DULOXETINE ALMUS 30 mg HARD GASTRO-RESISTANT CAPSULES

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

Do not take Duloxetine Almus 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 "Taking Duloxetine Almus with other medicines")
• 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 "Taking Duloxetine Almus with other medicines")

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

Warnings and precautions

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

• you are using other medicines to treat depression (see "Taking Duloxetine Almus 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 had bleeding problems (tendency to develop bruises), 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 elderly person)
• you are being treated with other medicines that may cause liver damage
• you are taking other medicines that contain duloxetine (see "Taking Duloxetine Almus with other medicines")

Duloxetine may cause a feeling of restlessness or 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 in the same class as Duloxetine Almus (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase 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 under 25 years of age who are being treated with antidepressants for psychiatric disorders

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

Children and adolescents under 18 years

Duloxetine should not normally be used in children and adolescents under 18 years. Also, 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 may be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 years and you want to discuss it, please go back to the doctor. You should tell 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.

Taking Duloxetine Almus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The main component of Duloxetine Almus, 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 Almus with other medicines. Do not start or stop taking any medicine, including those bought 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. 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, 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 notice any unusual symptoms when using any of these medicines with Duloxetine Almus, you should 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 Duloxetine Almus with food, drinks, and alcohol

Duloxetine Almus can be taken with or without food. You should be careful if you drink alcohol while being treated with duloxetine.

Pregnancy, breastfeeding, and fertility

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

• Tell your doctor if you become pregnant or are planning to become pregnant while taking this medicine. You should only use duloxetine after discussing the potential benefits and risks to the fetus with your doctor.

• Make sure your midwife and/or doctor know 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 faster and turn blue. These symptoms usually start during 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 near the end of your pregnancy, your baby may have some symptoms when it is born. These usually start at birth or in the first few days after your baby is born. These symptoms include weak muscles, tremors, restlessness, 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 near the end of your pregnancy, there is a greater risk of excessive vaginal bleeding shortly after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking duloxetine so that they can advise you.

• Data available 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 child. If you take duloxetine during the second half of pregnancy, there may be a greater risk that the baby will be born prematurely (6 additional premature babies per 100 women taking duloxetine in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

• Tell your doctor if you are breastfeeding. Duloxetine is not recommended during breastfeeding. Ask your doctor or pharmacist for advice.

Driving and using machines

While taking duloxetine, you may feel drowsy or dizzy. Do not drive or use tools or machines until you know how the treatment with duloxetine affects you.

Duloxetine contains sucrose

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

Duloxetine contains sodium

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

3. How to take Duloxetine Almus

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Duloxetine Almus should be taken orally. You should swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose of Duloxetine Almus 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 Almus 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 Almus.

To help you remember to take Duloxetine Almus, it may be useful to take it at the same time every day.

Discuss with your doctor how long you should take Duloxetine Almus. Do not stop taking Duloxetine Almus, or change your dose, without consulting your doctor. It is important 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 more difficult to treat.

If you take more Duloxetine Almus than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91.562.04.20, indicating the medicine and the amount taken. 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 Almus

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 a day.

If you stop taking Duloxetine Almus

Do not stop taking your capsules without your doctor's advice, even if you feel better.If your doctor thinks you do not need to continue taking Duloxetine Almus, they will tell you to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who have stopped taking Duloxetine Almus 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, feeling restless or agitated, feeling anxious, nausea or vomiting, tremors, headaches, muscle pain, feeling irritable, 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 further questions on 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 disappear, often, within a few weeks.

Very Frequent Adverse Effects (may affect more than 1 in 10 patients)

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

Frequent Adverse Effects (may affect up to 1 in 10 patients)

• loss of appetite.
• difficulty sleeping, feeling of agitation, decreased sexual desire, anxiety, 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 (itching).
• muscle pain, muscle spasms.
• difficulty 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 suffered 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.

Infrequent Adverse Effects (may affect up to 1 in 100 patients)

• 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 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.
• dilation of the pupils (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 of the 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 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.
• Duloxetina Almus may cause effects that you may not be aware of, 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 patients)

• 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, convulsions, 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 feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling of being 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 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.
• Cough, wheezing, and shortness of breath, which may be accompanied by high fever.

Very Rare Adverse Effects (may affect up to 1 in 10,000 patients)

• inflammation of the blood vessels in the skin (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, fainting, and irregular heartbeats.

Reporting 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Duloxetina Almus

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

Aluminum/Aluminum Blister:

Store below 30 ºC.

Transparent PVC/PCTFE Aluminum Blister:

Store below 30 ºC.

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

6. Package Contents and Additional Information

Duloxetine Composition

• The active ingredient is duloxetine as hydrochloride.

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

• The other components are:

• Capsule content: Sugar spheres, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 30% (Eudragit L30D55), hypromellose, sucrose, colloidal anhydrous silica, talc, triethyl citrate, Plasacryl T20 (glycerol monostearate, triethyl citrate, polysorbate 80, water).
• Capsule shell: titanium dioxide (E171), gelatin, FD&C Blue 2, water.

Product Appearance and Package Contents

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

Duloxetina Almus 30 mg hard gastro-resistant capsules EFG are hard gelatin capsules with a blue opaque cap and a white opaque body.

Transparent PVC/PCTFE Aluminum Blister and Aluminum/Aluminum Blister

Duloxetina Almus 30 mg hard gastro-resistant capsules EFG are available in packages of 7 and 28 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

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

Date of the last revision of this prospectus:September 2024

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