Duloxetine +pharma

Package Leaflet: Information for the User

Duloxetine +pharma, 30 mg, Gastro-Resistant Capsules, Hard

Duloxetine +pharma, 60 mg, Gastro-Resistant Capsules, Hard

Duloxetine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Duloxetine +pharma and what is it used for
• 2. Important information before taking Duloxetine +pharma
• 3. How to take Duloxetine +pharma
• 4. Possible side effects
• 5. How to store Duloxetine +pharma
• 6. Contents of the pack and other information

1. What is Duloxetine +pharma and what is it used for

Duloxetine +pharma contains the active substance duloxetine. Duloxetine +pharma increases the concentration of serotonin and noradrenaline in the nervous system.
Duloxetine +pharma is indicated for the treatment of adults with:

• depression
• generalized anxiety disorder (persistent feeling of anxiety or nervousness)
• diabetic neuropathic pain (usually described as burning, stabbing, stinging, shooting, or feeling like an electric shock. In a specific area of the body, there may be a loss of sensation, or sensations such as touch, heat, cold, or pressure may cause pain).

In most people with depression or anxiety, Duloxetine +pharma starts working within two weeks of starting treatment, but it may take 2 to 4 weeks before an improvement in mood is noticed. The patient should consult their doctor if they do not feel better after this time. Even if the patient's condition improves, the doctor may recommend continuing to take Duloxetine +pharma to prevent a relapse of depression or anxiety.
In people with diabetic neuropathic pain, an improvement in condition may occur after several weeks.
The patient should consult their doctor if an improvement has not occurred after 2 months.

2. Important information before taking Duloxetine +pharma

When not to take Duloxetine +pharma

• if the patient is allergic to duloxetine or any of the other ingredients of this medication (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 medication called a monoamine oxidase inhibitor (MAOI) (see "Duloxetine +pharma and other medications")
• if the patient is taking fluvoxamine, which is mainly used to treat depression, ciprofloxacin, or enoxacin - medications used to treat certain infections
• if the patient is taking other medications containing duloxetine (see "Duloxetine +pharma and other medications").

The patient should inform their doctor if they have high blood pressure or heart disease. The doctor will decide whether the patient should take Duloxetine +pharma.

Warnings and precautions

The following are reasons why Duloxetine +pharma may not be suitable for the patient. Before starting treatment with Duloxetine +pharma, the patient should discuss this with their doctor if:

• the patient is taking other antidepressant medications (see "Duloxetine +pharma and other medications");
• the patient is taking herbal remedies 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 certain types 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 currently taking other medications that may cause liver damage;
• the patient is taking other medications containing duloxetine (see "Duloxetine +pharma and other medications").

Duloxetine +pharma may cause a feeling of restlessness or an inability to sit still or stay in one place. If such symptoms occur, the patient should inform their doctor.
The patient should also contact their doctor:
if they experience objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting, as this may indicate serotonin syndrome.
In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome.
The 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 tests).
Medications like Duloxetine +pharma (so-called SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.
Suicidal thoughts and worsening depression or anxiety
People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the start of treatment with antidepressants, as these medications may start working only after some time, usually after 2 weeks, but sometimes later.
The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

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

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

It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient can also ask for their opinion on whether the patient's depressive or anxious state has worsened or if changes in behavior are causing concern. The patient may ask to be informed if they notice that the depression or anxiety has worsened or if there are worrying changes in behavior.

Children and adolescents under 18 years of age

Duloxetine +pharma should not normally be used in children and adolescents under 18 years of age. In patients under 18 years of age taking medications from this group, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and manifestations of anger). However, the doctor may recommend the use of Duloxetine +pharma in patients under 18 years of age if they decide it is beneficial for them. If there are any doubts about the recommendation to use Duloxetine +pharma in a patient under 18 years of age, the doctor should be consulted again. The doctor should be informed if any of the above side effects occur or worsen in a patient under 18 years of age taking Duloxetine +pharma.
Additionally, there is a lack of long-term safety data on the use of Duloxetine +pharma in this age group regarding growth, maturation, and cognitive and behavioral development.

Duloxetine +pharma and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription.
Duloxetine, the main ingredient in Duloxetine +pharma, may also be present in medications used to treat other conditions:

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

The patient should avoid taking more than one of these medications at the same time. The patient should consult their doctor if they are taking other medications containing duloxetine.
The doctor will decide whether Duloxetine +pharma can be taken with other medications.

Do not start or stop taking other medications, including over-the-counter medications and herbal preparations, without consulting a doctor.

The patient should also inform their doctor if they are taking any of the following medications:
Monoamine Oxidase Inhibitors (MAOIs)
Duloxetine +pharma should not be taken with another antidepressant medication called a monoamine oxidase inhibitor (MAOI) or within a short period of time (within 14 days) after stopping an MAOI.
Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medications, including Duloxetine +pharma, can cause serious or life-threatening side effects.
After stopping an MAOI, at least 14 days should pass before starting Duloxetine +pharma. Similarly, at least 5 days should pass after stopping Duloxetine +pharma before starting an MAOI.
Sedative medications
These include prescription medications such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
Medications that increase serotonin levels
Tryptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (such as paroxetine and fluoxetine), selective noradrenaline reuptake inhibitors (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, buprenorphine, St. John's Wort (Hypericum perforatum), and MAOIs (such as moclobemide and linezolid). These medications increase the risk of side effects.
If unusual symptoms occur while taking these medications with Duloxetine +pharma, the patient should consult their doctor.
Oral anticoagulants or antiplatelet agents
Medications that thin the blood or prevent blood clotting may increase the risk of bleeding.

Duloxetine +pharma with food, drink, and alcohol

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

Pregnancy and breastfeeding

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

• The patient should inform their doctor if they become pregnant or plan to become pregnant while taking Duloxetine +pharma. The patient may take Duloxetine +pharma only after discussing the possible benefits and risks with their doctor.
• The patient should inform their midwife and/or doctor that they are taking Duloxetine +pharma. The use of similar medications (selective serotonin reuptake inhibitors) during pregnancy may increase the risk of a serious condition in children called persistent pulmonary hypertension of the newborn, causing rapid breathing and bluish discoloration in the baby. These symptoms usually occur within the first 24 hours after birth. If the patient notices them in their baby, they should immediately contact their midwife and/or doctor.
• If the patient takes Duloxetine +pharma at the end of pregnancy, the newborn may experience certain symptoms. These symptoms usually occur at birth or within a few days. The symptoms may include floppiness, trembling, jittering, difficulty feeding, difficulty breathing, and seizures. If the patient notices any of these symptoms or is concerned about their baby's health, they should consult their doctor or midwife for help.
• If the patient takes Duloxetine +pharma at the end of pregnancy, there is an increased risk of excessive bleeding from the uterus shortly after delivery, especially if the patient has a history of bleeding disorders. The patient should inform their doctor or midwife about taking duloxetine so that they can recommend appropriate action.

Available data on the use of duloxetine during the first three months of pregnancy do not generally indicate an increased risk of congenital malformations in the baby. If the patient takes Duloxetine +pharma 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 duloxetine in the second half of pregnancy).

• The patient should inform their doctor if they are breastfeeding. It is not recommended to take Duloxetine +pharma during breastfeeding. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and using machines

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

Duloxetine +pharma contains sucrose

Duloxetine +pharma contains sucrose. If the doctor has previously determined that the patient has an intolerance to some sugars, the patient should consult their doctor before taking this medication.

3. How to take Duloxetine +pharma

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

Taking a higher dose of Duloxetine +pharma than prescribed

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

Missing a dose of Duloxetine +pharma

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose as usual. The patient should not take a double dose to make up for the missed dose. The patient should not take more than the prescribed daily dose of Duloxetine +pharma.

Stopping treatment with Duloxetine +pharma

THE PATIENT SHOULD NOT STOP TAKING DULOXETINE +PHARMA WITHOUT CONSULTING THEIR DOCTOR, even if they feel better. If the doctor decides that the patient no longer needs to take Duloxetine +pharma, they will recommend gradually reducing the dose over at least 2 weeks.
In some patients who stop taking Duloxetine +pharma abruptly, the following symptoms may occur:

• dizziness, tingling sensation similar to pins and needles or electric shock (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty falling asleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremors, headaches, muscle pain, irritability, diarrhea, excessive sweating, or dizziness of vestibular origin.

These symptoms are usually not serious and resolve within a few days. However, if they are bothersome, the patient should consult their doctor.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Duloxetine +pharma can cause side effects, although not everyone gets them.
These effects are usually mild to moderate and usually resolve within a few weeks.
Very common(may affect more than 1 in 10 people)

• headache, drowsiness
• nausea, dry mouth

Common(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 slowed down, tremors, numbness including numbness, tingling, or prickling sensation of the skin
• blurred vision
• tinnitus (hearing a sound in the ears when there is no external source)
• palpitations
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhea, abdominal pain, vomiting, reflux or dyspepsia, flatulence
• increased sweating
• (itchy) rash
• muscle pain, muscle spasms
• painful urination, frequent urination
• difficulty or inability to achieve erection, changes in ejaculation
• falls (especially in the elderly), fatigue
• weight loss

