Duloxetine Sandoz

Package Leaflet: Information for the Patient

Duloxetine Sandoz, 30 mg, Hard Gastro-Resistant Capsules

Duloxetine Sandoz, 60 mg, Hard Gastro-Resistant Capsules

Duloxetine

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication 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 Package 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 Package and Other Information

1. What is Duloxetine Sandoz and What is it Used For

Duloxetine Sandoz contains the active substance duloxetine. The medication 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, shooting, cutting, or like an electric shock. In a specific area of the body, there may be a loss of sensation or a feeling of touch, heat, cold, and pressure may be painful).

In most people with depression or anxiety, Duloxetine Sandoz starts working within two weeks of starting treatment, but improvement in mood may take 2 to 4 weeks. If after this time the patient does not feel better, they should tell their doctor. Even if there has been an improvement in the patient's condition, the doctor may recommend continued use of Duloxetine Sandoz to prevent a relapse of depression or anxiety.
In people with diabetic neuropathic pain, improvement may occur after several weeks. The doctor should be consulted 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 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 Sandoz and Other Medications".
• if the patient is taking fluvoxamine (a medication usually used to treat depression),

cyproheptadine or enoxacin (medications used to treat certain infections).
The doctor should be told if the patient has 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 taking Duloxetine Sandoz may not be suitable for the patient.
Before taking Duloxetine Sandoz, the doctor should be consulted if the patient:

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

Duloxetine Sandoz may cause restlessness or an inability to sit or stand still. If such symptoms occur, the doctor should be informed.
The doctor should also be contacted:

If the patient experiences objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, 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.
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 Sandoz (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

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 antidepressant medications, as these medications start working only after some time, usually after 2 weeks, but sometimes later.
Suicidal thoughts, self-harm, or suicide attempts 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 indicate an increased risk of suicidal behavior in people under 25 with mental disorders taking antidepressant medications.

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 may ask them to tell them if they notice that the depression or anxiety has worsened or if there are any worrying changes in 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 medications from this group, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). However, the doctor may prescribe Duloxetine Sandoz to patients under 18 years of age, considering it to be 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 doctor should be consulted. If such a patient taking Duloxetine Sandoz experiences or worsens the above symptoms, the doctor should be informed. Additionally, so far, there are no data on the long-term safety of using Duloxetine Sandoz in this age group regarding growth, maturation, and cognitive and behavioral development.

Duloxetine Sandoz and Other Medications

The doctor or pharmacist should be told about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Duloxetine, the active ingredient in Duloxetine Sandoz, is also contained in other medications used to treat:

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

Avoid taking more than one of these medications at the same time. If the patient is already taking other medications containing duloxetine, they should consult their doctor.
The doctor will decide whether Duloxetine Sandoz 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 doctor should also be told about taking any of the following medications:

Monoamine Oxidase Inhibitors (MAOIs)

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

Sedative Medications

These include prescription medications such as benzodiazepines, strong painkillers, antipsychotic medications, phenobarbital, and antihistamines.

Medications that Increase Serotonin Levels

Tryptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (SSRIs, e.g., paroxetine and fluoxetine), selective norepinephrine 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 medications increase the risk of side effects. If any unusual symptoms occur while taking any of these medications with Duloxetine Sandoz, the doctor should be contacted.

Oral Anticoagulants or Antiplatelet Medications

Medications 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. Caution should be exercised 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 consult their doctor or pharmacist before taking this medication.
The doctor should be told if the patient becomes pregnant or plans to become pregnant while taking Duloxetine Sandoz. Duloxetine Sandoz should only be taken after discussing the expected benefits and potential risks to the unborn child with the doctor.
The doctor and/or midwife should be informed about the use of Duloxetine Sandoz. Similar medications (SSRIs) taken during pregnancy may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and bluish discoloration. These symptoms usually occur within the first 24 hours after birth. If the patient notices them in their baby, they should contact the midwife and/or doctor immediately.
If the patient takes Duloxetine Sandoz towards the end of pregnancy, the newborn may experience certain symptoms. They usually appear soon after birth or within a few days. These symptoms include: floppiness, trembling, seizures, difficulty feeding, difficulty breathing, and convulsions. If the newborn experiences any of these symptoms or the patient is concerned about their baby's health, they should contact the doctor or midwife, who will provide appropriate explanations.
If the patient takes Duloxetine Sandoz towards the end of pregnancy, there is an increased risk of excessive bleeding from the vagina shortly after delivery, especially if the patient has had bleeding disorders in the past. The doctor or midwife should be informed about the use of duloxetine so they can provide appropriate advice.
Available data on the use of duloxetine during the first three months of pregnancy do not generally indicate an increased risk of birth defects in the baby. If the patient takes Duloxetine Sandoz in the second half of 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 in the second half of pregnancy).
The doctor should be told if the patient is breastfeeding. The use of Duloxetine Sandoz during breastfeeding is not recommended. The doctor or pharmacist should be consulted 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 medication contains lactose. If the patient has intolerance to some sugars, they should consult their doctor before taking the medication.
This medication contains Allura Red AC (E 129), which may cause allergic reactions.
This medication contains less than 1 mmol (23 mg) of sodium per hard gastro-resistant capsule, which is considered "sodium-free".
Duloxetine Sandoz, 60 mg
This medication contains Orange Yellow FCF (E 110), which may cause allergic reactions.

