CYMBALTA 30 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Prospectus: information for the user

Cymbalta 30 mg hard gastro-resistant capsules

Cymbalta 60 mg hard gastro-resistant capsules

duloxetine (hydrochloride)

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus:

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

Contents of the package and additional information

1. What is Cymbalta and what is it used for

Cymbalta contains the active ingredient duloxetine. Cymbalta increases the levels of serotonin and noradrenaline in the nervous system.

Cymbalta is used in adults to treat:

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing, or shooting pain, tingling, or like an electric shock. There may be a loss of sensitivity in the affected area, or pain may occur when the area is touched or exposed to heat, cold, or pressure)

Cymbalta starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take between 2 and 4 weeks to start feeling better. Inform your doctor if you do not notice improvement after this time. Your doctor may continue to give you Cymbalta when you are feeling better to prevent your depression or anxiety from returning.

In people with diabetic neuropathic pain, it may take several weeks before they start to feel better. Consult your doctor if you do not feel better after 2 months.

2. What you need to know before taking Cymbalta

DO NOT take Cymbalta if

• you are allergic to duloxetine or any of the other components of this medication (listed in section 6)
• you have liver failure
• you have severe kidney failure
• you are taking or have taken in the last 14 days another medication known as a monoamine oxidase inhibitor (MAOI) (see "Use of Cymbalta with other medications")
• you are taking fluvoxamine, which is normally used to treat depression, ciprofloxacin, or enoxacin, which are used to treat some infections
• you are taking other medications that contain duloxetine (see "Use of Cymbalta with other medications")

Consult your doctor if you have high blood pressure or heart disease. Your doctor will indicate if you should take Cymbalta.

Warnings and precautions

Cymbalta may not be suitable for you for the following reasons. Consult your doctor before taking Cymbalta if:

• you are using other medications to treat depression (see "Use of Cymbalta with other medications")
• 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 hematomas), especially if you are pregnant (see "Pregnancy and breastfeeding")
• you are at risk of having low sodium levels (e.g., if you are taking diuretics, especially if you are an elderly person)
• you are being treated with other medications that may cause liver damage
• you are taking other medications that contain duloxetine (see "Use of Cymbalta with other medications")

Cymbalta may cause a feeling of restlessness or inability to sit or stand still. If this happens, you should inform 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, hyperactive 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 medications in the same group as Cymbalta (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of self-harm or suicide. These thoughts may be increased at the beginning of treatment with antidepressants, as all these medications take time to work, usually a couple of weeks but sometimes longer.

It is more likely that you will have thoughts of this type 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 who suffer from a psychiatric disorder and are being treated with antidepressants.

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

It may be helpful to discuss with a close family member or friend that you are depressed or suffer from an anxiety disorder, and ask them to read this prospectus. You can ask them to tell you if they notice that your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Children and adolescents under 18 years of age

Cymbalta should not normally be used in children and adolescents under 18 years of age. Additionally, you should know that patients under 18 years of age who take this type of medication have an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe Cymbalta to patients under 18 years of age because they decide it may be beneficial for the patient. If your doctor has prescribed Cymbalta to a patient under 18 years of age 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 of age who are taking Cymbalta. Additionally, in this age group, the long-term safety effects of Cymbalta related to growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Other medications and Cymbalta

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those purchased without a prescription.

The main component of Cymbalta, duloxetine, is used in other medications for other treatments:

• diabetic neuropathic pain, depression, anxiety, and urinary incontinence

It should be avoided to use more than one of these medications at the same time. Check with your doctor if you are already using other medications that contain duloxetine.

Your doctor will decide if you can take Cymbalta with other medications. Do not start or stop taking any medication, including those purchased without a prescription and herbal remedies, without consulting your doctor first.

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

Monoamine oxidase inhibitors (MAOIs):you should not take Cymbalta if you are taking, or have taken recently (in the last 14 days), another antidepressant medication known as a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medications, including Cymbalta, can cause serious side effects, even life-threatening. You should wait at least 14 days after stopping treatment with an MAOI before taking Cymbalta. Similarly, you should wait at least 5 days after stopping treatment with Cymbalta before starting treatment with an MAOI.

Medications that cause drowsiness:this includes medications prescribed by your doctor such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.

Medications 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 medications increase the risk of side effects; if you notice any unusual symptoms when using any of these medications with Cymbalta, you should inform your doctor.

