Setinin

Leaflet accompanying the packaging: patient information

Setinin, 25 mg, coated tablets

Setinin, 100 mg, coated tablets

Setinin, 200 mg, coated tablets

Setinin, 300 mg, coated tablets

Quetiapine

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Setinin and what is it used for

Setinin contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics.
Setinin can be used to treat diseases such as:

• Depression in bipolar disorder:when the patient feels deep sadness. The patient may feel depressed, guilty, lack energy, and lose appetite or have difficulty sleeping.
• Mania:the patient may be very excited, happy, agitated, enthusiastic, or overly active; may have an inappropriate assessment of the situation, including aggressive or destructive behavior
• Schizophrenia:the patient may hear or feel things that do not exist in reality, have beliefs that contradict reality, or be extremely suspicious, frightened, disoriented, guilty, tense, or depressed.

The doctor may recommend continued use of Setinin even if the patient's condition improves.

2. Important information before taking Setinin

When not to take Setinin

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking any of the following medicines:
• certain medicines used to treat HIV infection
• medicines from the "azole" group (used to treat fungal infections)
• erythromycin or clarithromycin (used to treat bacterial infections)
• nefazodone (used to treat depression)

In case of doubts, consult a doctor or pharmacist before taking Setinin.

Warnings and precautions

Before starting to take Setinin, discuss it with your doctor or pharmacist if:

• the patient or any of their family members have or have had heart problems, such as arrhythmias, heart muscle weakness, or myocarditis, or if the patient is taking any medicines that may affect heart rhythm
• the patient has low blood pressure
• the patient has had a stroke, especially if it concerns an elderly person
• the patient has liver problems
• the patient has ever had seizures (epileptic fits)
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may recommend blood sugar tests while taking Setinin.
• the patient has ever had a low white blood cell count (regardless of whether it was caused by taking other medicines or not)
• the patient is elderly and has dementia (loss of brain function). Such patients should not take Setinin, as medicines from the group to which Setinin belongs may increase the risk of stroke and, in some cases, also the risk of death.
• the patient is elderly and has Parkinson's disease/parkinsonism
• the patient or any of their family members have had blood clots; taking medicines from this group can cause them to form
• the patient has or has had breathing disorders in the form of short periods of apnea during sleep (called "sleep apnea syndrome") and is taking medicines that slow down the normal functioning of the brain ("depressants")
• the patient has or has had a disorder that makes it impossible to completely empty the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. Such symptoms may be caused by medicines (called "anticholinergic medicines") that affect the functioning of nerve cells, used to treat various diseases.
• the patient has a history of alcohol or drug abuse
• the patient has depression or other conditions that are treated with antidepressant medicines. Taking these medicines with Setinin may lead to the development of serotonin syndrome, a life-threatening condition (see: "Setinin and other medicines").

The patient should immediately inform their doctor if they experience any of the following symptoms after taking Setinin:

• a syndrome of symptoms: fever, severe muscle stiffness, excessive sweating, or disturbances of consciousness (a condition called "malignant neuroleptic syndrome"); immediate treatment may be necessary
• uncontrolled movements, especially of the face or tongue muscles
• dizziness or a feeling of intense drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• seizures (epileptic fits)
• prolonged and painful erection (priapism)
• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, immediately refer the patient to a cardiologist.

All these symptoms may occur during treatment with medicines from this therapeutic group.
The patient should immediately inform their doctor if they experience:

• fever, flu-like symptoms, sore throat, or any other infection, as this may be a consequence of a very low white blood cell count in the blood, and it may be necessary to discontinue Setinin and/or apply appropriate treatment
• constipation combined with persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more serious intestinal obstruction
• suicidal thoughts and worsening depressionDuring depression, thoughts of self-harm or suicide may sometimes occur. These thoughts may worsen at the beginning of treatment with antidepressant medicines, as these medicines start to work after some time, usually after 2 weeks, sometimes even later. These symptoms may also worsen when treatment is suddenly stopped. The likelihood of such thoughts is higher in young adults. Information obtained in clinical trials shows an increased risk of suicidal thoughts and/or behaviors in young adults, under the age of 25, with depression.

