CYMBALTA 60 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Cymbalta 30 mg Hard Gastro-Resistant Capsules

Cymbalta 60 mg Hard Gastro-Resistant Capsules

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 Cymbalta and what is it used for
   1. What you need to know before you take Cymbalta
   2. How to take Cymbalta
   3. Possible side effects
   4. Storing Cymbalta
   5. Pack contents and further information

1. What is Cymbalta and what is it used for

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

Cymbalta is used in adults to treat:

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

Cymbalta 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 notice any 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 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 Cymbalta

Do not take Cymbalta 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 medicinal product called a monoamine oxidase inhibitor (MAOI) (see “Using 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 “Using 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 using other medicines to treat depression (see "Using Cymbalta 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 Cymbalta with other medicines”)

Cymbalta may cause a feeling of restlessness or 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 group as Cymbalta (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase 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. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who are being treated with antidepressants.

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

Children and adolescents under 18 years

Cymbalta 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 Cymbalta to patients under 18 years if they decide that it can be beneficial for the patient. If your doctor has prescribed Cymbalta to a patient under 18 years and you want to discuss this, please go back to your doctor. You should tell your doctor if any of the above symptoms appear or worsen in patients under 18 years who are taking Cymbalta. Additionally, in this age group, the long-term safety effects of Cymbalta on growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Other medicines and Cymbalta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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

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 Cymbalta with other medicines. Do not start or stop taking any medicine, including those obtained without a prescription and herbal remedies, without talking to your doctor first.

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

Monoamine oxidase inhibitors (MAOIs):you should not take Cymbalta if you are taking, or have taken within 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 Cymbalta, can cause serious side effects, even life-threatening ones. You should wait at least 14 days after stopping an MAOI before taking Cymbalta. Similarly, you should wait at least 5 days after stopping Cymbalta before starting treatment with 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 Cymbalta, 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 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 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 Cymbalta. You should only use Cymbalta after discussing the potential benefits and risks with your doctor.
• Make sure your midwife and/or doctor know 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 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 Cymbalta near the end of your pregnancy, your baby may have some symptoms when it is born. These usually start at birth or in the first few days after your baby is born. These symptoms include weak muscles, trembling, restlessness, 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 will be able to advise you.

• If you take Cymbalta 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 Cymbalta during the first three months of pregnancy do not show an increased overall risk of birth defects in the child. If you take Cymbalta 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 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 use tools or machines until you know how Cymbalta affects you.

Cymbalta contains sucrose

Cymbalta contains sucrose.If your doctor has told you that you have an intolerance to some sugars, consult 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".

3. How to take Cymbalta

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Cymbalta should be taken by mouth. 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 may be adjusted up to 120 mg per day, depending on your response to Cymbalta.

To help you remember 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 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 Cymbalta than you should

Call your doctor or pharmacist immediately if you take more Cymbalta than prescribed by your doctor. Symptoms produced by an overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause 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 talking to your doctor first, even if you feel better.If your doctor thinks you do not need to take Cymbalta anymore, 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 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 bothersome, ask your doctor for advice.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild to moderate and often disappear within a few weeks.

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

• headache, drowsiness
• nausea, dry mouth

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

• loss of appetite
• difficulty sleeping, feeling agitated, decreased sexual desire, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling slow, 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 palpitations in the chest
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhea, stomach pain, vomiting, heartburn or indigestion, gas
• increased sweating, rash
• muscle pain, muscle spasms
• difficulty urinating, frequent urination
• difficulty getting an erection, changes in ejaculation
• falls (mainly in elderly people), fatigue
• weight loss

Children and adolescents under 18 years of age with depression treated with this medicine experienced a decrease in weight when they started taking this medicine. After 6 months of treatment, 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 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 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 ingredientis duloxetine.

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

The other ingredients are:

Capsule content:hypromellose, succinate acetate of hypromellose, 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 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 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.