when urinating, frequent urination
• difficulty achieving an erection, changes in ejaculation
• falls (mostly in elderly individuals), fatigue
• weight loss

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

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

• swelling of the throat causing hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding, feeling disoriented, lack of motivation
• muscle spasms and involuntary muscle movements, feeling of restlessness or inability to sit still or remain motionless, nervousness, difficulty concentrating, changes in taste sensation, difficulty controlling movements e.g.: lack of coordination or involuntary muscle movements, restless legs syndrome, poor quality sleep
• dilation of the pupils (the black center of the eye), vision problems
• feeling of dizziness or vertigo, ear pain
• rapid and/or irregular heartbeat
• fainting, dizziness, feeling of dizziness or lightheadedness when standing up, coldness in fingers and/or toes
• throat spasms, nosebleeds
• vomiting blood, or black stools, gastroenteritis, burping, difficulty swallowing
• liver inflammation which may cause abdominal pain and yellowing of the skin or whites 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 during the night, need to urinate more than normal, decreased urine flow
• abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular or prolonged menstruation, rarely light or missed periods, pain in the testicles or scrotum
• chest pain, feeling of coldness, thirst, chills, sensation of heat, change in walking pattern
• weight gain
• Duloxetine may cause effects you may not notice, such as increased liver enzymes or blood levels of potassium, creatine phosphokinase, blood sugar or cholesterol.

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

• severe allergic reactions causing difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions
• decreased activity of the thyroid gland, which may cause tiredness or weight gain
• dehydration, low blood sodium levels (mainly in elderly people; symptoms may include dizziness, weakness, confusion, drowsiness or extreme fatigue, nausea or vomiting; more serious symptoms include fainting, seizures, or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, mania (hyperactivity, racing thoughts, and reduced need for sleep), hallucinations, aggression, and anger
• "Serotonin syndrome" (a rare reaction that may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures
• 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 stools, bad breath, inflammation of the large intestine (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious illness causing blistering of the skin, mouth, eyes, and genitals), severe allergic reactions causing swelling of the face or throat (angioedema)
• contractions of the jaw muscle
• unusual odor of urine
• menopausal symptoms, abnormal production of breast milk in men or women
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage)

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

• inflammation of blood vessels in the skin (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, fainting, and irregular heartbeats

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide 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 expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Dulotex 120 mg

The active substance is duloxetine.

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

The other components are:

Capsule contents: hypromellose, sugar spheres (sucrose and corn starch), talc, sucrose, hypromellose phthalate, triethyl citrate and ascorbic acid.

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

Appearance of the product and contents of the container

Dulotex 120 mg is a gastro-resistant hard capsule.

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

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

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturing Responsible Person

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

Sant Joan Despí 08970

Barcelona – Spain

Manufacturing Responsible Person

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

Sant Joan Despí 08970

Barcelona – Spain

This medicinal product is authorized in:

Date of the most recent review of this leaflet: July 2024

Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/