Leaflet: information for the user

Duloxetina VIR 30 mg hard gastro-resistant EFG capsules

Duloxetina

Read this 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 you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Duloxetina VIR

3. How to take Duloxetina VIR

4. Possible side effects

5. Storage of Duloxetina VIR

6. Contents of the pack and additional information

Duloxetina VIR contains the active ingredient duloxetina. 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, pinching, stinging, or electric shock-like pain. There may be a loss of sensation in the affected area, or pain may occur when the area is touched or comes into contact with heat, cold, or pressure)

Duloxetina VIR begins to take effect 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 to give you Duloxetina VIR when you are feeling better 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.

Do not take Duloxetina VIR if:

• 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 “Taking Duloxetina VIR with other medicines”)
• You are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin or enoxacin, which are used to treat some infections
• You are taking other medicines that contain duloxetine (see “Taking Duloxetina VIR with other medicines”)

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

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 Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (determined by blood tests).

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 taking other medicines to treat depression (see “Taking 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 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 bruises, 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 elderly)
• You are being treated with other medicines that can damage the liver
• You are taking other medicines that contain duloxetine (see “Taking Duloxetina VIR with other medicines”)

Duloxetina VIR 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 Duloxetina VIR (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 behaviour in young 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 as soon as 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 you if your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents under 18 years

Duloxetina VIR 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 behaviour, and hostility (mainly aggression, oppositional behaviour, 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 duloxetine 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 above appear or get worse in patients under 18 years old who are taking duloxetine. Additionally, in this age group, the long-term safety effects of duloxetine related to growth, maturation, and cognitive and behavioural development have not yet been demonstrated.

Taking Duloxetina VIR with other medicines

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 ingredient, 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 if you can take duloxetine with other medicines. Do not start or stop taking any medicine, including those bought without a prescription and herbal remedies, without first consulting your doctor.

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

MAOIs:You should not take this medicine if you are taking, or have taken in the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI). For example, moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medicines, including duloxetine, can cause serious side effects, even life-threatening. You should wait at least 14 days after stopping treatment with an MAOI before taking duloxetine. You should also wait at least 5 days after stopping treatment with duloxetine before starting treatment with an MAOI.

Medicines that cause drowsiness:This includes 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 notice any unusual symptoms when using any of these medicines with duloxetine, 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 Duloxetina VIR with food, drinks, and alcohol

Duloxetine VIR can be taken with or without food. You should be careful if you take alcohol while taking duloxetine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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. 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 born. These usually start at birth or within the first few days after birth. These symptoms may include weak muscles, trembling, nervousness, difficulty feeding, breathing problems, and convulsions. If your baby has any of these symptoms when born or if you are concerned about your baby's health, contact your doctor or midwife for advice.

If you take Duloxetina VIR 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 Duloxetina during the first three months of pregnancy do not show an increased risk of congenital defects in the baby. If you take Duloxetina 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), mainly between weeks 35 and 36 of pregnancy.

• Inform your doctor if you are breastfeeding. Duloxetine VIR is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and operating machines

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

Duloxetina VIR contains saccharose.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

Duloxetine should be taken orally. Swallow the capsule whole with water.

For depression and diabetic neuropathic pain

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 to 120 mg per day depending on your response to duloxetine.

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 Duloxetine VIR than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service (phone: 915620420), 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 rigidity) seizures, vomiting, and high heart rate.

If you forgot to take Duloxetine VIR

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 duloxetine than prescribed for you in a day.

If you interrupt the treatment with Duloxetine VIR

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 this medication, 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 experienced 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, tremor, 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 (itching)
• 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 levels were similar to those of other children and adolescents of the same age and sex.

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

• throat inflammation causing 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
• pupil dilation (the black center of the eye), vision problems
• feeling dizzy or vertigo, ear pain
• rapid or irregular heartbeat
• loss of consciousness, dizziness, feeling dizzy or loss of consciousness when standing up, cold 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 periods, occasionally light or absent periods, testicular or scrotal pain
• chest pain, feeling cold, thirst, chills, feeling hot, gait alteration
• 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, or excessive fatigue, nausea, or vomiting, more serious symptoms are loss of consciousness, seizures, 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), 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 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 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)

Side effects of 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, loss of consciousness, and irregular heartbeat.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.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 date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Duloxetina VIR Composition

-The active ingredient is duloxetine.

Each capsule contains 30 mg of duloxetine (as hydrochloride).

-The other components are:

Capsule content:sugar spheres (containing sucrose and cornstarch), hypromellose, sucrose, talc, triethyl citrate, acetate succinate of hypromellose, titanium dioxide (E171)

Capsule coating:gelatin, titanium dioxide (E171) and indigo carmine (E132)

Product appearance and packaging contents

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

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

The 30 mg capsules are blue and white with a length of approximately 15.8 mm and a height of approximately 5.7 mm. The 60 mg capsules are blue and green with a length of approximately 19.5 mm and a height of approximately 6.8 mm.

Duloxetina VIR 30 mg is available in packaging of 7, 14, 28 and 98 hard capsules.

Only some packaging 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 with the following names:

GermanyDulasolan 30 mg gastro-resistant hard capsules

SpainDuloxetina VIR 30 mg hard, gastro-resistant EFG capsules

Last review date of this leaflet: August 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.