Prospecto:information for the patient

Duloxetina NORMON 30 mgcapsuleshard gastro-resistant EFG

Duloxetina, hydrochloride

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

• Keep this prospectus, asyou may need to read it again.
• If youhave any doubts, consult your doctorpharmacist.
• This medication has been prescribed only to you,and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experienceadverse effects, consult yourdoctororpharmacist, even if they are adverse effects that do not appear in this prospectus.See section 4.

1. What is Duloxetina NORMONand for what it is used

2. What you need to know before starting to takeDuloxetina NORMON

3. How to takeDuloxetina NORMON

4. Possible adverse effects

5. Storage ofDuloxetina 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 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 NORMONbegins 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 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 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 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 other medicines”)

Consult your doctor if you have high blood pressure or a heart condition. 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 medicines to treat depression (see “Taking 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 had bleeding problems (tendency to develop bruises)

- 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 medicines that can damage the liver

- You are taking other medicines that contain duloxetine (see “Taking other medicines”)

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

Some medicines in the same group as Duloxetine NORMON (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

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.

It is more likely that you will 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 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 immediately if 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 behaviour.

You must 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, diarrhoea, 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 can include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, 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 type of medicine 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 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 the doctor. You must tell 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 behavioural development have not yet been demonstrated.

Taking Duloxetine NORMON with other medicines

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

The main component of Duloxetine NORMON, duloxetine, is used in other medicines for other treatments:

• diabetic neuropathic pain, depression, anxiety and urinary incontinence

Do not use 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, without first consulting your doctor.

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

Monoamine oxidase inhibitors (MAOIs):You must 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 medicines, including duloxetine, can cause serious side effects, even life-threatening. You must wait at least 14 days after stopping treatment with an MAOI before taking duloxetine. Similarly, you must wait at least 5 days after stopping treatment with duloxetine before starting treatment with an MAOI.

Medicines that cause drowsiness:This includes prescription medicines prescribed by your doctor 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, amitriptyline), petidin, 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 DULOXETINA, 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 Duloxetine NORMON with food, drinks and alcohol

Duloxetine NORMON can be taken with or without food. You must 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 medicine.

• Inform your doctor if you become pregnant or if you are trying to become pregnant while taking this medicine. Only use duloxetine after discussing the potential benefits and any potential risks to the foetus with your doctor.

Make sure your midwife and/or doctor know that you are taking this medicine. Other similar medicines (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 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 the baby's birth. These symptoms may include weak muscles, trembling, nervousness, the baby not feeding 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.

• 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.

Duloxetine NORMON 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.

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, 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 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)

• inflammation of the throat that causes hoarseness

• suicidal thoughts, difficulty sleeping, grinding of teeth, feeling disoriented, lack of motivation

• muscle spasms and involuntary 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 and/or irregular heartbeat

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

• throat spasms, nosebleeds

• vomiting blood, or black stools, gastroenteritis, belching, difficulty swallowing

• inflammation of the liver that can cause abdominal pain and yellowing of the skin or 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, alteration in gait

• 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 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 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 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 above30ºC.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. 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.

Composition of Duloxetina NORMON

- The active ingredient is duloxetina .

Cada cápsula contiene 30 mg de duloxetina (como hidrocloruro).

- Los demás componentes son:

Content of the capsule: hypromellose, acetate succinate of hypromellose, saccharose, sugar spheres (saccharose and cornstarch), talc, polyethylene glycol and triethyl citrate. Capsule body: gelatin, titanium dioxide (E171) and indigo carmine (E132).

Appearance of the product and contents 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 30 mg capsules are white and blue.

Duloxetina NORMON 30 mg is available in packs of 7 and 28 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Duloxetina NORMON 60 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/79591/P_79591.html