Prospect: Information for the user

Duloxetina Genesis60 mg hard gastro-resistant EFG capsules

duloxetina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must 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 not listed in this prospect. See section 4.

1.What isDuloxetina Genesisand for what it is used

2.What you need to knowbefore starting to takeDuloxetina Genesis

3.How to takeDuloxetina Genesis

4.Possible adverse effects

5.Storage ofDuloxetina Genesis

6.Contents of the package and additional information

Duloxetina Genesiscontains the active ingredient duloxetine. Duloxetina Genesisincreases the levels of serotonin and norepinephrine in the nervous system.

Duloxetina Genesisis used in adults to treat:

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing, pinching, stinging, or electric shock-like pain. There may be a loss of sensation in the affected area, or pain may occur when touching the area or exposing it to heat, cold, or pressure)

Duloxetina Genesisbegins 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 Genesiswhen you are feeling better to prevent your depression or anxiety from returning.

In people with diabetic neuropathic pain, it may take several weeks to start feeling better. Consult your doctor if you do not feel better after 2 months.

Do not take Duloxetina Genesis if:

• You are allergic to duloxetine or any of the other ingredients in this medicine (listed in section 6)
• You have liver disease
• You have severe kidney disease
• You are taking or have taken in the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Taking Duloxetina Genesis 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 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 before taking duloxetine if:

• You are taking other medicines to treat depression (see “Taking Duloxetina Genesis 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 a tendency to develop bleeding problems, especially if you are pregnant (see “Pregnancy and breastfeeding”)
• You have a risk of 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 duloxetine with other medicines”)

Duloxetine may cause a feeling of restlessness or inability to sit 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 can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (determined by blood test).

Medicines like duloxetine (known as SSRIs/SNRIs) can cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms continue after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety

If you are depressed or have anxiety disorders, you may occasionally have thoughts of self-harm or suicide. These thoughts may be increased when you start taking 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 young adults under 25 years old who have a psychiatric disorder and are being treated with antidepressants.

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 close friend or family member that you are depressed or have anxiety disorders, and ask them to read this leaflet. They may be able to tell if your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents

Duloxetine should not normally be used in children and adolescents under 18 years old. 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 cognitive and behavioural development have not yet been demonstrated.

Taking Duloxetina Genesis with other medicines

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

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

• Diabetic neuropathic pain
• Depression
• Anxiety and
• Urinary incontinence

You should avoid taking more than one of these medicines at the same time. Consult your doctor if you are taking another medicine that contains duloxetine.

Your doctor will decide if you can take duloxetine with other medicines.Do not start or stop taking 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 antidepressant known as 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 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 drowsiness:This includes prescription medicines prescribed by your doctor, such as benzodiazepines, powerful analgesics, 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 and amitriptyline), petidin, 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, you should tell your doctor.

Oral anticoagulants or antiplatelet agents:Medicines that thin the blood or prevent the formation of blood clots. These medicines may increase the risk of bleeding.

Taking Duloxetina Genesis with food, drink, and alcohol

Duloxetine can be taken with or without food. You should be careful if you take alcohol while taking duloxetine.

Pregnancy and breastfeeding

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 duloxetine. You should only use duloxetine after discussing the potential benefits and any potential risks to the foetus with your doctor.

Make sure your midwife and/or doctor know that 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 more rapidly and turn blue. These symptoms usually start within 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 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 birth. These symptoms may include weak muscles, trembling, restlessness, difficulty feeding, 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 an increased risk of excessive vaginal bleeding immediately after delivery, especially if you have had previous bleeding problems.

Your doctor or midwife should know that you have been taking duloxetine, so they should be aware.

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

Driving and using 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 Genesis contains lactose and colourant Red Allura (E-129), Yellow Orange S (E-110) and Sodium

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

Red Allura and Yellow Orange S (E-110): This medicine may cause allergic reactions because it contains Red Allura (E-129) and Yellow Orange S (E-110) colourants.

