Duloxetine Alter 60 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Duloxetina Alter 60 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it could 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 Alter is and what it is used for
2. What you need to know before taking Duloxetina Alter
3. How to take Duloxetina Alter
4. Possible side effects
5. How to store Duloxetina Alter
6. Contents of the pack and other information

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

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

Duloxetina Alter is used in adults to treat:

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

Duloxetina begins 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 feel better after this time. Your doctor may continue to prescribe duloxetina 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 Alter

Do not take Duloxetina Alter:

• if you are allergic to duloxetine or 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 "Use of Duloxetina Alter with other medicines")
• if you are taking fluvoxamine, which is normally 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 Alter with other medicines")

Consult your doctor if you have high blood pressure or a heart disease. Your doctor will advise whether you should take duloxetine.

Warnings and precautions

Duloxetine may not be suitable for you for the following reasons.

Some medicines in the group to which Duloxetina Alter belongs (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Consult your doctor before starting to take this medicine if:

• you are using other medicines to treat depression (see "Use of Duloxetina Alter 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 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)
• you are at risk of low sodium levels (for example, if you are taking diuretics, especially 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 Alter with other medicines")

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

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 take effect, 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 behaviour in psychiatric patients under 25 years of age being treated with antidepressants

Contact your doctor or go immediately to hospital 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 suffer from an anxiety disorder, and ask them to read this leaflet. You may ask them to inform 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 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 (determined by blood test).

Children and adolescents

Duloxetine should normally 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 (predominantly 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 above-mentioned symptoms 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, maturation, and cognitive and behavioural development have not yet been established.

Use of Duloxetina Alter with other medicines

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

The main component of Duloxetina Alter, duloxetine, is used in other medicines for other treatments:

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

It is advisable to 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 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 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 duloxetine, can cause serious adverse effects and may even be life-threatening. 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 that cause drowsiness: This includes medicines prescribed by your doctor such as benzodiazepines, strong analgesics, 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 duloxetine, you must 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 Alter with food, drinks and alcohol

Duloxetine can be taken with or without food. You should exercise caution if consuming alcohol while being treated with duloxetine.

Pregnancy, breastfeeding and fertility

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 use duloxetine 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 duloxetine. Other similar medicines (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 develop a bluish colouration. These symptoms usually begin within the first 24 hours after 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 experience certain symptoms after birth. These usually begin at birth or during the first few days after delivery. Symptoms may include weak muscles, tremors, irritability, poor feeding, breathing difficulties, and seizures. If your baby shows 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.

• 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 Alter contains sucrose

Duloxetina contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Duloxetina Alter

Follow exactly the administration instructions for 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 and diabetic neuropathic pain:

The recommended dose of duloxetina is 60 mg once daily, but your doctor will prescribe the dose best suited to your needs.

For generalized anxiety disorder:

The usual starting dose of duloxetina is 30 mg once daily, after which most patients will receive 60 mg once daily. However, your doctor will prescribe the dose best suited to your needs. The dose may be adjusted up to 120 mg daily depending on your response to duloxetina.

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 take 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 more severe and harder to treat.

If you take more Duloxetina Alter than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91.562.04.20, indicating the medicine and the amount ingested.

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 Alter

If you forget to take a dose, take it as soon as you remember. However, if it is nearly 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 than prescribed for you in one day.

If you stop taking Duloxetina Alter

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

Some patients who have abruptly stopped treatment with duloxetina have experienced symptoms such as:

• dizziness, tingling sensations like electric shocks or pins and needles (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feelings of 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 will experience 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
• discomfort (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 patients), fatigue
• weight loss

Children and adolescents under 18 years of age with depression treated with this medicine experienced a decrease in weight when starting treatment. After 6 months of treatment, 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 patients)

• 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 of sleep
• dilation of the pupils (the black center of the eye), vision problems
• feeling dizzy or vertigo, ear pain
• rapid and/or irregular heartbeat
• fainting, dizziness, feeling dizzy or faint when standing up, coldness in the 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 initiating urination, need to urinate during the night, need to urinate more than normal, decreased urine flow
• abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular or prolonged periods, rarely light or missed periods, pain in the testicles or scrotum
• 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 patients; symptoms may include dizziness, 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 stiffness), seizures
• increased eye pressure (glaucoma)
• mouth inflammation, bright red blood in stools, bad breath
• 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
• cough, wheezing and shortness of breath, which may be accompanied by high fever
• menopausal symptoms, abnormal production of breast milk in men or women

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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Duloxetine Alter

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.

Store in the original packaging. Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Duloxetina Alter

• The active substance is duloxetina. Each capsule contains 60 mg of duloxetina (as hydrochloride).

• The other components are:

Capsule contents: hypromellose, sugar spheres (corn starch and sucrose), talc, sucrose, hypromellose phthalate, and triethyl citrate.

Capsule coating: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and indigotine.

Appearance of the product and contents of the pack

Duloxetina Alter 60 mg is a hard gastro-resistant capsule. The capsules are blue and green.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid - Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Date of the most recent review of this leaflet:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.