In children and adolescents under 18 years of age with depression, treated with this medication, a decrease in weight was 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(may affect up to 1 in 100 people)

• pharyngitis causing hoarseness
• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, disorientation, lack of motivation
• sudden involuntary movements or muscle twitching, feeling of restlessness or inability to sit still or stay in one place, agitation, confusion, 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 disturbances
• feeling of dizziness or "spinning" (vestibular dizziness), 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
• throat tightness, nosebleeds
• vomiting blood or black, tarry stools, gastritis, reflux or dyspepsia, difficulty swallowing
• liver inflammation, which can cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
• muscle stiffness and twitching
• difficulty or inability to urinate, frequent urination, need to urinate at night, need to urinate more often than usual, decreased urine output
• abnormal vaginal bleeding, menstrual disturbances, including heavy, painful, irregular, or prolonged menstrual periods, or absence of menstruation
• testicular or scrotal pain
• chest pain, feeling of cold, thirst, chills, feeling of heat, gait disturbances
• weight gain

Duloxetine +pharma may cause side effects that the patient may not be aware of, such as increased liver enzyme activity or potassium levels in the blood, increased creatine phosphokinase activity, blood glucose or cholesterol levels.

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

• severe allergic reaction causing difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions
• decreased thyroid function, which can cause fatigue or weight gain
• dehydration, low sodium levels in the blood (especially in the elderly; symptoms may include dizziness, weakness, confusion, drowsiness, nausea, or vomiting; more severe symptoms include fainting, seizures, and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, manic episodes (excessive activity, racing thoughts, and decreased need for sleep), hallucinations, aggression, and manifestations of anger
• serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination disorders, anxiety, especially motor anxiety, feeling of intoxication, fever, sweating, or muscle stiffness), seizures
• 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 disease with skin ulcers, mouth, eye, and genital ulcers)
• severe allergic reaction causing facial or throat swelling (angioedema)
• jaw muscle spasm
• abnormal urine odor
• menopausal symptoms, abnormal milk production in men or women
• cough, wheezing, shortness of breath, possibly with fever
• excessive bleeding from the uterus shortly after delivery (postpartum hemorrhage)

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

• inflammation of blood vessels in the skin

Frequency not known(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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 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 medication.

5. How to store Duloxetine +pharma

The medication should be stored out of sight and reach of children.
Duloxetine +pharma should not be taken after the expiration date stated on the package and blister after "EXP". The expiration date refers to the last day of the specified month.
There are no special storage instructions for this medication.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Duloxetine +pharma contains

• The active substance of Duloxetine +pharma is duloxetine.

Duloxetine +pharma, 30 mg, Gastro-Resistant Capsules, Hard
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Duloxetine +pharma, 60 mg, Gastro-Resistant Capsules, Hard
Each capsule contains 60 mg of duloxetine (as hydrochloride).

• Other ingredients are:
• capsule contents: sucrose, pellets (contains cornstarch), methacrylic acid and ethyl acrylate copolymer 1:1, dispersion 30% (Eudragit L30D55), hypromellose, sucrose, silicon dioxide, talc, triethyl citrate, Plasacryl T20 (glyceryl stearate, triethyl citrate, polysorbate 80, water).
• capsule shell Duloxetine +pharma, 30 mg:titanium dioxide (E 171), gelatin, indigo carmine (E 132), water. Duloxetine +pharma, 60 mg:titanium dioxide (E 171), gelatin, indigo carmine (E 132), iron oxide yellow (E 172), water.
• green ink (only Duloxetine +pharma, 30 mg): shellac, propylene glycol, potassium hydroxide, iron oxide black (E 172), iron oxide yellow (E 172).
• white ink (only Duloxetine +pharma, 60 mg): shellac, propylene glycol, povidone, titanium dioxide (E 171).

What Duloxetine +pharma looks like and contents of the pack

Duloxetine +pharma is available in the form of hard gastro-resistant capsules. Each capsule contains duloxetine hydrochloride pellets coated with a protective layer to prevent them from coming into contact with stomach acid.
Duloxetine +pharma, 30 mg, Gastro-Resistant Capsules, Hard
The capsules are hard, size 3, consisting of a non-transparent white body with a yellow print "30 mg" and a non-transparent blue cap with a yellow print "DLX".
Duloxetine +pharma, 60 mg, Gastro-Resistant Capsules, Hard
The capsules are hard, size 1, consisting of a non-transparent green body with a white print "60 mg" and a non-transparent blue cap with a white print "DLX".
Duloxetine +pharma is available in packs of 10, 28, and 30 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria
Date of last revision of the leaflet:August 2024