Dutilox

Leaflet accompanying the packaging: information for the user

Dutilox, 30 mg, gastro-resistant hard capsules

Dutilox, 60 mg, gastro-resistant hard capsules

Duloxetine (in the form of hydrochloride)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should 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 Dutilox and what is it used for
• 2. Important information before taking Dutilox
• 3. How to take Dutilox
• 4. Possible side effects
• 5. How to store Dutilox
• 6. Contents of the packaging and other information

1. What is Dutilox and what is it used for

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

• depression,
• generalized anxiety disorders (chronic feeling of anxiety or nervousness),
• diabetic neuropathic pain (usually described as burning, piercing, stabbing, tearing, or electric shock-like pain. In a specific part of the body, there may be a loss of sensation or a feeling of touch, heat, cold, or pressure that can cause pain).

In most people with depression or anxiety, Dutilox starts working within two weeks of starting treatment, but it may take 2 to 4 weeks before an improvement occurs. If no improvement occurs after this time, you should consult your doctor. Your doctor may recommend continuing to take Dutilox to prevent a relapse of depression or anxiety, even if your condition has improved.
In people with diabetic neuropathic pain, an improvement in condition may occur after several weeks. You should consult your doctor if an improvement does not occur after 2 months.

2. Important information before taking Dutilox

When not to take Dutilox

• 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,

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• if the patient is taking or has taken in the last 14 days another medicine called a monoamine oxidase inhibitor (MAOI) (see "Dutilox and other medicines"),
• if the patient is taking fluvoxamine, which is mainly used to treat depression, ciprofloxacin, or enoxacin, medicines used to treat some infections,
• if the patient is taking other medicines containing duloxetine (see "Dutilox and other medicines").

You should tell your doctor if you have high blood pressure or heart disease. Your doctor will decide whether you should take Dutilox.

Warnings and precautions

Below are listed some reasons why Dutilox may not be suitable for you. Before taking Dutilox, you should inform your doctor if any of the following apply:

• taking other antidepressant medicines (see "Dutilox and other medicines") or buprenorphine. Taking these medicines at the same time as Dutilox may lead to a condition called serotonin syndrome, a potentially life-threatening condition (see "Dutilox and other medicines"),
• taking herbal medicines containing St. John's Wort (Hypericum perforatum),
• kidney disease,
• a history of seizures,
• a history of manic episodes,
• bipolar disorder,
• eye diseases, such as a certain type of glaucoma (increased pressure in the eye),
• bleeding disorders in the past (tendency to bruise), especially if you are pregnant (see "Pregnancy and breastfeeding"),
• risk of low sodium levels (e.g., when taking diuretics, especially in elderly patients),
• taking other medicines that may cause liver damage,
• taking other medicines containing duloxetine (see "Dutilox and other medicines").

Dutilox may cause a feeling of restlessness or an inability to sit or stand still. If such symptoms occur, you should inform your doctor.
Medicines like Dutilox (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening depression or anxiety
Depression and/or anxiety can lead to suicidal thoughts or self-harm. They may worsen after starting antidepressant medicines, as it may take some time, usually two weeks or longer, before the medicines start working.
These thoughts may worsen:

• in patients who have had suicidal thoughts or self-harm in the past,
• in young adults. Data from clinical trials have shown an increased risk of suicidal behavior in adults under 25 years of age with mental health conditions who were treated with antidepressant medicines.

If you experience suicidal thoughts or self-harm, you should contact your doctor or go directly to the hospital immediately.
It may be helpful to inform a relative or close friend about your depressive or anxious state and ask them to read this leaflet for you. You can also ask for their opinion on whether your depressive or anxious state has worsened, and whether changes in behavior are worrying them.
You should also contact your doctor:

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If you experience objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, increased 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.
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 tests).

Children and adolescents under 18 years of age

Dutilox is not usually given to children and adolescents under 18 years of age.
In patients under 18 years of age taking medicines of this class, the risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger) is increased. However, your doctor may recommend Dutilox for patients under 18 years of age if they decide it is beneficial for them. If you have any doubts when your doctor recommends Dutilox for a patient under 18 years of age, you should consult your doctor again. You should inform your doctor if a patient under 18 years of age taking Dutilox experiences any of the above side effects or if they worsen. Additionally, there is a lack of long-term safety data on the use of Dutilox in this age group regarding growth, maturation, and cognitive and behavioral development.

Dutilox and other medicines

You should 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 that are available without a prescription.
Duloxetine, the active substance of Dutilox, is also found in other medicines used to treat other conditions:

• diabetic neuropathic pain, depression, anxiety, and urinary incontinence. You should avoid taking more than one of these medicines at the same time. If you are already taking another medicine containing duloxetine, you should consult your doctor.

