Prospecto:Information for the Patient

Duloxetina NORMON60 mgCapsulesDurable Gastric-Resistant EFG

Duloxetina, hydrochloride

Read this prospectus carefully beforestarting to takethis medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 prospectus.See section 4.

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

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

3. How to take Duloxetina NORMON

4. Possible adverse effects

5. Storage of Duloxetina NORMON

6. Contents of the package and additional information

Duloxetina NORMONcontains the active ingredient duloxetina.Duloxetina NORMONincreases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina NORMONis used in adults to treat:

• depression

• generalized anxiety disorder (chronic sensation 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 touching the area or exposing it to heat, cold, or pressure).

Duloxetina NORMONbegins 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 youDuloxetina NORMONwhen 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 NORMON

• You are allergic to duloxetine or any of the other components of 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 “Use of other medications”)
• You are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin or enoxacin, which are used in the treatment of some infections
• You are taking other medications that contain duloxetine (see “Use of other medications”)

Consult your doctor if you have high blood pressure or a heart disease. Your doctor will tell you if you should take Duloxetina NORMON.

Warnings and precautions

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

- You are taking other medications to treat depression (see “Use of other medications”)

- You are taking St. John's Wort, a herbal treatment (Hypericum perforatum)

- You have any kidney disease

- You have had seizures (epileptic attacks)

- You have had mania

- You suffer from bipolar disorder

- You have eye problems, such as some types of glaucoma (increased eye pressure)

- You have had bleeding problems (tendency to develop hematomas)

- You have a risk of having low sodium levels (for example, if you are taking diuretics, especially if you are an elderly person).

- You are being treated with other medications that can cause liver damage

- You are taking other medications that contain duloxetine (see “Use of other medications”)

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 Normon belongs (called SSRIs/SNRIs) may 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 disorder

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 medications take time to take effect, usually two weeks but sometimes longer.

You are more likely to have these thoughts if:

- You have had previous thoughts of self-harm or suicide

- 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 you if your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

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 rigidity, confusion, and increased muscle enzymes (determined by blood test).

Children and adolescents under 18 years

Duloxetine 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 medications have an increased risk of developing side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe duloxetine to patients under 18 years old if 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 inform your doctor if any of the above symptoms 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.

Taking Duloxetina NORMON with other medications

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

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

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

You should avoid using 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 antidepressant known as a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medications, 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. 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 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, and MAOIs (such as moclobemide and linezolid). These medications increase the risk of side effects; if you observe any unusual symptoms when using any of these medications with DULOXETINA, you should inform your doctor.

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

Taking Duloxetina NORMON with food, drinks, and alcohol

Duloxetine NORMON 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 this medication. 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 this medication. Other similar medications (SSRIs), taken during pregnancy, may increase the risk of a serious disease 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. These usually start at birth or within the first few days after your baby's birth. These symptoms may include weak muscles, tremors, nervousness, difficulty feeding, 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.

• 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 NORMON contains saccharose

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

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

Duloxetina NORMONshould be taken orally. Swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose ofDuloxetina NORMONis 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 ofDuloxetina NORMONis 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 toDuloxetina NORMON.

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

Discuss with your doctor for how long you should takeDuloxetina NORMON. Do not stop takingDuloxetina NORMON, 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 moreDuloxetina NORMONthan 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 takeDuloxetina NORMON

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 than the prescribed amount ofDuloxetina NORMONin a day.

If you interrupt treatment withDuloxetina NORMON

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 takeDuloxetina NORMON, they will instruct you to reduce your dose for at least 2 weeks before stopping treatment.

Some patients, who suddenly stop treatment withDuloxetina NORMONhave presented symptoms such as:

• dizziness, feeling of pins and needles or electric shock sensation (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 important 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

• discomfort (nausea), dry mouth

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

• loss of appetite

• difficulty sleeping, feeling agitated, decreased libido, anxiety, difficulty or inability to have an orgasm, unusual dreams

• dizziness, feeling of slowness, 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 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 while urinating, urinating frequently

• 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, their 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 that causes hoarseness

• suicidal thoughts, difficulty sleeping, bruxism, feeling disoriented, lack of motivation

• muscle spasms and involuntary muscle movements, feeling restless or unable to sit or stay 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

• dilated pupils (the black center of the eye), vision problems

• feeling of dizziness or vertigo, ear pain

• rapid or irregular heartbeat

• fainting, dizziness, feeling of dizziness or fainting when standing up, cold hands and/or feet

• throat spasms, nasal bleeding

• 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, irregular 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

This medicine 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 patients)

• severe allergic reactions, which can 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 extreme fatigue, nausea or vomiting, more serious symptoms are fainting, 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)

• inflammation of the mouth, bright red blood in the stool, bad breath

• 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

• cough, wheezing, and shortness of breath, which may be accompanied by high fever.

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 heartbeats.

Reporting 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 leaflet. You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Use: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.

Store in the original packaging to protect from moisture, do not store at a temperature above30°C.Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Composition of Duloxetina NORMON

- The active ingredient is duloxetina .

Cada cápsula contiene 60 mg de duloxetina (como hidrocloruro).

- Los demás componentes son:

Content of the capsule: hypromellose, acetate succinate of hypromellose, sucrose, sugar spheres (sucrose and cornstarch), talc, polyethylene glycol and triethyl citrate. Capsule body: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow quinoline (E104) and erythrosine red (E127).

Appearance of the product and content of the packaging

Duloxetina NORMON is a hard, gastro-resistant capsule. Cada cápsula de Duloxetina NORMON contains pellets of duloxetina hydrochloride with a coating to protect them from stomach acid.

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

The 60 mg capsules are ivory and blue.

Duloxetina NORMON 60 mg is available in packs of 28 and 56 capsules.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (ESPAÑA)

OTHER PRESENTATIONS

Duloxetina NORMON 30 mg hard gastro-resistant capsules EFG.

Last review date of this leaflet: July 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79592/P_79592.html