Duloxetine Normon 120 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Duloxetina Normon 120 mg gastro-resistant hard capsules

duloxetine

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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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).

Duloxetine begins to work in most people with depression or anxiety within two weeks after starting treatment, but it may take between two and four weeks before you start to feel better. Inform your doctor if you do not notice any improvement after this time. Your doctor may continue to give you duloxetine once you feel better to prevent your depression or anxiety from returning.

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 insufficiency,
• if you have severe renal insufficiency,
• if you are taking or have taken within the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see "Other medicines and Duloxetina Normon"),
• if you are taking fluvoxamine, which is commonly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections.

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

Warnings and precautions

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

• you are using other medicines to treat depression (see "Other medicines and Duloxetina Normon"),
• you are taking St. John’s wort (Hypericum perforatum), a herbal remedy,
• you have any kidney disease,
• you have had seizures (epileptic fits),
• you have experienced mania,
• you suffer from 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 having low sodium levels (for example, if you are taking diuretics, particularly if you are elderly),
• you are receiving treatment with other medicines that may cause liver damage,
• you are taking other medicines containing duloxetine (see "Other medicines and Duloxetina Normon").

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

Some medicines in the same class as duloxetine (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping 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 suicidal thoughts or thoughts of self-harm,
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour 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 ask them to tell you if they notice your depression or anxiety worsening, or if they are concerned about changes in your behaviour.

You should also contact your doctor:

If you experience signs and symptoms such as agitation, 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).

Children and adolescents

This medicine must 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 developing side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe duloxetine to patients under 18 years of age if they decide it may be beneficial for the patient. If your doctor has prescribed duloxetine 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 duloxetine. Furthermore, in this age group, the long-term effects of duloxetine on growth, puberty, and cognitive and behavioural 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 of Duloxetina Normon, 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. Consult your doctor if you are already taking another medicine containing duloxetine.

Your doctor will decide whether you can take duloxetine 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 duloxetine if you are taking, or have recently taken (within the last 14 days), another medicine for depression 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 duloxetine, may cause serious, even life-threatening, side effects. You must wait at least 14 days after stopping treatment with an MAOI before starting duloxetine. Likewise, you must wait at least 5 days after stopping duloxetine before starting treatment with an MAOI.

Medicines causing drowsiness: include 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 (such as paroxetine and fluoxetine), serotonin-noradrenaline reuptake inhibitors (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 side effects; if you notice any unusual symptoms when taking any of these medicines together with duloxetine, 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

This medicine may be taken with or without food. You should exercise caution if consuming alcohol while being treated with duloxetine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 taking duloxetine. You should only take duloxetine after your doctor has evaluated the potential benefits of treatment against any potential risks to the fetus.

• Ensure that your midwife and/or doctor know that you are taking duloxetine. Other similar medicines (called SSRIs), 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 appear bluish. 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 duloxetine 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 include weak muscles, tremors, restlessness, feeding difficulties, breathing problems, and seizures. If your baby has any of these symptoms at birth, 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 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 appropriately.

• 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 child. If you take duloxetine during the second half of pregnancy, there may be an increased risk of premature birth (6 additional premature births per 100 women taking duloxetine during the second half of pregnancy), especially 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 duloxetine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this treatment affects you.

Duloxetina Normon contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Duloxetina Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

3. How to take Duloxetina Normon

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

For depression:

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 are given 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.

This medicine can be taken with or without food.

Taking the capsule at the same time every day may help you remember to take duloxetine.

Discuss with your doctor how long you should take this medicine. Do not stop taking duloxetine 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 may become worse and more difficult to treat.

If you take more Duloxetina Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Symptoms caused by an 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 forget to take a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take the next dose at your usual time. Do not take a double dose to make up for a missed dose. Do not take more Duloxetina Normon than prescribed for you in one day.

If you stop taking Duloxetina Normon

Do not stop taking your capsules without your doctor's advice, even if you feel better. If your doctor decides you no longer need to continue taking duloxetine, 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, feelings of restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, and excessive sweating or dizziness.

These symptoms are usually not serious and disappear within a few days. However, if you experience bothersome symptoms, consult 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 may 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 patients)

• Headache, drowsiness.
• Nausea, dry mouth.

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

• Loss of appetite.
• Difficulty sleeping, feeling restless, decreased sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams.
• Dizziness, feeling slowed down, 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 (mostly in elderly people).
• Weight loss.

Children and adolescents under 18 years of age with depression treated with this medicine experienced weight loss when starting treatment. After six months of treatment, weight returned 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 patients)

• Swelling of the throat causing hoarseness.
• Suicidal thoughts, difficulty sleeping, grinding or clenching teeth, feeling disoriented, lack of motivation.
• Muscle spasms and spontaneous 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.
• Pupil dilation (the black center of the eye), vision problems.
• Feeling dizzy or vertigo, ear pain.
• Rapid and/or irregular heartbeat.
• Fainting, dizziness, feeling lightheaded or faint upon standing, coldness in fingers and/or toes.
• Throat spasms, nosebleeds.
• Vomiting blood, or black stools, gastroenteritis, burping, difficulty swallowing.
• Liver inflammation which 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, unusually light or missed periods, testicular or scrotal pain.
• Chest pain, feeling cold, thirst, chills, feeling hot, change in walking pattern.
• Weight gain.
• Duloxetine 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 patients)

• 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 sodium levels in the blood (mostly in elderly people; symptoms may include feeling dizzy, weakness, confusion, drowsiness or extreme tiredness, nausea or vomiting. More serious symptoms are 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 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.
• Mouth inflammation, bright red blood in stools, bad breath, inflammation of the large intestine (leading to diarrhoea).
• Liver failure, yellowing of the skin or whites of the eyes (jaundice).
• Stevens-Johnson syndrome (a serious illness with 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 patients)

• 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 heartbeat.

Reporting of adverse effects

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

5. Storage of Duloxetina Normon

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

PVC/PVDC-Aluminum blister: Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Duloxetina Normon 120mg

The active substance is duloxetine.

Each gastro-resistant hard capsule contains 120 mg of duloxetine (as hydrochloride).

The other components are:

Capsule contents: hypromellose, talc, titanium dioxide (E-171), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing sodium lauryl sulfate and polysorbate 80), triethyl citrate, sugar spheres (containing sucrose and corn starch), sucrose.

Capsule shell: Gelatin, brilliant blue FCF (E-133), printing ink (black iron oxide [E-172], potassium hydroxide, shellac).

Appearance of the product and contents of the pack

Duloxetina is a gastro-resistant hard capsule. Each duloxetine hard capsule contains duloxetine hydrochloride in the form of pellets coated to protect them from gastric acid.

Duloxetina Normon 120 mg gastro-resistant hard capsules are size 00 hard gelatin capsules with a transparent blue cap and a transparent blue body, printed in black ink (cap: "DU", body: "120"), approximately 23.2 mm in length.

This medicine is available in blisters of 28 gastro-resistant hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97,

Martorelles, 08107, Barcelona,

Spain

Date of latest review of this leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) 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 outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/88029/P_88029.html