Leaflet: information for the user

Duloxetina Aristo 60 mg hard gastro-resistant EFG capsules

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, 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 is Duloxetina Aristo and what it is used for

2.What you need to know before starting to take Duloxetina Aristo

3.How to take Duloxetina Aristo

4.Possible side effects

5.Storage of Duloxetina Aristo

6. Contents of the pack and additional information

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

This medication is used to treat:

• depression,
• generalized anxiety disorder (chronic sensation of anxiety or nervousness),
• diabetic neuropathic pain (often described as burning, stabbing, pinching, stinging, or as an electric shock. 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 act 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 this medication 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 Aristo 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 “Other medicines and Duloxetina Aristo”),

-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 “Other medicines and Duloxetina Aristo”).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Duloxetina Aristo.

This medicine may not be suitable for you for the following reasons. Consult your doctor or pharmacist before starting to take Duloxetina Aristo:

• you are taking other medicines to treat depression. (see “Other medicines and Duloxetina Aristo”), you are taking St. John’s Wort, a herbal treatment (Hypericum perforatum),
• you have any kidney disease,
• you have had convulsions (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 breast-feeding”),
• you have a risk of 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 other medicines that contain duloxetine (see “Other medicines and Duloxetina Aristo”).

This medicine may cause a feeling of restlessness or inability to sit or stay 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, hyperactive reflexes, diarrhoea, coma, nausea, vomiting, as you may be suffering from a serotonin syndrome.

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

Some medicines in the group to which Duloxetina Aristo belongs (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 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 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 relative or friend that you are depressed or have an anxiety disorder, 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

Duloxetina Aristo is usually not used in children and adolescents under 18 years old. Also, you should 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 attempts 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 the doctor. You should tell your doctor if any of the symptoms mentioned above appear or worsen 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 development of cognitive and behavioural functions have not yet been demonstrated.

Other medicines and Duloxetina Aristo

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

The main component of this 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 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 antidepressant known as a monoamine oxidase inhibitor (MAOI). For example, 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 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 experience any of these symptoms when taking any of these medicines with Duloxetina Aristo, contact 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 Aristo with food, drinks and alcohol

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

Pregnancy and breast-feeding

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

Pregnancy

Inform your doctor if you are pregnant or intend to become pregnant during your treatment with Duloxetina Aristo. You should only use duloxetine after discussing the potential benefits and any potential risks for the foetus with your doctor.

Make sure your midwife and/or doctor know that you are taking duloxetine. 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 this medicine when you are near 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 is born. 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 Duloxetina Aristo when you are near 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 Duloxetina 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 Duloxetina during the second half of pregnancy, there may be a higher risk of the baby being born prematurely (6 additional premature babies per 100 women who take Duloxetine in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding. Duloxetina Aristo is not recommended during breast-feeding. Ask your doctor or pharmacist for advice.

Driving and using machines

The effect of Duloxetina on your ability to drive and use machines may be mild to moderate. During treatment with duloxetine, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how the treatment with this medicine affects you.

Duloxetina Aristo contains lactose, red 40 (E 129), yellow 6 (E 110) and sodium

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

This medicine may cause allergic reactions because it contains red 40 (E 129) and yellow 6 (E 110). It may cause asthma, especially in patients allergic to aspirin.

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 as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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

The recommended dose is:

• For depression and diabetic neuropathic pain:The recommended dose of this medication 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 this medication 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 Aristo.

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 duloxetina 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 Aristo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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 Aristo

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 Aristo

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

Some patients who suddenly stopped treatment with Duloxetina Aristo 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 important 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 people)

• headache, drowsiness,
• unpleasantness (nausea), dry mouth.

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

• loss of appetite,
• difficulty sleeping, anxiety, feeling agitated, decreased libido, 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, 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, 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 people)

• inflammation of the throat that causes hoarseness,
• suicidal thoughts, difficulty sleeping, grinding of teeth, feeling disoriented, lack of motivation,
• muscle spasms and involuntary 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, 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, hives, 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,
• effects that may not be noticed, 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 people)

• 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 tiredness, nausea, or vomiting; severe symptoms include 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 feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures,
• increased pressure in the eye (glaucoma),
• coughs, 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 spasms,
• 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 people)

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

Frequency not known (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 Vigilance of Medicinal Products for Human Use:https://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 carton, on the bottle, and on the bottle label after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need if you are unsure. By doing so, you will help protect the environment.

Duloxetina Aristo Composition

• Theactive ingredientis duloxetina.Each capsule contains 60 mg of duloxetina (as hydrochloride).
• Theothercomponents are:

• Capsule content::Maize pregelatinized starch, microcrystalline cellulose, povidone, talc, magnesium stearate, sodium stearate fumarate, titanium dioxide (E171), lactose monohydrate, hypromellose 464, macrogol E1521, hypromellose acetate succinate.
• Capsule coating:Titanium dioxide (E171), gelatin, quinoline yellow (E104), brilliant blue (E133), allura red (E129), and yellow-orange S (E110).
• Printing ink:Shellac glaze, aluminium lacquer indigo carmine (E132), titanium dioxide (E171), propylene glycol (E1520).

Appearance of the product and contents of the package

Duloxetina Aristo are hard gastro-resistant capsules. Each capsule contains white to off-white, round, biconvex duloxetina hydrochloride tablets with a coating to protect them from stomach acid.

The capsules are opaque blue cap and green-yellow body marked with a “60”.

Duloxetina Aristo is available in:

PVC/PE/PCTFE blisters in packs of 28, 56, 84, 98, 100, and 500 hard gastro-resistant capsules.

PA/Aluminium/PVC-Aluminium blisters in packs of 28, 56, 84, 98, 100, and 500 hard gastro-resistant capsules.

HDPE bottles with child-resistant polypropylene screw caps containing 30 hard gastro-resistant capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible manufacturer

Pharmathen International S.A., BIO IIA

Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi

69300

Greece

Ó

Pharmathen S.A.

6, Dervenakion str., Pallini, Attiki

153 51

Greece

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

This medicine is authorized in the EEA member states under the following names:

Last review date of this leaflet: November 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/