Dulxetenon

Leaflet accompanying the packaging: patient information

Dulxetenon, 90 mg, gastro-resistant hard capsules

Dulxetenon, 120 mg, gastro-resistant hard capsules

Duloxetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dulxetenon and what is it used for
• 2. Important information before taking Dulxetenon
• 3. How to take Dulxetenon
• 4. Possible side effects
• 5. How to store Dulxetenon
• 6. Contents of the pack and other information

1. What is Dulxetenon and what is it used for

Dulxetenon contains the active substance duloxetine. Dulxetenon increases the levels of serotonin and noradrenaline in the nervous system.
Dulxetenon is indicated in adults for the treatment of:

• depression
• generalized anxiety disorders (persistent feeling of anxiety or nervousness)

In most people with depression or anxiety, Dulxetenon starts working within two weeks of starting treatment, but it may take 2 to 4 weeks before an improvement is noticed. You should see your doctor if you do not feel better after this time. Even if you feel better, your doctor may recommend continuing to take Dulxetenon to prevent a relapse of depression or anxiety.

2. Important information before taking Dulxetenon

Do not take Dulxetenon if:

• you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
• you have liver disease;
• you have severe kidney disease;
• you are taking or have taken within the last 14 days another medicine called a monoamine oxidase inhibitor (MAOI) (see “Dulxetenon and 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 containing duloxetine (see “Dulxetenon and other medicines”).

Tell your doctor if you have high blood pressure or heart disease. Your doctor will decide whether you should take Dulxetenon.

Warnings and precautions

Below are some reasons why Dulxetenon may not be suitable for you. Before taking Dulxetenon, discuss with your doctor if:

• you are taking other antidepressant medicines (see “Dulxetenon and other medicines”).
• you are taking herbal medicines containing St. John's Wort (Hypericum perforatum)
• you have kidney disease
• you have had seizures in the past
• you have had manic episodes in the past
• you have bipolar affective disorder
• you have eye diseases, such as certain types of glaucoma (increased pressure in the eye)
• you have had bleeding disorders (tendency to bruise), especially if you are pregnant (see “Pregnancy and breastfeeding”)
• you are at risk of decreased sodium levels (e.g., when taking diuretics, especially in the elderly)
• you are currently taking other medicines that may cause liver damage
• you are taking other medicines containing duloxetine (see “Dulxetenon and other medicines”). Medicines like Dulxetenon (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment has stopped.

Dulxetenon may cause a feeling of restlessness or an inability to sit still. If you experience such symptoms, you should inform your doctor.
You should also contact your doctor:
If you experience objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting, as this may indicate serotonin syndrome.
In its most severe form, serotonin syndrome can resemble malignant neuroleptic syndrome.
Objective and subjective symptoms of malignant neuroleptic syndrome may include:
a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzyme activity (determined by blood test).
Suicidal thoughts and worsening depression or anxiety
People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen when taking antidepressant medicines, as these medicines start working only after some time, usually after 2 weeks, but sometimes later.
Suicidal thoughts, self-harm, or suicidal thoughts are more likely to occur if:

• you have had suicidal thoughts or self-harm in the past
• you are a young adult - clinical trials have shown an increased risk of suicidal behavior in people under 25 with mental disorders taking antidepressant medicines.

If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.

It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You can also ask for their opinion on whether your depressive or anxious state has worsened or if changes in behavior are causing them concern. You can ask them to inform you if they notice that your depression or anxiety has worsened or if there are worrying changes in your behavior.

Children and adolescents under 18 years of age

Dulxetenon should not normally be used in children and adolescents under 18 years of age. In patients under 18 years of age taking medicines of this class, there is an increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and manifestations of anger). Nevertheless, your doctor may prescribe Dulxetenon for patients under 18 years of age if they decide that it is in their best interest. If you have any concerns about your doctor's recommendation to take Dulxetenon for a patient under 18 years of age, you should contact your doctor again. You should inform your doctor if a patient under 18 years of age taking Dulxetenon experiences any of the above side effects.
Additionally, there is a lack of long-term safety data on the use of Dulxetenon in this age group regarding growth, maturation, and cognitive and behavioral development.

Dulxetenon and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Duloxetine, the main ingredient in Dulxetenon, is also found in other medicines used to treat other diseases:

• diabetic neuropathic pain,
• depression,
• anxiety,
• urinary incontinence.

