Package Insert: Information for the User

Xeristar 90mg hard, gastro-resistant capsules

duloxetine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Xeristarcontains the active ingredient duloxetina.

Duloxetina increases the levels of serotonin and noradrenalina in the nervous system.

Xeristaris used in adults to treat:

•depression

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

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

Do not takeXeristar

• if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6),
• if you have liver disease,
• if you have severe kidney disease,
• if you are taking or have taken in the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see «Other medicines andXeristar»),
• if you are taking fluvoxamine, which is usually used to treat depression, or ciprofloxacin or enoxacin, which are used to treat some infections.

Consult your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you can takeXeristar.

Warnings and precautions

This medicine may not be suitable for you for the following reasons. Consult your doctor before starting to takeXeristarif:

• you are taking other medicines to treat depression (see «Other medicines andXeristar»),
• you are taking St. John's Wort(Hypericum perforatum), a herbal treatment,
• you have any kidney disease,
• you have had seizures (epileptic fits),
• you have had mania,
• you have bipolar disorder,
• you have eye problems, such as some types of glaucoma (increased eye pressure),

• you have had bleeding problems (tendency to develop bruises), especially if you are pregnant (see «Pregnancy and breast-feeding»)

• you are at risk of having low sodium levels (for example if you are taking diuretics, especially if you are an older person),
• you are being treated with other medicines that can damage the liver,
• you are taking other medicines that contain duloxetine (see «Other medicines andXeristar»).

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

Some medicines in the group to which duloxetine 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 your depression or anxiety

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 medicines take time to work, usually two weeks, but sometimes longer.

You are more likely to have these thoughts if:

• you have had thoughts of suicide or self-harm before,
• you are a young adult.There is information from clinical trials that has shown an increased risk of suicidal behaviour in adults under 25years who have a psychiatric disorder and are being treated with antidepressants.

Contact your doctor or go to the hospital immediately if 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 behaviour.

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, diarrhoea, coma, nausea, vomiting, as you may be suffering from a serotonin syndrome.

In its most severe form, serotonin syndrome may resemble Malignant Neuroleptic Syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by blood test).

Children and adolescents

This medicine should not be used in children and adolescents under 18years. Also, you should know that patients under 18years, when taking this class of medicines, have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Despite this, your doctor may prescribe duloxetine to patients under 18years because they decide it may be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18years and you want to talk about it, please go back to the doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18years who are taking duloxetine. Also, in this age group, the long-term safety effects of duloxetine related to growth, maturation, and cognitive and behavioural development have not yet been demonstrated.

Other medicines andXeristar

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those bought without a prescription.

The main component ofXeristar, 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. Consult your doctor if you are already taking another medicine that contains duloxetine.

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

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

MAOIs:do not take duloxetine if you are taking, or have taken in the last 14days, another medicine for the treatment of depression known as a monoamine oxidase inhibitor (MAOI). As examples of MAOIs, moclobemide (an antidepressant) and linezolid (an antibiotic) are included. Taking an MAOI with many prescription medicines, including duloxetine, may 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 finishing treatment with duloxetine before starting treatment with an MAOI.

Medicines that cause drowsiness:including prescription medicines such as benzodiazepines, powerful analgesics, antipsychotics, phenobarbital, and antihistamines.

Medicines that increase serotonin levels:triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (such as paroxetine and fluoxetine), serotonin and noradrenaline reuptake inhibitors (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 observe any unusual symptoms when taking any of these medicines with duloxetine, you should inform your doctor.

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

TakingXeristarwith food, drinks, and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, consult your doctor or pharmacist before using this medicine.

• Inform your doctor if you become pregnant or are trying to become pregnant while taking duloxetine. You should only take duloxetine after discussing the potential benefits of treatment with your doctor and any potential risk to the foetus.

• Make sure your midwife and/or doctor know that you are taking duloxetine. Other similar medicines (called 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 more rapidly and turn blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

• If you take duloxetine towards 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 birth. The symptoms are: weak muscles, trembling, nervousness, difficulty feeding, breathing problems, and seizures. If your baby has any of these symptoms at birth, or if you are concerned about your baby's health, contact your doctor or midwife, who can advise you.

