Duloxetine Combix 60 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Duloxetina Combix 60 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Duloxetina Combix is and what it is used for
2. What you need to know before taking Duloxetina Combix
3. How to take Duloxetina Combix
4. Possible side effects
5. How to store Duloxetina Combix
6. Contents of the pack and other information

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

Duloxetina Combix contains the active substance duloxetine. Duloxetina Combix increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetina Combix is used in adults to treat:

• depression

• generalized anxiety disorder (chronic feelings of anxiety or nervousness)

• diabetic neuropathic pain (often described as burning, stabbing, shooting, stinging pain, or like an electric shock. There may be loss of sensation in the affected area, or pain may occur upon touching the area or exposing it to heat, cold, or pressure).

Duloxetina Combix 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 before you start to feel better. Inform your doctor if you do not notice improvement by then. Your doctor may continue your treatment with Duloxetina Combix once you feel better to prevent your depression or anxiety from returning.

In people with diabetic neuropathic pain, it may take several weeks before you start to feel better. You should consult a doctor if your condition worsens or if you do not improve within 2 months.

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

Do not take Duloxetina:

• if you are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)
• if you have hepatic impairment
• if you have severe renal impairment
• if you are taking or have taken within the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see "Taking Duloxetina with other medicines")
• if you are taking fluvoxamine, which is usually used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections
• if you are taking other medicines containing duloxetine (see "Taking Duloxetina with other medicines")

Consult your doctor if you have high blood pressure or heart disease. Your doctor will determine whether you should take Duloxetina.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Duloxetina. Duloxetina may not be suitable for you for the following reasons if:

• you are using other medicines to treat depression (see "Taking Duloxetina with other medicines")
• you are taking St. John's wort, a herbal remedy (Hypericum perforatum)
• you have any kidney disease
• you have experienced seizures (epileptic fits)
• you have experienced mania
• you suffer from bipolar disorder
• you have eye problems, such as certain types of glaucoma (increased intraocular pressure)
• you have had bleeding problems (tendency to bruise easily)
• you are at risk of low sodium levels (for example, if you are taking diuretics, especially if you are elderly)
• you are being treated with other medicines that may cause liver damage
• you are taking other medicines containing duloxetine (see "Taking Duloxetina with other medicines")

Duloxetina may cause a feeling of restlessness or inability to sit still or remain motionless. If this happens, inform your doctor.

Some medicines in the same class as Duloxetina Combix (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 depression or anxiety disorder

If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to have such thoughts if:

• you have previously had thoughts of self-harm or suicide
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age being treated with antidepressants.

Contact your doctor immediately or go to hospital if you have any thoughts of self-harm or suicide.

It may be helpful to inform a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they notice your depression or anxiety worsening, or if they are concerned about changes in your behaviour.

You should also contact your doctor:

If you experience signs and symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, or vomiting, as you may be experiencing serotonin syndrome.

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

Children and adolescents

Duloxetina should normally not be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age taking this type of medicine have an increased risk of developing side effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger). Despite this, your doctor may prescribe Duloxetina to patients under 18 years of age if they decide it may be beneficial for the patient. If your doctor has prescribed Duloxetina to a patient under 18 years of age and you wish to discuss this, please return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age taking Duloxetina. Furthermore, in this age group, the long-term effects of Duloxetina on growth, maturation, and cognitive and behavioural development have not yet been established.

Taking Duloxetina with other medicines

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

The main component of Duloxetina Combix, duloxetine, is used in other medicines for different 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 containing duloxetine.

Your doctor will decide whether you can take Duloxetina with other medicines. Do not start or stop taking any medicine, including those obtained without a prescription and herbal remedies, without first consulting your doctor.

You should also inform your doctor if you are taking any of the following medicines:

Monoamine oxidase inhibitors (MAOIs): You must not take Duloxetina if you are taking, or have recently taken (within the last 14 days), another antidepressant medicine known as a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI together with many prescription medicines, including Duloxetina, can cause serious adverse effects, even life-threatening ones. You must wait at least 14 days after stopping treatment with an MAOI before starting Duloxetina. Likewise, you must wait at least 5 days after stopping Duloxetina before starting treatment with an MAOI.

Medicines that cause drowsiness: This includes 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), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), meperidine, St. John's wort, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of adverse effects; if you notice any unusual symptoms when taking any of these medicines together with Duloxetina, inform 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 with food, drinks, and alcohol

Duloxetina can be taken with or without food. You should exercise caution if you consume alcohol while being treated with Duloxetina.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you become pregnant or are trying to become pregnant while being treated with Duloxetina. You should only use Duloxetina after your doctor has evaluated the potential benefits and any potential risks to the fetus.

Ensure that your midwife and/or doctor know that you are taking Duloxetina. Other similar medicines (SSRIs), taken during pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Duloxetina near the end of your pregnancy, your baby may experience some symptoms after birth. These usually begin at birth or during the first few days after delivery. Symptoms may include weak muscles, tremors, restlessness, poor feeding, breathing difficulties, and seizures. If your baby shows any of these symptoms after birth or if you are concerned about your baby's health, contact your doctor or midwife, who can advise you.

Breastfeeding

Inform your doctor if you are breastfeeding. The use of Duloxetina during breastfeeding is not recommended. Seek advice from your doctor or pharmacist.

