LASDUL 60 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Lasdul 30 mg hard gastro-resistant capsules EFG

Lasdul 60 mg hard gastro-resistant capsules EFG

Duloxetine

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

1. What Lasdul is and what it is used for

Lasdul 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, causing pain).

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 Lasdul

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• 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 medicine called a monoamine oxidase inhibitor (MAOI) (see "Other medicines and Lasdul")
• 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 Lasdul")

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

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Duloxetine may not be suitable for you due to the following reasons. Consult your doctor before you start taking this medicine:

• you are using other medicines for depression (see "Other medicines and Lasdul")
• you are taking St. John's Wort, a herbal remedy (Hypericum perforatum)
• you have any kidney disease
• you have had seizures (fits)
• you have had mania
• you have bipolar disorder
• you have eye problems, such as certain types of glaucoma (increased eye pressure)
• you have had bleeding problems (a tendency to develop bruises), especially if you are pregnant (see "Pregnancy and breastfeeding")
• you are at risk of having low sodium levels (for example, if you are taking diuretics, especially if you are an elderly person)
• you are taking other medicines that may harm your liver
• you are taking other medicines that contain duloxetine (see "Other medicines and Lasdul")

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

Some medicines of the same class as duloxetine (called SSRIs and SNRIs) may cause 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 anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These thoughts may be increased when you first start taking antidepressants, since these medicines all 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.

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It may be helpful for a close relative or friend to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

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

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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 this medicine, 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 if you can take duloxetine with other medicines. Do not start or stop taking any medicines, including those obtained without a prescription, without talking to 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, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) in the last 14 days. Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medicines, including duloxetine, can cause serious side effects, even life-threatening ones. You should wait at least 14 days after stopping an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping duloxetine before starting an MAOI.

Medicines that cause drowsiness:these include medicines prescribed by your doctor, such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.

Medicines that increase serotonin levels:triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (SSRIs, such as paroxetine and fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs, such as venlafaxine), tricyclic antidepressants (such as clomipramine and 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 taking 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.

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

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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 if you are planning to become pregnant while taking 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 have some symptoms when it is born. These usually start at birth or in the first few days after birth. These symptoms include weak muscles, trembling, overactive reflexes, or poor feeding, breathing difficulties, seizures, and vomiting. If your baby has any of these symptoms when it is born, or if you are worried about your baby's health, contact your doctor or midwife, who can advise you.

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

• Data on the use of duloxetine in early pregnancy (first 3 months) do not show an increased risk of birth defects in the baby. If you take duloxetine during the second half of your 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.

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While taking duloxetine, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how duloxetine affects you.

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

Lasdul contains sodium

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

3. How to take Lasdul

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

Duloxetine 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 a day, depending on your response to duloxetine.

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

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

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In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91.562.04.20, indicating the medicine and the amount taken

Symptoms produced by an overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

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

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

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

• dizziness, sensations like pins and needles or electric shock-like sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, and excessive sweating or dizziness.

These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome, ask your doctor for advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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• headache, drowsiness
• nausea, dry mouth

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• loss of appetite
• difficulty sleeping, feeling restless, decreased sexual desire, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling slow, tremor, numbness, including numbness, itching, or tingling of the skin
• blurred vision
• tinnitus (hearing 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 urinating, frequent urination
• difficulty getting an erection, changes in ejaculation
• falls (mainly in elderly people), fatigue
• weight loss

Children and adolescents under 18 years of age with depression treated with this medicine had a decrease in weight when they first started taking this medicine. After 6 months of treatment, their weight increased to levels similar to those of other children and adolescents of the same age and sex.

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• 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 sit 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
• liver inflammation 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.

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• severe allergic reactions, which can 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 elderly people; symptoms may include feeling of dizziness, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting, the most serious symptoms are fainting, convulsions, or falls), syndrome of inadequate secretion of antidiuretic hormone (SIADH).
• suicidal behavior, mania (hyperactivity, accelerated thinking, and decreased need for sleep), hallucinations, aggression, and anger
• "Serotonin syndrome" (a rare reaction that can cause 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 in 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)
• contractions of the jaw muscle
• unusual odor of urine
• menopausal symptoms, abnormal milk production in men or women
• excessive vaginal bleeding shortly after birth (postpartum hemorrhage)

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

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If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it 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 medication.

5. Conservation of Lasdul

Keep this medication out of sight and reach of children.

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

Lasdul 30 mg hard gastro-resistant capsules EFG:

PVC-PVDC/Alu blister: Do not store at a temperature above 30°C. Keep in the original packaging to protect it from light.

Lasdul 60 mg hard gastro-resistant capsules EFG:

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the packaging and additional information

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• The active ingredientis duloxetine. Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).

• The othercomponents are:

• Capsule content: hypromellose, talc, titanium dioxide, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and methacrylic acid-ethyl acrylate copolymer), triethyl citrate, sugar spheres (cornstarch and sucrose), and sucrose.
• Capsule shell: gelatin, titanium dioxide (E171), FD&C blue 2/indigo carmine (E132).
• Capsule body: gelatin, titanium dioxide (E171), FD&C blue 2/indigo carmine (E132) (only for the 60 mg dose), yellow iron oxide (E172) (only for the 60 mg dose).
• Black printing ink: shellac, potassium hydroxide, and black iron oxide (E-172).

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

Lasdul 30 mg are printed capsules (cap E/body 127), with a blue opaque cap and a white opaque body, approximately 15 mm in length.

Lasdul 60 mg are printed capsules (cap E/body 129), with a blue opaque cap and a green opaque body, approximately 19 mm in length.

Lasdul 30 mg is available in blisters of 7 and 28 capsules.

Lasdul 60 mg is available in blisters of 28 and 56 capsules.

Only some pack sizes may be marketed.

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Marketing authorization holder:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona) Spain

Manufacturer:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona) Spain

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