DULOXETINE KERN PHARMA 30 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Duloxetine Kern Pharma30mg hard gastro-resistant capsules EFG

Duloxetine (as hydrochloride)

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 and other information:

1. What is Duloxetine Kern Pharma and what is it used for
2. What you need to know before you take Duloxetine Kern Pharma
3. How to take Duloxetine Kern Pharma
4. Possible side effects
5. Storage of Duloxetine Kern Pharma

1. Contents of the pack and further information

1. What is Duloxetine Kern Pharma and what is it used for

This medicine 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 happen that when the area is touched or put in 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 Duloxetine Kern Pharma

Do not take Duloxetine Kern Pharma:

• 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 known as a monoamine oxidase inhibitor (MAOI) (see "Using Duloxetine Kern Pharma with other medicines")
• 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 "Using Duloxetine Kern Pharma with other medicines")

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 to take this medicine:

• you are using other medicines to treat depression or buprenorphine. Using these medicines together with Duloxetine Kern Pharma may cause Serotonin Syndrome, a potentially life-threatening condition. (see "Using Duloxetine Kern Pharma with other medicines")
• you are taking St. John's Wort, a plant-based treatment (Hypericum perforatum)
• you have any kidney disease
• you have had seizures (epileptic fits)
• you have had mania
• you suffer from 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 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 cause liver damage
• you are taking other medicines that contain duloxetine (see "Using Duloxetine Kern Pharma with other medicines")

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

Some medicines in the same group as duloxetine (called IRSN) 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 suffer from anxiety disorders, you may sometimes 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 about two 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. There is information from clinical trials that has shown an increased risk of suicidal behavior in adults under 25 years of age who are being treated with antidepressants for a psychiatric disorder.

Contact your doctor or go directly to the hospital as soon as you have any thoughts of self-harm or suicide.

It may be useful for you to tell a close relative or friend that you are depressed or suffer from an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they notice that your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

You should also contact your doctor:

If you experience signs and symptoms of agitation, 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).

Children and adolescents under 18 years

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

Using Duloxetine Kern Pharma with other medicines

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, 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 recently (in the last 14 days), another antidepressant medicine known as 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. 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.

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

Medicines that increase serotonin levels: Triptans, tryptophan, selective serotonin reuptake inhibitors (SSRIs, such as paroxetine and fluoxetine), IRSN (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), St. John's Wort, MAOIs (such as moclobemide and linezolid), buprenorphine, tramadol, and pethidine. These medicines may interact with Duloxetine Kern Pharma, and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and temperature above 38°C. Contact your doctor when you experience these symptoms, as they may indicate a potentially life-threatening condition such as serotonin syndrome.

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

TakingDuloxetine Kern Pharma 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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 trying to become pregnant while being treated with duloxetine. You should only use duloxetine after discussing with your doctor the potential benefits and any potential risk to the fetus.

• 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 producing a serious disease 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's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

• If you take duloxetine when you are near the end of your pregnancy, your baby may have some symptoms when it is born. These symptoms usually start at birth or during the first few days after the baby's birth. Among these symptoms are weak muscles, tremors, 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 worried about your baby's health, contact your doctor or midwife, who will be able to advise you.

• If you take duloxetine when you are near the end of your pregnancy, there is a greater 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 that they can advise you.

• The available 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 greater 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. The use of duloxetine is not recommended during breastfeeding. 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 with duloxetine affects you.

Duloxetine Kern Pharma contains sucrose

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

Duloxetine Kern Pharma contains sodium

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

3. How to take Duloxetine Kern Pharma

Follow exactly the instructions of administration of this medicine indicated 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 useful 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 talking to your doctor. It is important 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 more difficult to treat.

If you take moreDuloxetine Kern Pharma than you should

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 heartbeat.

If you forget to takeDuloxetine Kern Pharma

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 one day.

If you stop takingDuloxetine Kern Pharma

Do not stop taking your capsules without your doctor's advice, even if you feel better. If your doctor thinks that 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-like 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 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 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 often disappear within a few weeks.

Very Common Adverse Effects (may affect more than 1 in 10 patients)

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

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

• 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, tremor, numbness 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 (itching)
• 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, 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 patients)

• 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 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
• 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 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 (mostly in elderly people; symptoms may include feeling of dizziness, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting; more serious symptoms are fainting, 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 feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling of being 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
• 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 patients)

• inflammation of the blood vessels in the skin (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, 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 prospectus. 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 Kern Pharma

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.

Alu/Alu Blister: This medicine does not require any special storage temperature. Store in the original packaging to protect it from light.

PVC-PVDC/Alu Blister: Store below 30°C. Store in the original packaging to protect it from light.

Bottle: This medicine does not require any special storage temperature. Keep the bottle tightly closed to protect it from light.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in the pharmacy. If in doubt, 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 Kern Pharma

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

• The othercomponents are:

• Capsule content: hypromellose, talc, titanium dioxide, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triethyl citrate, sugar spheres (cornstarch and sucrose) and sucrose.

Capsule shell: gelatin, titanium dioxide (E-171), carmine (E-132), printing ink (Shellac, black iron oxide (E-172), and potassium hydroxide).

Appearance and Packaging of Duloxetine Kern Pharma

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

Duloxetine Kern Pharma 30 mg are printed capsules (cap E/body 127), with a blue opaque cap and a white opaque body of approximately 15 mm.

Duloxetine Kern Pharma 30 mg is available in blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98, and 504 capsules; and bottles of 28 and 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Spain

Manufacturer:

TOWA PHARMACEUTICAL EUROPE S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

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

Date of the Last Revision of this Prospectus:July 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/