Duloxetine Vir 60 mg gastro-resistant hard capsules EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Duloxetina VIR 60 mg gastro-resistant hard capsules EFG

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 you should not give it 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.

Contents of the leaflet

1. What Duloxetina VIR is and what it is used for
2. What you need to know before taking Duloxetina VIR
3. How to take Duloxetina VIR
4. Possible side effects
5. How to store Duloxetina VIR
6. Contents of the pack and other information

1. What Duloxetina VIR is and what it is used for

Duloxetina VIR contains the active substance duloxetine. Duloxetina VIR increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina VIR is used in adults to treat:

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing, shooting, tingling, or electric shock-like pain. There may be loss of sensation in the affected area, or pain may occur when the area is touched or exposed to heat, cold, or pressure)

Duloxetina VIR 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 within this time. Your doctor may continue to prescribe Duloxetina VIR once you feel better in order to prevent your depression or anxiety from returning.

In people with diabetic neuropathic pain, it may take several weeks before you start to feel better. Consult your doctor if you do not feel better after 2 months.

2. What you need to know before taking Duloxetina VIR

DO NOT take Duloxetina VIR if:

• you are allergic to duloxetine or to 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 “Use of Duloxetina VIR 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 Duloxetina VIR with other medicines”)

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

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 suffering from 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 (determined by blood test).

Warnings and precautions

Duloxetina VIR may not be suitable for you for the following reasons. Consult your doctor before taking Duloxetina VIR if:

• you are using other medicines to treat depression (see “Use of Duloxetina VIR 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 Duloxetina VIR with other medicines”)

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

Some medicines in the group to which Duloxetina VIR belongs (called 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 work—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 or go immediately to 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 tell 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

Duloxetine should generally not be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age who take this type of medicine have an increased risk of 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 duloxetine to a patient under 18 years of age and you wish to discuss this, 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 duloxetine. Furthermore, in this age group, the long-term effects of duloxetine on growth, maturation, and cognitive and behavioural development have not yet been established.

Use of Duloxetina VIR with other medicines

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

The main active ingredient, duloxetine, is used in other medicines for different 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 containing duloxetine.

Your doctor will decide whether you can take duloxetine 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 this medicine if you are 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), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, 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 using any of these medicines together with duloxetine, inform 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 Duloxetina VIR with food, drinks, and alcohol

Duloxetine may be taken with or without food. Exercise caution if you consume alcohol while being treated with duloxetine.

Pregnancy and breastfeeding

If you are pregnant or 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 that 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 blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take duloxetine near the end of your pregnancy, your baby may experience some symptoms at birth. These usually begin at birth or during 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 Duloxetina 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 accordingly.

Available data on the use of Duloxetine during the first three months of pregnancy do not show an increased risk of congenital malformations in general. If Duloxetine is taken 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), mainly 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 using machines

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

Duloxetina VIR contains sucrose.

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

3. How to take Duloxetina VIR

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Duloxetina should be taken orally. You must swallow the capsule whole with water.

For depression and diabetic neuropathic pain

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.

To help you remember to take duloxetine, it may be helpful to take it at the same time 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 properly to help you improve. If left untreated, your condition may not go away and may become worse and more difficult to treat.

If you take more Duloxetina VIR than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist immediately, or call the Toxicology Information Service (telephone: 915620420), indicating the medicine and the amount ingested. Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction that may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heart rate.

If you forget to take Duloxetina VIR

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 a missed dose. Do not take more duloxetine than prescribed for you in one day.

If you stop taking Duloxetina VIR

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

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

• dizziness, tingling sensations like pins and needles or electric shock sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, 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 for advice.

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 experiences 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 patients)

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

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

• loss of appetite
• difficulty sleeping, feeling restless, decreased libido, 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, diarrhoea, 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 (mainly in elderly people), 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, 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)

• 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
• dilation of the pupils (the black center of the eye), vision problems
• feeling dizzy or vertigo, ear pain
• rapid and/or irregular heartbeat
• fainting, dizziness, feeling lightheaded or faint upon standing, coldness in the 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 initiating 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 periods, rarely light or missed periods, pain in the testicles or scrotum
• 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 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 sodium levels in the blood (mainly in elderly people; symptoms may include feeling dizzy, 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 well-being, 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
• mouth inflammation, bright red blood in stools, bad breath, inflammation of the large intestine (resulting in diarrhoea)
• 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)
• 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 haemorrhage)

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

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

Adverse effects with unknown frequency (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, talk to your doctor or pharmacist, 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 Duloxetine VIR

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the Sigre Point collection system at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and other information

Composition of Duloxetina VIR

• The active substance is duloxetine.

Each capsule contains 60 mg of duloxetine (as hydrochloride).

• The other components are:

Capsule contents: sugar spheres (containing sucrose and maize starch), hypromellose, sucrose, talc, triethyl citrate, hypromellose acetate succinate, titanium dioxide (E171)

Capsule shell: gelatin, yellow iron oxide, titanium dioxide (E171), indigo carmine (E132)

Appearance of the product and contents of the container

Duloxetina VIR is a gastro-resistant hard capsule. Each Duloxetina VIR capsule contains duloxetine hydrochloride pellets coated to protect them from stomach acid. The capsules are packaged in blisters made of polyvinyl chloride (PVC), polyethylene (PE), and polyvinylidene chloride (PVDC), sealed with an aluminum foil.

Duloxetina VIR is available in two strengths: 30 mg and 60 mg.

The 30 mg capsules are blue and white, approximately 15.8 mm in length and 5.7 mm in diameter. The 60 mg capsules are blue and green, approximately 19.5 mm in length and 6.8 mm in diameter.

Duloxetina VIR 60 mg is available in packs of 7, 14, 28, 56, 84, 98 and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

or

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany Dulasolan 60 mg gastro-resistant hard capsules

Spain Duloxetina VIR 60 mg gastro-resistant hard capsules EFG

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

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