DULOXETINE ARISTO 60 mg GASTRO-RESISTANT HARD CAPSULES

2. What you need to know before you take Duloxetine Aristo

Do not take Duloxetine Aristo 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 "Other medicines and Duloxetine Aristo"),
• 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 Duloxetine Aristo").

Tell your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take this medicine.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Duloxetine Aristo.

This medicine may not be suitable for you due to the following reasons. Tell your doctor or pharmacist before you start taking Duloxetine Aristo:

• you are using other medicines for depression. (see "Other medicines and Duloxetine Aristo"), you are taking St. John's Wort, a herbal remedy (Hypericum perforatum),
• you have kidney disease,
• you have had seizures (epileptic fits),
• you have had mania,
• you have bipolar disorder,
• you have eye problems, such as certain types of glaucoma (increased eye pressure),
• you have had bleeding problems (a tendency to develop bruises), especially if you are pregnant (see "Pregnancy and breast-feeding"),
• 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 "Other medicines and Duloxetine Aristo").

This medicine may cause a feeling of restlessness or an 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 of the same group as Duloxetine Aristo (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 disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. These thoughts may be increased at the start 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 previously had 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 aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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 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 think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents under 18 years

Duloxetine Aristo should not normally be used in children and adolescents under 18 years. In addition, you should know that patients under 18 years who take this type of medicine have an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger). Despite this, your doctor may prescribe duloxetine to patients under 18 years because they decide that it can be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 years and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the above symptoms appear or worsen in patients under 18 years who are taking duloxetine. Additionally, in this age group, the long-term safety effects of duloxetine related to growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

Other medicines and Duloxetine Aristo

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained 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

It should be avoided to use 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 medicines, including those obtained without a prescription, and herbal remedies, without first talking to 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 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 duloxetine, can cause serious side effects, even life-threatening ones. You should wait at least 14 days after stopping an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping duloxetine before starting 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, 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), pethidine, 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 using any of these medicines with Duloxetine 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 Duloxetine Aristo with food, drinks, and alcohol

Duloxetine can be taken with or without food. You should be cautious if you drink alcohol while being treated with Duloxetine Aristo.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant during treatment with Duloxetine Aristo. You should only use duloxetine after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor know 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 faster and turn blue. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take this medicine 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 of your baby's life. These symptoms include weak muscles, trembling, jitteriness, not feeding properly, 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 Duloxetine Aristo near the end of your pregnancy, there is a greater risk of excessive bleeding after delivery, 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 Duloxetine during the first three months of pregnancy do not show an increased overall risk of birth defects in the baby. If you take Duloxetine during the second half of pregnancy, there may be a greater risk that the baby will be born early (6 additional premature babies per 100 women taking Duloxetine in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

Breast-feeding

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

Driving and using machines

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

Duloxetine Aristo contains lactose, Allura red (E129), orange yellow S (E110), and sodium

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

This medicine may cause allergic reactions because it contains Allura red (E129) and orange yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Duloxetine Aristo

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Duloxetine Aristo should be taken by mouth. You should swallow the capsule whole with water.

The recommended dose is:

• For depression and diabetic neuropathic pain: the recommended dose of this medicine 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 medicine 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 Duloxetine Aristo.

To help you remember to take duloxetine, it may be helpful to take it at the same time every day.

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

In case of overdose or accidental intake, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine 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 stiffness), seizures, vomiting, and rapid heartbeat.

If you forget to take Duloxetine Aristo

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 duloxetine than prescribed for you in one day.

If you stop taking Duloxetine Aristo

Do not stop taking your capsules without the advice of your doctor, even if you feel better.If your doctor thinks you do not need to take duloxetine anymore, they will tell you to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who stop taking Duloxetine Aristo abruptly have experienced symptoms such as dizziness, tingling sensations like pins and needles or electric shock-like sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. These effects are usually mild to moderate and often disappear within a few weeks.

Very Common Adverse Effects (may affect more than 1 in 10 people)

• headache, drowsiness,
• nausea, dry mouth.

Common Adverse Effects (may affect up to 1 in 10 people)

• loss of appetite,
• difficulty sleeping, anxiety, feeling of agitation, decreased sexual desire, difficulty or inability to have an orgasm, unusual dreams,
• dizziness, feeling of slowness, 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 or pain when urinating, frequent urination,
• difficulty getting an erection, changes in ejaculation,
• falls (mostly 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, the weight increased to similar levels as other children and adolescents of the same age and sex.

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• inflammation of the throat that causes hoarseness,
• suicidal thoughts, difficulty sleeping, teeth grinding, feeling of disorientation, lack of motivation,
• muscle spasms and involuntary movements, feeling of restlessness or inability to sit 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 dot in the center of the eye), vision problems,
• feeling of dizziness or vertigo, ear pain,
• rapid and/or irregular heartbeats,

• fainting, dizziness, feeling of dizziness or fainting when standing up, coldness in the fingers and/or toes,
• 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, rash, 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 of cold, thirst, chills, feeling of heat, alteration in gait,
• weight gain,
• effects of which you may not be aware, such as increased liver enzymes or potassium levels in the blood, creatine phosphokinase, sugar, or cholesterol.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• severe allergic reactions that 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 (mostly in elderly people; symptoms may include feeling of dizziness, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting, the most serious symptoms are fainting, seizures, or falls), syndrome of inadequate secretion of antidiuretic hormone (SIADH),
• suicidal behavior, mania (hyperactivity, accelerated thinking, and decreased need for sleep), hallucinations, aggression, and anger,

• “Serotonin syndrome” (a rare reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling of being 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 Adverse Effects (may affect up to 1 in 10,000 people)

• 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Duloxetine Aristo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, on the bottle, and on the label of the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Duloxetine Aristo

• The active ingredient is duloxetine. Each capsule contains 60 mg of duloxetine (as hydrochloride).
• The other ingredients are:

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

Appearance of the Product and Package Contents

Duloxetine Aristo is a hard gastro-resistant capsule. Each capsule contains white to off-white, round, biconvex duloxetine hydrochloride tablets with a coating to protect them from stomach acid.

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

Duloxetine Aristo is available in:

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

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

HDPE bottles with a child-resistant polypropylene screw cap with 30 hard gastro-resistant capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Pharmathen International S.A., BIO IIA

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

69300

Greece

Or

Pharmathen S.A.

6, Dervenakion str., Pallini, Attiki

153 51

Greece

You can request more information about this medicine 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:

Date of the Last Revision of this Leaflet: November 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/