Kvetina

Package Leaflet: Information for the Patient

Kwetina, 25 mg, Coated Tablets

Kwetina, 100 mg, Coated Tablets

Kwetina, 200 mg, Coated Tablets

Kwetina, 300 mg, Coated Tablets

Quetiapine

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you; do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Kwetina and what is it used for
• 2. Important information before taking Kwetina
• 3. How to take Kwetina
• 4. Possible side effects
• 5. How to store Kwetina
• 6. Package contents and other information

1. What is Kwetina and what is it used for

Kwetina contains the active substance quetiapine. It belongs to a group of medications called antipsychotics.
Kwetina is used to treat conditions such as:

• Depressive episodes in bipolar disorder, when the patient feels sad, very depressed, lacks energy, loses appetite, feels guilty, or has difficulty sleeping;
• Mania, when the patient is extremely excited, elated, agitated, enthusiastic, or overly active, or has impaired critical judgment, is aggressive, or troublesome;
• Schizophrenia, when the patient hears and sees unreal voices and images, believes in non-existent things, is overly suspicious, worried, confused, feels guilty, is tense, or depressed.

The doctor may recommend continuing to take Kwetina even when the patient's condition has improved.

2. Important information before taking Kwetina

When not to take Kwetina:

• certain medications used to treat HIV infection,
• azole medications (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

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

Warnings and precautions

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

• the patient or a family member has or has had any heart disease, such as arrhythmias, heart muscle weakness, or myocarditis, or if the patient is taking or has taken any medications that may affect heart function,
• the patient has low blood pressure,
• the patient has had a stroke, especially if the patient is elderly,
• the patient has liver problems,
• the patient has had seizures (epilepsy),
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may check the patient's blood sugar levels during treatment with Kwetina,
• the patient has had a decreased white blood cell count (which may or may not have been caused by other medications),
• the patient is an elderly person with dementia (cognitive impairment); in such cases, Kwetina should not be taken, as medications in the same class as Kwetina may increase the risk of stroke and sometimes death in elderly patients with dementia,
• the patient is elderly and has Parkinson's disease and/or parkinsonism,
• the patient or their family members have had blood clots, as the use of medications like this one is associated with the formation of blood clots,
• the patient has or has had breathing difficulties, such as short periods of breathlessness during sleep (sleep apnea syndrome), and is taking medications that slow down or weaken normal brain function (depressants),
• the patient has or has had difficulty emptying the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may be caused by medications (called anticholinergic medications) that affect the function of nerve cells, used to treat various conditions,
• the patient has or has had problems with alcohol or medication abuse,
• if the patient has depression or other conditions that are being treated with antidepressant medications. The use of these medications with Kwetina may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Kwetina and other medications").

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

• a combination of symptoms such as fever, muscle stiffness, excessive sweating, or disturbances of consciousness (a condition called malignant neuroleptic syndrome). Immediate treatment may be necessary,
• involuntary muscle movements, especially of the face and tongue,
• dizziness or excessive drowsiness. These symptoms may increase the risk of accidental injury (falls) in elderly patients,
• seizures (epilepsy),
• prolonged, painful erections (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 medications in this therapeutic class.
The patient should immediately inform their doctor if they experience:

• a combination of 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, which may require discontinuation of Kwetina and/or appropriate treatment.
• constipation combined with persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more serious bowel obstruction.

Suicidal thoughts or worsening depression.

Patients with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviors may worsen during the initial phase of treatment, as all antidepressant medications take some time to start working, usually after 2 weeks, sometimes later. These thoughts may worsen after sudden discontinuation of the medication. Young adults are more likely to experience such thoughts.
According to clinical trial data, there is an increased risk of suicidal thoughts and/or suicidal behavior in patients under 25 years of age with depression.
If the patient has ever had suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform family members or friends about the depression and ask them to read this package leaflet.
It may also be helpful to ask these individuals to tell the patient if they notice any worsening of depressive symptoms or other concerning changes in behavior.

Severe skin reactions

Very rarely, severe skin reactions (SCAR, severe cutaneous adverse reactions) have been reported with quetiapine treatment, which can be life-threatening or fatal. They usually occur as:

• Stevens-Johnson syndrome, a widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals,
• Toxic epidermal necrolysis, a more severe form causing widespread peeling of the skin,
• Drug rash with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme activity),
• Acute generalized exanthematous pustulosis (AGEP), small blisters filled with pus,
• Erythema multiforme, a skin rash with red, itchy, irregular patches.

If the patient experiences any of these symptoms, they should discontinue Kwetina and immediately contact their doctor or seek medical attention.

Weight gain

Weight gain has been observed in patients taking Kwetina. The patient and their doctor should regularly check the patient's weight.

