Depratal

Leaflet accompanying the packaging: patient information

Depratal, 30 mg, enteric-coated tablets

Depratal, 60 mg, enteric-coated tablets

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 Depratal and what is it used for
• 2. Important information before taking Depratal
• 3. How to take Depratal
• 4. Possible side effects
• 5. How to store Depratal
• 6. Package contents and other information

1. What is Depratal and what is it used for

Depratal contains the active substance duloxetine. Depratal increases the concentration of serotonin and norepinephrine in the nervous system.
Depratal is indicated for adults 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 sensations of touch, heat, or cold, and pressure may cause pain).

In most people with depression or anxiety, Depratal starts working within two weeks of starting treatment, but it may take 2 to 4 weeks before improvement occurs. If no improvement occurs after this time, consult a doctor. Even when the patient's condition has improved, the doctor may recommend continuing to take Depratal to prevent a relapse of depression or anxiety.
In people with diabetic neuropathic pain, improvement may occur after several weeks. Consult a doctor if improvement does not occur after 2 months.

2. Important information before taking Depratal

When not to take Depratal

• 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) (see "Depratal and other medicines");
• if the patient is taking fluvoxamine, which is mainly used to treat depression, ciprofloxacin, or enoxacin, which are used to treat certain infections;
• if the patient is taking other medicines containing duloxetine (see "Depratal 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 can take Depratal.

Warnings and precautions

The following are some reasons why Depratal should not be taken by the patient. Before starting Depratal, discuss with the doctor if any of the following apply:

• the patient is taking other antidepressant medicines (see "Depratal 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 manic episodes in the past,
• the patient has bipolar affective disorder,
• the patient has eye diseases, such as a certain type of glaucoma (increased pressure in the eye),
• the patient has had bleeding disorders in the past (tendency to bruise), especially if the patient is pregnant (see "Pregnancy and breastfeeding"),
• the patient is at risk of decreased sodium levels (e.g., when taking diuretics, especially in the elderly),
• the patient is taking other medicines that may cause liver damage,
• the patient is taking other medicines containing duloxetine (see "Depratal and other medicines"),
• the patient is being treated with buprenorphine. Taking this medicine with Depratal may lead to serotonin syndrome, a life-threatening condition (see "Depratal and other medicines")

Depratal may cause restlessness or an inability to sit still. If such symptoms occur, the patient should inform their doctor.
The patient should also contact their doctor:
If the patient experiences objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, sweating, or muscle stiffness, as these may indicate serotonin syndrome.
In severe cases, serotonin syndrome can resemble neuroleptic malignant syndrome.
The objective and subjective symptoms of neuroleptic malignant syndrome can include:
a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzyme activity (measured by blood tests).
Medicines like Depratal (so-called SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.
Suicidal thoughts and worsening depression or anxiety
Depression and/or anxiety can contribute to suicidal thoughts or behaviors. These may worsen after starting antidepressant medicines, as it may take some time, usually two weeks or longer, for the medicines to start working.
These thoughts may worsen in:

• patients who have had suicidal thoughts or self-harm in the past.
• young adults. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 with mental health conditions treated with antidepressant medicines.

In case of suicidal thoughts or self-harm, contact a doctor or go to the hospital immediately.

It may be helpful to inform a relative or close friend about the depressive or anxious state and ask them to read this leaflet. The patient can also ask for their opinion on whether the depressive or anxious state has worsened, and whether changes in behavior are causing concern.
Children and adolescents under 18 years of age
Depratal is not normally given to children and adolescents under 18 years of age. In patients under 18 years of age taking medicines of this class, there is a greater risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and expressions of anger). However, the doctor may recommend Depratal for patients under 18 years of age if they decide it is in their best interest. If the doctor recommends Depratal for a patient under 18 years of age, the patient should contact the doctor again. The patient should inform the doctor if any of the above side effects occur or worsen in patients under 18 years of age taking Depratal. Additionally, there is a lack of long-term safety data on the use of Depratal in this age group regarding growth, maturation, and cognitive and behavioral development.