Your doctor will decide whether you can take Dutilox with other medicines. You should not start or stop taking other medicines, including those available without a prescription and herbal products, without consulting your doctor.
You should inform your doctor if you are taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs):You should not take Dutilox at the same time as another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) or within a short period of time (within 14 days) after stopping an MAOI. Examples of MAOIs are moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medicines, including Dutilox, can cause serious or even life-threatening side effects. After stopping an MAOI, at least 14 days must pass before starting Dutilox. You can start taking an MAOI only after 5 days have passed since stopping Dutilox.
Sedatives:These include prescription medicines, such as benzodiazepines, strong painkillers, antipsychotic medicines, phenobarbital, and antihistamines.
Medicines that increase serotonin levels:Triptans, tryptophan, selective serotonin reuptake inhibitors (e.g., paroxetine and fluoxetine), selective noradrenaline reuptake inhibitors (e.g., venlafaxine), tricyclic antidepressants (e.g., clomipramine, amitriptyline), St. John's Wort, MAOIs (e.g., moclobemide and linezolid), buprenorphine, tramadol, and pethidine. These medicines may interact with Dutilox, and you may experience involuntary, rhythmic muscle contractions, especially in the muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, fever above 38°C. You should contact your doctor if you experience any of these symptoms, as they may indicate a potentially life-threatening condition known as serotonin syndrome.
Oral anticoagulants or antiplatelet agents:Medicines that thin the blood or prevent blood clotting. These medicines may increase the risk of bleeding.

Taking Dutilox with food, drink, and alcohol

Dutilox can be taken with or without food.
You should be cautious when consuming alcohol while taking Dutilox.

Pregnancy and breastfeeding

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

• You should inform your doctor if you become pregnant or plan to become pregnant while taking Dutilox. You may take Dutilox after discussing the expected benefits of treatment and the possible risk to the unborn child with your doctor.

You should inform your midwife and/or doctor that you are taking Dutilox.
Taking 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. Such symptoms usually occur within the first 24 hours after birth. If you notice their occurrence in your baby, you should contact your midwife and/or doctor immediately.
If you take Dutilox towards the end of your pregnancy, certain symptoms may occur in your baby after birth. They usually occur at birth or within a few days after birth. The symptoms may include muscle weakness, trembling, jittering, difficulty feeding, breathing problems, and seizures. If you notice any of these symptoms or are concerned about your baby's health, you should consult your doctor or midwife, who will provide you with appropriate explanations.
If you take Dutilox towards the end of your pregnancy, there is an increased risk of excessive bleeding from the uterus shortly after delivery, especially if you have a history of bleeding disorders. You should inform your doctor or midwife about taking duloxetine so that they can recommend appropriate action.
Available data on the use of Dutilox during the first three months of pregnancy do not generally indicate an increased risk of congenital malformations in the child. If you take Dutilox in the second half of pregnancy, there may be an increased risk of premature birth, mainly between the 35th and 36th week of pregnancy (6 additional premature births per 100 women taking Dutilox in the second half of pregnancy).

• You should inform your doctor if you are breastfeeding. It is not recommended to take Dutilox while breastfeeding. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and using machines

Dutilox may cause drowsiness or dizziness. You should not drive or operate machinery until you know how Dutilox affects you.
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Dutilox contains sucrose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

Dutilox contains sodium

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

3. How to take Dutilox

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
Dutilox is taken orally. The capsule should be swallowed whole with water.
Treatment of depression and diabetic neuropathic pain
The usual dose of Dutilox is 60 mg taken 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 Dutilox 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 to 120 mg depending on your response to treatment.
Taking Dutilox at the same time every day may help you remember to take it.
Your doctor will tell you how long to take Dutilox. You should not stop taking Dutilox or change your dose without consulting your doctor. It is important to treat your condition properly, so that you feel better. If left untreated, your condition may persist or worsen and become difficult to treat.

Taking more Dutilox than prescribed

If you take more Dutilox than prescribed, 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, especially motor restlessness, feeling of intoxication, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Dutilox

If you miss 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. You should not take a double dose to make up for a missed dose. You should not take more than the prescribed daily dose of Dutilox.

Stopping treatment with Dutilox

YOU SHOULD NOT stop taking the capsules without consulting your doctor, even if you feel better. If your doctor decides that you no longer need to take Dutilox, they will recommend gradually reducing the dose over at least 2 weeks.
In some patients who stopped taking Dutilox abruptly, the following symptoms occurred:

• dizziness, feeling of tingling or electric shock (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty sleeping), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremors, headaches, muscle pain,

