DEDULOX 30 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Dedulox 30 mg Hard Gastro-Resistant Capsules EFG

Duloxetine (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 Dedulox and what is it used for

1. What you need to know before you take Dedulox
2. How to take Dedulox
3. Possible side effects

1. Storage of Dedulox
2. Contents of the pack and further information

1. What is Dedulox and what is it used for

Dedulox 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)

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 Dedulox

Do not take Dedulox if:

• you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
• you have liver failure
• you have severe kidney disease
• you are taking or have taken within the last 14 days another medicine called a monoamine oxidase inhibitor (MAOI) (see "Using Dedulox with other medicines")

• you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin, or enoxacin, which are used to treat some infections.

• you are taking other medicines that contain duloxetine (see "Using Dedulox with other medicines")

Tell your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take this medicine.

Warnings and precautions

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

• you are using other medicines for depression (see "Using Dedulox with other medicines")

• you are taking St. John's Wort, a herbal remedy (Hypericum perforatum)

• you have kidney disease
• you have had seizures (epileptic 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 being treated with other medicines that may cause liver damage
• you are taking other medicines that contain duloxetine (see "Using Dedulox with other medicines")

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

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, 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).

Some medicines in the same class as Dedulox (called SSRIs/SNRIs) may cause symptoms of 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 an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. These thoughts may be increased at the start 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 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 under 25 years with psychiatric conditions who were treated with an antidepressant.

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 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.

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 attempted suicide, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe duloxetine to patients under 18 years if they decide that it can 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 the doctor. You should tell your doctor if any of the above symptoms appear or worsen in patients under 18 years who are taking this medicine. 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 Dedulox 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 Dedulox, 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. 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, 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.

Taking Dedulox 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 planning to become pregnant while being treated with 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 this medicine. 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 within the first few days after your baby is born. These symptoms include weak muscles, trembling, overactive reflexes, difficulty feeding, 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 can advise you.

• If you take Dedulox when you are near the end of your pregnancy, there is a greater risk of excessive vaginal bleeding shortly after giving birth, 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 Dedulox during the first three months of pregnancy do not show an increased overall risk of birth defects in the baby. If you take Dedulox 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 Dedulox 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 this medicine, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how the treatment with duloxetine affects you.

Dedulox contains sucrose

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

Dedulox contains sodium

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

3. How to take Dedulox

Follow exactly the instructions of your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Duloxetine should be taken by mouth. 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 this medicine. 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 get better and may become more serious and more difficult to treat.

If you take more Dedulox than you should

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.

Contact your doctor or pharmacist immediately if you take more duloxetine than prescribed by your doctor. Symptoms produced by an overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

If you forget to take Dedulox

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 taking Dedulox

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

Some patients who have stopped taking this medicine have had symptoms such as:

• dizziness, tingling sensations like pins and needles or electric shock-like sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious,

nausea or vomiting, tremors, headaches, muscle pain, feeling irritable, 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 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 disappear, often, 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, 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 (itching)

• muscle pain, muscle spasms

• difficulty 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 suffered a decrease in weight when they started taking this medicine. After 6 months of treatment, the 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

• pupil dilation (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, 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 that 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, the most serious symptoms are fainting, seizures, 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 feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness), seizures
• increased pressure in the eye (glaucoma)

• 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
• Cough, wheezing, and shortness of breath that may be accompanied by high fever.
• Excessive vaginal bleeding shortly after childbirth (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 the available data)

• signs and symptoms of a condition called “stress cardiomyopathy”, which may include chest pain, difficulty breathing, dizziness, fainting, and irregular heartbeats.

Reporting of 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 leaflet. 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 Dedulox

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

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Aluminum/aluminum blister pack

Do not store above 30°C

Transparent PVC/PCTFE blister pack sealed with aluminum.

Do not store above 30°C

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Dedulox Composition

• The active ingredientis duloxetine as hydrochloride.

Each capsule contains 30 mg of duloxetine (as hydrochloride).

• The otheringredients are:

• Capsule content: sugar spheres, methacrylic acid-ethyl acrylate copolymer (1:1) in 30% dispersion (Eudragit L30D55), hypromellose, sucrose, colloidal anhydrous silica, talc, triethyl citrate, Plasacryl T20 (glycerol monostearate, triethyl citrate, polysorbate 80, water).
• Capsule body:

• 30 mg capsules: titanium dioxide (E171), gelatin, FD&C Blue 2, water

Appearance of Dedulox and Package Contents

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

Dedulox 30 mg capsules are hard gelatin capsules, with the cap opaque blue and the body opaque white.

Aluminum/aluminum blister pack

Dedulox 30 mg hard gastro-resistant capsules are available in packs of 7, 10, 28, 30, 56, 84, 98, 100, and 500 capsules.

Transparent PVC/PCTFE blister pack sealed with aluminum.

Dedulox 30 mg hard gastro-resistant capsules are available in packs of 7, 10, 28, 30, 56, 84, 98, 100, and 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Exeltis Healthcare, S.L

Avda. Miralcampo, 7.

Pol. Ind. Miralcampo.

19200 Azuqueca de Henares (Guadalajara).

Spain

Manufacturer

Pharmascience International Limited

Julia House, Themistokli Dervi, 3

P.C. 1066, Nicosia

Cyprus

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

Netherlands:Duloxetine Laboratorios Liconsa 30 mg hard gastro-resistant capsules

Date of the Last Revision of this Leaflet:

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/