Kvetaplex Xr

Package Leaflet: Information for the Patient

Kwetaplex XR, 50 mg, prolonged-release tablets

Kwetaplex XR, 200 mg, prolonged-release tablets

Kwetaplex XR, 300 mg, prolonged-release tablets

Kwetaplex XR, 400 mg, prolonged-release tablets

Quetiapine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Kwetaplex XR and what is it used for.
• 2. Important information before taking Kwetaplex XR.
• 3. How to take Kwetaplex XR.
• 4. Possible side effects.
• 5. How to store Kwetaplex XR.
• 6. Contents of the pack and other information.

1. What is Kwetaplex XR and what is it used for

Kwetaplex XR contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Kwetaplex XR can be used to treat diseases such as:

• depression in bipolar disorder and major depressive episodes in major depression, when the patient feels intense sadness or depression, has a sense of guilt, lack of energy and appetite, or difficulty sleeping;
• mania: when the patient may be very agitated, excited, enthusiastic, overactive, or has limited critical judgment, including being aggressive or exhibiting destructive behavior;
• schizophrenia, when the patient hears or feels non-existent voices and things, has hallucinations, is overly suspicious, fearful, anxious, confused, has a sense of guilt, tension, or depression.

In the case of treatment of major depressive episodes in major depression, Kwetaplex XR will be used in combination with another medicine. The doctor may recommend continued use of Kwetaplex XR, even if the patient's condition improves.

2. Important information before taking Kwetaplex XR

When not to take Kwetaplex XR:

• 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 certain medicines for HIV infection, azole antifungals,

erythromycin or clarithromycin (used to treat infections), nefazodone (used to treat depression). If in doubt, consult a doctor or pharmacist before taking Kwetaplex XR.

Warnings and precautions

Before starting to take Kwetaplex XR, discuss with your doctor if:

the patient or their family members have or have had heart disease, such as arrhythmias; heart muscle weakness or myocarditis; the patient is taking 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 function disorders; the patient has ever had a seizure (epilepsy); the patient has diabetes or is at risk of developing diabetes. In this case, the doctor may recommend glucose tests during treatment with Kwetaplex XR; 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 an elderly person with senile dementia (reduced cognitive function). Such a person should not take Kwetaplex XR, as medicines in this group may increase the risk of stroke and sometimes the risk of death in such patients; if the patient is an elderly person with Parkinson's disease/parkinsonism; if the patient or a family member has a history of blood clots, as taking medicines in this group can cause them to form; if the patient has or has had conditions during which breathing stops for short periods during normal nighttime sleep (so-called sleep apnea) and takes medicines that slow down normal brain activity (so-called depressants); if the patient has or has had difficulty completely emptying the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms are sometimes caused by medicines (so-called anticholinergic medicines) used to treat certain diseases that affect the functioning of nerve cells; if the patient has or has had a problem with alcohol or drug abuse; if the patient has depression or other conditions that are treated with antidepressants. Taking these medicines with Kwetaplex XR may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Kwetaplex XR and other medicines").

Tell your doctor immediately if you experience any of the following symptoms after taking Kwetaplex XR: a combination of fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary; involuntary movements, especially of the face or tongue; dizziness, a feeling of extreme drowsiness. This can increase the risk of accidental injuries (falls) in elderly patients; seizure (convulsions); prolonged and painful erection (priapism). Rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, immediately refer the patient to a cardiologist. All these symptoms can occur during treatment with medicines in this therapeutic group.

Tell your doctor as soon as possible if you experience symptoms such as: fever, flu-like symptoms, sore throat, or other infections that may be a sign of a low white blood cell count. This may require discontinuation of Kwetaplex XR therapy and/or the use of appropriate treatment; constipation with persistent abdominal pain or constipation that does not respond to treatment. This can lead to serious bowel obstruction.

Severe skin reactions

Very rarely, severe skin reactions (SCAR, severe cutaneous adverse reactions) have been reported with this medicine, 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 reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with a rash, fever, swelling of the glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes). If the patient experiences these symptoms, they should stop taking Kwetaplex XR and seek medical attention immediately.

Weight gain

Patients taking Kwetaplex XR have experienced weight gain. It is recommended to regularly monitor weight, either alone or with a doctor.

Children and adolescents

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

Kwetaplex XR and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Do not take Kwetaplex XR if you are taking: certain medicines for HIV infection; azole antifungals; erythromycin or clarithromycin (used to treat infections); nefazodone (used to treat depression). Tell your doctor if you are taking: antiepileptic medicines (such as phenytoin or carbamazepine); antihypertensive medicines; barbiturates (medicines used to treat sleep disorders); thioridazine or lithium (or other antipsychotic medicines); medicines that affect heart rhythm, such as medicines that disrupt electrolyte balance (decreased potassium or magnesium levels), such as diuretics or certain antibiotics; laxatives; medicines (called anticholinergic medicines) that affect the way nerve cells function to treat certain diseases; antidepressants. These medicines may interact with Kwetaplex XR and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor. Do not stop taking other medicines without consulting a doctor.

