Duloxetine Sandoz

Leaflet accompanying the packaging: patient information

Duloxetine Sandoz, 30 mg, hard gastro-resistant capsules

Duloxetine Sandoz, 60 mg, hard gastro-resistant capsules

Duloxetine

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Duloxetine Sandoz and what is it used for

Duloxetine Sandoz contains the active substance duloxetine. The medicine increases the levels of serotonin and noradrenaline in the nervous system.
Duloxetine Sandoz is used in adults for the treatment of:

• depression,
• generalized anxiety disorder (persistent feeling of anxiety or nervousness),
• diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting, or like an electric shock. In some cases, there may be a loss of sensation or a feeling of touch, heat, cold, or pressure may be painful).

In most people with depression or anxiety, Duloxetine Sandoz starts to work within two weeks of starting treatment, but improvement in mood may take up to 2 to 4 weeks. If the patient does not feel better after this time, they should tell their doctor. Even if there is an improvement in the patient's condition, the doctor may recommend continued treatment with Duloxetine Sandoz to prevent a relapse of depression or anxiety.
In people with diabetic neuropathic pain, improvement may occur after several weeks. The patient should consult their doctor if there is no improvement after 2 months.

2. Important information before taking Duloxetine Sandoz

When not to take Duloxetine Sandoz

• 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 called a monoamine oxidase inhibitor (MAOI), see "Duloxetine Sandoz and other medicines".
• if the patient is taking fluvoxamine (a medicine used to treat depression),

cyproheptadine or enoxacin (medicines used to treat certain infections).
The patient should tell their doctor if they have high blood pressure or heart disease. The doctor will decide whether the patient should take Duloxetine Sandoz.

Warnings and precautions

The following are reasons why Duloxetine Sandoz may not be suitable for the patient.
Before taking Duloxetine Sandoz, the patient should discuss with their doctor if they:

• are taking other antidepressant medicines (see "Duloxetine Sandoz and other medicines");
• are taking a herbal remedy containing St. John's Wort (Hypericum perforatum);
• have kidney disease;
• have had seizures in the past;
• have had episodes of mania in the past;
• have bipolar disorder;
• have eye problems, such as a certain type of glaucoma (increased pressure in the eye);
• have had bleeding disorders (tendency to bruise), especially if they are pregnant (see "Pregnancy and breastfeeding");
• are at risk of low sodium levels (associated with, for example, the use of diuretics, especially in the elderly).
• are taking other medicines that may cause liver damage;
• are taking another medicine containing duloxetine (see "Duloxetine Sandoz and other medicines").

Duloxetine Sandoz may cause feelings of restlessness or an inability to sit or stand 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 anxiety, hallucinations, disorientation, rapid heartbeat, increased blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting, as this may indicate serotonin syndrome.
In its most severe form, serotonin syndrome can resemble 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, increased muscle enzyme activity (determined by blood tests).
Medicines such as Duloxetine Sandoz (so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after treatment has stopped.

Suicidal thoughts and worsening depression or anxiety

People with depression and/or anxiety may sometimes have thoughts of self-harm or suicide. These thoughts may worsen when first taking antidepressant medicines, as these medicines may take some time to work, usually about 2 weeks, but sometimes longer.
Suicidal thoughts or thoughts of self-harm or suicide are more likely to occur:

• if the patient has had suicidal thoughts or self-harm in the past;
• if the patient is a young adult - clinical trial data suggest an increased risk of suicidal behavior in young adults with mental health problems taking antidepressant medicines.

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

It may be helpful for the patient to tell their relatives or friends that they are taking this medicine and ask them to read this leaflet. The patient may want to ask them to tell them if they notice any worsening of their depression or anxiety or any changes in their behavior.

Children and adolescents under 18 years of age

Duloxetine Sandoz should not normally be used in children and adolescents under 18 years of age. When taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as attempted suicide, suicidal thoughts, and hostility (especially aggression, rebelliousness, and anger). However, the doctor may prescribe Duloxetine Sandoz to patients under 18 years of age, considering that it is in their best interest. If the doctor has prescribed Duloxetine Sandoz to a patient under 18 years of age and this has raised concerns, the patient should discuss this with their doctor. If such a patient taking Duloxetine Sandoz experiences or worsens the above symptoms, they should inform their doctor. Additionally, there are no data on the long-term safety of Duloxetine Sandoz in this age group regarding growth, maturation, and cognitive and behavioral development.

Duloxetine Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking now or have recently taken, as well as any medicines they plan to take.
Duloxetine, the active ingredient of Duloxetine Sandoz, is also contained in other medicines used to treat:

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

The patient should avoid taking more than one of these medicines at the same time. If the patient is already taking another medicine containing duloxetine, they should consult their doctor.
The doctor will decide whether the patient can take Duloxetine Sandoz with other medicines. Do not
start or stop taking other medicines, including those available without a prescription and herbal preparations, without consulting a doctor.
The patient should also tell their doctor if they are taking any of the following medicines:

Monoamine oxidase inhibitors (MAOIs)

If the patient is taking or has taken another antidepressant medicine, an MAOI, within the last 14 days, they should not take Duloxetine Sandoz. MAOIs include, for example, moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medicines, including Duloxetine Sandoz, can cause serious or even life-threatening side effects. After stopping an MAOI, the patient must wait at least 14 days before starting to take Duloxetine Sandoz, and after stopping Duloxetine Sandoz, they must wait at least 5 days before taking an MAOI.