Children and adolescents

Kwetina is not intended for use in children and adolescents under 18 years of age.

Kwetina and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Do not take Kwetina if you are taking any of the following medications:

• certain medications used to treat HIV infection,
• azole medications (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

Tell your doctor if you are taking any of the following medications:

• antiepileptic medications (such as phenytoin or carbamazepine),
• medications used to treat high blood pressure,
• barbiturates (used to treat sleep disorders),
• thioridazine or lithium (other antipsychotic medications),
• medications that affect heart rhythm, such as those that can disrupt electrolyte balance (decrease potassium or magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (which fight infections),
• medications that can cause constipation,
• medications (called anticholinergic medications) used to treat various conditions that affect the function of nerve cells,
• antidepressant medications. These medications may interact with Kwetina and cause symptoms such as involuntary, rhythmic muscle contractions, including those of the eye muscles, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Do not stop taking other medications without consulting your doctor.

Kwetina with food, drinks, and alcohol

Tablets can be taken with or without food.
During treatment, be cautious when consuming alcoholic beverages, as the combined effect of this medication and alcohol may cause drowsiness.
While taking this medication, do not consume grapefruit juice. It may affect the way the medication works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Do not take Kwetina during pregnancy without first discussing it with your doctor.
Kwetina should not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took quetiapine during pregnancy (last 3 months of pregnancy):
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, contact your doctor.

Driving and using machines

This medication may cause drowsiness. Do not drive or operate machinery until you know how the medication affects you.

Effect on urine tests for drug detection

In patients taking this medication, urine tests for drug detection performed using certain methods may show the presence of methadone or certain antidepressant medications (tricyclic antidepressants), even if the patient is not taking these medications. It is recommended to perform these tests using other methods to confirm the results.

Kwetina contains lactose and sodium

Kwetina contains 7 mg of lactose in a 25 mg tablet, 28 mg in a 100 mg tablet, 56 mg in a 200 mg tablet, and 84 mg in a 300 mg tablet. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medication.
This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free."

3. How to take Kwetina

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The initial dose will be determined by your doctor. The maintenance dose (daily dose) will depend on the severity of the disease and the individual patient's needs, but it usually ranges from 150 mg to 800 mg.

• Take the tablets once a day, before bedtime, or twice a day, depending on the condition being treated.
• Swallow the tablets whole with water.
• Tablets can be taken with or without food.
• While taking Kwetina, do not consume grapefruit juice, as it may affect the way the medication works.
• Do not stop taking the tablets even when your condition improves, unless your doctor tells you to.

Patients with liver function disorders

Your doctor may recommend a dose change if you have liver function disorders.

Elderly patients

Your doctor may recommend a dose change if you are an elderly patient.

Use in children and adolescents

Kwetina should not be used in children and adolescents under 18 years of age.

Taking more than the prescribed dose of Kwetina

If you take more Kwetina than prescribed, you may experience drowsiness, dizziness, or irregular heartbeat. Immediately consult your doctor or go to the nearest hospital. Take the Kwetina packaging with you.

Missing a dose of Kwetina

If you miss a dose, take it as soon as you remember. If the time to the next dose is short, wait and take the dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Kwetina treatment

If you suddenly stop taking this medication, you may experience difficulty sleeping (insomnia) or feel:
nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Kwetina can cause side effects, although not everybody gets them.
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 with Kwetina) (may lead to falls).
• Withdrawal symptoms (symptoms that occur after stopping Kwetina) including: difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, irritability. It is recommended to gradually stop taking the medication over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements; this may be difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Changes in blood levels of certain fats (triglycerides and total cholesterol).

Common(may affect up to 1 in 10 people):

• Increased heart rate (fast heartbeat).
• Feeling of irregular heartbeat, very strong heartbeat, fast heartbeat, or pauses in heart rhythm.
• Constipation, stomach upset (indigestion).
• Weakness.
• Swelling of hands or feet.
• Decrease in blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decrease in the number of certain types of blood cells.
• Increased liver enzyme levels in the blood.
• Increased levels of the hormone prolactin in the blood. Increased prolactin levels may rarely lead to:
• breast enlargement in both men and women, and unexpected milk production,
• absence or irregular menstrual periods in women.

Uncommon(may affect up to 1 in 100 people):

• Seizures or convulsions.
• Allergic reactions, such as blisters on the skin, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the lower limbs (also known as restless legs syndrome).
• Difficulty swallowing.
• Involuntary muscle movements, especially of the face and tongue.
• Sexual function disorders.
• Diabetes.
• Changes in the electrical activity of the heart visible on an ECG (prolonged QT interval).
• Slower than normal heart rate, which may occur when starting treatment and may be associated with decreased blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in red blood cell count.
• Decrease in sodium levels in the blood.
• Worsening of existing diabetes.
• Disorientation.

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

• A combination of high body temperature, sweating, muscle stiffness, and disturbances of consciousness (a condition called malignant neuroleptic syndrome).
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged, painful erections (priapism).
• Breast enlargement and unexpected milk production.
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), and a fragment of the clot may break off and travel with the blood to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Sleepwalking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called metabolic syndrome) in which there is a combination of 3 or more of the following features: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels.
• A 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).
• Bowel obstruction.
• Increased levels of the enzyme creatine phosphokinase in the blood (a substance derived from muscles).

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

• Severe skin reactions, blisters, or red patches on the skin.
• Severe allergic reactions (anaphylaxis), which may cause difficulty breathing or shock.
• Rapidly developing swelling of the skin, usually around the eyes and mouth, as well as the throat (angioedema).
• Severe skin reaction with blisters, peeling of the skin, and mucous membrane involvement (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of the hormone that regulates urine production.
• Muscle breakdown and muscle pain (rhabdomyolysis).

Frequency not known(frequency cannot be estimated from the available data):

• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Sudden onset of red skin areas with small 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 (toxic epidermal necrolysis). See section 2.
• Drug rash with eosinophilia and systemic symptoms (DRESS). Includes flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme activity). See section 2.

Withdrawal symptoms may occur in newborns of mothers who took quetiapine during pregnancy.

• Stroke.
• Heart muscle disorders (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Blood vessel inflammation (vasculitis), often with a skin rash and small red or purple spots.

Medications in the same class as Kwetina may cause heart rhythm disorders, which can be dangerous and, in severe cases, may lead to death.
Certain side effects can only be detected by blood tests in a laboratory. These include changes in levels of certain fats (triglycerides and total cholesterol) or sugar 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 lead to:

• breast enlargement in both men and women, and unexpected milk production,
• absence or irregular menstrual periods in women. Your doctor may recommend regular blood tests.

Additional side effects in children and adolescents

The same side effects that occur in adults may also occur in children and adolescents.
The following side effects have been observed more frequently or exclusively in children and adolescents:
Very common(may affect more than 1 in 10 people):

• Increased levels of the hormone prolactin in the blood. This may rarely lead to:
• breast enlargement and unexpected milk production in boys and girls,
• absence or irregular menstrual periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, including difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Increased blood pressure.

Common(may affect up to 1 in 10 people):

• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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. By reporting side effects, you can help provide more information on the safety of this medication.

• The marketing authorization holder is responsible for the monitoring of the safety of this medication. Reporting side effects will also be forwarded to the marketing authorization holder.

5. How to store Kwetina

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Kwetina contains

• The active substance is quetiapine. One coated tablet contains quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine.
• The other ingredients (excipients) are: hypromellose, calcium hydrogen phosphate dihydrate, lactose monohydrate, corn starch, sodium carboxymethylcellulose type A, magnesium stearate, microcrystalline cellulose, talc, anhydrous colloidal silica, and the tablet coating.
• The coating of the 25 mg tablet: iron oxide red (E 172), iron oxide yellow (E 172), hypromellose HPMC 2910, titanium dioxide (E 171), macrogol 400, orange yellow (E 110).
• The coating of the 100 mg tablet: iron oxide yellow (E 172), hypromellose HPMC 2910, titanium dioxide (E 171), macrogol 400.
• The coating of the 200 mg and 300 mg tablets: hydroxypropylcellulose, hypromellose HPMC 2910, titanium dioxide (E 171), talc.

What Kwetina looks like and package contents

Kwetina, 25 mg: peach-colored, round, biconvex coated tablets with a diameter of 5.7 mm.
Kwetina, 100 mg: yellow, round, biconvex coated tablets with a score line on one side, with a diameter of 9.1 mm.
Kwetina, 200 mg: white, round, biconvex coated tablets with a score line on one side, with a diameter of 12.1 mm.
Kwetina, 300 mg: white, oval, biconvex coated tablets with a score line on one side, with dimensions of 19.1 mm x 9.1 mm.
One package of Kwetina, 25 mg contains 30 or 60 coated tablets in PVC/Aluminum blisters in a cardboard box.
One package of Kwetina, 100 mg, 200 mg, and 300 mg contains 60 coated tablets in PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder

PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A.
Żmigrodzka Street 242 E, 51-131 Wrocław

Manufacturer

Genepharm S.A.
18th km Marathonos Avenue,
15351 Pallini Attiki
Greece

Medication information

Phone: 22 742 00 22
Email: [email protected]

Date of last revision of the package leaflet: 07/2024