Package Insert: Information for the User

Duloxetine Viatris Pharmaceuticals 60 mg Hard Gastropersistent Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Duloxetine Viatris Pharmaceuticals and for what it is used

2. What you need to know before starting to take Duloxetine Viatris Pharmaceuticals

3. How to take Duloxetine Viatris Pharmaceuticals

4. Possible adverse effects

5. Storage of Duloxetine Viatris Pharmaceuticals

6.Contents of the package and additional information

Duloxetina Viatris Pharmaceuticals contains the active ingredient duloxetina. Duloxetina increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina is used in adults to treat:

• depression
• generalized anxiety disorder (chronic sensation of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing pain like pinpricks, stinging or like an electric shock. There may be a loss of sensation in the affected area or pain may occur when touching the area or exposing it to heat, cold or pressure)

Duloxetina begins to act 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 when you are feeling better to prevent your depression or anxiety from returning.

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

Do not take Duloxetina Viatris Pharmaceuticals if:

• You are allergic to duloxetine or any of the other ingredients in this medication (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 medication known as a monoamine oxidase inhibitor (MAOI) (see “Other Medications and Duloxetina Viatris Pharmaceuticals”)
• 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 medications that contain duloxetine (see “Other Medications and Duloxetina Viatris Pharmaceuticals”).

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

Warnings and Precautions

Duloxetine may not be suitable for you for the following reasons.Consult your doctor before starting to take this medication if:

• You are taking other medications to treat depression or medications known as opioids, for example, buprenorphine, used to relieve pain.

The use of these medications with duloxetine may cause serotonin syndrome, a potentially life-threatening condition (see “Other Medications and Duloxetina Viatris Pharmaceuticals”)

• 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 have bipolar disorder
• You have eye problems, such as some types of glaucoma (increased eye pressure)
• You have had bleeding problems, especially if you are pregnant (see “Pregnancy and Breastfeeding”)
• You have a risk of low sodium levels (for example, if you are taking diuretics, especially if you are an older person)
• You are being treated with other medications that may cause liver damage
• You are taking other medications that contain duloxetine (see “Other Medications and Duloxetina Viatris Pharmaceuticals”).

Duloxetine may cause a feeling of restlessness or inability to sit or stay still. If this happens, tell your doctor.

Some medications in the group to which Duloxetina Viatris Pharmaceuticals belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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 serotonin syndrome.

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

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may have thoughts of self-harm or suicide. These thoughts may be increased at the beginning of treatment with antidepressants, as all these medications 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 behavior in 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 if your depression or anxiety is getting worse or if they are concerned about changes in your behavior.

Children and adolescents under 18 years

Duloxetine is usually not used in children and adolescents under 18 years. You should also know that patients under 18 years old who take this class of medications have an increased risk of adverse effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and irritability). Despite this, your doctor may prescribe duloxetine 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 mentioned above appear or worsen 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 behavioral development have not yet been demonstrated.

Other Medications and Duloxetina Viatris Pharmaceuticals

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

The main component of Duloxetina Viatris Pharmaceuticals, duloxetine, is used in other medications for other treatments:

• Diabetic neuropathic pain, depression, anxiety, and urinary incontinence.

It should be avoided to use more than one of these medications at the same time. Check with your doctor if you are already using other medications that contain duloxetine.

Your doctor will decide if you can take duloxetine with other medications.Do not start or stop using any medication, including those purchased without a prescription, without first consulting your doctor.

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

Monoamine oxidase inhibitors (MAOIs):You should not take duloxetine if you are taking, or have taken in the last 14 days, another medication known as a monoamine oxidase inhibitor (MAOI). As examples of MAOIs, moclobemide (an antidepressant) and linezolid (an antibiotic) are included. Taking an MAOI with many prescription medications, including duloxetine, may cause serious side effects, even putting your life at risk. You should wait at least 14 days after stopping treatment with an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping treatment with duloxetine before starting treatment with an MAOI.

Medications that cause drowsiness:This includes prescription medications prescribed by your doctor, such as benzodiazepines, powerful analgesics, antipsychotics, phenobarbital, and antihistamines.

Medications 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, MAOIs (such as moclobemide and linezolid), and opioids (such as buprenorphine).These medications may interact with duloxetine and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

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

Taking Duloxetina Viatris Pharmaceuticals with food, drinks, and alcohol

Duloxetine 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, consult your doctor or pharmacist before using this medication.

• 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 medications (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 near the end of your pregnancy, your baby may have some symptoms when born. Usually, they start at birth or within the first few days after the baby's birth. These symptoms may include weak muscles, tremors, nervousness, that the baby does not feed properly, breathing problems, and seizures. 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, who can advise you.