Driving and using machines

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

Duloxetina contains sucrose

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

3. How to take Duloxetina Combix

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Duloxetina Combix should be taken orally. You must swallow the capsule whole with water.

For depression and diabetic neuropathic pain:

The recommended dose of Duloxetina Combix is 60 mg once daily, but your doctor will prescribe the dose that is best for you.

For generalized anxiety disorder:

The usual starting dose of Duloxetina Combix is 30 mg once daily, after which most patients will be given 60 mg once daily, 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 Duloxetina Combix.

To help you remember to take Duloxetina Combix, it may be helpful to take it at the same time each day.

Discuss with your doctor how long you should continue taking Duloxetina Combix. Do not stop taking Duloxetina Combix or change your dose without consulting your doctor. It is important to treat your condition properly to help you improve. If left untreated, your condition may not resolve and may become worse and more difficult to treat.

If you take more Duloxetina Combix than you should

Call your doctor or pharmacist immediately if you take more Duloxetina Combix than prescribed by your doctor. Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction that may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures, vomiting, and rapid heart rate.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Duloxetina Combix

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for a missed dose. Do not take more Duloxetina Combix than prescribed for you in one day.

If you stop taking Duloxetina Combix

DO NOT stop taking your capsules without consulting your doctor, even if you feel better. If your doctor decides that you no longer need to continue taking Duloxetina Combix, he or she will advise you to gradually reduce your dose over at least 2 weeks before stopping treatment.

Some patients who stop treatment with Duloxetina Combix abruptly have experienced symptoms such as:

• dizziness, tingling sensations like pins and needles or electric shocks (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, restlessness or agitation, feelings of anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, and excessive sweating or vertigo.

These symptoms are usually not serious and disappear within a few days, but if you experience bothersome symptoms, seek advice from your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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
• discomfort (nausea), dry mouth

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

• loss of appetite
• difficulty sleeping, feeling restless, decreased sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling slowed down, tremor, 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, diarrhoea, stomach pain, vomiting, heartburn or indigestion, gas
• increased sweating, rash (itching)
• muscle pain, muscle spasms
• pain when urinating, frequent urination
• difficulty achieving 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 starting treatment. After 6 months of treatment, weight increased to levels similar to those of other children and adolescents of the same age and sex.

Uncommon adverse effects (may affect up to 1 in 100 people)

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding, feeling disoriented, lack of motivation
• muscle spasms and involuntary muscle movements, feeling restless or unable to sit still or remain motionless, nervousness, difficulty concentrating, changes in taste sensation, difficulty controlling movements e.g.: lack of coordination or involuntary muscle movements, restless legs syndrome, poor quality of sleep
• dilation of the pupils (the black center of the eye), vision problems
• feeling dizzy or vertigo, ear pain
• rapid and/or irregular heartbeat
• fainting, dizziness, feeling lightheaded or faint when standing up, coldness in the fingers and/or toes
• throat spasms, nosebleeds
• vomiting blood, or black stools, gastroenteritis, burping, difficulty swallowing
• liver inflammation which may cause abdominal pain and yellowing of the skin or whites 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 normal, decreased urine flow
• abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular or prolonged periods, exceptionally light or missed periods, pain in the testicles or scrotum
• chest pain, feeling cold, thirst, chills, feeling hot, change in walking pattern
• weight gain
• Duloxetine may cause effects you may not notice, such as increased liver enzymes or blood potassium levels, creatine phosphokinase, blood sugar or cholesterol.

Rare adverse effects (may affect up to 1 in 1,000 people)

• severe allergic reactions causing difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions
• decreased activity of the thyroid gland, which may cause tiredness or weight gain
• dehydration, low levels of sodium in the blood (mostly in elderly people; symptoms may include dizziness, weakness, confusion, drowsiness or extreme tiredness, nausea or vomiting; more serious symptoms include fainting, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behaviour, mania (hyperactivity, racing thoughts and reduced need for sleep), hallucinations, aggression and anger
• "Serotonin syndrome" (a rare reaction that may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased pressure in the eye (glaucoma)
• mouth inflammation, bright red blood in the stools, bad breath, inflammation of the large intestine (resulting in diarrhoea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious illness with blistering of the skin, mouth, eyes and genitals), severe allergic reactions causing swelling of the face or throat (angioedema)
• contractions of the jaw muscle
• unusual odour of the urine
• menopausal symptoms, abnormal production of breast milk 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 people)

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

Reporting of adverse effects

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

5. Storage of Duloxetina Combix

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duloxetina Combix

• The active substance is duloxetine.

Each capsule contains 67,360 mg of duloxetine hydrochloride, equivalent to 60 mg of duloxetine.

• The other components are:

Capsule contents: hypromellose (E464), succinate acetate of hypromellose, sucrose, sugar spheres, talc (E553b), titanium dioxide (E171), triethyl citrate (E1505) and red iron oxide (E172).

Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Duloxetina Combix 60 mg is available as hard gelatin capsules of size 1, with an opaque blue cap and an opaque green body, containing pink pellets.

Duloxetina Combix 60 mg is available in PVC/PVDC-Aluminum blisters, OPA/Alu/PVC-Aluminum blisters, and Desiccant/OPA/Al/PE-Aluminum/PE blisters, in packages containing 28 and 56 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz, 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the most recent review of this leaflet: July 2024

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