Kwetaplex XR with food, drink, and alcohol

Taking food may interfere with the action of the medicine, so Kwetaplex XR should be taken at least 1 hour before a meal or before bedtime. Be careful when drinking alcoholic beverages. Taking Kwetaplex XR and alcohol at the same time may cause drowsiness. Do not consume grapefruit juice while taking Kwetaplex XR, as it may affect the way the medicine works.

Pregnancy and breastfeeding

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 medicine. Kwetaplex XR should not be used during pregnancy, unless the doctor recommends it. Kwetaplex XR should not be used during breastfeeding. In newborns and mothers who took quetiapine during the last trimester of pregnancy (last three months of pregnancy), the following symptoms may occur: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, feeding difficulties. If the child experiences any of these symptoms, it may be necessary to consult a doctor.

Driving and using machines

Kwetaplex XR may cause drowsiness. Do not drive or operate machinery until you are sure how the medicine affects you.

Effect on urine drug tests

If you are taking Kwetaplex XR and undergoing urine tests for drugs, some test methods may show a positive result for methadone or tricyclic antidepressants (TCAs), even if they have not been taken. In such cases, more detailed tests should be performed.

Kwetaplex XR contains sodium

Kwetaplex XR 50 mg, 200 mg, 300 mg, prolonged-release tablets: The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free". Kwetaplex XR 400 mg, prolonged-release tablets: The medicine contains 25.67 mg of sodium (the main component of common salt) per tablet, which corresponds to 1.28% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Kwetaplex XR

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 usual daily maintenance dose of Kwetaplex XR is between 150 mg and 800 mg, depending on the patient's symptoms and needs. Take the medicine once a day. Do not divide, chew, or crush the tablets. Swallow the tablets whole with water. Take the tablets without food (at least 1 hour before a meal or before bedtime, as recommended by your doctor). Do not consume grapefruit juice while taking Kwetaplex XR, as it may affect the way the medicine works. Even if you feel better, do not stop taking the medicine unless your doctor decides to do so.

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

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

Taking a higher dose of Kwetaplex XR than recommended

If you take more Kwetaplex XR than recommended, you may experience drowsiness, dizziness, or abnormal heart rhythm. Consult your doctor or go to the nearest hospital immediately. Take the Kwetaplex XR packaging with you.

Missing a dose of Kwetaplex XR

If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, take the medicine at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Kwetaplex XR

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

dizziness (which may cause falls), headache, dry mouth; drowsiness (which may resolve during continued treatment) (may cause falls); withdrawal symptoms (symptoms that may occur when stopping treatment), including difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop treatment over 1-2 weeks; weight gain; abnormal muscle movements. Difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain; changes in levels of certain fats (triglycerides and total cholesterol) in the blood.

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

rapid heartbeat; feeling of palpitations or irregular heartbeat; constipation, indigestion; feeling of weakness; swelling of hands or feet; drops in blood pressure when standing up. These can cause dizziness or fainting (which may cause falls); increased blood glucose levels; blurred vision; unpleasant dreams and nightmares; increased appetite; feeling of irritability; speech disorders; suicidal thoughts and depression. shortness of breath; vomiting (mainly in elderly patients); fever; changes in thyroid hormone levels in the blood; changes in the number of certain types of blood cells; increased liver enzyme activity; increased prolactin levels in the blood - which can rarely lead to: breast swelling and unexpected milk production, in both women and men; absence or irregular menstrual periods in women.

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

seizures; allergic reactions, including hives and blisters on the skin, swelling of the skin and around the mouth; unpleasant sensations in the legs (so-called restless legs syndrome); difficulty swallowing; involuntary movements, mainly of the face or tongue; sexual disorders; diabetes; changes in the electrocardiogram (ECG) (prolonged QT interval). low heart rate, which may occur at the beginning of treatment and lead to low blood pressure and loss of consciousness; difficulty urinating; fainting (which may cause falls); stuffy nose; decreased red blood cell count; decreased sodium levels in the blood; increased risk of existing diabetes. neutropenia (decreased white blood cell count).

