Duloxetine Genesis 30 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Duloxetina Genesis 30 mg gastro-resistant hard capsules EFG

duloxetine

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Duloxetina Genesis is used in adults to treat:

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing, shooting, tingling, or like an electric shock. There may be loss of sensation in the affected area, or pain may occur when the area is touched or exposed to heat, cold, or pressure)

Duloxetina Genesis begins to work in most people with depression or anxiety within two weeks after 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 any improvement after this time. Your doctor may continue your treatment with Duloxetina Genesis once you feel better in order 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. Consult your doctor if you do not feel better after 2 months.

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

Do not take Duloxetina Genesis if:

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

Consult your doctor if you have high blood pressure or a heart condition. Your doctor will determine whether you should take duloxetine.

Warnings and precautions

Duloxetine may not be suitable for you for the following reasons. Consult your doctor before taking duloxetine if:

• you are using other medicines to treat depression (see "Use of Duloxetina Genesis 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), especially if you are pregnant (see "Pregnancy and breastfeeding")
• you are at risk of low sodium levels (for example, if you are taking diuretics, particularly if you are elderly)
• you are receiving treatment with other medicines that may cause liver damage
• you are taking other medicines containing duloxetine (see "Use of duloxetine with other medicines")

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

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, diarrhea, 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 a blood test).

Medicines such as duloxetine (known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may 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 treated with antidepressants.

Contact your doctor or go immediately 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 inform you if they notice your depression or anxiety worsening, or if they are concerned about changes in your behaviour.

Children and adolescents

Duloxetine 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 who take this type of medicine have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe duloxetine to patients under 18 years of age if they decide it may be beneficial for the patient. If your doctor has prescribed duloxetine 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 duloxetine. In addition, the long-term effects of duloxetine on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Use of Duloxetina Genesis with other medicines

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

The active ingredient in Duloxetina Genesis, duloxetine, is used in other medicines for other conditions:

• diabetic neuropathic pain
• depression
• anxiety
• urinary incontinence

It is recommended to avoid using more than one of these medicines at the same time. Check with your doctor if you are already taking other medicines containing duloxetine.

Your doctor will decide whether you can take duloxetine with other medicines. Do not start or stop taking any medicine, including over-the-counter medicines 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 duloxetine 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 duloxetine, can cause serious adverse effects, even life-threatening ones. You must wait at least 14 days after stopping treatment with an MAOI before starting duloxetine. Likewise, you must wait at least 5 days after stopping duloxetine 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, buprenorphine, tramadol, tryptophan, 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 using any of these medicines together with duloxetine, you must 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 Genesis with food, drinks and alcohol

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

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.

Inform your doctor if you become pregnant or are trying to become pregnant while being treated with duloxetine. You should only use duloxetine 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 duloxetine. Other similar medicines (SSRIs), when 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 blue. 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 duloxetine near the end of your pregnancy, your baby may experience certain symptoms at birth. These usually begin at birth or within the first few days after birth. Symptoms may include weak muscles, tremors, irritability, poor feeding, breathing difficulties, and seizures. If your baby has 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.

If you take duloxetine near the end of your pregnancy, there is an increased risk of excessive vaginal bleeding immediately after delivery, especially if you have had previous bleeding disorders. Your doctor or midwife should be aware that you have been taking duloxetine.

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

Driving and use of machines

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

Duloxetina Genesis contains lactose, Allura Red dye (E-129), and sodium

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

Allura Red: This medicine may cause allergic reactions as it contains Allura Red dye (E-129).

Sodium: This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., essentially "sodium-free".

3. How to take Duloxetina Genesis

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

For depression and diabetic neuropathic pain:

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

For generalized anxiety disorder:

The recommended starting dose of duloxetine is 30 mg once daily, after which most patients will receive 60 mg once daily. However, 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.

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

Discuss with your doctor how long you should continue taking duloxetina. Do not stop taking duloxetina 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 could become more severe and more difficult to treat.

If you take more Duloxetina Genesis than you should

Call your doctor or pharmacist immediately if you take more duloxetine 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 stiffness), 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. Telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Duloxetina Genesis

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 the next dose at your regular time. Do not take a double dose to make up for a missed dose. Do not take more duloxetine than prescribed for you in one day.

If you stop taking Duloxetina Genesis

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 take duloxetine, they will instruct you to gradually reduce your dose over at least 2 weeks before stopping treatment.