You should avoid taking more than one of these medicines at the same time. You should consult your doctor if you are taking other medicines containing duloxetine.
Your doctor will decide whether you can take Dulxetenon with other medicines. Do not
start or stop taking other medicines, including those available without a prescription and herbal preparations, without consulting your doctor.
You should inform your doctor if you are taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs):
Do not take Dulxetenon with another antidepressant medicine called a monoamine oxidase inhibitor (MAOI), or shortly after stopping an MAOI (within 14 days).
Examples of MAOIs are moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medicines, including Dulxetenon, can cause serious or life-threatening side effects.
After stopping an MAOI, you must wait at least 14 days before starting to take Dulxetenon. Before starting an MAOI, you must wait at least 5 days after stopping Dulxetenon.
Sedative medicines:
These may be prescription medicines, e.g., benzodiazepines, strong painkillers, antipsychotic medicines, phenobarbital, and antihistamines.
Medicines that increase serotonin levels:
Tryptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (e.g., paroxetine and fluoxetine), selective noradrenaline reuptake inhibitors (e.g., venlafaxine), tricyclic antidepressants (e.g., clomipramine and amitriptyline), pethidine, St. John's Wort (Hypericum perforatum), and MAOIs (e.g., moclobemide and linezolid). These medicines increase the risk of side effects.
If you experience any symptoms while taking these medicines with Dulxetenon, you should contact your doctor.
Oral anticoagulants or antiplatelet agents:
Medicines that thin the blood or prevent blood clotting. These medicines may increase the risk of bleeding.

Dulxetenon with food, drink, and alcohol

Dulxetenon can be taken with or without food. You should be careful when consuming alcohol while taking Dulxetenon.

Pregnancy and breastfeeding

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

• If you become pregnant while taking duloxetine, you should inform your doctor. You can take duloxetine only after discussing the expected benefits and potential risks to the unborn baby with your doctor.
• You should inform your midwife and/or doctor that you are taking duloxetine. The use of similar medicines (selective serotonin reuptake inhibitors) during pregnancy may increase the risk of a serious condition in children called persistent pulmonary hypertension of the newborn, which causes rapid breathing and bluish discoloration. These symptoms usually occur within the first 24 hours after birth. If you notice their occurrence in your child, you should contact your midwife and/or doctor immediately.
• If you take duloxetine towards the end of your pregnancy, your baby may experience symptoms such as floppiness, trembling, jittering, difficulty feeding, breathing difficulties, and seizures. These usually occur at birth or within a few days of birth. If you notice any of these symptoms or are concerned about your baby's health, you should contact your doctor or midwife for help.
• If you take duloxetine towards the end of your pregnancy, there is an increased risk of excessive bleeding from the uterus shortly after delivery, especially if you have had bleeding disorders in the past. You should inform your doctor or midwife that you are taking duloxetine so that they can recommend appropriate action.
• You should inform your doctor if you are breastfeeding. Duloxetine is not recommended during breastfeeding. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and using machines

Duloxetine may cause drowsiness or dizziness. You should not drive or operate machinery until you know how duloxetine affects you.

Dulxetenon contains sucrose

Dulxetenon contains sucrose.If your doctor has previously determined that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Dulxetenon

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Duloxetine is taken orally. The capsule should be swallowed whole with water.
Treatment of depression:
The usual dose of duloxetine is 60 mg once a day. However, your doctor will prescribe the dose that is right for you.
Treatment of generalized anxiety disorder:
The usual starting dose of duloxetine is 30 mg once a day. In most patients, the dose is then increased to 60 mg once a day. However, your doctor will prescribe the dose that is right for you.
The dose may be increased up to 120 mg, depending on your response to treatment.
If a dose of 30 mg or 60 mg is prescribed, other medicines containing duloxetine should be used in these doses.
Taking duloxetine at the same time every day will help you remember to take it.
Your doctor will tell you how long to take Dulxetenon. Do not stop taking Dulxetenon or change your dose without consulting your doctor. Proper treatment of your condition is important so that you feel better. If left untreated, your condition may persist or worsen and become difficult to treat.

What to do if you take more Dulxetenon than you should

If you take more Dulxetenon than you should, you should contact your doctor or pharmacist immediately. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination disorders, restlessness, drunkenness, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

What to do if you forget to take Dulxetenon

If you forget to take a dose, you should take it as soon as possible. However, if it is time for your next dose, you should skip the missed dose and take a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily dose of duloxetine prescribed by your doctor.

What to do if you stop taking Dulxetenon

Even if you feel better, do notstop taking Dulxetenon without consulting your doctor. If your doctor decides that you no longer need to take duloxetine, they will recommend gradually reducing the dose over at least 2 weeks.
In some patients who stop taking duloxetine abruptly, symptoms may occur, such as dizziness, tingling or numbness, especially in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremors, headaches, muscle aches, irritability, diarrhea, or excessive sweating or dizziness.
These symptoms are usually not serious and resolve within a few days. However, if they are bothersome, you should contact your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dulxetenon can cause side effects, although not everybody gets them.
These effects are usually mild or moderate and usually disappear within a few weeks.

