DULOXETINE AUROVITAS 30 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Duloxetine Aurovitas 30 mg Hard Gastro-Resistant Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Duloxetine Aurovitas is and what it is used for

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

Duloxetine is used in adults to treat:

• depression.
• generalized anxiety disorder (a chronic feeling of anxiety or nervousness).
• diabetic neuropathic pain (often described as burning, shooting, stabbing, stinging, or like an electric shock. There may be loss of sensation in the affected area, or it may occur that when the area is touched or comes into contact with heat, cold, or pressure, pain is produced).

Duloxetine 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 before you start to feel better. Tell your doctor if you do not notice any improvement after this time. Your doctor may continue to give you duloxetine when you are feeling better 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 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 in the last 14 days another medicine 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 to take 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 plant-based treatment (Hypericum perforatum).
• you have any kidney disease.
• you have had seizures (epileptic fits).
• you have had mania.
• you suffer from bipolar disorder.
• you have eye problems, such as some types of glaucoma (increased eye pressure).
• you have had bleeding problems (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 that contain 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 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 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 in the same group as Duloxetine Aurovitas (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Duloxetine may cause a feeling of restlessness or inability to sit or stand still. If this happens to you, 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 self-harm or suicide. These thoughts may be increased at the beginning of treatment with antidepressants, as all these medicines take time to work, usually about two 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. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age who are being treated with antidepressants for psychiatric disorders.

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 relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. 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.

Children and adolescents under 18 years of age

Duloxetine should not normally be used in children and adolescents under 18 years of age. Also, you should know that patients under 18 years of age, when taking this type of medicine, 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 duloxetine to patients under 18 years of age because they decide that it may be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 years of age and you want to discuss this, please go back to your doctor. You must inform your doctor if any of the above symptoms appear or worsen in patients under 18 years of age who are taking duloxetine. Additionally, in this age group, the long-term safety effects of duloxetine related to growth, maturation, and cognitive and behavioral development have 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 main component of the medicine, duloxetine, is used in other medicines for other treatments:

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

It should be avoided to use 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 medicine, including those obtained without a prescription and herbal remedies, without consulting your doctor first.

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

Monoamine oxidase inhibitors (MAOIs):you should not take duloxetine if you are taking or have taken recently (in the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). 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 life-threatening. You should wait at least 14 days after stopping treatment with an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping treatment with duloxetine before starting treatment with 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 from forming. These medicines may increase the risk of bleeding.

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

Medicines that contain buprenorphine: these medicines may interact with duloxetine and you may experience symptoms such as involuntary muscle contractions, including the muscles that control eye movement, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Tell your doctor if you become pregnant or plan to become pregnant while taking this medicine. You should only use duloxetine after weighing the potential benefits and any potential risk to the fetus with your doctor.

Make sure your midwife and/or doctor know that you are taking this medicine. Other similar medicines (SSRIs), taken during pregnancy, may increase the risk of producing 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 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 born. These symptoms usually start at birth or during the first few days after the baby is born. These symptoms can include weak muscles, tremors, nervousness, difficulty feeding, breathing problems, and seizures. If your baby has any of these symptoms when born 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 a greater risk of excessive vaginal bleeding shortly after delivery, 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 available on the use of duloxetine during the first three months of pregnancy do not show an overall increase in the risk of birth defects in the child. If you take duloxetine during the second half of pregnancy, there may be a greater risk that the baby will be born prematurely (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. The use of 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 tools or machines until you know how the treatment with 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

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Duloxetine Aurovitas should be taken orally. 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 per day depending on your response to duloxetine.

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

Discuss with your doctor how long you should take duloxetine. 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 your condition is not treated, it may not disappear and may become more severe and more difficult to treat.

If you take more Duloxetine Aurovitas 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 medicine 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 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 you normally would. Do not take a double dose to make up for missed doses. Do not take more duloxetine than prescribed for you in one day.

If you stop taking Duloxetine Aurovitas

DO NOT stop taking your capsules without your doctor's advice, even if you feel better.If your doctor thinks you do not need to continue taking duloxetine, they will tell you to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who have stopped taking duloxetine abruptly have experienced symptoms such as:

• dizziness, sensation of pins and needles or electric shock (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 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, 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 (itching).
• 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 suffered 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 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, seizures, 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 a feeling 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 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: 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 the 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 the sewage system or in the trash. 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 30 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:titanium dioxide (E171), 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 “3”, with the cap of opaque blue color and the body of opaque white color, filled with white or off-white granules, with “DLX” printed on the cap and “30” on the body with black ink.

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

Package sizes: 7 and 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/).