Sedative medicines

These include, for example, benzodiazepines, strong painkillers, antipsychotic medicines, phenobarbital, and antihistamines.

Medicines that increase serotonin levels

Tryptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (SSRIs, e.g., paroxetine and fluoxetine), selective noradrenaline reuptake inhibitors (SNRIs, e.g., venlafaxine), tricyclic antidepressants (e.g., clomipramine, amitriptyline), pethidine, buprenorphine, 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 unusual symptoms while taking any of these medicines with Duloxetine Sandoz, they should contact their doctor.

Oral anticoagulants or antiplatelet agents

Medicines that thin the blood or prevent blood clotting. They may increase the risk of bleeding.

Duloxetine Sandoz with food, drink, and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.
The patient should tell their doctor if they become pregnant or plan to become pregnant while taking Duloxetine Sandoz. Duloxetine Sandoz should only be taken after consulting a doctor and weighing the expected benefits of treatment against the possible risks to the unborn child.
The patient should make sure that their midwife and/or doctor know that they are taking Duloxetine Sandoz. Similar medicines (SSRIs) taken during pregnancy may increase the risk of the baby having a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and bluish skin. These symptoms usually occur within the first 24 hours after birth. If the patient notices them in their baby, they should contact their midwife and/or doctor immediately.
If the patient takes Duloxetine Sandoz towards the end of their pregnancy, their baby may experience certain symptoms, such as floppiness, trembling, seizures, difficulty feeding, difficulty breathing, and fits. If the patient notices any of these symptoms in their baby or is concerned about their baby's health, they should contact their doctor or midwife, who will be able to advise them.
If the patient takes Duloxetine Sandoz towards the end of their pregnancy, there is an increased risk of heavy bleeding from the vagina after giving birth, especially if they have had bleeding disorders in the past. The patient should tell their doctor or midwife that they are taking duloxetine so that they can advise them accordingly.
Available data on the use of duloxetine during the first three months of pregnancy do not indicate an increased risk of birth defects. However, if the patient takes Duloxetine Sandoz during the second half of their pregnancy, there may be an increased risk of premature birth, especially between the 35th and 36th week of pregnancy (6 additional premature births per 100 women taking duloxetine during the second half of pregnancy).
The patient should tell their doctor if they are breastfeeding. Taking Duloxetine Sandoz while breastfeeding is not recommended. The patient should ask their doctor or pharmacist for advice.

Driving and using machines

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

Duloxetine Sandoz contains lactose, Allura Red AC (E 129), sodium, and orange yellow FCF (E 110)

This medicine contains lactose. If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine.
This medicine contains Allura Red AC (E 129), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per hard gastro-resistant capsule, which is essentially "sodium-free".
Duloxetine Sandoz, 60 mg
This medicine contains orange yellow FCF (E 110), which may cause allergic reactions.

3. How to take Duloxetine Sandoz

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist.

Treatment of depression and diabetic neuropathic pain

The usual dose of Duloxetine Sandoz is 60 mg once a day, but the doctor will prescribe the dose that is right for the patient.

Treatment of generalized anxiety disorder

The usual starting dose of Duloxetine Sandoz is 30 mg once a day. For most patients, the dose will be increased to 60 mg once a day, but the doctor will prescribe the dose that is right for the patient. The dose can be increased to 120 mg, depending on the patient's response to treatment.
Duloxetine Sandoz is for oral use. The capsules should be swallowed whole with water.
Taking Duloxetine Sandoz at the same time each day may help the patient remember to take it.
The doctor will tell the patient how long they should take Duloxetine Sandoz. The patient should not stop taking their medicine or alter the dose without the advice of their doctor. It is important to treat the patient's condition correctly, so they can feel better. Without treatment, the patient's condition may persist or worsen and become difficult to treat.

Taking a higher dose of Duloxetine Sandoz than prescribed

If the patient takes more Duloxetine Sandoz than they should, they 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 disorders, anxiety, especially restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Duloxetine Sandoz

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

Stopping treatment with Duloxetine Sandoz

The patient should not stop taking the capsules without the advice of their doctor, even if they feel better. If the doctor decides that the patient should stop taking Duloxetine Sandoz, they will gradually reduce the dose over at least 2 weeks before stopping the medicine completely.
In some patients who stop taking Duloxetine Sandoz abruptly, the following symptoms may occur:

• dizziness
• tingling or electric shock-like sensations (especially in the head)
• sleep disturbances (vivid dreams, nightmares, insomnia)
• fatigue, drowsiness
• restlessness or agitation
• anxiety
• nausea or vomiting
• tremors
• headaches
• muscle aches
• irritability
• diarrhea
• excessive sweating

These symptoms are usually not serious and go away within a few days. However, if they are troublesome, the patient should contact their doctor.
If the patient has any further questions about their medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Duloxetine Sandoz can cause side effects, although not everybody gets them.
These effects are usually mild or moderate and often disappear 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 sluggish
• tremors
• numbness, tingling, or prickling sensation of the skin
• blurred vision
• ringing in the ears (hearing a sound in the ears without an external source)
• palpitations
• increased blood pressure, flushing
• increased yawning
• constipation
• diarrhea
• abdominal pain
• vomiting
• heartburn or indigestion, gas
• increased sweating, rash (itching)
• muscle aches, 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 who take duloxetine, weight loss has been observed at the beginning of treatment. After 6 months of treatment, body weight increased and normalized with that of other children and adolescents of the same age and sex.