3. How to Take Duloxetine Sandoz

This medication should always be taken as directed by the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.

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 suitable for each patient.

Treatment of Generalized Anxiety Disorder

The usual starting dose of Duloxetine Sandoz is 30 mg once a day. In most patients, the dose is then increased to 60 mg once a day, but the doctor will prescribe the appropriate dose for each patient. The dose can be increased up 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 every day may help remember to take it.
The doctor will inform the patient how long to take Duloxetine Sandoz. The patient should not stop taking the medication or change the dose without consulting the doctor. Proper treatment of the condition is essential for the patient to feel better. Without treatment, the patient's condition may persist or worsen and become difficult to treat.

Taking More Than the Prescribed Dose of Duloxetine Sandoz

If a larger dose than prescribed is taken, the doctor or pharmacist should be contacted immediately. Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination disorders, restlessness, especially motor, feeling of intoxication, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a Dose of Duloxetine Sandoz

If a dose is missed, it should be taken as soon as remembered. However, if the time for the next dose is near, the missed dose should be skipped and a single dose taken as usual. A double dose should not be taken to make up for the missed dose.
A higher daily dose of Duloxetine Sandoz than prescribed by the doctor should not be taken.

Stopping Treatment with Duloxetine Sandoz

The capsules should not be stopped without the doctor's advice, even if the patient feels better. If the doctor decides that the patient no longer needs to take Duloxetine Sandoz, they will recommend gradually reducing the dose over at least 2 weeks before completely stopping the medication.
In some patients who stop taking Duloxetine Sandoz abruptly, the following symptoms may occur:

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

These symptoms are usually not severe and resolve within a few days. However, if they are bothersome, the doctor should be consulted.
If there are any further doubts about taking this medication, the doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medications, Duloxetine Sandoz can cause side effects, although not everybody gets them.
These effects are usually mild or moderate and often disappear within 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 sexual desire, anxiety, difficulty or inability to achieve orgasm
• unusual dreams
• dizziness
• feeling of slowing down
• 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
• excessive yawning
• constipation
• diarrhea
• abdominal pain
• vomiting
• heartburn or indigestion, gas
• 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 taking duloxetine, weight loss was observed at the start 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)

• throat inflammation causing hoarseness
• suicidal thoughts
• difficulty falling asleep
• grinding or clenching teeth
• disorientation
• lack of motivation
• sudden involuntary movements or muscle tremors
• feeling of restlessness or inability to sit or stand still
• irritability
• concentration disorders
• taste disorders
• difficulty controlling movements, such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• pupil dilation (the dark central part 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 of cold in the fingers of the hands and/or feet
• pressure in the throat
• nosebleeds
• vomiting blood or black, tarry stools
• inflammation of the stomach and intestines, regurgitation
• difficulty swallowing
• liver inflammation, which can cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, hives, cold sweats
• sensitivity to sunlight
• increased tendency to bruise
• muscle stiffness and tremors
• difficulty or inability to urinate
• difficulty starting urination
• need to urinate at night
• need to urinate more often than usual
• decreased amount of urine
• abnormal vaginal bleeding
• menstrual disorders, including heavy, painful, irregular, or prolonged menstrual periods
• abnormally light or absent menstrual periods
• testicular or scrotal pain
• chest pain
• feeling of cold, thirst, chills, fever
• gait disturbances
• weight gain

Duloxetine Sandoz may cause 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, possibly with 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 reduced need for sleep)
• hallucinations, aggression, and anger
• serotonin syndrome (a rare reaction - feeling of excessive happiness, drowsiness, coordination disorders, restlessness, especially motor, feeling of intoxication, fever, sweating, or muscle stiffness)
• seizures
• increased eye pressure (glaucoma)
• mouth inflammation
• red blood in the stool, bad breath, colon inflammation (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a severe disease with blistering of the skin, mouth, eyes, and genitals)
• severe allergic reaction causing facial or throat swelling (angioedema)
• jaw muscle spasms
• abnormal urine odor
• menopausal symptoms
• abnormal breast milk secretion in men or women
• excessive vaginal bleeding shortly after delivery (postpartum hemorrhage)

Very Rare Side Effects (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 any side effects occur, including those not listed in this leaflet, the doctor, pharmacist, or nurse should be told.
Side effects can be reported directly to the Department of Adverse Reaction 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.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Duloxetine Sandoz

The medication should be stored out of sight and reach of children.
Do not use this medication 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.
Medications should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package 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).
• Other ingredients are: capsule contents: corn 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 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 Package

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 off-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 off-white, round, biconvex tablets.
Hard gastro-resistant capsules are packaged in PVC/PE/PCTFE/Aluminum or PA/Aluminum/PVC/Aluminum blisters and placed in a cardboard box.
Package sizes: 7, 14, 28, 30, 50, 56, 84, 98 hard gastro-resistant capsules
Not all package 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 Medication and Its Names in European Economic Area Member States, 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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