If thoughts of self-harm or suicide occur, the patient should contact their doctor or go directly to the hospital. It may be helpful for the patient to inform someone from their family or a close friend about their depression and ask them to read this leaflet. The patient can ask this person to tell them if they notice an increase in depression or worrying changes in behavior.

Severe skin reactions

During treatment with quetiapine, very rare severe skin reactions (SCARs) have been reported, which can be life-threatening or cause death. They are mainly manifested as:

• Stevens-Johnson syndrome (SJS) - a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals
• toxic epidermal necrolysis (TEN) - a more severe form causing widespread peeling of the skin
• drug reaction with eosinophilia and systemic symptoms (DRESS) - including flu-like symptoms with a rash, high body temperature, lymph node enlargement, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes)
• acute generalized exanthematous pustulosis (AGEP) - small pus-filled blisters
• erythema multiforme (EM) - a skin rash with irregular, itchy, red patches

If such symptoms occur, the patient should discontinue Setinin and seek medical attention immediately.

Weight gain

Patients taking Setinin have been observed to gain weight. The patient and their doctor should regularly check the patient's weight.

Children and adolescents

Setinin is not intended for use in children and adolescents under the age of 18.

Setinin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Setinin should not be taken if the patient is taking:

• certain medicines used to treat HIV infection
• medicines from the "azole" group (used to treat fungal infections)
• erythromycin or clarithromycin (used to treat bacterial infections)
• nefazodone (used to treat depression)

The patient should inform their doctor if they are taking any of the following medicines:

• antiepileptic medicines (such as phenytoin or carbamazepine)
• medicines used to treat high blood pressure
• barbiturates (medicines used to treat sleep disorders)
• thioridazine or lithium salts (other antipsychotic medicines)
• medicines that affect heart rhythm, such as those that can cause electrolyte disturbances (decreased potassium or magnesium levels), such as diuretics or certain antibiotics (used to treat infections)
• medicines that can cause constipation
• medicines ("anticholinergic medicines") that affect the functioning of nerve cells, used to treat various diseases
• antidepressant medicines. These medicines may interact with Setinin and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, the patient should consult their doctor.

Before stopping any medicine, the patient should consult their doctor.

Setinin with food, drink, and alcohol

• Setinin can be taken with or without food
• The patient should be careful with the amount of alcohol they consume, as the combined effect of Setinin and alcohol may cause drowsiness
• The patient should not drink grapefruit juice while taking Setinin. Grapefruit juice may affect the action of Setinin.

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 medicine. Setinin should not be taken during pregnancy, unless agreed upon with the doctor. Setinin should not be taken during breastfeeding.
In newborns of mothers who took quetiapine in the last trimester of pregnancy (the last 3 months of pregnancy), the following symptoms may occur, indicating withdrawal syndrome: seizures, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If the child experiences any of these symptoms, they may need to see a doctor.

Driving and using machines

Setinin may cause drowsiness. The patient should not drive or operate any tools or machines until they know how they react to the medicine.

Effect on urine tests for drugs

Taking Setinin may cause false-positive results for methadone or certain tricyclic antidepressants (TCA) in urine tests using certain testing methods. If this happens, a more specific testing method should be used.

Setinin contains lactose and sodium

If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking Setinin.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Setinin

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The doctor will determine the initial dose for the patient. The usual dose (daily dose) is between 150 mg and 800 mg, depending on the severity of the disease and the patient's needs.

• The tablet should be taken once a day before bedtime or twice a day, depending on the disease the patient is suffering from.
• The tablet should be swallowed whole, with a glass of water.
• The tablets can be taken with or without food.
• While taking Setinin, the patient should not consume grapefruit juice. It may affect the action of the medicine.
• The patient should not stop taking Setinin even if they feel better, unless the doctor decides otherwise.

Liver function disorders

If the patient has liver problems, the doctor may recommend a dose change.

Elderly patients

If the patient is elderly, the doctor may recommend a dose change.

Use in children and adolescents

Setinin should not be taken by children and adolescents under the age of 18.

Taking a higher dose of Setinin than recommended

If the patient takes a higher dose of Setinin than prescribed by the doctor, they may experience:
drowsiness, dizziness, heart rhythm disturbances. The patient should immediately contact their doctor or go to the nearest hospital. They should take all remaining Setinin tablets with them.

Missing a dose of Setinin

If the patient misses a dose of Setinin, they should take it as soon as possible. If it is almost time for the next dose, they should take the medicine at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Setinin

If the patient suddenly stops taking Setinin, they may experience: insomnia, nausea, or headache, diarrhea, vomiting, dizziness, or irritability. To reduce the risk of these symptoms, the doctor will recommend a gradual reduction in dose before stopping treatment.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Setinin can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should

IMMEDIATELY contact their doctor:

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

• abnormal muscle movements. These symptoms include difficulty starting to move, tremors, feeling anxious, or painless muscle stiffness

Common(may affect up to 1 in 10 people)

• suicidal thoughts and worsening depression

Uncommon(may affect up to 1 in 100 people)

• diabetes
• seizures or epileptic fits
• allergic reactions, including lumps on the skin, skin swelling, and mouth area
• uncontrolled movements, especially of the face or tongue muscles
• changes in the electrical activity of the heart visible on an ECG (QT interval prolongation)
• difficulty urinating
• worsening of existing diabetes
• confusion

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

• a syndrome of symptoms: high temperature (fever), sweating, muscle stiffness, feeling of intense drowsiness, or fainting (a condition called "malignant neuroleptic syndrome")
• yellowing of the skin and eyes (jaundice)
• hepatitis
• prolonged and painful erection (priapism)
• blood clots, especially in the legs (symptoms include: swelling, pain, and redness of the legs); these clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties (venous thromboembolism). If the patient notices any of these symptoms, they should go to the hospital immediately.
• pancreatitis
• combined occurrence of fever, flu-like symptoms, sore throat, or any other infection caused by a very low white blood cell count in the blood (a condition called agranulocytosis)
• intestinal obstruction

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

• severe rash, blisters, or red patches on the skin
• severe allergic reactions (anaphylactic reactions) that can cause breathing difficulties or shock
• sudden swelling of the skin, usually around the eyes, mouth, and throat (angioedema)
• severe skin reaction with blisters, peeling skin, and mucous membrane involvement (Stevens-Johnson syndrome) (see section 2)
• abnormal secretion of the hormone regulating urine volume
• muscle breakdown and muscle pain (rhabdomyolysis)

Unknown(frequency cannot be estimated from available data)

• skin rash with irregular, red, itchy patches (erythema multiforme) (see section 2)
• sudden appearance of areas of red skin with small pus-filled blisters (acute generalized exanthematous pustulosis (AGEP)) (see section 2)
• severe, sudden allergic reaction with symptoms such as fever and blisters on the skin, and peeling of the skin (toxic epidermal necrolysis) (see section 2)
• skin rash with eosinophilia and systemic symptoms (DRESS) including flu-like symptoms with a rash, high body temperature, lymph node enlargement, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes) (see section 2)
• stroke

Other side effects

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

• dizziness (which may lead to falls), headache, dry mouth
• feeling drowsy (which may resolve during continued treatment) and may lead to falls
• withdrawal symptoms (symptoms that occur after stopping quetiapine), including: difficulty sleeping (insomnia), nausea (nausea), headache, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over a period of at least 1-2 weeks.
• weight gain
• changes in the levels of certain fats (triglycerides and cholesterol) in the blood
• decrease in hemoglobin level

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• feeling of palpitations, rapid or irregular heartbeat
• constipation, stomach upset (indigestion)
• weakness
• swelling of hands or feet
• low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls).
• increased blood sugar levels
• blurred vision
• unusual and disturbing dreams
• increased appetite
• feeling irritable
• speech and language disorders
• shortness of breath
• vomiting (mainly in elderly people)
• fever
• changes in thyroid hormone levels in the blood
• changes in the number of certain types of white blood cells in the blood
• increased levels of liver enzymes (ALT, gamma-GT) in the blood
• increased levels of the hormone prolactin in the blood. Increased prolactin levels may rarely cause:
• breast swelling and unexpected milk production in women and men
• absence of menstruation or irregular menstrual cycles in women

