Package leaflet: information for the patient

Depratal, 30 mg, enteric-coated tablets
Depratal, 60 mg, enteric-coated tablets
Duloxetine (as hydrochloride)
Please read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Depratal is and what it is used for
Important information before taking Depratal
How to take Depratal
Possible side effects
How to store Depratal
Contents of the pack and other information

1. What Depratal is and what it is used for

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

depression,
generalized anxiety disorders (chronic feelings of anxiety or nervousness),
pain associated with diabetic neuropathy (usually described as burning, shooting, stabbing, aching, or electric-shock-like pain. In certain areas of the body, loss of sensation may occur, or touch, heat, or cold may be painful, and pressure may cause pain).

In most people with depression or anxiety, Depratal begins to work within two weeks of starting
treatment, although it may take from 2 to 4 weeks before improvement is noticeable. If there is no
improvement after this time, please consult your doctor. Even when your condition has improved,
your doctor may recommend continuing treatment with Depratal to prevent recurrence of depression
or anxiety.
In people with pain due to diabetic neuropathy, improvement may occur after several weeks. Please
consult your doctor if no improvement is observed after 2 months.

2. Important information before using Depratal

When not to use 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 within the last 14 days another medicine which is a monoamine oxidase inhibitor (MAOI) (see "Depratal with other medicines");
if the patient is taking fluvoxamine, which is mainly used in the treatment of depression, or ciprofloxacin or enoxacin, medicines used to treat certain infections;
if the patient is taking other medicines containing duloxetine (see "Depratal with other medicines"). Tell your doctor if the patient has high blood pressure or heart disease. The doctor will decide whether the patient can take Depratal.

Warnings and precautions
Below is a list of reasons why Depratal should not be used in a patient. Before starting treatment with Depratal, discuss with the doctor if any of the following apply:

the patient is taking other antidepressant medicines (see "Depratal with other medicines"),
the patient is taking herbal medicines containing St. John's wort (Hypericum perforatum),
the patient has kidney disease,
the patient has ever had seizures,
the patient currently has or has had episodes of mania in the past,
the patient has bipolar affective disorder,
the patient has eye diseases, such as a specific 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 low sodium levels (for example, when taking diuretics, particularly in elderly people),
the patient is taking other medicines that may cause liver damage,
the patient is taking other medicines containing duloxetine (see "Depratal with other medicines"),
the patient is being treated with buprenorphine. Taking this medicine together with Depratal may lead to serotonin syndrome, a potentially life-threatening condition (see section "Depratal with other medicines").

Depratal may cause feelings of restlessness or an inability to sit or stand still. If such symptoms occur, inform the doctor.
You should also contact the doctor:
If the patient experiences subjective and objective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, increased reflexes, diarrhoea, drowsiness, nausea, vomiting, as these may indicate serotonin syndrome.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome.
Symptoms of neuroleptic malignant syndrome may include:
fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased levels of muscle enzymes (detected by blood tests).
Medicines such as Depratal (so-called SNRIs) may cause symptoms of 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 may lead to thoughts of self-harm or suicide. These may worsen after starting antidepressant treatment, as it takes some time, usually two weeks or longer, before the medicines begin to work.
These thoughts may worsen:

in patients who previously had suicidal thoughts or thoughts of self-harm.
in young adults. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

If thoughts of self-harm or suicide occur, contact the doctor immediately
or go directly to hospital.
It may be helpful to inform a relative or close friend about the depressive or anxious condition and ask them to read this leaflet. You may also ask for their opinion on whether the depression or anxiety has worsened or whether changes in behaviour are concerning.

Children and adolescents under 18 years of age
Depratal is generally not recommended for use 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 adverse reactions such as suicide attempts, suicidal thoughts and hostility (mainly aggression, defiant behaviour and manifestations of anger). However, the doctor may prescribe Depratal for patients under 18 years of age if they decide it is beneficial. If in doubt, and the doctor recommends Depratal for a patient under 18 years of age, contact the doctor again. Inform the doctor if any of the adverse reactions listed above occur or worsen in a patient under 18 years of age taking Depratal. In addition, there are no long-term safety data on the use of Depratal in this age group regarding growth, maturation, cognitive development and behavioural development.

Depratal with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Duloxetine, the main ingredient in Depratal, is also present in other medicines used to treat other conditions:

diabetic neuropathic pain, depression, anxiety and urinary incontinence. Avoid taking more than one of these medicines simultaneously. The patient should consult the doctor if taking other medicines containing duloxetine.