Uncommon side effects (may affect up to 1 in 100 people)

• sore throat causing hoarseness
• suicidal thoughts
• difficulty sleeping
• grinding or clenching teeth
• disorientation
• lack of motivation
• sudden involuntary movements or muscle twitching
• feeling restless or inability to sit or stand still
• irritability
• difficulty concentrating
• disturbances of taste
• difficulty controlling movements, such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• pupil dilation (the black center of the eye), vision disturbances
• dizziness or feeling of spinning
• ear pain
• rapid or irregular heartbeat
• fainting, dizziness
• feeling of emptiness in the head or fainting when standing up
• feeling cold in the fingers and/or toes
• pressure in the throat
• nosebleeds
• vomiting blood or black, tarry stools
• gastritis, indigestion
• 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
• stiffness and muscle twitching
• difficulty or inability to urinate
• difficulty starting to urinate
• need to urinate at night
• need to urinate more often than usual
• decreased amount of urine
• abnormal vaginal bleeding
• menstrual disturbances, including heavy, painful, irregular, or prolonged menstrual periods
• scanty or absent menstrual periods
• testicular or scrotal pain
• chest pain
• feeling cold, thirst, chills, fever
• gait disturbances
• weight gain

Duloxetine Sandoz may cause side effects that the patient may not be aware of, such as increased liver enzyme activity or:

• increased potassium levels in the blood
• increased creatine kinase activity
• increased glucose levels
• increased cholesterol levels in the blood.

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

• cough, wheezing, and shortness of breath, which may be accompanied by fever
• 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 (mainly in the elderly; symptoms may include dizziness, weakness, confusion, drowsiness, or severe fatigue, nausea, or vomiting; more severe symptoms are fainting, seizures, or falls)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior
• mania (excessive activity, racing thoughts, and decreased need for sleep)
• hallucinations, aggression, and anger
• serotonin syndrome (a rare reaction - feeling excessively happy, drowsy, coordination disorders, anxiety, especially restlessness, feeling drunk, fever, sweating, or muscle stiffness)
• seizures
• increased eye pressure (glaucoma)
• mouth inflammation
• red blood in the stool, unpleasant breath, colitis (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a severe disease with blisters on the skin, in the mouth, eyes, and genitals)
• severe allergic reaction causing swelling of the face or throat (angioedema)
• jaw muscle spasm
• abnormal urine odor
• menopausal symptoms
• abnormal milk secretion from the breasts in men or women
• excessive bleeding from the vagina shortly after childbirth (postpartum hemorrhage)

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

• vasculitis of the skin

Frequency not known (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 those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Duloxetine Sandoz

The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 30°C.
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. Contents of the pack and other information

What Duloxetine Sandoz contains

• The active substance is duloxetine. Each hard gastro-resistant capsule contains 30 mg or 60 mg of duloxetine (as duloxetine hydrochloride).
• The other ingredients are: capsule contents: maize starch, microcrystalline cellulose, povidone K30, talc, magnesium stearate, sodium stearyl fumarate, hypromellose acetate succinate, titanium dioxide (E171), lactose monohydrate, hypromellose, and macrogol 4000. capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), Allura Red AC (E 129), and for the 60 mg capsules: quinoline yellow (E104) and orange yellow FCF (E110). printing ink: shellac, indigo carmine (E132), titanium dioxide (E171), propylene glycol

What Duloxetine Sandoz looks like and contents of the pack

Duloxetine Sandoz, 30 mg
A capsule (size 2) with a matte white body and "30" printed on it and a matte dark blue cap, containing 4 white or almost white, round, biconvex tablets.
Duloxetine Sandoz, 60 mg
A capsule (size 0E) with a yellow-green body and "60" printed on it and a matte dark blue cap, containing 8 white or almost white, round, biconvex tablets.
The hard gastro-resistant capsules are packed in blisters of PVC/PE/PCTFE/Aluminum or PA/Aluminum/PVC/Aluminum and placed in a cardboard box.
Package sizes: 7, 14, 28, 30, 50, 56, 84, 98 hard gastro-resistant capsules
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer

Pharmathen International S.A.
Industrial Park Sapes Rodopi Prefecture, Block No 5
69300 Rodopi, Greece
Pharmathen S.A.
Dervenakion 6
15351 Pallini Attiki, Greece
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For more information on this medicine and its authorized names in the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:08/2024
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