Dulxetenon

Leaflet accompanying the packaging: patient information

Dulxetenon, 30 mg, gastro-resistant hard capsules

Dulxetenon, 60 mg, gastro-resistant hard capsules

Duloxetine (in the form of hydrochloride)

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents and other information

1. What is Dulxetenon and what is it used for

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

• depression
• generalized anxiety disorders (persistent feeling of anxiety or nervousness),
• diabetic neuropathic pain (usually described as burning, stabbing, shooting, cutting, or electric shock-like pain. There may be a loss of sensation in the affected area, and sensations such as touch, heat, cold, or touch may cause pain)

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. If the patient does not feel better after this time, they should consult their doctor. Even if the patient's condition improves, the doctor may recommend continuing to take Dulxetenon to prevent a relapse of depression or anxiety.
In people with diabetic neuropathic pain, an improvement in condition may occur only after several weeks.
If an improvement has not occurred after 2 months, the patient should consult their doctor.

2. Important information before taking Dulxetenon

When not to take Dulxetenon:

• if the patient is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver disease;
• if the patient has severe kidney disease;
• if the patient is taking or has taken another medicine called a monoamine oxidase inhibitor (MAOI) in the last 14 days (see "Dulxetenon and other medicines");
• if the patient is taking fluvoxamine, which is usually used to treat depression, ciprofloxacin, or enoxacin, which are used to treat certain infections;
• if the patient is taking other medicines containing duloxetine (see "Dulxetenon and other medicines").

The patient should tell their doctor if they have high blood pressure or heart disease.
The doctor will decide whether the patient should take Dulxetenon.

Warnings and precautions

The following are some reasons why Dulxetenon may not be suitable for the patient.
Before starting Dulxetenon, the patient should discuss with their doctor if:

• the patient is taking other antidepressant medicines (see "Dulxetenon and other medicines").
• the patient is taking herbal medicines containing St. John's Wort (Hypericum perforatum)
• the patient has kidney disease
• the patient has had seizures in the past
• the patient has had episodes of mania in the past
• the patient has bipolar affective disorder
• the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eye)
• the patient has had bleeding disorders (tendency to bruise)
• the patient is at risk of decreased sodium levels (e.g., when taking diuretics, especially in the elderly)
• the patient is currently taking other medicines that may cause liver damage the patient is taking other medicines containing duloxetine (see "Dulxetenon and other medicines").

Medicines like Dulxetenon (so-called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after treatment is stopped.

• 4). In some cases, these symptoms persist after treatment is stopped.

Dulxetenon may cause restlessness or an inability to sit or stand still. If such symptoms occur, the patient should inform their doctor.
The patient should also contact their doctor if they experience:
Objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, increased blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting, as these may indicate serotonin syndrome.
In its most severe form, serotonin syndrome can resemble malignant neuroleptic syndrome. The 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 starting to take antidepressant medicines, as these medicines start to work only after some time, usually after 2 weeks, but sometimes later.
Suicidal thoughts, self-harm thoughts, or suicide attempts are more likely if:

• the patient has had suicidal thoughts or self-harm in the past
• the patient is a young adult - clinical trials indicate an increased risk of suicidal behavior in people under 25 with mental disorders taking antidepressant medicines.

If the patient experiences suicidal thoughts or self-harm thoughts, they should immediately contact their doctor or go to the hospital.

It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient can also ask for their opinion on whether their depressive or anxious condition has worsened or if changes in behavior are worrying them. The patient may ask to be informed if they notice that depression or anxiety has worsened or if worrying changes in behavior have occurred.

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 suicide attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may recommend the use of Dulxetenon in patients under 18 years of age if they decide that it is beneficial for them. In case of doubts about the recommendation to use Dulxetenon in a patient under 18 years of age, the doctor should be consulted again. The doctor should be informed if a patient under 18 years of age taking Dulxetenon experiences any of the above-mentioned 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Duloxetine, the active ingredient of Dulxetenon, is also found in other medicines used to treat other diseases:

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

The patient should avoid taking more than one of these medicines at the same time. The patient should consult their doctor if they are taking other medicines containing duloxetine.
The doctor will decide whether the patient can take Dulxetenon with other medicines. Do not
start or stop taking other medicines, including over-the-counter medicines and herbal products, without consulting a doctor.
The patient should inform their doctor if they are taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs):
Dulxetenon should not be taken 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, at least 14 days should pass before starting to take Dulxetenon. Before starting to take an MAOI, at least 5 days should pass 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 the patient experiences any symptoms while taking these medicines with Dulxetenon, they should consult their 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.
The patient should be cautious when consuming alcohol while taking Dulxetenon

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
If the patient becomes pregnant while taking duloxetine, they should inform their doctor. The patient may take duloxetine only after discussing the expected benefits of treatment and the possible risk to the unborn child with their doctor.
The patient should inform their midwife and/or doctor that they 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 in the baby. These symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in their baby, they should immediately contact their midwife and/or doctor.
If the patient takes duloxetine towards the end of their pregnancy, their baby may experience:
muscle weakness, trembling, shaking, difficulty feeding, breathing problems, and seizures.
These usually occur at birth or within a few days of birth. If the patient notices any of these symptoms or is concerned about their baby's health, they should consult their doctor or midwife for help.
Breastfeeding
The patient should inform their doctor if they 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. The patient should not drive or operate machinery until they know how duloxetine affects them.

Dulxetenon contains sucrose

Dulxetenon contains sucrose.If the doctor has previously determined that the patient has an intolerance to some sugars, the patient should consult their doctor before taking this medicine.