The doctor will decide whether it is safe to take Depratal together with other medicines. Do not
start or stop taking other medicines, including those sold without a prescription and herbal
medicines, without consulting the doctor.
Inform the doctor if the patient is taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs): Do not take Depratal together 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 together with many prescription medicines, including Depratal, may cause severe or even life-threatening adverse reactions.
At least 14 days must pass after stopping an MAOI before starting Depratal. At least 5 days must pass after stopping Depratal before starting an MAOI.
Medicines causing drowsiness: These may include prescription medicines such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Medicines increasing 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, amitriptyline), pethidine, St. John's wort (Hypericum perforatum) and MAOIs (e.g. moclobemide and linezolid). These medicines increase the risk of adverse effects. If any symptoms occur (particularly involuntary, rhythmic muscle contractions, including those affecting eye movement, agitation, hallucinations, drowsiness, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C) while taking these medicines together with Depratal, contact the doctor.
Oral anticoagulants or antiplatelet medicines: 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 during or between meals. Exercise caution when consuming alcohol while taking Depratal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

The patient should inform the doctor if she becomes pregnant or plans to become pregnant while taking Depratal. The patient may take Depratal only after discussing with the doctor the expected benefits of treatment and possible risks to the unborn child.
The patient should inform the midwife and (or) doctor about taking Depratal. Taking similar medicines (selective serotonin reuptake inhibitors) during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn, causing rapid breathing and cyanosis in the baby. These symptoms usually occur within the first 24 hours after birth. If the patient notices such symptoms in her baby, she should contact the midwife and (or) doctor immediately.
If the patient takes Depratal towards the end of pregnancy, such symptoms may occur in her newborn at birth. They usually occur at birth or within a few days after birth. Symptoms may include muscle weakness, tremor, jitteriness, feeding difficulties, breathing problems and seizures. If the patient observes any of these symptoms or is concerned about the baby's health, she should contact the doctor or midwife for help.
If the patient takes Depratal towards the end of pregnancy, there is an increased risk of excessive vaginal bleeding shortly after delivery, especially if bleeding disorders occurred in the past. Inform the doctor or midwife about taking duloxetine so they can recommend appropriate management.
Available data on the use of Depratal during the first three months of pregnancy generally do not show an increased risk of congenital malformations in the child. If the patient takes Depratal during 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 Depratal in the second half of pregnancy).
The patient should inform the doctor if she is breastfeeding. Use of Depratal during breastfeeding is not recommended. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and operating machinery
Depratal may cause drowsiness or dizziness. The patient should not drive or operate machinery until they know how they react to Depratal.

Depratal contains a sugar – compressible sugar
Depratal contains sugar – compressible sugar (98% sucrose). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking the medicine.

3. How to take Depratal

This medicine should always be taken as directed by the physician or pharmacist. In case of doubt,
consult a physician 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 once daily. The physician will determine the appropriate dose
for the individual patient.

Treatment of generalized anxiety disorders
The usual initial dose of Depratal is 30 mg once daily. In most patients, the dose is subsequently
increased to 60 mg once daily. The physician will recommend the appropriate dose for the individual
patient. The dose may be increased up to 120 mg depending on the patient's response to treatment.
Taking Depratal at the same time each day will help ensure regular dosing.
The physician will inform the patient how long Depratal should be taken. Do not discontinue
treatment with Depratal or alter the dose without consulting the physician. Proper treatment of the
condition is essential for the patient to feel better. Without treatment, the condition may persist,
and the patient's condition may worsen and become difficult to treat.

Taking more Depratal than prescribed
If more Depratal than prescribed has been taken, contact a physician or pharmacist immediately.
Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction which may
cause excessive feelings of well-being, drowsiness, impaired motor coordination, restlessness,
alcohol-like intoxication, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Depratal
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip
the missed dose and take the next dose at the regular time. Do not take a double dose to make up for
a missed dose. Do not exceed the daily dose of Depratal prescribed by the physician.

Stopping Depratal treatment
Even if you feel better, DO NOT stop taking Depratal tablets without consulting your physician.
If the physician decides that the patient no longer needs to take Depratal, the dose will be gradually
reduced over at least two weeks.
In some patients who abruptly discontinue Depratal, the following symptoms may occur:

dizziness, tingling sensations like pins and needles or electric shocks (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty falling asleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhoea, excessive sweating, or dizziness caused by vestibular disturbances. These symptoms are usually not serious and resolve within a few days. However, if they are bothersome, contact the physician.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These reactions are usually mild or moderate and typically resolve after a few weeks.

