DULOXETINE STADA 60 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Duloxetine STADA60mg hard gastro-resistant capsulesEFG

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

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

Duloxetine Stada 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 persistent 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 become sensitive to touch, heat, cold, or pressure)

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 feel better 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 some weeks before you feel better. Consult your doctor if you do not feel better after 2 months.

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

Do not take Duloxetine Stada:

• 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 Stada")
• 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 Stada").

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 this medicine if:

• you are using other medicines for depression (see "Other medicines and Duloxetine Stada")
• 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, breast-feeding and fertility").
• 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 Stada")

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

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 of the same class as Duloxetine Stada (called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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 harming or killing yourself. These thoughts may be increased when you first start taking antidepressants, as all these medicines take time to work, usually about 2 weeks, but sometimes longer. You are more likely to 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 should ask them to tell you if they notice any change in your behavior that might be related to your depression or anxiety.

Children and adolescents

Duloxetine should not normally be used in children and adolescents under 18 years. Also, 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 for patients under 18 because they decide that it is in the patient's best interest. If your doctor has prescribed duloxetine to a patient under 18 and you want to discuss this, please go back to your doctor. You should inform 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 Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The main component of Duloxetine Stada, duloxetine, is used in other medicines for other treatments:

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

You should avoid taking more than one of these medicines at the same time. Check with your doctor if you are already taking other medicines that contain duloxetine.

Your doctor will decide whether you can take Duloxetine Stada with other medicines. Do not start or stop taking any medicines, including those bought 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):you should not take duloxetine if you are taking, or have taken within 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 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 taking 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), 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, 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.

TakingDuloxetineStada with food, drinks, and alcohol

Duloxetine Stada can be taken with or without food. You should be cautious if you drink alcohol while being treated with duloxetine.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, 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 being treated with duloxetine. 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 duloxetine. 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 experience some symptoms when it is born, such as weak muscles, trembling, jitteriness, or problems with breathing. If your baby has any of these symptoms when it is born, or if you are concerned about your baby's health, contact your doctor or midwife.

• If you take duloxetine near the end of your pregnancy, there is a greater risk of excessive vaginal bleeding after giving birth, especially if you have had bleeding problems. Your doctor or midwife should know that you are taking duloxetine so they can advise you.

• Data on the use of duloxetine in 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 pregnancy, there may be an increased 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 breast-feeding. Duloxetine is not recommended during breast-feeding. 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 affects you.

Duloxetine Stada 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.

3. How to take Duloxetine Stada

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

Dose

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.

Method of administration

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

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

Duration of use

Discuss with your doctor for how long you should take duloxetine. Do not stop taking duloxetine, or change your dose, without talking to your doctor. It is important to treat your condition adequately 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 moreDuloxetine Stadathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 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 takeDuloxetine Stada

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 a day.

If you stop takingDuloxetine Stada

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, he or she will tell you to reduce your dose over at least 2 weeks before stopping treatment.

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

• dizziness, sensation of pins and needles, or electric shock-like sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, nausea or vomiting, tremor, headache, muscle pain, feeling irritable, 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 further questions on the use of this product, 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 people)

• headache, drowsiness
• discomfort (nausea), dry mouth

Common Adverse Effects (may affect up to 1 in 10 people)

• 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
• difficulty or 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 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 people)

• 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 and/or toes
• throat spasms, nosebleeds
• vomiting blood, or black 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, rash, 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 people)

• 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 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 people)

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

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 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 leaflet. 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 Stada

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

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.Store in the original packaging to protect it from moisture.

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. 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 Stada

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

Contents of the capsule: hypromellose, succinate acetate hypromellose, sucrose, sugar spheres, talc, titanium dioxide (E171), hydroxypropyl cellulose.

Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Duloxetine Stada is a hard gastro-resistant capsule. Each Duloxetine Stada capsule contains pellets of duloxetine hydrochloride with a coating to protect them from stomach acid.

Duloxetine Stada is available in 2 doses: 30 and 60 mg.

The 60 mg capsules have a green body, dark blue cap, and are filled with white gastro-resistant pellets.

Duloxetine Stada 60 mg is presented in packages of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, or 140 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

info@stada.es

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

AT Duloxetin STADA 30, 60 mg magensaftresistente Hartkapseln

BE Duloxetine Eurogenerics 30, 60 mg harde maagsapresistente capsules

DE Duloxetin STADA 30, 60 mg magensaftresistente Hartkapseln

DK Duloxetin STADA

ES Duloxetina Stada 30, 60 mg cápsulas duras gastrorresistentes EFG

FI Duloxetin STADA 30, 60 mg kova enterokapseli

FR Duloxetine EG 30, 60 mg, gélule gastro-résistante

LU Duloxetine Eurogenerics 30 mg gélules gastro-résistantes

HR Duloksetin Stada 30 mg/60 mg tvrde želucanootporne kapsule

HU Duloxetin STADA 30, 60 mg gyomornedv-ellenálló kemény kapszula

IE Duloxetine Clonmel 30, 60 mg hard gastro-resistant capsules

NL Duloxetine CF 30, 60 mg, maagsapresistente capsules, hard

PT Duloxetina Ciclum

RO Duloxetina Stada 30, 60 mg capsule gastrorezistente

SE Duloxetin STADA 30, 60 mg enterokapslar, hårda

SK Duloxetin Stada 60mg tvrdé gastrorezistentné kapsuly

Date of the Last Revision of this Leaflet:October 2024.

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/)