Depratal

Leaflet attached to the packaging: patient information

Depratal, 30 mg, gastro-resistant tablets

Depratal, 60 mg, gastro-resistant tablets

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 to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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. Contents of the pack 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 noradrenaline in the nervous system.
Depratal is indicated for the treatment of adults with:

• depression,
• generalized anxiety disorders (chronic feelings of anxiety or nervousness),
• diabetic neuropathic pain (usually described as burning, stabbing, shooting, shooting, 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, you should consult a doctor. Even when your condition improves, your 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. You should consult a doctor if improvement does not occur after 2 months.

2. Important information before taking Depratal

When not to take Depratal

• if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
• if you have liver disease;
• if you have severe kidney disease;
• if you are taking or have taken another medicine called a monoamine oxidase inhibitor (MAOI) in the last 14 days (see "Depratal and other medicines");
• if you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin, or enoxacin, which are used to treat certain infections;
• if you are taking other medicines containing duloxetine (see "Depratal and other medicines"). You should tell your doctor if you have high blood pressure or heart disease. The doctor will decide whether you can take Depratal.

Warnings and precautions

Below are some reasons why Depratal should not be used in a patient. Before starting Depratal, you should discuss this with your doctor if any of the following apply:

• you are taking other antidepressant medicines (see "Depratal 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 episodes of mania in the past,
• you have bipolar affective disorder,
• you have eye diseases, such as a certain type of glaucoma (increased pressure in the eye),
• you have had bleeding disorders in the past (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 taking other medicines that may cause liver damage,
• you are taking other medicines containing duloxetine (see "Depratal and other medicines"),
• you are 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 feelings of restlessness or an inability to sit or stand 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, elevated body temperature, sweating, or muscle stiffness, as this may indicate serotonin syndrome.
In the most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome.
Objective and subjective symptoms of neuroleptic malignant syndrome may include:
a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzyme activity (determined by blood test).
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 may contribute to suicidal thoughts or self-harm. They may worsen after starting antidepressant medication, 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.
• in young adults. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 with mental health disorders treated with antidepressant medication.

In case of 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. You can also ask for their opinion on whether your 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 this type of medicine, 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, your doctor may prescribe Depratal for patients under 18 years of age if they decide it is in their best interest. If your doctor prescribes Depratal for a patient under 18 years of age, you should contact your doctor again if you have any doubts. You should inform your doctor if any of the above side effects occur or worsen in a patient 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

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available 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. 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 Depratal with other medicines. Do not
start or stop taking other medicines, including those available without a prescription and herbal medicines, 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 Depratal with another antidepressant medicine called a monoamine oxidase inhibitor (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, you must wait at least 14 days before starting Depratal. Before starting an MAOI, you must wait at least 5 days after stopping Depratal.
Sedative medicines:These may be prescription medicines, e.g., 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 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 (especially involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, diarrhea, coma, nausea, vomiting) while taking these medicines with Depratal, 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.

Depratal with food, drink, and alcohol

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

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 Depratal. You can only take Depratal after discussing the expected benefits and potential risks to the unborn child with your doctor.
• You should inform your midwife and/or doctor that you 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. Such symptoms usually occur within the first 24 hours after birth. If you notice such symptoms in your child, you should contact your midwife and/or doctor immediately.
• If you take Depratal towards the end of your pregnancy, such symptoms may occur in your child at birth. They usually occur at birth or within a few days after birth. 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 child's health, you should contact your doctor or midwife for help.
• If you take Depratal 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.
• Available data on the use of Depratal during the first three months of pregnancy do not generally indicate an increased risk of birth defects. If you take Depratal during the second half of 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).
• You should inform your doctor if you 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. You should not drive or operate machinery until you know how Depratal affects you.

Depratal contains sugar

Depratal contains sugar(98% sucrose). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Depratal

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.
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. Your doctor will prescribe the dose that is right for you.
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. 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.
Taking Depratal at the same time every day will help you remember to take it.
Your doctor will tell you how long to take Depratal. You should not stop taking Depratal or change your dose without consulting your doctor. It is important to treat your condition properly, so that you feel better. Without treatment, your condition may persist, and your symptoms may worsen and become difficult to treat.

What to do if you take more Depratal than you should

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

What to do if you miss a dose of Depratal

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and take your usual dose at the usual time. You should not take a double dose to make up for a missed dose. You should not take more than the daily dose of Depratal prescribed by your doctor.

What to do if you stop taking Depratal

Even if you feel better, do notstop taking the tablets without consulting your doctor. If your doctor decides that you no longer need to take Depratal, they will advise you to gradually reduce 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 disorders. These symptoms are usually not serious and subside within a few days. However, if they are troublesome, you should contact your doctor.

If you have any further questions about the use of this medicine, you should ask your 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 sensation 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 spasms
• 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, 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)

• pharyngitis 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 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 central point 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 coldness in the fingers of the hands and/or feet
• throat constriction, nosebleeds
• vomiting blood or black, tarry stools, gastritis, reflux, difficulty swallowing
• hepatitis, 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 of coldness, thirst, chills, feeling of heat, gait disturbances
• weight gain
• Depratal 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 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, or 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 expressions of 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
• tremors, muscle stiffness, slow movements, and gait disturbances (extrapyramidal symptoms)
• psychomotor agitation
• hypertensive crisis (sudden increase in blood pressure with organ complications, affecting brain, heart, or kidney function)
• increased eye pressure (glaucoma)
• stomatitis, 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, 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)

• vasculitis of the skin

Side effects with unknown frequency (cannot be estimated from 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects 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
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 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 storage instructions for this medicine.
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 pack and other information

What Depratal contains

The active substance 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 gastro-resistant 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 gastro-resistant 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: