Setinin

Package Leaflet: Information for the Patient

Setinin, 25 mg, Film-Coated Tablets

Setinin, 100 mg, Film-Coated Tablets

Setinin, 200 mg, Film-Coated Tablets

Setinin, 300 mg, Film-Coated Tablets

Quetiapine

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

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on 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 package leaflet, inform a doctor or pharmacist. See section 4.

Table of Contents of the Package 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 Package 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 medications called antipsychotics.
Setinin may 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 actually exist, 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 medication (listed in section 6)
• if the patient is taking any of the following medications:
• certain medications used to treat HIV infection
• medications 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 with a 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 medications 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 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 during treatment with Setinin.
• the patient has ever had a low white blood cell count (regardless of whether it was caused by taking other medications or not)
• the patient is elderly and has dementia (loss of brain function). In these patients, Setinin should not be used, as medications 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 someone in their family has had blood clots; taking medications from this group can cause them to form
• the patient has or has had breathing difficulties in the form of short periods of apnea during sleep (called "sleep apnea syndrome") and is taking medications that slow down normal brain function (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 medications (called "anticholinergic medications") 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 antidepressants. Taking these medications with Setinin may lead to the development of serotonin syndrome, a life-threatening condition (see: "Setinin and Other Medications").

Inform a doctor immediately if, after taking Setinin, any of the following symptoms occur:

• 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 severe 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 medications from this therapeutic group.
Inform a doctor immediately if the patient experiences:

• 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 DepressionDuring depression, suicidal thoughts or self-harm may sometimes occur. These thoughts may intensify at the beginning of treatment with antidepressants, as the medications start to work after some time, usually after 2 weeks, sometimes even later. These symptoms may also intensify when treatment is suddenly discontinued. 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 suicidal thoughts or self-harm occur, consult a doctor or go directly to the hospital. It may be helpful to inform someone from the patient's family or a close friend about the depression and ask them to read this package leaflet. The patient can ask this person to tell them if they notice an intensification of depression or disturbing 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 fatal. They manifest mainly 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, discontinue taking Setinin and seek medical attention immediately.

Weight Gain

In patients taking Setinin, weight gain has been observed. The patient and the 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 Medications

Tell a doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Do not take Setinin if the patient is taking:

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

Inform a doctor if the patient is taking any of the following medications:

• antiepileptic medications (such as phenytoin or carbamazepine)
• medications used to treat high blood pressure
• barbiturates (medications used to treat sleep disorders)
• thioridazine or lithium salts (other antipsychotic medications)
• medications that affect heart rhythm, such as medications that can cause electrolyte disturbances (decreased potassium or magnesium levels), such as diuretics or certain antibiotics (used to treat infections)
• medications that can cause constipation
• medications (anticholinergic medications) that affect the functioning of nerve cells, used to treat various diseases
• antidepressants. These medications 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, consult a doctor.

Before discontinuing any medication, the patient should consult a doctor.

Setinin with Food, Drink, and Alcohol

• Setinin can be taken with or without food
• Be careful with the amount of alcohol consumed, as the combined effect of Setinin and alcohol may cause drowsiness
• Do 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 a doctor or pharmacist before taking this medication. Setinin should not be used during pregnancy, unless agreed upon with a doctor. Setinin should not be used 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, consult a doctor.

Driving and Operating Machines

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

Effect on Urine Tests for Narcotics

Taking Setinin may cause false-positive results for methadone or certain tricyclic antidepressants (TCA) in urine tests using some 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 some sugars, they should consult a doctor before taking Setinin.
The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Setinin

This medication should always be taken as directed by a 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, do not consume grapefruit juice. It may affect the action of the medication.
• Do not discontinue taking Setinin even if the patient feels 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 used in children and adolescents under the age of 18.

Taking a Higher Dose of Setinin Than Prescribed

If the patient takes a higher dose of Setinin than prescribed by the doctor, they may experience:
drowsiness, dizziness, arrhythmias. Consult a doctor or go to the nearest hospital immediately. Bring all remaining Setinin tablets.

Missing a Dose of Setinin

If a dose of Setinin is missed, take it as soon as possible. If it is close to the time for the next dose, take the medication at the usual time. Do not take a double dose to make up for the missed dose.

Discontinuing 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 discontinuing treatment.
In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

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

If the Patient Experiences Any of the Following Side Effects, They Should

IMMEDIATELY Consult a 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 depression

Uncommon(may affect up to 1 in 100 people)

• diabetes
• seizures or epileptic fits
• allergic reactions, including the formation of lumps on the skin, skin swelling around the mouth
• 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 fever (fever), sweating, muscle stiffness, feeling severely drowsy 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 bloodstream to the lungs, causing chest pain and difficulty breathing (venous thromboembolism). If the patient notices any of these symptoms, they should go to the hospital immediately.
• pancreatitis
• the combination of fever, flu-like symptoms, sore throat, or any other infection, which may be a consequence of 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), which can cause difficulty breathing 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 lesions (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)
• 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) (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 discontinuing quetiapine), including: difficulty sleeping (insomnia), nausea (nausea), headache, diarrhea, vomiting, dizziness, irritability. It is recommended to gradually discontinue the medication 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 levels

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 the 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
• disturbing and vivid dreams
• increased appetite
• feeling irritable
• speech and language disorders
• shortness of breath
• vomiting (mainly in elderly patients)
• 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 decreased 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 the levels of certain thyroid hormones in the blood
• hypothyroidism
• increased levels of the liver 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 three or more of the following symptoms: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides in the blood, 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
• vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple bumps

This class of medications, to which Setinin belongs, may cause heart rhythm disorders, 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 rarely cause:

• breast swelling and unexpected milk production in women and men
• absence of menstruation or irregular menstrual cycles in women

Additional Side Effects in Children and Adolescents

The side effects described above should also be considered when using quetiapine 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 package leaflet, inform a 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 will help gather more information on the safety of this medication.

5. How to Store Setinin

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging and blister pack after the term "EXP". The expiration date refers to the last day of the specified month.
There are no special precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Package and Other Information

What Setinin Contains

• The active substance of Setinin is quetiapine. Setinin, film-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, yellow iron oxide (E 172) (in 25 mg and 100 mg tablets) and red iron oxide (E 172) (only in 25 mg tablets)

What Setinin Looks Like and Contents of the Package

Setinin, 25 mg: film-coated tablet, round, 5.5 mm in diameter, biconvex, light orange, with the inscription "Q" on one side.
Setinin, 100 mg: film-coated tablet, round, 8.5 mm in diameter, biconvex, yellow, with the inscription "Q" on one side.
Setinin, 200 mg: film-coated tablet, oval, 16 mm x 8.2 mm, biconvex, white, with the inscription "Q" on one side.
Setinin, 300 mg: film-coated tablet, oval, 19 mm x 7.6 mm, biconvex, white, with the inscription "Q" on one side and "300" on the other side.
Package Sizes
Blister packs
Setinin, 25 mg/100 mg/200 mg/300 mg, film-coated tablets: 30, 60, 90 tablets
Not all package 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 about this medication, 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: [email protected]
Date of Last Revision of the Package Leaflet:July 2024