Product Information for the Patient

Duloxetina Tevagen 30 mg Hard Gastrorresistant Capsules EFG

Duloxetina Tevagen 60 mg Hard Gastrorresistant Capsules EFG

duloxetina

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

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

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

Duloxetina 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 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 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 Duloxetina Tevagen if:

• You are allergic to duloxetine or any of the other ingredients in 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 Duloxetina Tevagen 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 Duloxetina Tevagen 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.

Warnings and precautions

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

• You are taking other medicines to treat depression (see “Taking Duloxetina Tevagen 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 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 “Taking Duloxetina Tevagen with other medicines”)

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

Some medicines in the same group as duloxetine (called SSRIs/SNRIs) can 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 and/or have anxiety disorders, you may occasionally have thoughts of self-harm or suicide. These thoughts may be increased when you start taking antidepressants, as all 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 has shown 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 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 an anxiety disorder, 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.

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, diarrhoea, 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 can include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by blood test).

Children and adolescents under 18 years

Duloxetine 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 class of medicines 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 above appear or get worse in patients under 18 years old who are taking duloxetine. Also, in this age group, the long-term safety effects of duloxetine related to growth, maturation, and cognitive and behavioural development have not yet been demonstrated.

Taking Duloxetina Tevagen with other medicines

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

The active ingredient in the medicine, 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 using 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):You should not take duloxetine 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, can cause serious side effects, even life-threatening. You should wait at least 14 days after stopping treatment with an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping treatment with duloxetine 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, buprenorphine, 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 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 the formation of blood clots. These medicines may increase the risk of bleeding.

Taking Duloxetina Tevagen with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

• Inform your doctor if you become pregnant or are trying to become pregnant while taking this medicine. You should only use duloxetine 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 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 more rapidly and turn blue. These symptoms usually start within 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 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 birth. These symptoms can include weak muscles, trembling, nervousness, difficulty feeding, 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 for advice.

• If you take duloxetine 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 is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and operating machines

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

Duloxetina Tevagen 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. In case of doubt, consult your doctor or pharmacist again.

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 can be adjusted up to 120 mg per day depending on your response to duloxetine.

Duloxetine should be taken orally. You should swallow the capsule whole with water. You can take it with or without food

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

Discuss with your doctor for how long you should take duloxetine. Do not stop taking duloxetine, 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 Tevagen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested.Among the symptoms produced by an overdose are drowsiness, coma, serotonin syndrome (a rare reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity) seizures, vomiting, and high heart rate.

If you forgot to take Duloxetina Tevagen

If you forget to take a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose and take a single dose as you normally do. Do not take a double dose to compensate for the missed doses. Do not take more duloxetine than prescribed for you in a day.

If you interrupt treatment with Duloxetina Tevagen

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

Some patients who have stopped duloxetine treatment abruptly have presented symptoms such as:

• dizziness, feeling of pins and needles or electric shock sensation (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 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.
• ringing in the ears (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 of other children and adolescents of the same age and sex.

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

• throat inflammation that causes hoarseness.
• suicidal thoughts, difficulty sleeping, grinding of teeth, 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.
• pupil dilation (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.
• 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 periods, occasionally light or absent periods, testicular or scrotal pain.
• chest pain, feeling cold, thirst, chills, feeling hot, gait disturbance.
• weight gain.
• duloxetine 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 excessive fatigue, nausea, or vomiting, more serious symptoms are loss of consciousness, seizures, 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), 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 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).

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. 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 after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Duloxetina Tevagen Composition

The active ingredient is duloxetine.

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

Theothercomponents are:

Capule content:sugar spheres (cornstarch and sucrose), hypromellose phthalate, hypromellose, triethyl citrate, hydroxypropyl cellulose, and talc.

30 mg capsule:Hypromellose (E-464), titanium dioxide (E-171), brilliant blue FCF (E-172), iron oxide black (E-172), printing ink.

60 mg capsule:Hypromellose (E-464), titanium dioxide (E-171), iron oxide black (E-172), printing ink.

Printing ink content:shellac, propylene glycol, strong ammonia solution, iron oxide black (E-172), potassium hydroxide.

Product appearance and packaging content

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

Duloxetine Tevagen is available in two doses: 30 mg and 60 mg.

The 30 mg capsules have a grey opaque body with “DLX 30” printed and a blue opaque cap with “DLX 30” printed, length 18 mm.

The 60 mg capsules have a grey opaque body with “DLX 60” printed and a white opaque cap with “DLX 60” printed, length 20 mm.

Duloxetine Tevagen 30 mg is available in:

Duloxetine Tevagen 60 mg is available in:

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva B.V.

Swensweg 5, Haarlem

2031 GA

Netherlands

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

Teva Pharma, S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer:

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa 2600

Bulgaria

Last review date of this leaflet: September 2024

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.