Package Insert: Information for the Patient

Duloxetina Almus 60 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it 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 package insert. See section 4.

1. What is Duloxetina Almus and for what it is used

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

3. How to take Duloxetina Almus

4. Possible adverse effects

5. Storage of Duloxetina Almus

6. Contents of the package and additional information

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

Duloxetina Almus is used in adults to treat:

• depression
• generalized anxiety disorder (chronic sensation of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing, likepinching, stinging, or like an electric shock. There may be a loss of sensation in the affected area, or it may occur that touching the area or putting it in contact with heat, cold, or pressure causes pain)

Duloxetina Almus 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 to give you Duloxetina Almus 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 before you start to feel better. Consult your doctor if you do not feel better after 2 months.

Do not take Duloxetina Almus 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 Almus 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 Almus 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 starting to take duloxetine if:

• You are taking other medicines to treat depression (see “Taking Duloxetina Almus with other medicines”)
• You are taking St. John's Wort, a herbal treatment (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 taking other medicines that can damage the liver
• You are taking other medicines that contain duloxetine (see “Taking Duloxetina Almus with other medicines”)

Duloxetine may cause a feeling of restlessness or inability to sit or stay still. If this happens, 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, diarrhea, coma, nausea, vomiting, as you may be suffering from a serotonin syndrome.

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

Some medicines in the same group as Duloxetina Almus (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 as soon as 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 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

Duloxetine is usually not used in children and adolescents under 18 years. 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 mentioned 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 development of cognitive and behavioural functions have not yet been demonstrated.

Taking Duloxetina Almus with other medicines

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

The main component of Duloxetina Almus, 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 Almus 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:

MAOIs (monoamine oxidase inhibitors):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). For example, moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medicines, including duloxetine, may 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 drowsinessThis includes prescription medicines prescribed by your doctor such as benzodiazepines, powerful analgesics, antipsychotics, phenobarbital and antihistamines.

Medicines that increase serotonin levelsTriptans, 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, amitriptyline), petidina, St. John's Wort and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you observe any unusual symptoms when using any of these medicines with Duloxetina Almus, you should tell your doctor.

Oral anticoagulants or antiplatelet agentsMedicines that thin the blood or prevent the formation of blood clots in the blood. These medicines may increase the risk of bleeding.

Taking Duloxetina Almus with food, drinks and alcohol

Duloxetina Almuscan 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 for 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 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 duloxetine towards the end of your pregnancy, there is a higher risk of excessive vaginal bleeding after birth, especially if you have a history of bleeding disorders. 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 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.

Duloxetina contains sodium

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

Duloxetina Almusshould be taken orally. Swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose ofDuloxetina Almusis 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 ofDuloxetina Almusis 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 toDuloxetina Almus.

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

Discuss with your doctor for how long you should takeDuloxetina Almus. Do not stop takingDuloxetina Almus, 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 Almus 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. Symptoms produced by an overdose include 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 forget to take Duloxetina Almus

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 Almus

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

Some patients who have stopped treatment withDuloxetina Almushave presented 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 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 of slowness, 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 (itching).
• 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, 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.
• pupil dilation (the black center of the eye), vision problems.
• feeling of dizziness or vertigo, ear pain.
• rapid or irregular heartbeat.
• loss of consciousness, dizziness, feeling of dizziness or loss of consciousness when standing up, coldness in the fingers of the 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 alteration.
• weight gain.
• Duloxetina Almus 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, 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 feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), convulsions.
• increased pressure in the eye (glaucoma).
• inflammation of the mouth, bright red blood in the stool, bad breath.
• 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.
• cough, wheezing, and shortness of breath, which may be accompanied by high fever.

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

• 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 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.?

Aluminum/Aluminum Blister:

Store below 30 °C.

Transparent PVC/PCTFE Aluminum Blister:

Store below 30 °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.?

Composition of duloxetine

• The active ingredient is duloxetine as hydrochloride.

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

• The other components are:

• Content of the capsule: Sugar spheres, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (Eudragit L30D55), hypromellose, sucrose, anhydrous colloidal silica, talc, triethyl citrate, Plasacryl T20 (monoester of glyceryl, triethyl citrate, polysorbate 80, water).
• Capsule coating: Titanium dioxide (E171), gelatin, FD&C Blue 2, yellow iron oxide (E172), water.

Appearance of the product and contents of the package

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

Duloxetine Almus 60 mg hard gastro-resistant capsules EFG are hard gelatin capsules with a blue opaque cap and a green opaque body.

Transparent PVC/PCTFE aluminum blister and aluminum/aluminum blister

Duloxetine Almus 60 mg hard gastro-resistant capsules EFG is available in packs of 28 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

Last review date of this leaflet:September 2024

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