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irritability, diarrhea, and excessive sweating or dizziness due to balance disorders.
These symptoms are usually not serious and resolve within a few days. However, if they are troublesome, you should consult your doctor.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dutilox 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, agitation, decreased libido, anxiety, difficulty or inability to achieve orgasm, vivid 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 without an 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 erection, changes in ejaculation,
• falls (especially in elderly patients), 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, body weight increased and became comparable to that of 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 or clenching, 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 (the black center of the eye), vision problems,
• dizziness, dizziness due to balance disorders, ear pain,
• rapid and/or irregular heartbeat,
• fainting, dizziness, feeling of emptiness in the head or fainting when standing up, feeling of cold in the fingers of the hands and/or feet, 6
• throat constriction, nosebleeds,
• vomiting blood or black, tarry stools, stomach and intestinal inflammation, 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, difficulty starting to urinate, need to urinate at night, need to urinate more often than usual, weak urine stream,
• abnormal vaginal bleeding, menstrual disturbances, including heavy, painful, irregular, or prolonged menstrual periods, or absence of menstruation, testicular pain or swelling,
• chest pain, feeling of cold, thirst, chills, feeling of heat, gait disturbances,
• weight gain,
• Dutilox 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 elderly patients; symptoms may include dizziness, weakness, confusion, drowsiness, excessive fatigue, or nausea and vomiting, or more severe symptoms such as fainting, seizures, and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• suicidal behavior, mania (excessive activity, racing thoughts, and decreased need for sleep), hallucinations, aggression, and anger,
• serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination disorders, restlessness, especially motor restlessness, feeling of intoxication, fever, sweating, or muscle stiffness), seizures,
• increased eye pressure (glaucoma),
• cough, wheezing, and shortness of breath, which may be accompanied by fever,
• mouth inflammation, red 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 condition with skin ulcers, mouth, eye, and genital ulcers), severe allergic reaction causing swelling of the face or throat (angioedema),
• jaw muscle spasm,
• abnormal urine odor,
• menopausal symptoms, abnormal milk production in men or women,
• 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 blood vessels in the skin.

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

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

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Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported 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 Dutilox

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister/bottle and carton after EXP. The expiry date refers to the last day of the month.
30 mg:
OPA/Aluminum/PVC/Aluminum blisters:
There are no special storage instructions for the medicine.
Store in the original packaging to protect from light and moisture.
PVC/PVDC/Aluminum blisters:
Store at a temperature below 30°C.
Store in the original packaging to protect from light and moisture.
Bottle:
There are no special storage instructions for the medicine.
Store in the original packaging to protect from light and moisture.
60 mg:
OPA/Aluminum/PVC/Aluminum blisters:
There are no special storage instructions for the medicine.
Store in the original packaging to protect from moisture.
PVC/PVDC/Aluminum blisters:
Store at a temperature below 30°C.
Store in the original packaging to protect from moisture.
Bottle:
There are no special storage instructions for the medicine.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dutilox contains

• The active substance of Dutilox is duloxetine. 30 mg: each gastro-resistant hard capsule contains 30 mg of duloxetine (in the form of hydrochloride). 60 mg: each gastro-resistant hard capsule contains 60 mg of duloxetine (in the form of hydrochloride).

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• Other ingredients are: Capsule contents: hypromellose, talc, titanium dioxide (E 171), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, triethyl citrate, sucrose spheres, and sucrose.

Capsule shell:gelatin, titanium dioxide (E 171), indigo carmine (E 132), purified water, printing ink (iron oxide black (E 172), potassium hydroxide, and shellac), iron oxide yellow (E 172) (only in 60 mg capsules).

What Dutilox looks like and contents of the pack

Dutilox is a gastro-resistant hard capsule. Each Dutilox capsule contains duloxetine hydrochloride granules coated with a protective layer that prevents them from coming into contact with stomach acid.
The 30 mg capsules with imprint (cap E/body 127) are blue and white.
The 60 mg capsules with imprint (cap E/body 129) are blue and green.
Dutilox is available in:
30 mg:
OPA/Aluminum/PVC/Aluminum blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98 (2x49), and 504 (8x63) (hospital packaging) gastro-resistant hard capsules.
PVC/PVDC/Aluminum blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98, and 504 (4x126) (hospital packaging) gastro-resistant hard capsules.
A PE bottle with a PP cap and a desiccant sachet containing 500 gastro-resistant hard capsules (hospital packaging).
60 mg:
OPA/Aluminum/PVC/Aluminum blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60 (2x30), 84 (2x42), 98 (2x49), and 504 (8x63) (hospital packaging) gastro-resistant hard capsules.
PVC/PVDC/Aluminum blisters of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98, and 504 (4x126) (hospital packaging) gastro-resistant hard capsules.
A PE bottle with a PP cap and a desiccant sachet containing 500 gastro-resistant hard capsules (hospital packaging).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer

TOWA Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona
Spain
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TERAPIA SA
Str. Fabricii, nr.124,
Cluj-Napoca, Judet Cluj,
400632, Romania

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

Germany:
Dutilox 30 mg magensaftresistente Hartkapseln
Dutilox 60 mg magensaftresistente Hartkapseln
Austria:
Dutilox 30 mg magensaftresistente Hartkapseln
Dutilox 60 mg magensaftresistente Hartkapseln
Netherlands:
Dutilox 30 mg maagsapresistente capsules, harde
Dutilox 60 mg maagsapresistente capsules, harde
Poland:
Dutilox
Romania:
Duloxetină Terapia 30 mg capsule gastrorezistente
Duloxetină Terapia 60 mg capsule gastrorezistente
Belgium:
{FR}: Dutilox 30 mg, gélules gastro-résistantes
{NL}: Dutilox 30 mg maagsapresistente capsules, hard
{DE}: Dutilox 30 mg magensaftresistente Hartkapseln
Belgium:
{FR}: Dutilox 60 mg, gélules gastro-résistantes
{NL}: Dutilox 60 mg maagsapresistente capsules, hard
{DE}: Dutilox 60 mg magensaftresistente Hartkapseln
Date of last revision of the leaflet:July 2024
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