Leaflet: Information for the user

Duloxetina Zentiva 30 mg hard gastro-resistant capsules EFG

Duloxetina Zentiva 60 mg hard gastro-resistant capsules EFG

duloxetina

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any of the side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Duloxetina Zentiva contains the active ingredient duloxetina. Duloxetina Zentiva increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina Zentiva is used in adults to treat:

• depression;
• generalized anxiety disorder (chronic feeling of anxiety or nervousness);
• diabetic neuropathic pain (often described as burning, stabbing, pinching, stinging, or electric shock-like pain. There may be a loss of sensation in the affected area, or pain may occur when touching the area or exposing it to heat, cold, or pressure).

Duloxetina Zentiva 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 to give you duloxetina Zentiva 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 you start feeling better. Consult your doctor if you do not feel better after 2 months.

Do not take Duloxetine Zentiva 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 failure;
• You are taking or have taken in the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Taking Duloxetine Zentiva with other medicines”);
• You are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin or enoxacin, which are used in the treatment of some infections;
• You are taking other medicines that contain duloxetine (see “Taking Duloxetine Zentiva with other medicines”);

Consult your doctor if you have high blood pressure or a heart condition. Your doctor will tell you if you should take Duloxetine Zentiva.

Warnings and precautions

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

• You are taking other medicines to treat depression (see “Taking Duloxetine Zentiva with other medicines”);
• You are taking St. John's Wort, a herbal remedy (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 had 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 being treated with other medicines that can damage the liver;
• You are taking any opioid medicines, such as those containing buprenorphine, tramadol and pethidine. Taking these medicines with Duloxetine Zentiva can cause serotonin syndrome, a potentially life-threatening condition (see “Taking Duloxetine Zentiva with other medicines”);
• You are taking other medicines that contain duloxetine (see “Taking Duloxetine Zentiva with other medicines”).

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

Some medicines in the same group as Duloxetine Zentiva (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 depression or anxiety

If you are depressed or have anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These thoughts may be increased when you start taking antidepressant medicines, as these medicines take time to work, usually two weeks but sometimes longer.

You are more likely to 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 shows an increased risk of suicidal behaviour in 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 immediately if 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 if your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents under 18 years

Duloxetine Zentiva 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 duloxetine to patients under 18 years old because they decide it may be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 years old and you want to talk about it, please go back to your doctor. You should tell your doctor if any of the symptoms mentioned above appear or get worse in patients under 18 years old who are taking Duloxetine Zentiva. Additionally, in this age group, the long-term safety effects of duloxetine related to growth, maturation and development of cognitive and behavioural functions have not yet been demonstrated.

Taking Duloxetine Zentiva with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to take any other medicine.

The main component of Duloxetine Zentiva, 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 should decide if you can take Duloxetine Zentiva with other medicines.Do not start or stop taking any medicine, including those bought without a prescription and herbal remedies, without first consulting your doctor.

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

• Monoamine oxidase inhibitors (MAOIs): Do not take Duloxetine Zentiva if you are taking, or have taken 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 Zentiva, can cause serious side effects and even put your life at risk. You should wait at least 14 days after stopping treatment with an MAOI before taking Duloxetine Zentiva. You should also wait at least 5 days after stopping treatment with Duloxetine Zentiva 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, 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), St. John's Wort, MAOIs (such as moclobemide and linezolid) and opioid medicines such as those containing buprenorphine, tramadol and pethidine. These medicines increase the risk of side effects such as serotonin syndrome (see section “Warnings and precautions”). If you notice any unusual symptoms when using any of these medicines with Duloxetine Zentiva, tell 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 Duloxetine Zentiva with food, drinks and alcohol

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

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 if you are trying to become pregnant while taking Duloxetine Zentiva. You should only use Duloxetine Zentiva after discussing the potential benefits and any potential risks to the foetus with your doctor.

• Make sure your midwife and/or doctor know that you are taking Duloxetine Zentiva. 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. These symptoms usually start 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 Duloxetine Zentiva towards the end of your pregnancy, your baby may have some symptoms when born. These usually start at birth or within the first few days after birth. These symptoms may include weak muscles, trembling, restlessness, 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 for advice.

