LASDUL 30 mg HARD GASTRO-RESISTANT 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 symptoms are the same as yours.
• If you experience 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 Lasdul and what is it 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 is Lasdul and what is it 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 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 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 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 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 in 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 should take duloxetine.

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Duloxetine may not be suitable for you for the following reasons. Consult your doctor before starting to take this medicine:

• you are using other medicines to treat 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 (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 (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 being treated with 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 group as duloxetine (called SSRIs/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 anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. These thoughts may be increased at the beginning of treatment with antidepressants, as all these medicines take time to work, usually about 2 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 with psychiatric disorders who are being treated with antidepressants.

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It may be helpful for you to 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 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 of age. Also, you should know that patients under 18 years of age who take this type of medicine have an increased risk of side effects such as attempted suicide, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe duloxetine to patients under 18 years of age if they decide that it can 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 should tell 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 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 using, have recently used, or might use 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

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 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 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 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 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.

Tasdul with food, drinks, and alcohol

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 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 duloxetine. You should only use duloxetine after discussing the potential benefits and risks with your doctor.

• Make sure your midwife and/or doctor know that 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 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 in the first few days after your baby is born. These symptoms may include weak muscles, tremors, restlessness, difficulty feeding, breathing problems, and seizures. If your baby has any of these symptoms when 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 higher 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 they can advise you.

• Data 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 higher 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. Duloxetine is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

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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.

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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 administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, 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 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 you do not treat it, your condition may not improve 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, 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 heart rate.

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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 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.

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DO NOTstop 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 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 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 of 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 experienced a decrease in weight when they started taking this medicine. After 6 months of treatment, the 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 sense of 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 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)
• contractions of the jaw muscle
• unusual odor of urine
• menopausal symptoms, abnormal production of breast milk 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 medicine.

5. Conservation of Lasdul

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.

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 medicines 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 medicines 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 of approximately 15 mm.

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

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

First revision of this prospectus:December 2021

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