Kwetina

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
Quetiapinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Kwetina is and what it is used for
2. What you need to know before taking 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 Kwetina is and what it is used for

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

• depressive episodes in bipolar disorder, when the patient feels sadness, profound low mood, lack of energy, loss of appetite, feelings of guilt, or inability to sleep;
• mania, when the patient is extremely excited, elated, overactive, enthusiastic, or excessively active, has impaired judgment, or is aggressive or troublesome;
• schizophrenia, when the patient hears or sees unreal voices and images, believes in non-existent things, is excessively suspicious, anxious, confused, feels guilt, or is tense and depressed.

Your doctor may recommend continuing treatment with Kwetina even after your condition has improved.

2. Important information before taking 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,
• azole antifungals (used in fungal infections),
• erythromycin or clarithromycin (used in infections),
• nefazodone (used to treat depression).

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

• the patient or a family member has or has had any heart problems, such as irregular heartbeat, weakened heart muscle, 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, particularly if the patient is elderly,
• the patient has liver problems,
• the patient has ever had seizures (epilepsy),
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor the patient's blood sugar levels during treatment with Kwetina,
• the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines),
• the patient is an elderly person with dementia (a brain disorder); in this case, Kwetina should not be used, as medicines of this class may increase the risk of stroke and sometimes even risk of death in elderly patients with dementia,
• the patient is elderly and has Parkinson's disease and (or) parkinsonism,
• the patient or a family member has a history of blood clots, as medicines such as this one may increase the risk of thrombosis,
• the patient currently has or has previously had breathing problems involving brief periods of stopped breathing during sleep (called sleep apnoea syndrome) and is taking medicines that slow down or weaken normal brain function (called depressants),
• the patient currently 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 conditions,
• the patient has or has had problems with alcohol or drug abuse,
• the patient has depression or other conditions treated with antidepressants. Taking these medicines together with Kwetina may lead to serotonin syndrome, a potentially life-threatening condition (see "Kwetina and other medicines").

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

• a combination of symptoms such as: fever, severe muscle stiffness, excessive sweating, or altered mental status (this condition is known as neuroleptic malignant syndrome). Immediate medical 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 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 of these symptoms may occur during treatment with medicines of this therapeutic class.
Immediately inform the doctor if the patient experiences:

• fever together with flu-like symptoms, sore throat, or any other infection, as this may indicate a very low number of white blood cells in the blood, which may require discontinuation of Kwetina and/or appropriate treatment.
• constipation together with persistent abdominal pain or persistent constipation despite treatment, as this may lead to more serious intestinal obstruction.
• Suicidal thoughts or worsening depression. Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen during the initial phase of treatment, as all antidepressants take time to work, usually at least two weeks, sometimes longer. These thoughts may worsen after abrupt discontinuation of the medicine. Young adults are more likely to experience such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behaviour in people under 25 years of age with depression.

If the patient ever experiences suicidal thoughts or thoughts of self-harm,
contact a doctor immediately or go to hospital. It may be helpful
to inform family members or friends about the depression and ask them to read this leaflet.
You may also ask these people to inform the patient if they notice worsening of depressive symptoms
or other concerning changes in behaviour.
Severe skin reactions
Severe cutaneous adverse reactions (SCARs) have very rarely been reported with quetiapine treatment, which may be life-threatening or fatal. These usually present as:

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

If any of these symptoms occur, stop taking Kwetina immediately and
contact a doctor or seek medical help immediately.
Weight gain
Weight gain has been observed in patients taking Kwetina. The patient and doctor should regularly monitor the patient's body 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 currently taking, has recently taken, or plans to take.
Do not take Kwetina if the patient is taking any of the following medicines:

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

Tell the 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 for sleep disorders),
• thioridazine or lithium (other antipsychotic medicines),
• medicines affecting heart rhythm, for example, medicines that may disturb electrolyte balance (reduced potassium or magnesium levels), such as diuretics (causing increased urine output) or certain antibiotics (used to treat infections),
• medicines that may cause constipation,
• medicines (called anticholinergic medicines) used to treat various conditions that affect nerve cell function,
• antidepressants. These medicines may interact with Kwetina and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movement disorders, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor.

Do not stop taking other medicines without consulting your doctor.
Kwetina with food, drink, and alcohol
Tablets may be taken with or without food.
During treatment, exercise caution when consuming alcoholic beverages, as the combined effect of this medicine and alcohol may cause drowsiness.
While taking this medicine, do not consume grapefruit juice. It may affect how the medicine works.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The patient should not take Kwetina during pregnancy without first discussing this with her 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 the third trimester of pregnancy (last 3 months of pregnancy):
tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, the mother should contact a doctor.
Driving and operating machinery
This medicine may cause drowsiness. Do not drive or operate machinery until you know how this medicine affects you.
Effect on urine drug screening tests
In patients taking this medicine, urine drug screening tests performed by certain methods may show the presence of methadone or certain antidepressants known as tricyclic antidepressants (TCA), even though the patient is not taking these medicines. It is recommended to confirm test results using alternative methods.
Kwetina contains lactose and sodium
Kwetina contains 7 mg lactose in the 25 mg tablet, 28 mg in the 100 mg tablet, 56 mg in the 200 mg tablet, and 84 mg in the 300 mg tablet. If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

3. How to take Kwetina

This medicine should always be taken as directed by the physician. If in doubt, consult your doctor or pharmacist.
The initial dose will be determined by the doctor. The maintenance dose (daily dose) will depend on the severity of the disease and the individual patient's needs, but usually ranges from 150 mg to 800 mg.

• Kwetina tablets should be taken once daily, before bedtime, or twice daily, depending on the patient's condition.
• Tablets should be swallowed whole with water.
• Tablets may be taken with or without food.
• Grapefruit juice should not be consumed during treatment with Kwetina, as it may affect the medicine's action.
• Do not discontinue taking the tablets even if symptoms improve, unless otherwise advised by the doctor.

Patients with hepatic impairment
The doctor may adjust the dose of Kwetina in patients with impaired liver function.
Elderly patients
The doctor may adjust the dose of Kwetina in elderly patients.
Use in children and adolescents
Kwetina should not be used in children and adolescents under 18 years of age.
Taking more Kwetina than recommended
If more tablets are taken than prescribed, symptoms such as drowsiness, dizziness, or irregular heartbeat may occur. Seek immediate medical attention from a doctor or go to the nearest hospital. Bring the Kwetina packaging with you.
Missed dose of Kwetina
If a dose is missed, take it as soon as remembered. 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 Kwetina treatment
If treatment with Kwetina is suddenly discontinued, difficulty sleeping (insomnia) may occur, or the patient may experience nausea, headache, diarrhoea, vomiting, dizziness, or irritability. The doctor may 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (may occur in more than 1 in 10 patients):

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may subside during continued treatment with Kwetina) (may lead to falls).
• Withdrawal symptoms (symptoms occurring after discontinuation of Kwetina) including: difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements; this may include difficulty initiating movement, tremor, restlessness, or painless muscle stiffness.
• Changes in blood levels of certain lipids (triglycerides and total cholesterol).

Common (may occur in 1 in 10 patients):

• Increased heart rate (rapid heartbeat).
• Sensation of irregular heartbeat, very strong heartbeat, rapid heartbeat, or pauses in heart rhythm.
• Constipation, stomach irritation (dyspepsia).
• Weakness.
• Swelling of hands or feet.
• Decreased blood pressure upon standing. This may cause dizziness or fainting (may lead to falls).
• Increased blood glucose levels.
• Blurred vision.
• Unusual dreams and nightmares.
• Increased appetite.
• Feeling of irritability.
• Speech and articulation disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in blood.
• Decreased number of certain types of blood cells.
• Increased liver enzyme levels in blood.
• Increased blood levels of the hormone prolactin. Elevated prolactin levels may lead to:
• Breast enlargement in both men and women, and unexpected milk production,
• Absence or irregular menstruation in women.

Uncommon (may occur in 1 in 100 patients):

• Seizures or convulsions.
• Allergic reactions such as skin blisters (vesicles), 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 dysfunction.
• Diabetes.
• Changes in the electrical activity of the heart visible on ECG (prolongation of QT interval).
• Slower than usual heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Nasal congestion.
• Decreased number of red blood cells in blood.
• Decreased sodium levels in blood.
• Worsening of existing diabetes.
• Disorientation.

Rare (may occur in 1 in 1,000 patients):

• Combination of high body temperature (fever), sweating, muscle stiffness, drowsiness or near-fainting (a condition known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis (liver inflammation).
• Prolonged, painful penile erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhea).
• Menstrual cycle disturbances.
• Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the legs); a clot fragment may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the patient should seek immediate medical attention at a doctor's office or hospital.
• Walking, talking, eating, or performing other activities during sleep.
• Decreased body temperature (hypothermia).
• Pancreatitis (inflammation of the pancreas).
• A condition (known as "metabolic syndrome") characterized by a combination of 3 or more of the following features: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of certain blood lipids (triglycerides), high blood pressure, and increased blood glucose levels.
• Combination of fever, flu-like symptoms, sore throat, or any other infection with a very low number of white blood cells in blood (a condition known as agranulocytosis).
• Intestinal obstruction.
• Increased blood levels of creatine kinase (a substance derived from muscles).

Very rare (may occur in 1 in 10,000 patients):

• Severe rash, blisters, or red spots on the skin.
• Severe hypersensitivity reactions (anaphylactic reaction), manifesting as breathing difficulties or shock.
• Rapid swelling of the skin, usually around the eyes, mouth, and throat (angioedema).
• Severe disorder with blister formation on the skin, mouth, eyes, and genital organs (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of a hormone regulating urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Frequency 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 blisters (small vesicles filled with white/yellow fluid), called acute generalized exanthematous pustulosis (AGEP). See section 2.

• Severe, sudden allergic reaction with symptoms such as: fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis). See section 2.

• Drug rash with eosinophilia and systemic symptoms (DRESS). Includes flu-like symptoms with rash, high fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See section 2.

• Newborns of mothers who took Kwetina during pregnancy may experience withdrawal symptoms.

• Stroke.

• 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.

Medicines in the class to which Kwetina belongs may cause disturbances in heart rhythm, which could be dangerous and, in severe cases, may even lead to death.

Some adverse effects can only be detected by laboratory blood tests. These include changes in blood levels of certain lipids (triglycerides and total cholesterol) or glucose, changes in thyroid hormone levels in blood, increased liver enzyme levels, decreased number of certain types of blood cells, decreased number of red blood cells, increased blood levels of creatine kinase (a substance derived from muscles), decreased sodium levels in blood, and increased blood levels of the hormone prolactin. Elevated prolactin levels may rarely lead to:

• Breast enlargement in both men and women, and unexpected milk production,
• Absence or irregular menstruation in women. The doctor may recommend periodic blood monitoring tests.

Additional adverse effects in children and adolescents
The same adverse effects observed in adult patients may occur in children and adolescents.
The following adverse effects have been observed more frequently or exclusively in children and adolescents:

Very common (may occur in more than 1 in 10 patients):

• Increased blood levels of the hormone prolactin. In rare cases, this may lead to:
• Breast enlargement and unexpected milk production in boys and girls,
• In girls, absence or irregular menstruation.
• Increased appetite.
• Vomiting.
• Abnormal muscle contractions, including difficulty initiating intended movement, tremors, muscle restlessness, or muscle stiffness without pain.
• Increased blood pressure.

Common (may occur in up to 1 in 10 patients):

• Feeling of weakness, fainting (may lead to falls).
• Nasal congestion.
• Feeling of irritability.

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

5. How to store Kwetina

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special storage requirements for this medicinal product.
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 package and other information

What Kwetina contains

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

What Kwetina looks like and contents of the pack
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, oblong, biconvex coated tablets with a score line on one side, measuring 19.1 mm x 9.1 mm.
One package of Kwetina 25 mg contains 30 or 60 coated tablets in PVC/Aluminum blisters, packed in a cardboard box.
One package of Kwetina 100 mg, 200 mg and 300 mg contains 60 coated tablets in PVC/Aluminum blisters, packed in a cardboard box.

Marketing Authorisation Holder
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław, Poland

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

Product information
Tel.: 22 742 00 22
E-mail: [email protected]