Leaflet: information for the user

Xeristar 30 mg hard gastro-resistant capsules EFG

Xeristar 60 mg hard gastro-resistant capsules EFG

Duloxetine (hydrochloride)

Read this leaflet carefully before you start taking this medicine, because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Xeristar is and what it is used for

2. What you need to know before you start taking Xeristar

3. How to take Xeristar

4. Possible side effects

5. Storage of Xeristar

6. Contents of the pack and additional information

Xeristar contains the active ingredient duloxetine. Duloxetine increases the levels of serotonin and noradrenalina in the nervous system.

Duloxetine is used in adults to treat:

•depression

•generalized anxiety disorder (chronic feeling of anxiety or nervousness)

•diabetic neuropathic pain (often described as burning, stabbing, like pinpricks, stinging, or like an electric shock. There may be a loss of sensation in the affected area, or pain may occur when touching the area or exposing it to heat, cold, or pressure)

Duloxetine begins to take effect in most people with depression or anxiety within two weeks of starting treatment, but it may take between 2 and 4 weeks to start feeling better. Inform your doctor if you do not notice improvement after this time. Your doctor may continue to give you duloxetine when you are feeling better to prevent your depression or anxiety from coming back.

In people with diabetic neuropathic pain, it may take several weeks to start feeling better. Consult your doctor if you do not feel better after 2 months.

Do not take Xeristar:

-if you are allergic to duloxetine or any of the other ingredients in this medication(listed in section 6)

-if you have liver failure

-if you have severe kidney failure

-if you are taking or have taken within the last 14 days another medication known as a monoamine oxidase inhibitor (MAOI) (see “Use of Xeristar 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 duloxetine (see “Use of Xeristar with other medications”)

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

Warnings and precautions

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

Consult your doctor before starting to take this medication if:

• you are taking other medications to treat depression (see “Use of Xeristar with other medications”)
• you are taking St. John's Wort, a herbal treatment (Hypericum perforatum)
• you have any kidney disease
• you have had seizures (epileptic attacks)
• you have had mania
• you have bipolar disorder
• you have eye problems, such as some types of glaucoma (increased eye pressure)
• you have a tendency to develop bleeding problems,

especially if you are pregnant (see “Pregnancy and breastfeeding”)

• you have a risk of low sodium levels (for example, if you are taking diuretics, especially if you are an older person).
• you are being treated with other medications that can cause liver damage
• you are taking other medications that contain duloxetine (see “Use of Xeristar with other medications”)

Xeristar may cause restlessness or an inability to sit or stay still. If this happens, tell your doctor.

Some medications in the group to which Xeristar belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety disorder

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

You are more likely to have these thoughts if:

• you have had thoughts of self-harm or suicide before
• you are a young adult. There is information from clinical trials that has shown an increased risk of suicidal behavior in adults under 25 years old who have a psychiatric disorder and are being treated 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 to tell a close friend or family member that you are depressed or have an anxiety disorder, and ask them to read this leaflet. They may be able to tell if your depression or anxiety is getting worse, or if they are concerned 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, hyperactive 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, and increased muscle enzymes (determined by blood tests).

Children and adolescents under 18 years

Duloxetine is usually not used in children and adolescents under 18 years. You should also know that patients under 18 years old who take this class of medications have an increased risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe duloxetine to patients under 18 years old because they decide it may be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 years old and you want to talk about it, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years old 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.

Use of Xeristar with other medications

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

The main component of Xeristar, duloxetine, 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 duloxetine.

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

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

Monoamine oxidase inhibitors (MAOIs):You should not take duloxetine if you are taking, or have taken recently (within 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 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.

Medications that cause drowsiness:This includes prescription medications such as benzodiazepines, powerful analgesics, 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 and amitriptyline), petidin, St. John's Wort, and MAOIs (such as moclobemide and linezolid). These medications increase the risk of side effects; if you observe any unusual symptoms when using any of these medications with duloxetine, you should inform your doctor.

Oral anticoagulants or antiplatelet agents:Medications that thin the blood or prevent the formation of blood clots. These medications may increase the risk of bleeding.

Taking Xeristar with food, drinks, and alcohol

Duloxetine can be taken with or without food. You should be careful if you take alcohol while taking duloxetine.

Pregnancy, breastfeeding, and fertility

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

•Inform your doctor if you become pregnant or if you are trying to become pregnant while taking duloxetine. You should only use duloxetine after discussing the potential benefits and any potential risks to the fetus with your doctor.

•Make sure your midwife and/or doctor know that you are taking duloxetine. Other similar medications (SSRIs), taken during pregnancy, mayincrease the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe more rapidly and turn 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 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 after the baby's birth. These symptoms may include weak muscles, trembling, nervousness, the baby not feeding properly, breathing problems, and seizures. 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, who can advise you.

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

• The available data on the use of duloxetine during the first three months of pregnancy do not show a general increase in the risk of birth defects in the baby. If you take duloxetine during the second half of pregnancy, there may be a higher risk of the baby being born prematurely (6 additional premature births per 100 women taking duloxetine in the second half of pregnancy); especially between weeks 35 and 36 of pregnancy.

•Inform your doctor if you are breastfeeding. Duloxetine is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and operating machinery

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

Xeristar contains saccharose

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

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

Duloxetine should be taken orally. 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 initial normal 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 can be adjusted to 120 mg per day depending on your response to duloxetine.

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

Discuss with your doctor for how long you should take duloxetine. Do not stop taking duloxetine, or change your dose without consulting your doctor. It is essential to treat your condition properly to help you improve. If you do not treat it, your condition may not disappear and may become more severe and harder to treat.

