Duloxetine Normon 60 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Duloxetina Normon 60 mg gastro-resistant hard capsules EFG

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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Duloxetina Normon 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 like an electric shock. 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).

This medicine starts to work in most people with depression or anxiety within two weeks of 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 any improvement after this time. Your doctor may continue your duloxetine treatment 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 Normon

Do not take Duloxetina Normon

• if you are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)
• if you have hepatic impairment
• if you have severe renal impairment
• if you are taking or have taken within the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see "Use of Duloxetina Normon with other medicines")
• if you are taking fluvoxamine, which is usually used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections
• if you are taking other medicines containing duloxetine (see "Use of Duloxetina Normon with other medicines")

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

Warnings and precautions

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

• you are using other medicines to treat depression (see "Use of Duloxetina Normon 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 have 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 being treated with other medicines that may cause liver damage
• you are taking other medicines containing duloxetine (see "Use of Duloxetina Normon with other medicines")

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

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, vomiting, as you may be experiencing 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 (detected by blood test).

Some medicines in the same class as Duloxetina Normon (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms may 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 behavior in psychiatric patients under 25 years of age 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 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 request that they inform you if they notice your depression or anxiety worsening, or if they are concerned about changes in your behavior.

Children and adolescents under 18 years of age

Duloxetina Normon 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 taking this type of medicine have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe Duloxetina Normon to patients under 18 years of age if they decide it may be beneficial for the patient. If your doctor has prescribed Duloxetina Normon 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 Duloxetina Normon. Furthermore, in this age group, the long-term effects of Duloxetina Normon on growth, maturation, and cognitive and behavioral development have not yet been established.

Other medicines and Duloxetina Normon

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

The active ingredient in Duloxetina Normon, duloxetine, is used in other medicines for other conditions:

• 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 Duloxetina Normon 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 Duloxetina Normon 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 Duloxetina Normon, can cause serious adverse effects and may even be life-threatening. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Normon. Likewise, you must wait at least 5 days after stopping Duloxetina Normon before starting 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), meperidine, 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 Duloxetina Normon, 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 Normon with food, drinks, and alcohol

Duloxetina Normon can be taken with or without food. Exercise caution if you consume alcohol while being treated with Duloxetina Normon.

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 being treated with Duloxetina Normon. Duloxetina Normon 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 Duloxetina Normon. 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 turn blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

• If you take Duloxetina Normon 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 birth. Symptoms may include weak muscles, tremors, restlessness, poor feeding, breathing difficulties, and seizures. If your baby has 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 Normon 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.

• Available data on the use of Duloxetina Normon during the first three months of pregnancy do not show a general increase in the risk of birth defects. If you take Duloxetina Normon during the second half of pregnancy, there may be an increased risk of premature birth (6 additional premature babies per 100 women taking Cymbalta in the second half of pregnancy), particularly 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 Duloxetina Normon, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this medicine affects you.

Duloxetina Normon contains sucrose

Duloxetina Normon contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Duloxetina Normon

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Duloxetina Normon 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 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. However, your doctor will prescribe the dose that is best for you. The dose may be adjusted up to 120 mg daily depending on your response to duloxetine.

To help you remember to take duloxetina, it may be helpful to take it at the same time each day.

Discuss with your doctor how long you should continue taking duloxetina. Do not stop taking duloxetina 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 resolve and could become worse and more difficult to treat.

If you take more Duloxetina Normon than you should

Call your doctor or pharmacist immediately if you take more duloxetine than prescribed. 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 Normon

If you miss 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 of this medicine than prescribed for you in one day.

If you stop taking Duloxetina Normon

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, they will instruct 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, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or dizziness.

These symptoms are usually mild and resolve within a few days. However, if you experience bothersome symptoms, seek advice from your doctor.

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 can 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 people)

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

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

• loss of appetite
• difficulty sleeping, feeling restless, decreased sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling sluggish, 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 they started taking it. After 6 months of treatment, their 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 people)

• 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 vertiginous, ear pain
• rapid and/or irregular heartbeats
• fainting, dizziness, feeling lightheaded or faint when standing up, coldness in fingers and/or toes
• throat spasms, nosebleeds
• vomiting blood, or black stools, gastroenteritis, burping, difficulty swallowing
• liver inflammation that 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 starting urination, need to urinate at night, need to urinate more than normal, decreased urine flow
• abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular, or prolonged periods; exceptionally light or missed periods; testicular or scrotal pain
• chest pain, feeling cold, thirst, chills, feeling of heat, change in walking pattern
• weight gain
• Duloxetina Normon 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 people)

• 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 levels of sodium 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 that 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

• inflammation of the mouth, 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 people)

• inflammation of blood vessels in the skin (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, fainting, and irregular heartbeats.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Duloxetine Normon

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

Store in the original container to protect from moisture. Do not store above 30°C. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duloxetina Normon

• The active substance is duloxetine.

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

• The other components are:

Capsule contents: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres (sucrose and maize starch), talc, polyethylene glycol and triethyl citrate.
Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), quinoline yellow (E104), and erythrosine red (E127).

Appearance of the product and contents of the pack

Duloxetina Normon is a gastro-resistant hard capsule. Each Duloxetina Normon capsule contains duloxetine hydrochloride pellets coated to protect them from stomach acid.

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

The 60 mg capsules are ivory and blue in colour.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Duloxetina Normon 30 mg gastro-resistant hard capsules EFG.

Date of the most recent review of this leaflet: December 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios) (http://www.aemps.gob.es).

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79592/P_79592.html