DULOXETINE GENESIS 30 mg HARD GASTRO-RESISTANT CAPSULES

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

Do not take Duloxetine Genesisif:

• 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 "Using Duloxetine 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

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. Tell your doctor before taking duloxetine if:

• you are using other medicines for depression (see "Using Duloxetine 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 (fits)
• you have had mania
• you have bipolar disorder
• you have eye problems, such as certain types of glaucoma (increased eye pressure)
• you have had bleeding problems (a 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 "Using duloxetine with other medicines")

Duloxetine may cause a feeling of restlessness or an 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).

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

Suicidal thoughts and worsening of your depression or anxiety

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These thoughts may be increased at the start 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 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 with psychiatric conditions who were treated with an antidepressant

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 might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents

Duloxetine is not normally used in children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger) when they take this type of medicine. Despite this, your doctor may prescribe duloxetine to patients under 18 because they decide that it may be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 and you want to discuss it, please go back to the doctor. You must tell your doctor if any of the above symptoms occur or worsen in patients under 18 who are taking duloxetine. Also, 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.

Using Duloxetine Genesis with other medicines

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

The active substance of Duloxetine Genesis, duloxetine, is used in other medicines for other conditions:

• 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 taking other medicines that contain duloxetine.

Your doctor will decide if you can take duloxetine with other medicines. Do not start or stop taking any medicines, 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):do not take duloxetine if you are taking, or have taken within 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 ones. 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, buprenorphine, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), 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, 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 Genesis with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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 if you are planning to become pregnant while being treated with duloxetine. 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 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 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 within a few days of birth. These symptoms include weak muscles, trembling, overactive reflexes, difficulty feeding, 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 an increased risk of vaginal bleeding immediately after delivery, especially if you have had bleeding problems before. Your doctor or midwife should know that you have been taking duloxetine, so they can be prepared.

Tell 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 use tools or machines until you know how duloxetine affects you.

Duloxetine Genesiscontainslactose, colorant Allura Red (E-129), and sodium

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

Allura Red: This medicine may cause allergic reactions because it contains the colorant Allura Red (E-129).

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

3. How to take Duloxetine Genesis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Duloxetine should be taken by mouth. You should 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 up to 120 mg per day, depending on your response to duloxetine.

To help you remember to take duloxetine, it may be helpful to take it at the same times every day.

Discuss with your doctor how long you should take duloxetine. Do not stop taking duloxetine, or change your dose, without talking to your doctor. It is important to treat your condition properly to help you improve. If you do not treat it, your condition may not get better and may become more serious and more difficult to treat.

If you take more Duloxetine Genesis than you should

Contact your doctor or pharmacist immediately if you take more duloxetine than your doctor prescribed. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Duloxetine Genesis

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 your doctor prescribed for you in a day.

If you stop taking Duloxetine Genesis

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 take duloxetine anymore, they will tell you how to reduce your dose over at least 2 weeks before stopping treatment.

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

• dizziness
• a sensation of pins and needles or electric shock-like sensations (especially in the head)
• sleep disturbances (vivid dreams, nightmares, inability to sleep)
• fatigue
• drowsiness
• a feeling of restlessness or agitation
• a feeling of anxiety
• nausea or vomiting
• tremors
• headaches
• muscle pain
• a feeling of irritability
• diarrhea
• excessive sweating
• dizziness

These symptoms are usually not serious and go away within a few days, but if you have symptoms that are troublesome, ask your doctor for advice.

If you have any other 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 all people suffer from 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 agitation
• decreased sexual desire, difficulty or inability to have an orgasm
• anxiety
• unusual dreams
• dizziness
• feeling of slowness
• 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 of palpitations in the chest
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhea, stomach pain, vomiting, heartburn, or indigestion, gas
• increased sweating, rash
• muscle pain, muscle spasms
• difficulty or pain when 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.

Uncommon Adverse 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 clenching teeth
• feeling of disorientation
• lack of motivation
• muscle spasms and involuntary movements
• feeling of restlessness or inability to stay seated or still
• nervousness
• difficulty concentrating
• changes in taste
• difficulty controlling movements, e.g., lack of coordination or involuntary muscle movements, restless legs syndrome
• 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
• 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 menstruation, exceptionally light or absent menstruation
• pain in the testicles or scrotum
• chest pain
• feeling of cold, feeling of heat
• alteration in gait
• thirst, chills
• weight gain

Duloxetine 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 Adverse Effects (may affect up to 1 in 1,000 patients)

• severe allergic reactions, which can 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 can include feeling of dizziness, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting, the most serious symptoms are fainting, seizures, 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 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 serious disease with blistering of the skin, mouth, eyes, and genitals)
• severe allergic reactions that cause swelling of the face or throat (angioedema)
• contractions of the jaw muscle
• unusual odor of urine
• 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 the blood vessels in the skin (cutaneous vasculitis)

Frequency Not Known (cannot be estimated from the available data)

Signs and symptoms of a condition called “stress cardiomyopathy”, which can 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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the blister/pack/box after “EXP”. 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 away in drains or trash. Deposit the containers and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Duloxetine Genesis

• The active ingredient is duloxetine

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

• The other excipients are:

Capsule content:pregelatinized starch (from corn), microcrystalline cellulose, povidone K 30, talc, magnesium stearate, fumaric acid, and sodium, succinic acid, 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, indigo carmine (E-132), titanium dioxide (E-171), propylene glycol (E-1520).

Appearance of the Product and Package Contents

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

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

Package sizes:

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

Duloxetine Genesis hard gastro-resistant capsules are also available in HDPE bottles with a child-resistant screw cap.

Package size: 30 capsules

Not all package 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:March 2022

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