Product Information for the User

Cymbalta 30 mg Hard Gastric-Resistant Capsules

Cymbalta 60 mg Hard Gastric-Resistant Capsules

duloxetina (hydrochloride)

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Cymbalta is and what it is used for

1. What you need to know before you start taking Cymbalta
2. How to take Cymbalta
3. Possible side effects
4. Storage of Cymbalta
5. Contents of the pack and additional information

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

Cymbalta is used in adults to treat:

Cymbalta begins to take effect 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 giving 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 to start feeling better. Consult your doctor if you do not feel better after 2 months.

Do not take Cymbalta if

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

Consult your doctor if you have high blood pressure or heart disease. Your doctor will tell you 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 taking other medicines to treat depression (see "Cymbalta with other medicines")
• you are taking St. John's Wort, a herbal treatment(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 a tendency to develop bleeding problems, 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 older person)
• you are taking other medicines that can damage the liver
• you are taking other medicines that contain duloxetine (see "Cymbalta with other medicines")

Cymbalta may cause a feeling of restlessness or inability to sit or stay still. If this happens, tell your doctor.

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 a serotonin syndrome.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by blood tests).

Some medicines in the same group as Cymbalta (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Thoughts of suicide and worsening of your depression or anxiety

If you are depressed or have 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 medicines take time to work, usually two weeks but sometimes longer.

It is more likely that you will have these thoughts if:

• you have had thoughts of self-harm or suicide before
• you are a young adult. There is information from clinical trials that has shown an increased risk of suicidal behaviour in young adults under 25 years old who have 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 tell a close friend or family member that you are depressed or have anxiety disorders, and ask them to read this leaflet. They may be able to tell you if your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents under 18 years

Cymbalta is usually not used in children and adolescents under 18 years old. You should also know that patients under 18 years old who take this type of medicine have an increased risk of side effects such as suicidal thoughts, suicidal behaviour, and hostility (mainly aggression, oppositional behaviour, and irritability). Despite this, your doctor may prescribe Cymbalta to patients under 18 years old because they decide it may be beneficial for the patient. If your doctor has prescribed Cymbalta to a patient under 18 years old andyou want to talk about it, please go back to the doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years old who are taking Cymbalta. Additionally, in this age group, the long-term safety effects of Cymbalta related to growth, maturation, and cognitive and behavioural development have not yet been demonstrated.

Other medicines and Cymbalta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those bought without a prescription.

The main component of Cymbalta, 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 Cymbalta with other medicines.Do not start or stop taking any medicine, including those bought without a prescription, without first consulting your doctor.

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

Monoamine oxidase inhibitors (MAOIs):Do not take Cymbalta if you are taking, or have taken in the last 14 days, another antidepressant known as a monoamine oxidase inhibitor (MAOI). As examples of MAOIs, moclobemide (an antidepressant) and linezolid (an antibiotic) are included. Taking an MAOI with many prescription medicines, including Cymbalta, may 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.

Medicines that cause drowsiness:This includes prescription medicines prescribed by your doctor, such as benzodiazepines, powerful analgesics, 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), petidin, St. John's Wort, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you observe any unusual symptoms when using any of these medicines with Cymbalta, you should inform your doctor.

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

Taking Cymbalta with food, drinks, and alcohol

Cymbalta can be taken with or without food. You should be careful if you take alcohol while taking Cymbalta.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

• Inform your doctor if you become pregnant or are trying to become pregnant while taking Cymbalta. You should only use Cymbalta after discussing the potential benefits and any potential risks to the fetus with your doctor.
• Make sure your midwife and/or doctor know that you are taking Cymbalta. 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 turn blue.This usually starts within 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 Cymbalta towards 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 the baby's birth. These symptoms may include weak muscles, trembling, nervousness, the baby not feeding properly,breathing problems, and convulsions.If your baby has any of these symptoms when it is born or if you are concerned about your baby's health, contact your doctor or midwife, who can advise you.

• If you take Cymbalta towards 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.

• The available data on the use of Cymbalta during the first three months of pregnancy do not show a general increase in the risk of birth defects in the baby. If you take Cymbalta during the second half of pregnancy,there may be a higher risk of the baby being born prematurely (6 additional premature births per 100 women taking Cymbalta in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

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

Driving and operating machinery

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

Cymbalta contains saccharose

Cymbalta containssaccharose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Cymbalta contains sodium

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

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. Swallow the entire capsule 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 for how long you should take Cymbalta. Do not stop taking Cymbalta, or change your dose without consulting your doctor. It is essential 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 harder 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 intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and high heart rate.

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 do. Do not take a double dose to make up for the missed doses. Do not take more Cymbalta than prescribed for you in a day.

If you interrupt treatment with Cymbalta

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

Some patients who suddenly stopped treatment with Cymbalta have experienced symptoms such as:

• Dizziness, feeling 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 vertigo.

These symptoms are usually not significant 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side 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
• uncomfortable feeling (nausea), dry mouth

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

• loss of appetite
• difficulty sleeping, feeling agitated, decreased sex drive, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling slow, tremor, numbness, including numbness, itchingor

tingling sensation in the skin

• blurred vision
• ringing in the ears (perception of sounds in the ear when there is no sound outside)
• feeling palpitations in the chest
• increase in blood pressure, flushing
• increase in yawning
• constipation, diarrhea, stomach pain, vomiting, heartburn, indigestion, gas
• increase in sweating, rash (itching)
• muscle pain, muscle spasms
• painful urination, urinating frequently
• difficulty achieving an erection, changes in ejaculation
• falls (mainly in older adults), 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 similar levels as 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, bruxism, feeling disoriented, lack of motivation
• muscle spasms and involuntary muscle movements, feeling restless 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
• enlarged pupils (the black center of the eye), vision problems
• feeling dizzy or vertigo, ear pain
• rapid or irregular heartbeat
• loss of consciousness, dizziness, feeling dizzy or loss of consciousness when standing up, cold hands and/or feet
• throat spasms, nosebleeds
• vomiting blood, or black stools, gastroenteritis, belching, difficulty swallowing
• inflammation of the liver 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 bleedingvaginalabnormal,irregular or prolonged menstrual periods, including exceptionally light or absent periods, painful 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 blood levels of potassium, creatine phosphokinase, sugar, or cholesterol.

Rare side effects (may affect up to 1 in 1,000 patients)

• severe allergic reactions, which 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 older adults; symptoms may include dizziness, weakness, confusion, sleepiness or extreme fatigue, nausea or vomiting, the most serious symptoms are loss of consciousness, convulsions, 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 a feeling of intense happiness,drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), convulsions
• increase in eye pressure (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 severe 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 odor of urine
• menopausal symptoms, abnormal milk production in men or women
• excessive vaginal bleeding after childbirth (postpartum hemorrhage)

Very rare side effects (may affect up to 1 in 10,000 patients)

• inflammation of the skin blood vessels (cutaneous vasculitis)

Unknown frequency (cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect,consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging.

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

Medications should not be disposed of through drains or trash.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Cymbalta

The active ingredient is duloxetine.

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

The other components are:

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

Capule body: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (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 of the product and contents of the package

Cymbalta is a hard, gastro-resistant capsule. Each Cymbalta capsule contains pellets of duloxetine hydrochloride 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 have "30 mg" and the code "9543" printed on them. The 60 mg capsules are blue and green and have "60 mg" and the code "9542" printed on them.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

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

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

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Date of the last revision of this prospectus:

The detailed information about this medicine is available on the website of the European Medicines Agency: https : // www . ema . europa . eu .