DULOXETINE ALTER 60 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Prospect:Information for the user

Duloxetina Alter 60mg gastro-resistant capsules EFG

The leaflet of the prospect that you should read carefully before taking the medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you, do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect:

1. What is Duloxetina Alter and what is it used for
2. What you need to know before taking Duloxetina Alter
3. How to take Duloxetina Alter
4. Possible adverse effects
5. Storage of Duloxetina Alter
6. Package contents and additional information

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

Duloxetina Alter contains the active principle duloxetina. Duloxetina increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina is used in adults to treat:

• depression
• generalized anxiety disorder (a chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing, or shooting pain, or as tingling, numbness, or a "pins and needles" sensation)

Duloxetina starts to work in most people with depression or anxiety within 2 weeks of starting treatment, but it may take between 2 and 4 weeks to start feeling better. Inform your doctor if you do not improve within this time. Your doctor may continue to give you duloxetina to prevent your depression or anxiety from returning.

In people with diabetic neuropathic pain, it may take a few 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 duloxetina or any of the other components of this medication

(including those listed in section 6)

• if you have liver failure
• if you have severe kidney disease
• if you are taking or have taken in the last 14 days another medication known as a monoamine oxidase inhibitor (MAOI) (see "Use of Duloxetina Alter with other medications")
• if you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin, or enoxacin, which are used to treat some infections
• if you are taking other medications that contain duloxetina (see "Use of Duloxetina Alter with other medications")

Consult your doctor if you have high blood pressure or heart disease. Your doctor will indicate if you should take duloxetina.

Warnings and precautions

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

Some medications in the same group as Duloxetina Alter (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is stopped.

Consult your doctor before starting to take this medication if:

• you are using other medications to treat depression (see "Use of Duloxetina Alter with other medications")
• 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 (a tendency to develop bruises)
• you are at 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 may cause liver damage
• you are taking other medications that contain duloxetina (see "Use of Duloxetina Alter with other medications")

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

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts may be increased at the start of treatment with antidepressants, as all these medications take time to work, usually around 2 weeks, but sometimes longer.

It is more likely that you will 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 who are being treated for a psychiatric disorder 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 if you tell a close relative or friend that you are depressed or have an anxiety disorder and ask them to read this prospect. You can ask them to tell you if they notice that your depression or anxiety is getting worse, or if they are worried 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, overactive 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 can include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Children and adolescents

Duloxetina should not normally be used in children and adolescents under 18 years of age. Additionally, you should know that patients under 18 years of age who take this type of medication have an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe duloxetina to patients under 18 years of age because they decide it may be beneficial for the patient. If your doctor has prescribed duloxetina to a patient under 18 years of age and you want to discuss it, please go back to the doctor. You should inform your doctor if any of the above symptoms appear or worsen in patients under 18 years of age who are taking duloxetina. Additionally, in this age group, the long-term safety effects of duloxetina related to growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Use of Duloxetina Alter with other medications

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

The main component of Duloxetina Alter, duloxetina, 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 duloxetina.

Your doctor will decide if you can take duloxetina with other medications. Do not start or stop taking any medication, including those obtained without a prescription, without consulting your doctor first.

You should also inform your doctor if you are taking any of the following medications:

Monoamine oxidase inhibitors (MAOIs):you should not take duloxetina if you are taking, or have taken recently (in the last 14 days), another antidepressant medication 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 duloxetina, can cause serious side effects, even life-threatening. You should wait at least 14 days after stopping treatment with an MAOI before taking duloxetina. Similarly, you should wait at least 5 days after stopping treatment with duloxetina before starting treatment with an MAOI.

Medications that cause drowsiness:this includes medications prescribed by your doctor such as benzodiazepines, strong painkillers, 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, amitriptyline), pethidine, St. John's Wort, and MAOIs (such as moclobemide and linezolid). These medications increase the risk of side effects; if you notice 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 blood clots. These medications may increase the risk of bleeding.

Taking Duloxetina Alter with food, drinks, and alcohol

Duloxetina can be taken with or without food. You should be cautious if you drink alcohol while being treated with duloxetina.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Tell your doctor if you become pregnant or plan to become pregnant while being treated with duloxetina. You should only use duloxetina after evaluating with your doctor the potential benefits and any potential risk to the fetus.