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

Taking Cymbalta with food, drinks, and alcohol

Cymbalta can be taken with or without food. You should be cautious if you drink alcohol while being treated with Cymbalta.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Tell your doctor if you become pregnant or plan to become pregnant while being treated with Cymbalta. You should only use Cymbalta after evaluating 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 Cymbalta. Other similar medications (SSRIs), taken during pregnancy, may increase the risk of 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 within the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

• If you take Cymbalta when approaching the end of your pregnancy, your baby may have some symptoms when born. These usually start at birth or in the first few days after birth. These symptoms can include weak muscles, tremors, nervousness, difficulty feeding, breathing problems, and seizures. If your baby has any of these symptoms when born or if you are concerned about your baby's health, contact your doctor or midwife, who can advise you.

• If you take Cymbalta when approaching the end of your pregnancy, there is a higher risk of excessive vaginal bleeding shortly after birth, especially if you have had bleeding problems. Your doctor or midwife should know that you are taking duloxetine so they can advise you.

• Data available on the use of Cymbalta during the first three months of pregnancy do not show an overall increased risk of birth defects in the child. If you take Cymbalta 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 Cymbalta in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

• Tell your doctor if you are breastfeeding. Cymbalta is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and using machines

During treatment with Cymbalta, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Cymbalta affects you.

Cymbalta contains sucrose

Cymbalta contains sucrose.If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

Cymbalta contains sodium

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

3. How to take Cymbalta

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Cymbalta should be taken orally. You should swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose of Cymbalta 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 Cymbalta 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 can be adjusted up to 120 mg per day depending on your response to Cymbalta.

To avoid forgetting to take Cymbalta, it may be helpful to take it at the same time every day.

Discuss with your doctor how long you should take Cymbalta. Do not stop taking Cymbalta or change your dose without consulting your doctor. It is important to treat your disease properly to help you improve. If it is not treated, your disease may not disappear and may become more severe and more difficult to treat.

If you take more Cymbalta than you should

Call your doctor or pharmacist immediately if you take more Cymbalta than prescribed by your doctor. Symptoms of 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 Cymbalta

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 Cymbalta than prescribed for you in a day.

If you stop taking Cymbalta

DO NOT stop taking your capsules without your doctor's advice, even if you feel better.If your doctor thinks you no longer need to take Cymbalta, they will tell you to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who have stopped taking Cymbalta abruptly have experienced symptoms such as:

• dizziness, sensation of pins and needles or electric shock-like sensation (especially in the head), sleep disturbances (vivid 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. These effects are usually mild to moderate and often disappear within a few weeks.

Very common side effects (may affect more than 1 in 10 patients)

• headache, drowsiness
• nausea, dry mouth

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

• loss of appetite
• difficulty sleeping, feeling of agitation, decreased sexual desire, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling of slowness, tremors, numbness, including numbness, tingling or

prickling sensation in 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 medication experienced a decrease in weight when they started taking this medication. After 6 months of treatment, weight increased to levels similar to those of other children and adolescents of the same age and sex.

Uncommon side effects (may affect up to 1 in 100 patients)

• inflammation of the throat that causes hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding, feeling disoriented, lack of motivation
• muscle spasms and involuntary movements, feeling restless or unable to sit or stand 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 dizzy or vertigo, ear pain
• rapid and/or irregular heartbeats
• fainting, dizziness, feeling dizzy or faint 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 often than normal, 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 cold, thirst, chills, feeling hot, alteration in gait
• weight gain
• Cymbalta 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 side effects (may affect up to 1 in 1,000 patients)

• 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 dizzy, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting, the most serious symptoms are fainting, seizures, or falls), syndrome of inadequate 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 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 side 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cymbalta

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

Do not use this medicine after the expiration date stated on the packaging.

Store in the original packaging to protect from moisture. Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Cymbalta

The active substanceis duloxetine.

Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).

The other ingredients are:

Capsule content:hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), and triethyl citrate (For more information on sucrose, see the end of section 2).

Capsule body:gelatin, sodium lauryl sulfate, titanium dioxide (E171), carmine indigo (E132), yellow iron oxide (E172) (only 60 mg), and edible green ink (30 mg) or edible white ink (60 mg).

Edible green ink:synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, and shellac.

Edible white ink:titanium dioxide (E171), propylene glycol, shellac, and povidone.

Appearance and packaging of the product

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

Cymbalta is available in two doses: 30 mg and 60 mg.

The 30 mg capsules are blue and white and are printed with "30 mg" and the code "9543". The 60 mg capsules are blue and green and are printed with "60 mg" and the code "9542".

Cymbalta 30 mg is available in packs of 7, 28, and 98 hard gastro-resistant capsules. Cymbalta 60 mg is available in packs of 28, 56, 84, and 98 hard gastro-resistant capsules and in multipacks containing 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer:Lilly S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid, Spain.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.