• If you take Duloxetine Zentiva towards the end of your pregnancy, there is a higher risk of excessive vaginal bleeding 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 duloxetine 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 duloxetine during the second half of pregnancy, there may be a higher risk of the baby being born prematurely (6 extra premature births per 100 women taking duloxetine in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

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

Driving and operating machines

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

Duloxetine Zentiva contains saccharose

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Duloxetina Zentiva should be taken orally. Swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose of Duloxetina Zentiva is 60 mg once a day, but your doctor will prescribe the dose that is best for you.

For generalized anxiety disorder:

The initial normal dose of Duloxetina Zentiva 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 to 120 mg per day depending on your response to Duloxetina Zentiva.

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

Discuss with your doctor for how long you should take Duloxetina Zentiva. Do not stop taking Duloxetina Zentiva, 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 Duloxetina Zentiva than you should:

Call your doctor or pharmacist immediately if you take more Duloxetina Zentiva than prescribed by your doctor. Symptoms of an overdose may include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures, vomiting, and high heart rate.

If you forgot to take Duloxetina Zentiva:

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 Duloxetina Zentiva than prescribed for you in a day.

If you interrupt treatment with Duloxetina Zentiva:

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 Duloxetina Zentiva, they will instruct you to reduce your dose for at least 2 weeks before stopping treatment.

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

• dizziness, tingling, feeling of electric shock or muscle cramp (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 experience bothersome symptoms, consult your doctor.

If you have any other doubts 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;
• unpleasantness (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, tremors, numbness, including numbness, itching, or tingling in the skin;
• blurred vision;
• tinnitus (perception of sounds in the ear when there is no sound outside);
• 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;
• 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 sudden involuntary movements, feeling restless or inability to sit still or remain quiet, 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 center of the eye), vision problems;
• feeling dizzy or vertigo, ear pain;
• rapid or irregular heartbeat;
• syncope, dizziness, feeling dizzy or syncope when standing up, cold hands and/or feet;
• throat spasms, nasal bleeding;
• 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 bleeding, abnormal menstrual periods, including heavy, painful, irregular, or prolonged periods, occasionally light or absent periods, testicular or scrotal pain;
• chest pain, feeling cold, thirst, chills, feeling hot, gait disturbance;
• weight gain;
• Duloxetina Zentiva may cause effects that you may not be aware of, such as increased liver enzymes or blood potassium levels, 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 thyroid gland activity, 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 excessive fatigue, nausea or vomiting, severe symptoms are syncope, 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 intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), convulsions;
• 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 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 shortly after birth (postpartum hemorrhage).

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

• inflammation of the skin blood vessels (cutaneous vasculitis).

Reporting 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 the national notification 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 box/blister after CAD. The expiration date is the last day of the month indicated.

Store below 30 °C. Store in the original packaging to protect it from moisture.

Do not dispose of the medication through the drains or in the trash. Ask your pharmacist where to dispose of the unused medication. This will help protect the environment.

What Duloxetina Zentiva contains

The active substance is duloxetine. Each capsule contains hydrochloride equivalent to 30 mg and 60 mg of duloxetine.

The other components are:

Capule content:sucrose; cornstarch; hypromellose; talc; acetate succinate of hypromellose; triethyl citrate.

Capsule coating:

Duloxetina Zentiva 30 mg:

Capsule cap: indigo carmine (E132); titanium dioxide (E171); gelatin.

Capsule body: titanium dioxide (E171); gelatin.

Duloxetina Zentiva 60 mg:

Capsule cap: indigo carmine (E132); titanium dioxide (E171); gelatin. Capsule body: yellow iron oxide (E172);titanium dioxide (E171); gelatin.

What Duloxetina Zentiva looks like and the contents of the pack

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

Duloxetina Zentiva is available in 2 doses: 30 mg and 60 mg.

The 30 mg capsules are hard, opaque gelatin capsules, approximately 15.9 mm in length, with a white opaque body and a light blue opaque cap, containing spherical pellets that are off-white to light yellowish-brown in colour.

The 60 mg capsules are hard, opaque gelatin capsules, approximately 19.4 mm in length, with a cream opaque body and a light blue opaque cap, containing spherical pellets that are off-white to light yellowish-brown in colour.

Duloxetina Zentiva 30 mg is available in packs of 7, 28, 56, 84 and 98 capsules.

Duloxetina Zentiva 60 mg is available in packs of 14, 28, 56, 84 and 98 capsules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder:

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Responsible for manufacturing:

S.C. Zentiva S.A.

Theodor Pallady Nr 50

032266 Bucharest

Romania

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.