• If you take duloxetine towards 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 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 use tools or machines until you know how duloxetine affects you.

Xeristarcontains saccharose

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

Xeristarcontains sodium

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

Xeristarcontains tartrazine

It may cause allergic reactions.

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:

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 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.

This medication can be taken with or without food.

Take the capsule every day at the same time to help you remember to take duloxetine.

Discuss with your doctor for how long you should take this medication. Do not stop taking duloxetine, or change your dose, without consulting your doctor. It is essential to treat your illness properly to help you improve. If you do not treat it, your illness 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. Within the symptoms produced by an overdose, include 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 already 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 dose. Do not take more Xeristar 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 that 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 suddenly stopped treatment with duloxetine have experienced symptoms such as:

• Dizziness, feeling 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 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
• Nausea, dry mouth

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

• Loss of appetite
• Difficulty sleeping, feeling agitated, decreased libido, anxiety, difficulty or inability to have an orgasm, unusual dreams
• Dizziness, feeling of slowness, tremors, numbness, including numbness, itching, or tingling in the skin
• Blurred vision
• Tinnitus (perception of sounds in the ear when there is no sound outside)
• 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
• Painful urination, frequent urination
• Difficulty achieving an erection, changes in ejaculation
• Falls (mainly in older adults)
• 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 six months of treatment, the weight normalized to levels 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)

• Throat inflammation that causes hoarseness
• Thoughts of suicide, difficulty sleeping, grinding or clenching teeth, feeling disoriented, lack of motivation
• Muscle spasms and involuntary movements of the muscles, 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.
• Dilated pupils (the black center of the eye), vision problems
• Feeling of dizziness or vertigo, ear pain
• Irregular or rapid heartbeat
• Loss of consciousness, dizziness, feeling of dizziness or loss of consciousness when standing up, coldness in the fingers of the hands and/or feet
• Throat spasms, nasal bleeding
• 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
• Nocturnal sweating, urticaria, 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, particularly light or absent periods, testicular or scrotal pain
• Chest pain, feeling cold, thirst, chills, feeling hot, gait disturbance
• Weight gain
• This medicine may cause effects that you may not be aware of, such as increased liver enzymes or blood potassium levels, creatine phosphokinase, sugar, or cholesterol.

Rare side 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 (mainly in older adults; symptoms may include dizziness, weakness, confusion, sleepiness, or excessive fatigue, nausea, or vomiting. The most 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 intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures
• Increased pressure in the eye (glaucoma)
• Cough, wheezing, and shortness of breath, which may be accompanied by high fever
• Throat inflammation, 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
• 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)

Frequency not known (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 side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: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 box. The expiration date is the last day of the month indicated.

PVC/PVDC-Aluminum Blister: Do not store at a temperature above 30 °C.

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

Composition ofXeristar90mg

The active ingredient is duloxetine.

Each gastro-resistant hard capsule contains 90mg of duloxetine (as hydrochloride).

The other components are:

Cap content:hypromellose, talc, titanium dioxide (E-171), copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (contains sodium lauryl sulfate and polysorbate 80), triethyl citrate, sugar spheres (contains sucrose and cornstarch), sucrose.

Capsule body: Gelatin, brilliant blue FCF (E-133), printing ink (iron oxide black [E-172], potassium hydroxide, shellac), tartrazine (E-102).

Appearance of the product and content of the container

Duloxetine is a gastro-resistant hard capsule. Each hard capsule of duloxetine contains duloxetine hydrochloride in the form ofpelletscoated to protect them from gastric acid.

Xeristar90mg hard gastro-resistant capsules are hard gelatin capsules of size 0 with a transparent green-colored cap and a transparent green-colored body printed with black ink (cap "DU"/body "90") approximately 21.5 mm in size.

This medicine is available in blisters of 28hard gastro-resistant capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97,

Martorelles, 08107, Barcelona,

Spain

Last review date of this leaflet: July 2024

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