Make sure your midwife and/or doctor know that you are taking duloxetina. 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 become 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 duloxetina near the end of your pregnancy, your baby may have some symptoms when born. These symptoms usually start at birth or in the first few days after the baby's birth. Among these symptoms are weak muscles, tremors, nervousness, difficulty feeding, breathing problems, and seizures. If your baby has any of these symptoms when born or if you are worried about your baby's health, contact your doctor or midwife, who can advise you.

• Tell your doctor if you are breastfeeding. The use of duloxetina is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and using machines

During treatment with duloxetina, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with duloxetina affects you.

Duloxetina Alter contains sucrose

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

3. How to take Duloxetina Alter

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Duloxetina should be taken orally. You should swallow the capsule whole with water.

For the treatment of depression and diabetic neuropathic pain:

The recommended dose of duloxetina is 60mg once a day, but your doctor will prescribe the dose that is best for you.

For the treatment of generalized anxiety disorder:

The initial dose of duloxetina is 30mg once a day, after which most patients will receive 60mg once a day, but your doctor will prescribe the dose that is best for you. The dose can be adjusted up to 120mg a day, depending on your response to duloxetina.

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

Discuss with your doctor how long you should take duloxetina. Do not stop taking duloxetina without consulting your doctor, or change your dose without consulting your doctor. It is important to treat your disease properly to help you improve. If you do not treat it, your disease may not disappear and may become more serious and more difficult to treat.

If you take more Duloxetina Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount taken.

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 stiffness), seizures, vomiting, and rapid heartbeat.

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 almost time for the next dose, skip the missed dose and take a single dose as you normally would. Do not take a double dose to make up for the 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 the advice of your doctor, even if you feel better.If your doctor thinks you no longer need to take duloxetina, they will tell you to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who have stopped taking duloxetina abruptly have presented symptoms such as:

• dizziness, tingling sensation like 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 dizziness.

These symptoms are usually not serious 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.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 of agitation, decreased sexual desire, anxiety, difficulty or inability to have an orgasm, unusual dreams.
• dizziness, feeling of slowness, tremors, 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, diarrhea, stomach pain, vomiting, heartburn or indigestion, gas.
• increased sweating, rash.
• muscle pain, muscle spasms.
• pain while urinating, frequent urination.
• difficulty getting an erection, changes in ejaculation.
• falls (mostly 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 this medicine. After 6 months of treatment, the weight increased to similar levels as other children and adolescents of the same age and sex.

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

• inflammation of the throat that causes hoarseness.
• suicidal thoughts, difficulty sleeping, teeth grinding, feeling of disorientation, lack of motivation.
• muscle spasms and involuntary movements, feeling of restlessness or inability to remain seated or 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.

• dilation of the pupils (the black dot in the center of the eye), vision problems.
• feeling of dizziness or vertigo, ear pain.
• rapid and/or irregular heartbeats.
• fainting, dizziness, feeling of dizziness or fainting when standing up, coldness in the fingers of the hands and/or feet.
• throat spasms, nosebleeds.
• vomiting blood, or black-colored 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, abnormal menstrual periods, including heavy, painful, irregular, or prolonged menstrual periods, exceptionally light or absent menstrual periods, pain in the testicles or scrotum.
• chest pain, feeling of cold, thirst, chills, feeling of heat, alteration in gait.
• weight gain.
• Duloxetine may cause effects that you may not be aware of, such as increased liver enzymes or potassium levels in the blood, creatine phosphokinase, sugar, or cholesterol.

Rare Adverse 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 (mostly in elderly people; symptoms may include feeling of dizziness, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting, the most serious symptoms are fainting, convulsions, or falls), syndrome of inadequate secretion of antidiuretic hormone (SIADH).
• suicidal behavior, mania (hyperactivity, accelerated thinking, and decreased need for sleep), hallucinations, aggression, and anger.
• "Serotonin syndrome" (a rare reaction that can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling of being 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).
• contractions of the jaw muscle.
• unusual odor of the 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 the 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Duloxetine Alter

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Duloxetine Alter

• The active ingredient is duloxetine. Each capsule contains 60mg of duloxetine (as hydrochloride).

• The other ingredients are:

Capsule content: hypromellose, sugar spheres (cornstarch and sucrose), talc, sucrose, hypromellose phthalate, and triethyl citrate.

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

Appearance of the Product and Package Contents

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

Duloxetine Alter 60 mg is available in packages 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 Last Revision of this Prospectus:

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.