• If you take duloxetine near 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 duloxetine during the first three months of pregnancy do not show a general increase in the risk of birth defects in the baby. If you take duloxetine 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), especially between weeks 35 and 36 of pregnancy.

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

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 duloxetine affects you.

Duloxetina Viatris Pharmaceuticals contains saccharose and sodium

This medication containssaccharose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Duloxetina Viatris Pharmaceuticals should be taken orally. Swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose of duloxetina is 60 mg once a day, but your doctor will prescribe the dose that is best for you.

For generalized anxiety disorder:

The initial normal dose of duloxetina 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 can be adjusted to 120 mg per day depending on your response to duloxetina.

To avoid forgetting to take duloxetina, it may be helpful to take it at the same time every day.

Discuss with your doctor for how long you should take duloxetina. Do not stop taking duloxetina 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 Duloxetina Viatris Pharmaceuticals than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Among the symptoms produced by an overdose are drowsiness, coma, serotonin syndrome (a rare reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures, vomiting, and high heart rate.

If you forgot to take Duloxetina Viatris Pharmaceuticals

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 duloxetina than prescribed for you in a day.

If you interrupt treatment with Duloxetina Viatris Pharmaceuticals

DO NOT stop taking your capsules without consulting your doctor, even if you feel better. If your doctor thinks you no longer need to take duloxetina, they will instruct you to reduce your dose for at least 2 weeks before stopping treatment.

Some patients who suddenly stopped treatment with duloxetina have presented 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 bothersome symptoms, 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 effects are usually mild to moderate and often disappear within a few weeks.

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

• headache, drowsiness
• unpleasantness (nausea), dry mouth.

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

• loss of appetite
• difficulty sleeping, feeling agitated, decreased libido, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling slow, tremors, 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, urinating frequently
• difficulty achieving an erection, changes in ejaculation
• falls (mainly in older people), 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 increased to similar levels to those of other children and adolescents of the same age and sex.

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

• throat inflammation that causes 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, for example: 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
• syncope, dizziness, feeling dizzy or syncope when standing up, cold hands and/or feet
• throat spasms, nasal bleeding
• vomiting blood, or black stools, gastroenteritis, belching, difficulty swallowing
• liver inflammation, which can cause abdominal pain and yellowing of the skin or the white part of the eyes
• nocturnal sweating, 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 potassium levels, creatine phosphokinase, sugar, or cholesterol.

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

• severe allergic reactions, which cause difficulty breathing or dizziness, with swelling of the tongue or lips, allergic reactions
• decreased thyroid gland activity, which can cause fatigue or weight gain
• dehydration, low sodium levels in the blood (mainly in older people; symptoms may include dizziness, weakness, confusion, sleepiness, or excessive fatigue, nausea, or vomiting, the most serious symptoms are syncope, convulsions, 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), 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, which 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 people)

• inflammation of the skin blood vessels (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, syncope, 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 expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Alu/Alu Blister: This medication does not require any special storage temperature. Store in the original blister to protect it from moisture.

PVC-PVDC/Alu Blister: Store below 30°C. Store in the original blister to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Duloxetina Viatris Pharmaceuticals

• The active ingredient is duloxetina.

Each capsule contains 67.36 mg of duloxetina hydrochloride equivalent to 60 mg of duloxetina.

• The other components are:

Caplet content : hypromellose, talc, titanium dioxide (E-171), copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate and polysorbate 80), triethyl citrate, sugar spheres (cornstarch and sucrose) and sucrose (for more information on sucrose, see the end of section 2).

Caplet body : gelatin, titanium dioxide (E-171), FD&C Blue No. 2/indigo carmine (E-132) and or yellow iron oxide (E-172) .

Black ink of the capsule: shellac (E-904), anhydrous alcohol, isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), concentrated ammonium solution (E-527), potassium hydroxide (E-525) and iron oxide black (E-172).

Appearance of the product and contents of the packaging

Hard, gastro-resistant capsule that contains pellets of duloxetina hydrochloride with a coating to protect it from stomach acid.

The capsules are composed of a green opaque body with "129" printed in black ink and a blue opaque cap with "E" printed in black ink.

It is available in packaging of 28, 56, and 504 capsules (clinical packaging).

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible manufacturer

TOWA PHARMACEUTICAL EUROPE S.L.

C/ Sant Martí, 75-97

08107 - Martorelles (Barcelona)

Spain

Revision date of this leaflet: August 2024

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