Depratal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
Duloxetine, the active ingredient in Depratal, is also found in other medicines used to treat other conditions:

• diabetic neuropathic pain, depression, anxiety, and 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 Depratal can be taken with other medicines. Do not
start or stop taking other medicines, including those sold without a prescription and herbal medicines, without consulting a doctor.
The patient should inform their doctor if they are taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs):Depratal should not be taken with another antidepressant medicine called an MAOI, or too soon (within 14 days) after stopping an MAOI. Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medicines, including Depratal, can cause serious or life-threatening side effects.
After stopping an MAOI, the patient must wait at least 14 days before starting Depratal. Before starting an MAOI, the patient must wait at least 5 days after stopping Depratal.
Sedatives:These can be prescription medicines, such as benzodiazepines, strong painkillers, antipsychotic medicines, phenobarbital, and antihistamines.
Medicines that increase serotonin levels:These include buprenorphine, triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (e.g., paroxetine and fluoxetine), selective norepinephrine 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 (especially involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, diarrhea, coma, nausea, vomiting) while taking these medicines with Depratal, they should contact their doctor.
Oral anticoagulants or antiplatelet agents:Medicines that thin the blood or prevent blood clotting. These medicines may increase the risk of bleeding.

Depratal with food, drink, and alcohol

Depratal can be taken with or without food. The patient should be cautious when consuming alcohol while taking Depratal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

• The patient should tell their doctor if they become pregnant or plan to become pregnant while taking Depratal. The patient can only take Depratal after discussing the expected benefits and potential risks to the unborn child with their doctor.
• The patient should inform their midwife and/or doctor that they are taking Depratal. 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 the patient notices such symptoms in their child, they should contact their midwife and/or doctor immediately.
• If the patient takes Depratal towards the end of their pregnancy, such symptoms may occur in their child at birth. They usually occur at birth or within a few days after birth. The symptoms may include muscle weakness, trembling, difficulty feeding, breathing problems, and seizures. If the patient notices any of these symptoms or is concerned about their child's health, they should contact their doctor or midwife for help.
• If the patient takes Depratal towards the end of their pregnancy, there is an increased risk of excessive bleeding from the vagina shortly after delivery, especially if they have had bleeding disorders in the past. The patient should inform their doctor or midwife that they are taking duloxetine so that they can recommend appropriate action.
• The available data on the use of Depratal during the first three months of pregnancy do not indicate an increased risk of birth defects. If the patient takes Depratal in the second half of their pregnancy, there may be an increased risk of premature birth, mainly between 35 and 36 weeks of pregnancy (6 additional premature births per 100 women taking Depratal in the second half of pregnancy).
• The patient should inform their doctor if they are breastfeeding. It is not recommended to take Depratal while breastfeeding. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and using machines

Depratal may cause drowsiness or dizziness. The patient should not drive or operate machinery until they know how Depratal affects them.

Depratal contains sugar

Depratal contains sugar(98% sucrose). If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Depratal.

3. How to take Depratal

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Depratal is taken orally. The tablet should be swallowed whole with water.
Treatment of depression and diabetic neuropathic pain
The usual dose of Depratal is 60 mg taken once a day. The doctor will prescribe the dose suitable for the patient.
Treatment of generalized anxiety disorder
The usual starting dose of Depratal is 30 mg once a day. In most patients, the dose is then increased to 60 mg once a day. The doctor will prescribe the suitable dose for the patient. The dose may be increased up to 120 mg depending on the patient's response to treatment.
Taking Depratal at the same time every day will help the patient remember to take it.
The doctor will tell the patient how long to take Depratal. The patient should not stop taking Depratal or change the dose without consulting their doctor. It is essential to treat the condition properly so that the patient feels better. Without treatment, the condition may persist, and the patient's condition may worsen and become difficult to treat.

Taking a higher dose of Depratal than recommended

In case of taking a higher dose of Depratal than recommended, the patient should contact their doctor or pharmacist immediately. Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination problems, restlessness, especially agitation, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Depratal

In case of missing a dose, the patient should take it as soon as possible. However, if it is close to the time for the next dose, the patient should skip the missed dose and take a single dose at the usual time. The patient should not take a double dose to make up for the missed dose. The patient should not take more than the daily dose of Depratal prescribed by their doctor.

