DULOXETINE AUROVITAS 60 mg GASTRO-RESISTANT HARD CAPSULES

2. What you need to know before you take Duloxetine Aurovitas

Do not take Duloxetine Aurovitas

• if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6).
• if you have liver failure.
• if you have severe kidney disease.
• if you are taking or have taken within the last 14 days another medicinal product called a monoamine oxidase inhibitor (MAOI) (see "Other medicines and Duloxetine Aurovitas").
• 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 medicines that contain duloxetine (see "Other medicines and Duloxetine Aurovitas").

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

Warnings and precautions

Duloxetine may not be suitable for you due to the following reasons. Consult your doctor before starting treatment with Duloxetine Aurovitas if:

• you are using other medicines to treat depression (see "Other medicines and Duloxetine Aurovitas").
• you are taking St. John's Wort, a herbal remedy (Hypericum perforatum).
• you have any kidney disease.
• you have had seizures (fits).
• you have had mania.
• you have bipolar disorder.
• you have eye problems, such as certain types of glaucoma (increased eye pressure).
• you have had bleeding problems (a tendency to develop bruises), especially if you are pregnant (see "Pregnancy and breastfeeding").
• you are at risk of having low sodium levels (e.g., if you are taking diuretics, especially if you are an elderly person).
• you are being treated with other medicines that may cause liver damage.
• you are taking other medicines that contain duloxetine (see "Other medicines and Duloxetine Aurovitas").
• you have depression or other conditions that are being treated with antidepressants.
• if you are taking medicines containing buprenorphine. The use of these medicines with duloxetine may cause serotonin syndrome, a potentially life-threatening disease (see "Other medicines and Duloxetine Aurovitas").

You should also contact your doctor:

If you experience signs and symptoms of agitation, 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 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).

Some medicines of the same group as Duloxetine Aurovitas (called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. These thoughts may be increased at the start of treatment with antidepressants, as all these medicines take time to work, usually about 2 weeks, but sometimes longer.

It is more likely that you will have these thoughts if:

• you have previously had thoughts of self-harm or suicide.
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

Contact your doctor or go to the hospital immediately if you experience any thoughts of self-harm or suicide.

It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents under 18 years

Duloxetine should not normally be used in children and adolescents under 18 years. In addition, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior, and anger) when they take this class of medicines. Despite this, your doctor may prescribe duloxetine to patients under 18 because they decide that it can be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 and you want to discuss it, please go back to the doctor. You must tell your doctor if any of the above symptoms occur or worsen in patients under 18 taking duloxetine. Additionally, in this age group, the long-term safety of duloxetine related to growth, maturation, and cognitive and behavioral development has not yet been demonstrated.

Other medicines and Duloxetine Aurovitas

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

The active substance of this medicine, 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. 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 medicines, including those obtained without a prescription, and herbal remedies, without first talking to your doctor.

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

Monoamine oxidase inhibitors (MAOIs):do not take duloxetine if you are taking or have taken another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) in the last 14 days. 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 death. You should wait at least 14 days after stopping an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping duloxetine before starting an MAOI.

Medicines that cause drowsiness:these 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 (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 medicines increase the risk of side effects; if you notice any unusual symptoms when using any of these medicines with Duloxetine Aurovitas, you should 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.

Some medicines may increase the side effects of duloxetine and may cause serious reactions. Do not take any other medicines while taking duloxetine without first talking to your doctor, especially:

Medicines containing buprenorphine:these medicines may interact with duloxetine, and you may experience symptoms such as muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, body temperature above 38°C. Contact your doctor if you experience these symptoms.

Taking Duloxetine Aurovitas with food, drinks, and alcohol

Duloxetine can be taken with or without food. You should be cautious if you drink 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Tell your doctor if you become pregnant or are planning to become pregnant while taking this medicine. You should only use duloxetine after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor know you are taking this medicine. Other similar medicines (SSRIs), taken during pregnancy, may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take duloxetine near the end of your pregnancy, your baby may have some symptoms when it is born. These usually start at birth or within the first few days of your baby's life. These symptoms include weak muscles, trembling, restlessness, difficulty feeding, breathing problems, and seizures. If your baby has any of these symptoms when it is born, or if you are worried 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 a greater risk of excessive vaginal bleeding shortly after giving birth, especially if you have had bleeding problems. Your doctor or midwife should know that you are taking duloxetine so that they can advise you.

Data on the use of duloxetine during the first three months of pregnancy do not show an increased overall risk of birth defects in the baby. If you take duloxetine during the second half of your pregnancy, there may be a greater risk that your baby will be born early (6 additional premature babies per 100 women taking duloxetine in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

Tell your doctor if you are breastfeeding. Duloxetine is not recommended during breastfeeding.

Ask your doctor or pharmacist for advice.

Driving and using machines

During treatment with duloxetine, you may feel drowsy or dizzy. Do not drive or operate machinery until you know how duloxetine affects you.

Duloxetine Aurovitas contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Duloxetine Aurovitas contains sodium

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

3. How to take Duloxetine Aurovitas

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Duloxetine Aurovitas should be taken by mouth. You should swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose of duloxetine is 60 mg once a day, 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 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 up to 120 mg a day depending on your response to duloxetine.

To help you remember to take duloxetine, you may find it helpful to take it at the same times each day.

Discuss with your doctor how long you should take duloxetine. Do not stop taking duloxetine, or reduce your dose, without consulting your doctor. It is important to treat your condition effectively to help you improve. If you do not treat your condition, it may not get better and may become more serious and more difficult to treat.

If you take more Duloxetine Aurovitas than you should

If you have taken more duloxetine than you should, contact your doctor or pharmacist immediately or go to the hospital. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

If you forget to take Duloxetine Aurovitas

If you forget to take a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more duloxetine than prescribed for you in a day.

If you stop taking Duloxetine Aurovitas

Do not stop taking your capsules without the advice of your doctor, even if you feel better. If your doctor thinks you do not need to take duloxetine anymore, they will tell you how to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who stop taking duloxetine have experienced symptoms such as:

• dizziness, sensations like pins and needles, or electric shock-like sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremors, headaches, muscle pain, 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 troublesome, ask your doctor for advice.

If you have any other 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 all people suffer from them. These effects are usually mild to moderate and disappear, often, 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, 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, diarrhea, stomach pain, vomiting, heartburn or indigestion, gas.
• increased sweating, rash (itching).
• muscle pain, muscle spasms.
• pain when 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 suffered a decrease in weight when they started taking this medicine. After 6 months of treatment, 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 stay 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 stools, gastroenteritis, belching, difficulty swallowing.
• inflammation of the liver 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 menstruation, exceptionally light or absent menstruation, 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 that 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).
• cough, wheezing, and shortness of breath, which may be accompanied by high fever.
• inflammation of the mouth, bright red blood in the stool, bad breath, inflammation of the large intestine (leading to diarrhea).
• liver failure, yellowing of the skin or the white part of the eyes (jaundice).
• Stevens-Johnson syndrome (a serious 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 urine odor.
• menopausal symptoms, abnormal milk production in men or women.
• excessive vaginal bleeding shortly after birth (postpartum hemorrhage).

Very Rare Adverse Effects (may affect up to 1 in 10,000 patients)

• inflammation of the blood vessels in the skin (cutaneous vasculitis).

Adverse Effects with Unknown Frequency (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 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: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Duloxetine Aurovitas

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after “EXP”. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Duloxetine Aurovitas

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

Capsule content:sugar spheres (sucrose and cornstarch), hypromellose type 2910 (5cP), hydroxypropylcellulose (low viscosity), crospovidone (type B), talc, triethyl citrate, titanium dioxide (E171), phthalate of hypromellose.

Capsule body:

Capsule cap:titanium dioxide (E171), blue FD & C (E132), gelatin, sodium lauryl sulfate. Capsule body:yellow iron oxide (E172), titanium dioxide (E171), blue FD & C (E132), gelatin, sodium lauryl sulfate.

Printing ink:shellac gum, propylene glycol, black iron oxide (E172), potassium hydroxide.

Appearance of the Product and Package Contents

Hard gelatin capsule of size “1”, with the cap of opaque blue color and the body of opaque green color, filled with white or off-white granules, with “DLX” printed on the cap and “60” on the body with black ink.

Duloxetine Aurovitas is available in PVC/Poliamide/Aluminum/PVC-Aluminum blister packs.

Package size: 28 hard capsules

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Date of the Last Revision of this Prospectus:07/2024

Other Sources of Information

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