Package Leaflet: Information for the User

Duloxetina Tarbis Farma 30 mg Hard Gastrorresistant Capsules EFG

Duloxetina Tarbis Farma 60 mg Hard Gastrorresistant Capsules EFG

Read this 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, consult 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 is Duloxetina Tarbis Farma and what it is used for

2. What you need to know before taking Duloxetina Tarbis Farma

3. How to take Duloxetina Tarbis Farma

4. Possible side effects

5. Storage of Duloxetina Tarbis Farma

6. Contents of the pack and additional information

Duloxetina Tarbis Farma contains the active ingredient duloxetine. This medicine increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina Tarbis Farma 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 the area is touched or comes into contact with heat, cold, or pressure)

This medicine usually 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 an improvement after this time. Your doctor may continue to prescribe Duloxetina Tarbis Farma for you when you are feeling better to prevent your depression or anxiety from coming back.

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 Tarbis Farma 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 “Other medicines and Duloxetina Tarbis Farma”)
• 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 “Other medicines and Duloxetina Tarbis Farma”)

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 before taking this medicine if:

• You are taking other medicines to treat depression (see “Other medicines and Duloxetina Tarbis Farma”)
• 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 elderly)
• You are being treated with other medicines that can damage the liver
• You are taking other medicines that contain duloxetine (see “Other medicines and Duloxetina Tarbis Farma”)

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

Thoughts of suicide and worsening of your 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 at the beginning of treatment with 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 young adults under 25 years old who have a psychiatric disorder and are being treated with antidepressants.

Contact your doctor or go 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 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.

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

Children and adolescents under 18 years

This medicine is usually not used in children and adolescents under 18 years old. You should also know that young patients taking 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 for patients under 18 years old if they decide it may be beneficial for the patient. If your doctor has prescribed this medicine for 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 above symptoms appear or worsen in patients under 18 years old taking duloxetine. 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 been demonstrated.

Other medicines and Duloxetina Tarbis Farma

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

The main component of Duloxetina Tarbis Farma, 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 Duloxetina Tarbis Farma 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):You should not take duloxetine if you are taking, or have taken in the last 14 days, another 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 Duloxetina Tarbis Farma, 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 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 and amitriptyline), petidina, 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, 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 Duloxetina Tarbis Farma with food, drink and alcohol

Duloxetine Tarbis Farma can be taken with or without food. You should be careful if you take alcohol while taking this medicine.

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. You should only use this medicine 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's birth. 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 the baby's birth. These symptoms may include weak muscles, trembling, nervousness, the baby not feeding properly, breathing problems and seizures. 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 this medicine 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.

• Inform your doctor if you are breastfeeding. Duloxetina Tarbis Farma is not recommended for use during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and operating machinery

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

Duloxetina Tarbis Farma contains saccharose

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

Duloxetina Tarbis Farma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it 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.

Duloxetina Tarbis Farma should be taken orally. Swallow the capsule whole with water. Do not crush or chew.

For depression and diabetic neuropathic pain:

The recommended dose of duloxetina 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 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 to 120 mg per day depending on your response to this medication.

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

Discuss with your doctor for how long you should take duloxetina. Do not stop taking this medication, 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 Tarbis Farma than you should

Call your doctor or pharmacist immediately if you take more duloxetina than prescribed by your doctor. Symptoms produced by 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 rigidity) seizures, vomiting, and high heart rate.

If you forgot to take Duloxetina Tarbis Farma

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 duloxetina than prescribed for you in a day.

If you interrupt treatment with Duloxetina Tarbis Farma

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

Some patients who have stopped duloxetina treatment abruptly 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 bothersome symptoms, 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 libido, anxiety, difficulty or inability to have an orgasm, unusual dreams
• dizziness, feeling slow, tremor, 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 (itching)
• muscle pain, muscle spasms
• painful urination, frequent urination
• 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, their weight levels were 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)

• throat inflammation 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
• pupil dilation (the black center of the eye), vision problems
• feeling dizzy or vertigo, ear pain
• rapid and/or irregular heartbeats
• 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
• liver inflammation that can cause abdominal pain and yellowing of the skin or 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 alteration
• 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 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 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 directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use website: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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Duloxetina Tarbis Farma

The active principle is duloxetina.

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

The other components are:

Capule content: Sugar spheres (containing sucrose and cornstarch), hypromellose (E464), crospovidone, calcium, sucrose, carboxymethyl ethyl cellulose, povidone, titanium dioxide (E171), macrogol (E1521), polysorbate 80 (E433)(For more information on sucrose, see the end of section 2).

Capule body (only 30 mg): Gelatin, titanium dioxide (E171), sodium lauryl sulfate, indigo carmine (E132).

Capule body (only 60 mg): Gelatin, titanium dioxide (E171), sodium lauryl sulfate, indigo carmine (E132), yellow iron oxide (E172).

Edible gold ink (only 30 mg):Shellac gum (E904), propylene glycol, yellow iron oxide (E172).

Edible white ink (only 60 mg):Shellac gum (E904), propylene glycol, potassium hydroxide, titanium dioxide (E171).

Appearance of the product and contents of the package

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

Duloxetina Tarbis Farma is available in two doses: 30 mg and 60 mg.

30 mg: Hard gelatin capsules with a blue opaque cap and a white opaque body, of size ‘3’ (approximately 16 mm) and printed with ‘H’ on the cap and with ‘191’ on the body, which include white to off-white pellets.

60 mg: Hard gelatin capsules with a blue opaque cap and a green opaque body, of size 1 (approximately 19 mm) and printed with ‘H’ on the cap and with ‘192’ on the body, which include white to off-white pellets.

Duloxetina Tarbis Farma gastro-resistant capsules 30 mg EFG are available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100, 120, and 500 capsules.

Duloxetina Tarbis Farma gastro-resistant capsules 60 mg EFG are available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100, 120, and 500 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Duloxetin Amarox 30 mg/60 mg magensaftresistente Hartkapseln

Netherlands:Duloxetine Amarox 30 mg/60 mg, harde maagsapresistente capsules

Spain:Duloxetina Tarbis Farma 30 mg/60 mg cápsulas duras gastrorresistentes EFG

Sweden:Duloxetine Amarox 30 mg/60 mg hårda enterokapslar

Date of the last review of this leaflet:September 2021

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/