Stopping Depratal treatment

Even if the patient feels better, they should not stop taking the tablets without consulting their doctor. If the doctor decides that the patient no longer needs to take Depratal, they will recommend gradually reducing the dose over at least 2 weeks.
In some patients who stop taking Depratal abruptly, the following symptoms may occur:

• dizziness, tingling sensation like pins and needles or electric shock-like sensation (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty sleeping), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremors, headaches, muscle pain, irritability, diarrhea, and excessive sweating or dizziness due to balance problems. These symptoms are usually not serious and subside within a few days. However, if they are troublesome, the patient should contact their doctor.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Depratal 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, agitation, decreased libido, anxiety, difficulty or inability to achieve orgasm, vivid dreams
• dizziness, feeling slowed down, tremors, numbness, tingling sensation, or prickling of the skin
• blurred vision
• tinnitus (hearing a sound in the ears without an external source)
• palpitations
• increased blood pressure, flushing
• excessive yawning
• constipation, diarrhea, abdominal pain, vomiting, heartburn or indigestion, bloating
• increased sweating, rash (itching)
• muscle pain, muscle cramps
• painful urination, frequent urination
• erectile dysfunction, 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, 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)

• pharyngitis causing hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding, disorientation, lack of motivation
• sudden involuntary movements or muscle twitching, feeling restless or an 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, vision problems
• dizziness, dizziness due to balance problems, ear pain
• rapid or irregular heartbeat
• fainting, dizziness, feeling lightheaded or fainting when standing up, feeling cold 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 tremors
• difficulty or inability to urinate, difficulty starting urination, need to urinate at night, increased urination, decreased urine output
• abnormal vaginal bleeding, menstrual disturbances, including heavy, painful, irregular, or prolonged menstrual periods, or rare light or absent menstrual periods, testicular or scrotal pain
• chest pain, feeling cold, thirst, chills, feeling hot, gait disturbances
• weight gain
• Depratal may cause side effects that are not apparent, 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 1000 people)

• severe allergic reaction causing difficulty breathing, dizziness, swelling of the tongue or lips, other 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 and vomiting, or more severe symptoms such as fainting, seizures, and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, manic excitement (excessive activity, racing thoughts, and decreased need for sleep), hallucinations, aggression, and expressions of anger
• serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination problems, restlessness, especially agitation, feeling drunk, fever, sweating, or muscle stiffness), seizures
• tremors, muscle stiffness, slow movements, and gait disturbances (extrapyramidal symptoms)
• psychomotor restlessness
• hypertensive crisis (sudden increase in blood pressure with organ damage, affecting brain, heart, or kidney function)
• increased eye pressure (glaucoma)
• oral inflammation, red blood in stool, unpleasant breath, colitis (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 ulcers, eye ulcers, 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, shortness of breath, which may be accompanied by fever
• excessive bleeding from the vagina shortly after delivery (postpartum hemorrhage).

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

• vasculitis of the skin

Side effects with unknown frequency (cannot be estimated from the available data)

• Objective and subjective symptoms of a condition 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Depratal

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. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
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 need. This will help protect the environment.

6. Package contents and other information

What Depratal contains

The active substance of Depratal is duloxetine.
Each tablet contains 30 or 60 mg of duloxetine (in the form of hydrochloride).
Otheringredients are:
Tablet core: sugar compress (Compressuc MS); cornstarch; magnesium stearate.
Tablet coating: methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%; triethyl citrate; talc; titanium dioxide (E171), simethicone (emulsion).

What Depratal looks like and contents of the pack

Depratal is available in two strengths: 30 mg and 60 mg.
30 mg enteric-coated tablets: white or almost white, round, biconvex, film-coated tablets with a diameter of 7.0-7.5 mm, with " )" embossed on one side.
60 mg enteric-coated tablets: white or almost white, round, biconvex, film-coated tablets with a diameter of 10.0-10.5 mm.
Available packaging:
7, 28, or 56 tablets in blisters and a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: