Kvetina

Package Leaflet: Information for the Patient

Kwetina, 25 mg, Film-Coated Tablets

Kwetina, 100 mg, Film-Coated Tablets

Kwetina, 200 mg, Film-Coated Tablets

Kwetina, 300 mg, Film-Coated Tablets

Quetiapine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Kwetina and what is it used for
• 2. Before you take Kwetina
• 3. How to take Kwetina
• 4. Possible side effects
• 5. How to store Kwetina
• 6. Contents of the pack and other information

1. What is Kwetina and what is it used for

Kwetina contains the active substance quetiapine, which belongs to a group of medicines called antipsychotics.
Kwetina is used to treat several diseases, such as:

• depressive episodes in bipolar disorder, when the patient feels sad, very depressed, lacks energy, loses appetite, feels guilty or cannot sleep;
• mania, when the patient is very excited, elated, agitated, full of enthusiasm or overly active, or has impaired critical judgment, is aggressive or troublesome;
• schizophrenia, when the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, worried, confused, feels guilty, is tense, depressed.

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

2. Before you take Kwetina

When not to take Kwetina:

• 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 infections),
• nefazodone (used to treat depression).

In case of doubt, consult your doctor or pharmacist before taking Kwetina.

Warnings and precautions

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

• the patient or a family member has or has had any heart disease, such as arrhythmias, heart failure, or myocarditis, or if the patient is taking or has taken any medicines 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 medicines),
• the patient is an elderly person with dementia (cognitive impairment); in such a case, Kwetina should not be taken, as medicines in the same group as Kwetina may increase the risk of stroke and sometimes death in elderly people 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 such medicines 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 medicines 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 medicines (called anticholinergic medicines) that affect the functioning of nerve cells, used to treat various diseases,
• the patient has or has had problems with alcohol or drug abuse,
• if the patient has depression or other conditions that are treated with antidepressants. Taking these medicines with Kwetina may lead to the development of serotonin syndrome, a life-threatening condition (see "Kwetina and other medicines").

Tell your doctor immediately if, after taking Kwetina, the patient experiences any of the following symptoms:

• 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 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, refer the patient to a cardiologist immediately.

All these symptoms may occur during treatment with medicines in this therapeutic group.
Tell your doctor immediately if the patient experiences:

• 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, and it may be necessary to discontinue Kwetina and/or apply 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.

People 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 medicines start to work after some time, usually after 2 weeks, sometimes later. These thoughts may worsen after sudden discontinuation of the medicine. Young adults are more likely to have such thoughts.
Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behaviors in people under 25 years of age with depression.
If the patient has ever had suicidal thoughts or thoughts of self-harm, they should contact their doctor or go to the hospital immediately. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. You can also ask these people to tell the patient if they notice any worsening of depressive symptoms or other worrying 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 (SJS), a widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals,
• toxic epidermal necrolysis (TEN), 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 (EM), a skin rash with red, itchy, irregular patches.

If the patient experiences these symptoms, they should discontinue Kwetina and seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking Kwetina. The patient and the 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 medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
Do not take Kwetina 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 infections),
• nefazodone (used to treat depression).

Tell your doctor if the patient is taking any of the following medicines:

• antiepileptic medicines (such as phenytoin or carbamazepine),
• medicines used to treat high blood pressure,
• barbiturates (used to treat sleep disorders),
• thioridazine or lithium (other antipsychotic medicines),
• medicines 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),
• medicines that can cause constipation,
• medicines (called anticholinergic medicines) used to treat various diseases, which affect the functioning of nerve cells,
• antidepressant medicines. These medicines may interact with Kwetina and may cause symptoms such as involuntary, rhythmic muscle contractions, including those of the eye muscles, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Do not stop taking other medicines without consulting a doctor.

Kwetina with food, drinks, and alcohol

The tablets can be taken with or without food.
During treatment, be cautious when consuming alcoholic beverages, as the combined effect of this medicine and alcohol may cause drowsiness.
Do not consume grapefruit juice during treatment with this medicine, as it may affect the way the medicine works.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
The patient should not take Kwetina during pregnancy without first discussing it with their 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 such symptoms are observed in the patient's child, they should contact their doctor.

Driving and using machines

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

Effects on urine tests for drugs

In patients taking this medicine, urine tests for drugs performed by some methods may show the presence of methadone or certain antidepressant medicines (tricyclic antidepressants), even if the patient is not taking these medicines. It is recommended to perform these tests by 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 medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Kwetina

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 is usually between 150 mg and 800 mg.

• The tablets should be taken once a day, before bedtime, or twice a day, depending on the disease the patient has.
• The tablets should be swallowed whole, with water.
• The tablets can be taken with or without food.
• During treatment with Kwetina, do not consume grapefruit juice, as it may affect the way the medicine works.
• Do not stop taking the tablets even when the patient's condition improves, unless the doctor recommends it.

Patients with liver function disorders

The doctor may recommend a dose change for patients with liver function disorders.

Elderly patients

The doctor may recommend a dose change for elderly patients.

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 a higher dose of Kwetina is taken than prescribed by the doctor, the patient may experience drowsiness, dizziness, irregular heartbeat. Consult a doctor or go to the nearest hospital immediately. Take the Kwetina packaging with you.

Missing a dose of Kwetina

If a dose of Kwetina is missed, take it as soon as possible. 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 treatment with Kwetina

If treatment with this medicine is stopped suddenly, the patient may experience difficulty sleeping (insomnia) or feel: nausea, headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose of Kwetina before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kwetina can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people):

• Dizziness (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 Kwetina 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):

• Fast heartbeat (tachycardia).
• Feeling of irregular heartbeat, very strong heartbeat, fast heartbeat, or pauses in heart rhythm.
• Constipation, stomach upset (indigestion).
• Weakness.
• Swelling of hands or feet.
• Low 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 people).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased levels of certain types of blood cells.
• Increased levels of liver enzymes in the blood.
• Increased levels of the hormone prolactin in the blood. Elevated 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 (QT interval prolongation).
• Slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decreased red blood cell count.
• Decreased 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 altered mental status (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), a fragment of the clot can break off and travel with the bloodstream to the lungs, causing chest pain and difficulty breathing. If the patient notices any of these symptoms, they should see a doctor immediately.
• Sleepwalking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called metabolic syndrome) in which at least 3 of the following features are present: increased waist circumference, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and elevated 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 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 (anaphylactic reaction), with symptoms such as 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, and shedding of the skin (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 appearance of areas of red skin 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.

wynikami badań krwi (w tym zwiększeniem liczby białych krwinek (eozynofilia) i enzymów wątrobowych). See section 2.

• Withdrawal symptoms 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 with small red or purple spots.

Medicines in the same group as Kwetina may cause heart rhythm disorders, which can be dangerous and, in severe cases, may lead to death.
Some side effects can only be detected by blood tests in the 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 levels of certain types of blood cells, decreased red blood cell count, increased levels of creatine phosphokinase in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Elevated prolactin levels may rarely lead to:

• breast enlargement in both men and women, and unexpected milk production,
• absence or irregular menstrual periods in women. The doctor may order periodic blood tests.

Additional side effects in children and adolescents

The same side effects that occur in adults can 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, talk to your doctor, pharmacist, or nurse. Side effects can also be reported 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 medicine.

• The marketing authorization holder is responsible for the reporting process.

5. How to store Kwetina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Kwetina contains

• The active substance is quetiapine. One film-coated tablet contains quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine.
• The other ingredients are: hypromellose, calcium hydrogen phosphate dihydrate, lactose monohydrate, maize starch, sodium carboxymethylcellulose type A, magnesium stearate, microcrystalline cellulose, talc, anhydrous colloidal silica, and 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 contents of the pack

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

Marketing authorization holder

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

Manufacturer

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

Information about the medicine

Phone: 22 742 00 22
Email: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: 07/2024