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

very high body temperature (fever), excessive sweating, muscle stiffness, drowsiness, or loss of consciousness (a condition called malignant neuroleptic syndrome); yellowing of the skin and eyes (jaundice); liver inflammation; prolonged and painful erection (priapism); breast swelling and unexpected milk production (galactorrhoea); irregular menstrual periods; blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, consult your doctor immediately; sleepwalking, talking, eating during sleep; low body temperature (hypothermia); pancreatitis; "metabolic syndrome", which includes a combination of three or more symptoms such as: abdominal obesity, decreased "good" cholesterol (HDL-C), increased triglycerides, increased blood pressure, and blood sugar; fever, flu-like symptoms, sore throat, infections with a very low white blood cell count in the blood (agranulocytosis); intestinal obstruction; increased activity of creatine phosphokinase in the blood.

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

severe rash, blisters, red spots on the skin; severe allergic reactions (anaphylactic reactions), which can cause difficulty breathing or shock; rapid onset of swelling of the skin, usually around the eyes, mouth, or throat (angioedema); blisters on the skin, in the mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2; abnormal secretion of the hormone regulating urine volume; muscle breakdown and muscle pain (rhabdomyolysis)

Unknown frequency (cannot be estimated from available data):

rash with irregular red spots (erythema multiforme); severe, sudden allergic reaction with symptoms such as fever and blisters on the skin, peeling of the skin (toxic epidermal necrolysis). See section 2; drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with a rash, fever, swelling of the glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes). See section 2; stroke; heart muscle disorders (cardiomyopathy); heart muscle inflammation; blood vessel inflammation (vasculitis), often with a skin rash and small red or purple spots; the group of medicines to which Kwetaplex XR belongs may cause heart rhythm disorders, which can be severe and, in severe cases, fatal.

Some side effects are revealed during laboratory tests of the blood. These include changes in the levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzyme activity, decreased white blood cell count, decreased red blood cell count, increased creatine phosphokinase activity in the blood, decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels can rarely lead to: breast swelling and unexpected milk production, in both women and men; absence or irregular menstrual periods in women. Your doctor may recommend regular check-ups.

Side effects in children and adolescents

The same side effects as those observed in adults can also occur in children and adolescents. The following side effects occurred more frequently in children and adolescents than in adult patients or were observed only in children and adolescents:

Very common side effects (may affect more than 1 in 10 patients):

increased prolactin levels, which can rarely lead to: breast swelling and unexpected milk production, in both girls and boys; absence or irregular menstrual periods in girls; increased appetite; vomiting; abnormal muscle movements, including difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain; increased blood pressure.

Common side effects (may affect up to 1 in 10 patients):

feeling of weakness, fainting (which may cause falls); stuffy nose; feeling of irritability.

Reporting side effects

If you experience any side effects, including those not listed in this 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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.

5. How to store Kwetaplex XR

Keep the medicine out of the sight and reach of children. There are no special storage instructions for the medicine. Store in the original packaging to protect from light and moisture. 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 month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Kwetaplex XR contains

• The active substance of the medicine is quetiapine. Each prolonged-release tablet contains 50 mg, 200 mg, 300 mg, or 400 mg of quetiapine (in the form of quetiapine fumarate).
• Other ingredients are: tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate; coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80, yellow iron oxide (E 172) (only in 50 mg, 200 mg, 300 mg tablets), red iron oxide (E 172) (only in 50 mg, 200 mg, 300 mg tablets), black iron oxide (E 172) (only in 50 mg, 300 mg tablets).

What Kwetaplex XR looks like and contents of the pack:

Kwetaplex XR 50 mg are brown, biconvex, prolonged-release tablets with "Q50" embossed on one side. Kwetaplex XR 200 mg are yellow, biconvex, prolonged-release tablets with "Q200" embossed on one side. Kwetaplex XR 300 mg are light yellow, biconvex, prolonged-release tablets with "Q300" embossed on one side. Kwetaplex XR 400 mg are white, biconvex, prolonged-release tablets with "Q400" embossed on one side. Blisters of PVC/Aclar/Aluminum or PVC/PVDC in cardboard boxes of 10, 20, 30, 50, 50x1 (perforated blister) (hospital packaging), 56 (calendar packaging), 60, 90, or 100 tablets. HDPE containers with a PP cap containing a desiccant, of 60 tablets. Kwetaplex XR 50 mg: packaging of 30 or 60 tablets. Kwetaplex XR 200 mg: packaging of 60 tablets. Kwetaplex XR 300 mg: packaging of 60 tablets. Kwetaplex XR 400 mg: packaging of 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Manufacturer:

• 1. TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen, Hungary
• 2. Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
• 3. Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov, Czech Republic
• 4. Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546, Kraków, Poland
• 5. TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
• 6. Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
• 7. Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Poland

Date of last revision of the leaflet:08.2024