Very common adverse reactions (may affect more than 1 in 10 people)

headache, drowsiness
nausea, dry mouth

Common adverse reactions (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 sluggishness, muscle tremors, numbness, tingling or prickling sensation of the skin
blurred vision
tinnitus (perception of ringing in the ears in the absence of external sound sources)
palpitations
increased blood pressure, sudden flushing of the face
excessive yawning
constipation, diarrhoea, abdominal pain, vomiting, heartburn or indigestion, bloating
increased sweating, rash (itchy)
muscle pain, muscle cramps
painful urination, frequent urination
problems achieving erection, changes in ejaculation
falls (especially in elderly people), fatigue
weight loss

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

Uncommon adverse reactions (may affect up to 1 in 100 people)

throat inflammation 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 still or stay in one place, irritability, difficulty concentrating, taste disturbances, difficulty controlling movements (e.g. lack of coordination or unintended muscle movements), restless legs syndrome, impaired sleep quality
dilated pupils (dark central spot of the eye), vision problems
dizziness, dizziness due to vestibular disorders, ear pain
fast and/or irregular heartbeat
fainting, dizziness, feeling of emptiness in the head or fainting upon standing, cold sensation in fingers of hands and/or feet
sore throat, nosebleeds
vomiting blood or black, tarry stools, inflammation of the stomach and intestines, regurgitation of stomach contents, difficulty swallowing
liver inflammation, which may cause abdominal pain and yellowing of the skin or whites of the eyes
night sweats, urticaria, cold sweats, photosensitivity, increased tendency to bruising
muscle stiffness and tremors
difficulty or inability to urinate, difficulty initiating urination, need to urinate at night, increased urination, reduced urine output
abnormal vaginal bleeding, menstrual disorders including heavy, painful, irregular or prolonged periods, rarely scanty periods or absence of menstruation, testicular or scrotal pain
chest pain, cold sensation, thirst, chills, hot flushes, gait disturbances
weight gain
Depratal may cause adverse reactions of which one may be unaware, such as increased liver enzyme activity or increased blood potassium levels, increased creatine kinase activity, increased blood glucose or cholesterol levels.

Rare adverse reactions (may affect up to 1 in 1,000 people)

severe allergic reaction causing difficulty breathing, dizziness, swelling of the tongue or lips, other allergic reactions
decreased thyroid function, which may cause fatigue or weight gain
dehydration, low blood sodium levels (especially in elderly people; symptoms may include: dizziness, weakness, confusion, drowsiness, excessive fatigue, nausea, or vomiting; more severe symptoms include fainting, seizures, and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
suicidal behaviour, manic state (excessive activity, racing thoughts, and reduced need for sleep), hallucinations, aggression, and expressions of anger
"serotonin syndrome" (a rare reaction that may cause feelings of excessive well-being, drowsiness, motor incoordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness), seizures
tremors, muscle rigidity, slowed movements, and gait disturbances (extrapyramidal symptoms)
psychomotor restlessness
hypertensive crisis (sudden increase in blood pressure with organ complications affecting the brain, heart, or kidneys)
increased intraocular pressure (glaucoma)
inflammation of the mouth, bright red blood in stool, bad breath, inflammation of the large intestine (leading to diarrhoea)
liver failure, yellowing of the skin or whites of the eyes (jaundice)
Stevens-Johnson syndrome (a serious condition with skin, oral cavity, eye, and genital ulceration), severe allergic reaction causing facial or throat swelling (angioedema)
jaw muscle spasm
abnormal urine odour
menopausal symptoms, abnormal milk production in men or women in the mammary glands
cough, wheezing, and shortness of breath, possibly accompanied by fever
excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage)

Very rare adverse reactions (may affect up to 1 in 10,000 people)

cutaneous vasculitis (inflammation of blood vessels in the skin)

Adverse reactions 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Depratal

Keep this medicine 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 stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. 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 (as hydrochloride).
Other ingredients are:
Tablet core: compressible sugar (Compressuc MS); maize starch; magnesium stearate.
Tablet coating: methacrylic acid copolymer and ethyl acrylate copolymer (1:1), 30% dispersion; 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.
Enteric-coated 30 mg tablets: white or almost white, round, biconvex coated tablets with a diameter of 7.0–7.5 mm, imprinted with " )" on one side.
Enteric-coated 60 mg tablets: white or almost white, round, biconvex coated tablets with a diameter of 10.0–10.5 mm.
Available pack sizes:
7, 28 or 56 tablets in blister packs within a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

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