3. How to take Dulxetenon

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Duloxetine is taken orally. The capsule should be swallowed whole, with a glass of water.
Treatment of depression and diabetic neuropathic pain:
The usual dose of duloxetine is 60 mg taken once a day. However, the doctor will prescribe a dose suitable for the individual patient.
Treatment of generalized anxiety disorder:
The usual initial dose of duloxetine is 30 mg once a day. In most patients, the dose is then increased to 60 mg once a day. However, the doctor will prescribe a suitable dose for the individual patient.
The dose may be increased up to 120 mg, depending on the patient's response to treatment.
Taking duloxetine at the same time every day will help the patient remember to take it.
The doctor will inform the patient how long they should take Dulxetenon. The patient should not stop taking Dulxetenon or change the dose without consulting their doctor. Proper treatment of the disease is essential for the patient to feel better. Without treatment, the patient's condition may persist or worsen and become difficult to treat.

Taking a higher dose of Dulxetenon than recommended

If the patient takes a higher dose of Dulxetenon than recommended, they should immediately consult their doctor or pharmacist. Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination disorders, anxiety, especially restlessness, feeling of intoxication, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Dulxetenon

If the patient misses a dose, they should take it as soon as possible. However, if it is time for the next dose, the patient should skip the missed dose and take a single dose as usual. The patient should not take a double dose to make up for the missed dose. The patient should not take a higher daily dose of duloxetine than prescribed by their doctor.

Stopping treatment with Dulxetenon

Even if the patient feels better, they should notstop taking Dulxetenon without consulting their doctor. If the doctor decides that the patient no longer needs to take duloxetine, they will recommend a gradual reduction of the dose over at least 2 weeks.
In some patients who stop taking duloxetine abruptly, the following symptoms may occur: dizziness, tingling sensation similar to pins and needles or electric shock-like sensation (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty falling asleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea, vomiting, tremors, headaches, muscle pain, irritability, diarrhea, or excessive sweating or dizziness.
These symptoms are usually not serious and subside within a few days. However, if they are troublesome, the patient should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their 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 subside after 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 of slowing down, tremors, numbness, including numbness, tingling, or prickling sensation of the skin
• blurred vision,
• ringing in the ears (hearing a sound in the ears when there is no external source of the sound)
• palpitations,
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhea, abdominal pain, vomiting, heartburn or indigestion, gas
• increased sweating, rash (itching)
• muscle pain, muscle spasms
• 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, a decrease in weight has been observed after starting treatment. After 6 months of treatment, weight increased and normalized with that observed in other children and adolescents of the same age and sex.

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

• pharyngitis causing hoarseness
• suicidal thoughts, difficulty falling asleep, teeth grinding, disorientation, lack of motivation
• sudden involuntary movements or muscle twitching, feeling of restlessness or inability to sit or stand 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 center 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 tightness, nosebleeds
• vomiting blood or black, tarry stools, gastritis, reflux, 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, frequent urination at night, need to urinate more often than usual, decreased amount of urine
• abnormal vaginal bleeding, menstrual disturbances, including heavy, painful, irregular, or prolonged menstrual periods, decreased menstrual periods, or absence of menstruation, testicular pain or scrotal pain
• chest pain, feeling of coldness, thirst, chills, feeling of warmth, gait disturbances
• weight gain

Duloxetine may cause side effects that the patient may not be 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, anxiety, especially restlessness, feeling of intoxication, fever, sweating, or muscle stiffness), seizures

alkoholowego, gorączkę, pocenie się lub sztywność mięśni), drgawki

• increased eye pressure (glaucoma)
• mouth inflammation, red blood in stool, bad breath, colitis (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.

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

• vasculitis of the skin.

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dulxetenon

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
The batch number is printed on the label and the carton (Lot).
Store in the original package. Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

Composition of Dulxetenon

The active substance of Dulxetenon is duloxetine. Each capsule contains 30 or 60 mg of duloxetine (in the form of hydrochloride).
Otheringredients are:
Contents of the capsule: hypromellose, sucrose, maize starch, talc, sucrose, hypromellose phthalate, triethyl citrate.
Body of the capsule:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only for 60 mg), indigo carmine (E 132) (only for 60 mg).
Capsule cap:gelatin, titanium dioxide (E 171), indigo carmine (E 132).

What Dulxetenon looks like and what the pack contains

Dulxetenon is a gastro-resistant hard capsule.
Dulxetenon is available in two strengths: 30 mg and 60 mg.
The 30 mg capsules are blue and white.
The 60 mg capsules are blue and green.
Dulxetenon 30 mg is available in PA/Aluminum/PVC/Aluminum blisters in cardboard boxes containing 7 or 28 capsules.
Dulxetenon 60 mg is available in PA/Aluminum/PVC/Aluminum blisters in cardboard boxes containing 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. Barcelona 69
08970 Sant Joan Despí (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. Domaniewska 37
02-672 Warsaw
info-poland@neuraxpharm.com

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

SPAIN
Dulxetenon 30 mg gastro-resistant hard capsules
Dulxetenon 60 mg gastro-resistant hard capsules
GERMANY
Dulxetenon 30 mg enteric-coated hard capsules
Dulxetenon 60 mg enteric-coated hard capsules
HUNGARY
Dulxetenon 30 mg gastro-resistant hard capsules
Dulxetenon 30 mg gastro-resistant hard capsules
ITALY
Dulxetenon FB HEALTH
PORTUGAL
Dulxetenon 30 mg gastro-resistant hard capsules
Dulxetenon 60 mg gastro-resistant hard capsules
SLOVAKIA
Dulxetenon 30 mg gastro-resistant hard capsules
Dulxetenon 60 mg gastro-resistant hard capsules
POLAND
Dulxetenon

Date of last revision of the leaflet: 07/2024