Oxitril 120 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxitril 120 mg gastro-resistant hard capsules

duloxetine

Read the 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, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Duloxetine is used in adults to treat:

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

Duloxetine begins to work in most people with depression or anxiety within two weeks after 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 after this time. Your doctor may continue to give you this medicine after you feel better to prevent your depression or anxiety from returning.

2. What you need to know before taking Oxitril 120 mg

Do not take Oxitril 120 mg if:

• you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
• you have hepatic insufficiency
• you have severe renal insufficiency
• you are taking or have taken within 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 normally used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections

Consult your doctor if you have high blood pressure or a heart condition. Your doctor will determine 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 “Other medicines and Oxitril”)
• 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 intraocular 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 undergoing treatment with other medicines that may cause liver damage
• you are taking other medicines containing duloxetine (see “Other medicines and Oxitril 120 mg”)

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, or 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 blood test).

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

Some medicines in the same class as this one (known as SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Suicidal thoughts and worsening of 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 become effective, 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 treated with antidepressants.

Contact your doctor immediately or go directly to the hospital 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 have an anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they notice your depression or anxiety worsening, 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 developing side effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger). Nevertheless, 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 your 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 on growth, maturation, and cognitive and behavioural development have not yet been established.

Other medicines and Oxitril 120 mg

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

The main active ingredient in this medicine, duloxetine, is used in other medicines for other conditions:

• 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 using other medicines containing duloxetine.

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

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, may cause serious adverse effects and may even be life-threatening. 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 analgesics, antipsychotics, phenobarbital, and antihistamines.

Medicines that increase serotonin levels: Triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (SSRIs, such as paroxetine and fluoxetine), 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 when taking any of these medicines together with this medicine, inform your doctor immediately.

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

Taking Oxitril 120 mg with food, drinks, and alcohol

This medicine may be taken with or without food. You should exercise caution if consuming alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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 taking duloxetine. Duloxetine should only be used after your doctor has evaluated the potential benefits and any potential risks to the fetus.

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

• If you take duloxetine near the end of your pregnancy, your baby may experience certain symptoms after birth. These usually begin at birth or within the first few days after delivery. Symptoms 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 advise you.

• 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 provide appropriate advice. Available data on the use of duloxetine during the first trimester of pregnancy do not show a general increase in the risk of birth defects. If you take duloxetine during the second half of pregnancy, there may be an increased risk of premature birth (6 additional premature births per 100 women taking duloxetine in the second half of pregnancy), particularly between weeks 35 and 36 of pregnancy.

• 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 operating machinery

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

Oxitril 120 mg contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him 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”.

3. How to take Oxitril 120 mg

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

This medicine is for oral use. 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. However, 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.

Oxitril 120 mg can be taken regardless of meals.

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 continue taking 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 could become worse and more difficult to treat.

If you take more Oxitril 120 mg than you should

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

If you forget to take Oxitril 120 mg

If you miss 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 a missed one. Do not take more of this medicine than prescribed for you in one day.

If you stop taking Oxitril 120 mg

Do not stop taking your capsules without your doctor's advice, even if you feel better. If your doctor decides that you no longer need to continue taking duloxetine, they will instruct you to gradually reduce your dose over at least two weeks before stopping treatment.

Some patients who stop duloxetine treatment suddenly have experienced symptoms such as:

• dizziness, tingling sensations like electric shocks or pins and needles (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, restlessness or agitation, feelings of anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or dizziness.

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 can cause adverse effects, although not everyone will experience them. These effects are usually mild to moderate and often disappear within a few weeks.

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

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

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

• 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)
• 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
• pain when urinating, frequent urination
• difficulty achieving an erection, changes in ejaculation
• falls (mostly in elderly people), fatigue
• weight loss

Children and adolescents under 18 years of age with depression treated with this medicine experienced weight loss when starting treatment. After 6 months of treatment, 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 people)

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding, feeling disoriented, lack of motivation
• muscle spasms and involuntary muscle movements, feeling restless or unable 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
• pupil dilation (the black center of the eye), vision problems
• feeling dizzy or vertigo, ear pain
• rapid and/or irregular heartbeat
• fainting, dizziness, feeling dizzy or faint when standing up, coldness in fingers and/or toes
• throat spasms, nosebleeds
• vomiting blood, or black stools, gastroenteritis, belching, difficulty swallowing
• liver inflammation which may cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, hives, 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 normal, decreased urine flow
• abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular or prolonged periods, rarely light or missed periods, testicular or scrotal pain
• chest pain, feeling cold, thirst, chills, feeling hot, change in walking pattern
• weight gain
• Duloxetine may cause effects you may not notice, such as increased liver enzymes or blood potassium levels, creatine phosphokinase, blood sugar or cholesterol.

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

• severe allergic reactions causing difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions
• decreased thyroid gland activity, which may cause tiredness or weight gain
• dehydration, low sodium levels in the blood (mostly in elderly people; symptoms may include dizziness, weakness, confusion, drowsiness or extreme tiredness, nausea or vomiting; more serious symptoms include fainting, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behaviour, mania (hyperactivity, racing thoughts and reduced need for sleep), hallucinations, aggression and anger
• “Serotonin syndrome” (a rare reaction which may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased eye pressure (glaucoma)
• cough, wheezing and shortness of breath, which may be accompanied by high fever
• mouth inflammation, 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 (serious illness with blistering of the skin, mouth, eyes and genitals), severe allergic reactions causing swelling of the face or throat (angioedema)
• jaw muscle contractions
• unusual odour 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 people)

• 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 heartbeat.

Reporting of adverse effects

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

5. Storage of Oxitril 120 mg

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxitril 120 mg

The active substance is duloxetine.

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

The other components are:

Capsule contents: hypromellose, talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing sodium lauryl sulfate and polysorbate 80), triethyl citrate, sugar spheres (containing corn starch and sucrose), sucrose.

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

Appearance of the product and contents of the pack

Oxitril 120 mg gastro-resistant hard capsules are gastro-resistant hard capsules.

Each capsule contains spherical granules of duloxetine hydrochloride coated to protect them from stomach acid.

Hard gelatin capsules with light blue cap/light blue body, size 00, printed in black ink (cap "DU"/body "120"), approximately 23.2 mm long.

Oxitril 120 mg gastro-resistant hard capsules are available in packs of 28 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.
C/ de las Rosas de Aravaca, 31 - 2nd floor
28023 Madrid
Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.
C/ de Sant Martí 75-97
08107 Martorelles (Barcelona)
Spain

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

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