Uncommon(may affect up to 1 in 100 people)

• unpleasant sensations in the legs (also known as restless legs syndrome)
• difficulty swallowing
• sexual disorders
• slow heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting
• fainting (which may lead to falls)
• stuffy nose
• decrease in the number of certain blood cells
• decrease in sodium levels in the blood
• decrease in thyroid hormone levels in the blood
• hypothyroidism
• increased levels of the enzyme AST in the blood

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

• breast swelling and unexpected milk production (galactorrhea)
• menstrual disorders
• walking, talking, eating, or performing other activities while asleep
• decreased body temperature (hypothermia)
• a condition called "metabolic syndrome", in which there is a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels
• increased levels of the enzyme creatine phosphokinase in the blood (a substance derived from muscles)

Unknown(frequency cannot be estimated from available data)

• withdrawal symptoms may occur in newborns of mothers who took quetiapine during pregnancy
• heart muscle disorders (cardiomyopathy)
• myocarditis
• inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple bumps

This class of medicines, to which Setinin belongs, may cause heart rhythm disturbances, which can be serious and, in rare cases, fatal.
Some side effects can only be detected by blood tests in a laboratory. These include changes in the levels of certain fats (triglycerides and cholesterol) in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme levels in the blood, decreased white blood cell count, decreased red blood cell count, increased creatine phosphokinase levels in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels may cause:

• breast swelling and unexpected milk production in women and men
• absence of menstruation or irregular menstrual cycles in women. The doctor may recommend regular check-ups.

Additional side effects in children and adolescents

The side effects described above should also be considered when quetiapine is used in children and adolescents.
The following side effects have a higher frequency in children and adolescents or have not been observed in adult patients:
Very common(may affect more than 1 in 10 people)

• increased levels of the hormone prolactin in the blood. This may rarely cause:
• breast swelling and unexpected milk production in both boys and girls
• absence of menstruation or menstrual disorders in girls
• increased appetite
• vomiting
• abnormal muscle movements. These symptoms include difficulty starting to move, tremors, feeling anxious, or painless muscle stiffness
• increased blood pressure

Common(may affect up to 1 in 10 people)

• feeling weak, fainting (which may lead to falls)
• stuffy nose
• feeling irritable

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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 can help gather more information on the safety of this medicine.

5. How to store Setinin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after the term "EXP". The expiry date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Setinin contains

• The active substance of Setinin is quetiapine. Setinin, coated tablets contain 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine (in the form of quetiapine fumarate).
• Other ingredients are: Tablet core: microcrystalline cellulose, povidone K29-32, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose (type A), lactose monohydrate, magnesium stearate Tablet coating: hypromellose 6cP, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, iron oxide yellow (E 172) (in 25 mg and 100 mg tablets) and iron oxide red (E 172) (only in 25 mg tablets)

What Setinin looks like and contents of the pack

Setinin, 25 mg: coated tablet, round, 5.5 mm in diameter, convex on both sides, light orange, with the inscription "Q" on one side.
Setinin, 100 mg: coated tablet, round, 8.5 mm in diameter, convex on both sides, yellow, with the inscription "Q" on one side.
Setinin, 200 mg: coated tablet, oval, 16 mm x 8.2 mm, convex on both sides, white, with the inscription "Q" on one side.
Setinin, 300 mg: coated tablet, oval, 19 mm x 7.6 mm, convex on both sides, white, with the inscription "Q" on one side and "300" on the other side.
Pack sizes
Blisters
Setinin, 25 mg/100 mg/200 mg/300 mg, coated tablets: 30, 60, 90 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
Zejtun ZTN3000
Malta
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
phone: +48 12 262 32 36
e-mail: krakow@pluspharma.eu
Date of last revision of the leaflet:July 2024