Sodium: This medicine contains less than 23 mg of sodium (1 mmol) per capsule, which 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.

Duloxetine 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 a day, 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 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 to 120 mg per day depending on your response to duloxetine.

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

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

Call your doctor or pharmacist immediately if you take more duloxetine than prescribed by your doctor. Symptoms of 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Duloxetine Genesis:

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 Duloxetine Genesis:

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

Some patients who have stopped taking duloxetine abruptly have experienced symptoms such as:

• dizziness
• tingling sensation like 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
• trembling
• headaches
• muscle pain
• feeling of irritability
• diarrhea
• excessive sweating
• dizziness

These symptoms are usually not significant and disappear within a few days, but if you experience bothersome symptoms, consult your doctor.

If you have any other questions 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 or moderate and often disappear after 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 of agitation
• decreased libido, difficulty or inability to have an orgasm
• anxiety
• unusual dreams
• dizziness
• feeling of slowness
• trembling
• 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 of 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, frequent urination
• 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, poor quality sleep
• grinding or clicking the teeth
• 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 the sense of taste
• difficulty controlling movements, e.g., lack of coordination or involuntary muscle movements, restless legs syndrome
• enlarged pupils (the black center of the eye), vision problems
• feeling of dizziness or vertigo
• ear pain
• rapid and/or irregular heartbeat
• syncope, dizziness, feeling of dizziness or syncope when standing up
• cold hands and/or feet
• throat spasms
• nosebleeds
• 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, 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 usual, decreased urine flow
• abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular, or prolonged periods,exceptionally light or missed periods
• testicular or scrotal pain
• chest pain
• feeling of coldness, feeling of heat
• change in gait
• thirst, chills
• weight gain

Duloxetine may cause side 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 syncope, 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 a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness)
• seizures
• increased pressure in the eye (glaucoma)
• inflammation of the mouth, bad breath
• bright red blood in the stool, 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 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
• excessive vaginal bleeding immediately after delivery (postpartum hemorrhage)

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

• inflammation of the skin blood vessels (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, syncope, 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 the Pharmacovigilance of Medicines for Human Use: https://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 blister / bottle / box after “CAD”. The expiration date is the last day of the month indicated.

Store below 30°C.

HDPE bottles: once opened, use within 30 days.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose ofthe containers and medicines you no longerneed.This will help protect the environment.

Composition of Duloxetina Genesis

• The active ingredient is duloxetine

Each gastro-resistant hard capsule of 60 mg contains 60 mg of duloxetine (as hydrochloride)

• The other excipients are:

Capule content:pregelatinized cornstarch, microcrystalline cellulose, povidone K 30, talc, magnesium stearate, stearic acid and sodium salt, hypromellose acetate succinate, titanium dioxide (E-171), lactose monohydrate, hypromellose, macrogol 4000, Quinoline Yellow (E-104) and Yellow Orange S (E-110.

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

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

Appearance of the product and packaging content

Duloxetina Genesis 60 mg gastro-resistant hard capsules are size 0E and consist of a dark blue coating and a yellow-green opaque body where "60" is printed, containing 8 white or almost white, round, biconvex tablets. Each capsule contains 60 mg of the active ingredient duloxetine.

Duloxetina Genesisgastro-resistant hard capsules are available in blisters (PVC/PE/PCTFE//Al or PA/Al/PVC//Al) contained in a box.

Packaging sizes:

Duloxetina Genesis60 mg gastro-resistant hard capsules EFG: 28, 56, 84, 98, 100 and 500 capsules

Duloxetina Genesisgastro-resistant hard capsules are available in HDPE bottles with a PP child-resistant screw cap.

Packaging size: 30 capsules

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Genesis Pharma S.L.

C/ Lorena 3.Urb. Parquelagos.

Galapagar. 28420-Madrid.

Spain

Responsible 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 with the following names:

Last review date of this leaflet:March 2022

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