If you take more Xeristar than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 rigidity) seizures, vomiting, and high heart rate.

If you forgot to take Xeristar

If you forget to take a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose and take a single dose as you normally do. Do not take a double dose to compensate for the missed doses. Do not take more duloxetine than prescribed for you in a day.

If you interrupt treatment with Xeristar

DO NOT stop taking your capsules without your doctor's advice, even if you feel better. If your doctor thinks you no longer need to take duloxetine, they will instruct you to reduce your dose for at least 2 weeks before stopping treatment.

Some patients who have stopped duloxetine treatment abruptly have presented symptoms such as:

•dizziness, feeling of 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 vertigo.

These symptoms are usually not important 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

These side effects are usually mild to moderate and often disappear within a few weeks.

Very common side effects (may affect more than 1 in 10 patients)

•headache, drowsiness

•unpleasantness (nausea), dry mouth

Common side effects (may affect up to 1 in 10 patients)

•loss of appetite

•difficulty sleeping, feeling agitated, decreased sexual desire, anxiety,difficulty or inability to have an orgasm, unusual dreams

•dizziness, feeling of slowness, tremors, numbness, including numbness, itching, ortingling in the skin

•blurred vision

•tinnitus (perception of sounds in the ear when there is no sound outside)

•feeling palpitations in the chest

•increase in blood pressure, flushing

•increase in yawning

•constipation, diarrhea, stomach pain, vomiting, heartburn, gas

•increase in sweating, rash (itching)

•muscle pain, muscle spasms

•painful urination, frequent urination

•difficulty achieving an erection, changes in ejaculation

•falls (mainly in older adults), 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, their weight levels were similar to those of other children and adolescents of the same age and sex.

Uncommon side effects (may affect up to 1 in 100 patients)

•inflammation of the throat that causes hoarseness

•suicidal thoughts, difficulty sleeping, grinding of teeth, feeling disoriented,lack of motivation

•muscle spasms and involuntary movements, feeling restless 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

•enlarged pupils (the black center of the eye), vision problems

•feeling dizzy or vertigo, ear pain

•rapid and/or irregular heartbeat

•loss of consciousness, dizziness, feeling dizzy or loss of consciousness when standing up, cold 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 periods, occasionally light or absent periods, testicular or scrotal pain

•chest pain, feeling cold, thirst, chills, feeling hot, gait disturbance

•weight gain

Duloxetine may cause effects that you may not be aware of, such as increased liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol.

Rare side effects (may affect up to 1 in 1,000 patients)

•severe allergic reactions, which 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 (mainly in older adults; symptoms may include dizziness, weakness, confusion, sleepiness, nausea, or vomiting, and more serious symptoms are loss of consciousness, seizures, or falls), syndrome of inappropriate antidiuretic hormone secretion (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 drunk, fever, sweating, or muscle stiffness), seizures

•increase in eye pressure (glaucoma)

• shortness of breath, wheezing, and lack of air, 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 severe 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 odor of urine

•menopausal symptoms, abnormal milk production in men or women

• excessive vaginal bleeding shortly after birth (postpartum hemorrhage)

Very rare side effects (may affect up to 1 in 10,000 patients)

•inflammation of the skin blood vessels (cutaneous vasculitis)

Unknown frequency (cannot be estimated from available data)

• Signs and symptoms of a condition called “stress cardiomyopathy”, which may include chest pain, difficulty breathing, dizziness, loss of consciousness, and irregular heartbeat

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Xeristar 30mg

Blister PVC-PVDC/Alu:

Store below 30°C. Store the blister in the outer packaging to protect it from light.

Blister Alu/Alu:

This medication does not require special storage conditions. Store in the original packaging to protect it from light.

Xeristar 60mg

Blister PVC-PVDC/Alu:

Store below 30°C.

Blister Alu/Alu:

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Xeristar 30 mg

-Theactive ingredientis duloxetine.

Cada cápsula contiene 30 mg de duloxetina (como hidrocloruro).

-Theothercomponents are:

Capule content: hypromellose, talc, titanium dioxide,copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30%,trietil citrate, sugar spheres (cornstarch and sucrose) and sucrose.

Capsule coating: gelatin, titanium dioxide (E171), FD&C blue 2/indigo carmine (E132) and black printing ink (containing shellac, anhydrous alcohol, isopropyl alcohol, propylene glycol, butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water and iron oxide black (E-172)).

Composition of Xeristar 60 mg

• Theactive ingredientis duloxetine.

Cada cápsula contiene 60 mg de duloxetina (como hidrocloruro).

• Theothercomponents are:

Capule content: hypromellose, talc, titanium dioxide, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30%,trietil citrate, sugar spheres (cornstarch and sucrose) and sucrose.

Capsule coating: gelatin, titanium dioxide (E171), FD&C blue 2/indigo carmine (E132), iron oxide yellow (E172) and black printing ink (containing shellac, anhydrous alcohol, isopropyl alcohol, propylene glycol, butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water and iron oxide black (E-172)).

Appearance of the product and packaging contents

Xeristar 30mg

Xeristar 30 mg is a hard, gastro-resistant capsule. The capsules are blue and white, printed with black ink.

Xeristar 30 mg is available in blisters of 7 and 28 hard, gastro-resistant capsules.

Xeristar 60mg

Xeristar 60 mg is a hard, gastro-resistant capsule. The capsules are blue and green, printed with black ink.

Xeristar 60 mg is available in blisters of 28 and 56 hard, gastro-resistant capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible manufacturer:

TOWA PHARMACEUTICAL EUROPE, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of thisleaflet: July 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/