Some patients who stop duloxetine treatment suddenly have experienced symptoms such as:

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

These symptoms are usually not serious and disappear within a few days. However, 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 can cause adverse effects, although not everyone will experience them.

These effects are usually mild or moderate and often disappear after a few weeks.

Very common adverse effects (may affect more than 1 in 10 patients)

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

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

• loss of appetite
• difficulty sleeping
• feeling of restlessness
• decreased sexual desire, difficulty or inability to achieve orgasm
• anxiety
• 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, diarrhea, 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 patients)

• throat inflammation causing hoarseness
• suicidal thoughts
• difficulty sleeping, poor-quality sleep
• teeth grinding or clenching
• feeling disoriented
• lack of motivation
• muscle spasms and involuntary muscle movements
• feeling restless or unable to sit still or remain quiet
• nervousness
• difficulty concentrating
• changes in taste sensation
• difficulty controlling movements, e.g.: lack of coordination or involuntary muscle movements, restless legs syndrome
• pupil dilation (the black center of the eye), vision problems
• feeling dizzy or lightheaded
• ear pain
• rapid and/or irregular heartbeat
• fainting, dizziness, lightheadedness or feeling faint upon standing
• coldness in 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, cold sweats, hives
• 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, and exceptionally light or missed periods
• pain in the testicles or scrotum
• chest pain
• feeling cold, feeling hot
• change in walking pattern
• thirst, chills
• weight gain

Duloxetine may cause effects you may not notice, such as increased levels of liver enzymes or blood levels of:

• potassium
• creatine phosphokinase
• sugar or
• cholesterol

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

• 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 sodium levels 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 behavior
• mania (hyperactivity, racing thoughts, and reduced need for sleep)
• hallucinations, aggression, and anger
• "Serotonin syndrome" (a rare reaction that may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity)
• seizures
• increased pressure in the eye (glaucoma)
• mouth inflammation, bad breath
• bright red blood in stools, inflammation of the large intestine (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious illness causing blistering of the skin, mouth, eyes, and genitals)
• severe allergic reactions causing swelling of the face or throat (angioedema)
• jaw muscle contractions
• unusual urine odor
• menopausal symptoms
• abnormal production of breast milk in men or women
• excessive vaginal bleeding immediately after childbirth (postpartum hemorrhage)

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

• 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 type of 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 via 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 Duloxetine Genesis

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

Do not use this medicine after the expiry date stated on the blister / bottle / carton after "EXP". The expiry date is the last day of the month indicated.

Store below 30°C.

HDPE bottles: once opened, use within 30 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duloxetina Genesis

• The active substance is duloxetina

Each 30 mg gastro-resistant hard capsule contains 30 mg of duloxetine (as hydrochloride)

• The other excipients are:

Capsule contents: pregelatinized starch (from corn), microcrystalline cellulose, povidone K 30, talc, stearic fumarate and sodium, succinate acetate of hypromellose, titanium dioxide (E-171), lactose monohydrate, hypromellose, and macrogol 4000.

Capsule shell: titanium dioxide (E-171), gelatin, Brilliant Blue FCF (E-133), Allura Red (E-129).

Printing ink: shellac glaze, indigotine (E-132), titanium dioxide (E-171), propylene glycol (E-1520).

Nature and contents of the container

Duloxetina Genesis 30 mg gastro-resistant hard capsules are size 2 and consist of a dark blue cap and an opaque white body, printed with “30”. Each capsule contains 4 white or almost white, round, biconvex tablets. Each capsule contains 30 mg of the active substance, duloxetine.

Duloxetina Genesis gastro-resistant hard capsules are available in blisters (PVC/PE/PCTFE//Al or PA/Al/PVC//Al) packed in a carton box.

Pack sizes:

Duloxetina Genesis 30 mg gastro-resistant hard capsules EFG: 7, 28 and 98 capsules

Duloxetina Genesis gastro-resistant hard capsules are also available in HDPE bottles with child-resistant PP screw caps.

Pack size: 30 capsules

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Genesis Pharma S.L.

C/ Lorena 3. Urb. Parquelagos.

Galapagar. 28420-Madrid.

Spain

Manufacturer:

Pharmathen S.A.

6, Dervenakion Str.

15351 Pallini Attiki

Greece

Or

Pharmathen International S.A.

Sapes Industrial Park, Block 5

69300 Rodopi

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: March 2022

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