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
Quetiapinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Setinin is and what it is 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 pack and other information

1. What Setinin is and what it is used for

Setinin contains an active substance called quetiapine. It belongs to a group of medicines known as antipsychotics.
Setinin may be used in the treatment of conditions such as:

• depressive episodes in bipolar disorder: when the patient feels deep sadness. The patient may feel depressed, guilty, lack energy, lose appetite, or have difficulty falling asleep.
• mania: the patient may be extremely excited, elated, overactive, over-enthusiastic, or excessively active; may have impaired judgment, including displaying aggressive or destructive behaviors
• schizophrenia: the patient may hear or sense things that do not exist in reality, have beliefs contrary to reality, be extremely suspicious, fearful, disoriented, feel guilt, or experience tension or depression.

Your doctor may recommend continuing treatment with Setinin even if your condition improves.

2. Important information before using Setinin

When not to use 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 in HIV infection
  • medicines from the "azole" group (used in fungal infections)
  • erythromycin or clarithromycin (used in bacterial infections)
  • nefazodone (used in depression).

If in doubt, consult a doctor or pharmacist before using Setinin.
Warnings and precautions
Before starting treatment with Setinin, discuss with your doctor or pharmacist if:

• the patient or anyone in their family has or has had heart problems, such as heart rhythm disorders, weakened heart muscle, 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 they are elderly
• 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 during treatment with 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). Setinin should not be used in these patients, as medicines in the class 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 venous thrombosis; use of medicines in this group may cause blood clots
• the patient has or has previously had breathing problems involving brief periods of breathing cessation during sleep (called "sleep apnoea syndrome") and the patient is taking medicines that slow down normal brain function ("depressants")
• the patient has or has previously had difficulty completely emptying the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may be caused by medicines (called "anticholinergic medicines") that affect nerve cell function, used in treating various diseases.
• the patient has previously abused alcohol or drugs
• the patient has depression or other conditions treated with antidepressant medicines. Using these medicines together with Setinin may lead to the development of serotonin syndrome, a potentially life-threatening condition (see: "Setinin with other medicines").

Immediately inform the doctor if any of the following symptoms occur after taking Setinin:

• a group of symptoms: fever, severe muscle stiffness, excessive sweating, or altered mental status (this condition is called "neuroleptic malignant syndrome"); immediate treatment may be necessary
• uncontrolled movements, especially of the face or tongue muscles
• dizziness or feeling of pronounced drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• seizures (epileptic fits)
• prolonged and painful erection (priapism)
• rapid or 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 in this therapeutic class.
Immediately inform the doctor if the patient experiences:

• fever, flu-like symptoms, sore throat, or any other infection, as this may be due to a very low number of white blood cells in the blood, which may require discontinuation of Setinin and/or appropriate treatment
• constipation accompanied by persistent abdominal pain or persistent constipation despite treatment, as this may lead to more serious intestinal obstruction
• suicidal thoughts and worsening of depression During depression, thoughts about self-harm or suicide may sometimes occur. These thoughts may worsen at the beginning of treatment with antidepressant medicines, as medicines take time to work, usually about 2 weeks, sometimes even longer. These symptoms may also worsen if treatment is suddenly stopped. The likelihood of such thoughts is higher in young adults. Data from clinical trials show an increased risk of suicidal thoughts and (or) behaviours in young adults under 25 years of age with depression.

If thoughts about self-harm or suicide occur, contact a doctor or go directly to hospital. It may be helpful for the patient to inform a family member or close friend about their depression and ask them to read this leaflet. The patient may ask this person to inform them if they notice worsening depression or concerning changes in behaviour.
Serious skin reactions
Very rarely, serious skin reactions (SCARs) have been reported during treatment with quetiapine, which may be life-threatening or fatal. These mainly present as:

• Stevens-Johnson syndrome (SJS) - widespread blistering rash and peeling skin, especially around the mouth, nose, eyes, and genitals
• toxic epidermal necrolysis (TEN) - a more severe form causing extensive skin peeling
• drug reaction with eosinophilia and systemic symptoms (DRESS) - including flu-like symptoms with rash, high fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
• acute generalised exanthematous pustulosis (AGEP) - small pustules filled with pus
• erythema multiforme (EM) - skin rash with irregular, itchy, red patches

If any of these symptoms occur, stop taking Setinin immediately and consult a doctor or seek medical help without delay.
Weight gain
Weight gain has been observed in patients taking Setinin. The patient and doctor should regularly monitor the patient's body weight.
Children and adolescents
Setinin is not intended for use in children and adolescents under 18 years of age.
Setinin with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Setinin if the patient is taking:

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

Inform the doctor if the patient is taking any of the following medicines:

• antiepileptic medicines (such as phenytoin or carbamazepine)
• medicines used for high blood pressure
• barbiturates (medicines used for sleep disorders)
• thioridazine or lithium salts (other antipsychotic medicines)
• medicines affecting heart rhythm, e.g. medicines that may cause electrolyte imbalances (low potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (used to treat infections)
• medicines that may cause constipation
• medicines ("anticholinergic medicines") affecting nerve cell function, used in treating various diseases
• antidepressant medicines. These medicines may interact with Setinin and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Before stopping any medicine, the patient should consult their doctor.
Setinin with food, drink, and alcohol

• Setinin may be taken with or without food
• Be cautious with alcohol consumption, 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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Do not use Setinin during pregnancy unless agreed with a doctor. Setinin should not be used during breastfeeding.
Newborns of mothers who took quetiapine during the third trimester of pregnancy (last three months of pregnancy) may experience the following symptoms indicating withdrawal syndrome: seizures, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If any of these symptoms occur in the baby, it may be necessary to contact a doctor.
Driving and operating machinery
Setinin may cause drowsiness. The patient should not drive or operate any tools or machinery until they know how they react to the medicine.
Effect on urine drug screening tests
Taking Setinin may cause false positive results for methadone or certain tricyclic antidepressants (TCA) when certain testing methods are used. If this occurs, a more specific testing method should be used.
Setinin contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

3. How to use Setinin

This medicine should always be taken exactly as prescribed by the doctor. In case of any doubts, consult
your doctor or pharmacist.
The doctor will determine the starting dose for the patient. The usual dose (daily dose) typically ranges
from 150 mg to 800 mg, depending on the stage of the disease
and the patient's individual needs.

• The tablet should be taken once daily before bedtime or twice daily, depending on the condition being treated.
• Swallow the tablet whole with water.
• Tablets may be taken with or without food.
• Grapefruit juice must not be consumed during treatment with Setinin. It may affect the way the medicine works.
• Do not stop taking this medicine even if the patient feels better, unless otherwise advised by the doctor.

Liver function disorders
If the patient has liver problems, the doctor may adjust the dose of the medicine.
Elderly patients
If the patient is elderly, the doctor may adjust the dose of the medicine.
Use in children and adolescents
Setinin must not be used in children and adolescents under 18 years of age.
Taking more Setinin than prescribed
If the patient takes more medicine than prescribed by the doctor, symptoms such as
drowsiness, dizziness, or heart rhythm disturbances may occur. Seek immediate medical advice from a doctor
or go to the nearest hospital. Bring all remaining tablets of Setinin with you.
Missed dose of Setinin
If a dose of Setinin is missed, take it as soon as possible. However,
if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
Stopping Setinin treatment
If the patient suddenly stops taking Setinin, symptoms such as
insomnia, nausea or headache, diarrhoea, vomiting, dizziness or irritability may occur. To reduce the risk of such symptoms, the doctor will recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the adverse reactions listed below, they should contact their doctor IMMEDIATELY:
Very common (may affect more than 1 in 10 people)

• abnormal muscle movements. These symptoms include difficulty initiating movement, tremor, restlessness, or painless muscle stiffness

Common (may affect up to 1 in 10 people)

• suicidal thoughts and worsening of depression

Uncommon (may affect up to 1 in 100 people)

• diabetes
• seizures or epileptic fits
• allergic reactions, including raised skin rashes, skin swelling, and swelling around the mouth
• uncontrolled movements, particularly of the facial muscles or tongue
• changes in the heart's electrical activity seen on ECG (prolongation of QT interval)
• difficulty in passing urine
• worsening of pre-existing diabetes
• confusion

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

• a group of symptoms: high temperature (fever), sweating, muscle stiffness, severe drowsiness or fainting (a condition known as "neuroleptic malignant syndrome")
• yellowing of the skin and eyes (jaundice)
• hepatitis (liver inflammation)
• prolonged and painful erection (priapism)
• venous thrombosis, especially in the lower limbs (symptoms include swelling, pain, and redness in the legs); these clots may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (venous thromboembolic disease). If the patient notices any of these symptoms, they should seek immediate hospital treatment.
• pancreatitis (inflammation of the pancreas)
• combination of fever, flu-like symptoms, sore throat, or presence of any other infection caused by a very low number of white blood cells in the blood (a condition known as agranulocytosis)
• intestinal obstruction

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

• severe rash, blisters, or red spots on the skin
• severe allergic reactions (anaphylactic reactions), which may cause breathing difficulties or shock
• sudden swelling of the skin, usually around the eyes, mouth, and throat (angioedema)
• severe condition with blistering of the skin, mouth, eyes, and genital organs (Stevens-Johnson syndrome) (see section 2)
• abnormal secretion of the hormone regulating urine volume
• breakdown of muscle fibers and muscle pain (rhabdomyolysis)

Not known (frequency cannot be estimated from available data)

• skin rash with irregular red patches (erythema multiforme) (see section 2)
• sudden appearance of red skin areas covered with small pustules (small blisters filled with whitish-yellow fluid, also known as acute generalized exanthematous pustulosis (AGEP)) (see section 2)
• severe, sudden allergic reaction with symptoms such as fever, blistering of the skin, and peeling of the epidermis (toxic epidermal necrolysis) (see section 2)
• rash with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, high fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes) (see section 2)
• stroke

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

• dizziness (which may lead to falls), headache, dry mouth
• drowsiness (which may diminish during continued treatment) potentially leading to falls
• withdrawal symptoms (symptoms occurring after discontinuation of quetiapine), including: difficulty falling asleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness, irritability. Gradual discontinuation of the medicine over a period of at least 1–2 weeks is recommended.
• weight gain
• changes in levels of certain blood lipids (triglycerides and cholesterol)
• decreased hemoglobin levels

Common (may affect up to 1 in 10 people)

• rapid heartbeat
• palpitations (fast or irregular heartbeat, or pauses in heart rhythm)
• constipation, stomach irritation (dyspepsia)
• weakness
• swelling of hands or feet
• low blood pressure when standing. This may cause dizziness or fainting (which may lead to falls).
• increased blood glucose 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 blood
• changes in the number of certain types of white blood cells in blood
• increased levels of liver enzymes (ALT, gamma-GT) seen in blood tests
• increased levels of prolactin hormone in blood. Elevated prolactin levels may rarely lead to:
  • breast enlargement and unexpected milk production in both 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 dysfunction
• slowed 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)
• nasal congestion
• decreased number of certain blood cells
• decreased sodium levels in blood
• decreased levels of certain thyroid hormones in blood
• hypothyroidism
• increased levels of liver enzyme (AST) measured in blood

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

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

Not known (frequency cannot be estimated from available data)

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

This class of medicines, to which Setinin belongs, may cause disturbances in heart rhythm, which may be serious and, in rare cases, fatal.
Some adverse reactions can only be detected through laboratory blood tests. These include changes in levels of certain blood lipids (triglycerides and total cholesterol) or blood glucose, changes in thyroid hormone levels in blood, increased liver enzyme levels in blood, decreased number of certain types of blood cells, decreased number of red blood cells in blood, increased levels of creatine kinase in blood (a substance derived from muscles), decreased sodium levels in blood, and increased levels of one of the hormones in blood—prolactin. Elevated levels of this hormone may lead to:

• breast enlargement and unexpected milk production in both women and men
• absence of menstruation or irregular menstrual cycles in women
  Your doctor may recommend periodic monitoring tests.

Additional adverse reactions in children and adolescents
The adverse reactions described above should also be considered when quetiapine is used in children and adolescents.
Below are adverse reactions that occur more frequently in children and adolescents or were not observed in adult patients:
Very common (may affect more than 1 in 10 people)

• increased levels of prolactin hormone in blood. This may rarely cause:
  • breast enlargement 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 initiating movement, tremor, restlessness, or painless muscle stiffness
• increased blood pressure

Common (may affect up to 1 in 10 people)

• feeling weak, fainting (which may lead to falls)
• nasal congestion
• feeling irritable

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Setinin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Setinin contains

• The active substance is quetiapine. Setinin film-coated tablets contain 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine (as quetiapine fumarate).
• Other ingredients are:
  Tablet core: microcrystalline cellulose, povidone K29-32, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (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: Film-coated tablet, round, 5.5 mm in diameter, biconvex, light orange, with an embossed "Q" on one side.
Setinin, 100 mg: Film-coated tablet, round, 8.5 mm in diameter, biconvex, yellow, with an embossed "Q" on one side.
Setinin, 200 mg: Film-coated tablet, oval, 16 mm x 8.2 mm, biconvex, white, with an embossed "Q" on one side.
Setinin, 300 mg: Film-coated tablet, oval, 19 mm x 7.6 mm, biconvex, white, with an embossed "Q" on one side and "300" on the other side.

Pack sizes
Blister packs
Setinin, 25 mg/100 mg/200 mg/300 mg, film-coated tablets: 30, 60, 90 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
Zejtun ZTN3000
Malta

For further information about this medicinal product, please contact the representative of the marketing authorisation holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
Tel: +48 12 262 32 36
E-mail: [email protected]