Very common side effects (may affect more than 1 in 10 people)

• headache, drowsiness
• nausea, dry mouth

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

• loss of appetite
• sleep disturbances, restlessness, decreased libido, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling slowed down, tremors, numbness, including numbness, tingling or prickling sensation of the skin
• blurred vision,
• ringing in the ears (hearing a sound in the ears without an external source of the sound)
• palpitations,
• increased blood pressure, sudden flushing of the face
• increased yawning
• constipation, diarrhea, abdominal pain, vomiting, heartburn or indigestion, gas
• increased sweating, rash (itching)
• muscle aches, muscle cramps
• painful urination, frequent urination
• difficulty or inability to achieve an erection, changes in ejaculation
• falls (especially in the elderly), fatigue
• weight loss

In children and adolescents under 18 years of age with depression treated with this medicine, weight loss has been observed after starting treatment. After 6 months of treatment, body weight increased and normalized compared to other children and adolescents of the same age and sex.

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

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding, disorientation, lack of motivation
• sudden involuntary movements or muscle twitching, feeling of restlessness or inability to sit still, agitation, difficulty concentrating, taste disturbances, difficulty controlling movements, e.g., lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• pupil dilation (dark central point of the eye), vision disturbances
• dizziness, feeling of spinning, ear pain
• rapid and/or irregular heartbeat
• fainting, dizziness, feeling of emptiness in the head or fainting when standing up, feeling of coldness in the fingers of the hands and/or feet
• throat constriction, nosebleeds
• vomiting blood or black, tarry stools, stomach and intestinal inflammation, reflux of stomach contents, difficulty swallowing
• liver inflammation, which can 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 and twitching
• difficulty or inability to urinate, difficulty starting to urinate, need to urinate at night, need to urinate more often than usual, decreased amount of urine passed
• abnormal vaginal bleeding, menstrual disturbances, including heavy, painful, irregular, or prolonged menstrual periods, scanty menstrual periods, or absence of menstrual periods, testicular pain or swelling
• chest pain, feeling of coldness, thirst, chills, feeling of heat, gait disturbances
• weight gain
• Duloxetine may cause side effects that you are not aware of, such as increased liver enzyme activity or potassium levels in the blood, increased creatine phosphokinase activity, blood glucose or cholesterol levels.

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

• severe allergic reaction causing difficulty breathing, dizziness with swelling of the tongue or lips, allergic reactions
• decreased thyroid function, which can cause fatigue or weight gain
• dehydration, low sodium levels in the blood (especially in the elderly; symptoms may include dizziness, weakness, confusion, drowsiness, excessive fatigue, or nausea, vomiting, more severe symptoms include fainting, seizures, and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, manic excitement state (excessive activity, racing thoughts, and decreased need for sleep), hallucinations, aggression, and manifestations of anger
• “serotonin syndrome” (a rare reaction that can cause excessive happiness, drowsiness, coordination disorders, restlessness, especially motor restlessness, drunkenness, fever, sweating, or muscle stiffness), seizures
• increased eye pressure (glaucoma)
• mouth inflammation, reddish blood in the stool, unpleasant breath, intestinal inflammation (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious disease with skin, mouth, eye, and genital ulcers), severe allergic reaction causing facial or throat swelling (angioedema)
• jaw muscle spasm
• abnormal urine odor
• menopausal symptoms, abnormal milk production in men or women in the breasts
• cough, wheezing, and shortness of breath, which may be accompanied by fever
• excessive bleeding from the uterus shortly after delivery (postpartum hemorrhage).

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

• inflammation of the blood vessels in the skin.

Frequency not known (cannot be estimated from the available data)

• objective and subjective symptoms of a disease called stress cardiomyopathy, which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dulxetenon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Blister (PA/Aluminum/PVC):
There are no special precautions for storage of the medicinal product.
Blister (PVC/PE/PVDC//Aluminum):
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dulxetenon contains

The active substanceis duloxetine.
Dulxetenon, 90 mg, gastro-resistant hard capsules
Each capsule contains 90 mg of duloxetine (as duloxetine hydrochloride).
Dulxetenon, 120 mg, gastro-resistant hard capsules
Each capsule contains 120 mg of duloxetine (as duloxetine hydrochloride).
Otheringredients are:
Contents of the capsule: hypromellose 2910, sucrose, maize starch, talc, sucrose, hypromellose phthalate, triethyl citrate.
Capsule shell:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only for Dulxetenon 90 mg), indigo carmine (E 132).

What Dulxetenon looks like and contents of the pack

Dulxetenon is a gastro-resistant hard capsule.
Dulxetenon is available in two strengths: 90 mg and 120 mg.
Capsules of 90 mg: White opaque body and green opaque cap, hard gelatin capsule size 0 E.
Capsules of 120 mg: Blue opaque body and blue opaque cap, hard gelatin capsule size 00.
Dulxetenon 90 mg is available in packs of 28 capsules.
Dulxetenon 120 mg is available in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona 69
Sant Joan Despí
08970 Barcelona
Spain
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
info-poland@neuraxpharm.com

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

GERMANY
Dulxetenon 90, 120 mg gastro-resistant hard capsules
ITALY
Dulxetenon
POLAND
Dulxetenon
PORTUGAL
Dulxetenon 90, 120 mg gastro-resistant hard capsules

Date of last revision of the leaflet: 07/2024