Kvetaplex Xr

Leaflet accompanying the packaging: patient information

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

It is very important to read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 antipsychotic medicines. Kwetaplex XR can be used to treat diseases such as:

• depression in bipolar disorder and severe depressive episodes in major depression, when the patient feels intense sadness or despair, 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 treating severe 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), or nefazodone (used to treat depression). In case of doubts, the doctor or pharmacist should be consulted before taking Kwetaplex XR.

Warnings and precautions

Before starting to take Kwetaplex XR, the doctor should be consulted if:

the patient or their family members have or have had heart diseases, such as arrhythmias; heart muscle weakness or myocarditis; the patient is taking medicines that may cause changes in 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 level tests while taking 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 (limited brain 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").

The doctor should be informed immediately if any of the following symptoms occur 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, mainly of the face or tongue; dizziness, a feeling of intense drowsiness. This may 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 may occur during treatment with medicines in this therapeutic group.

The doctor should be informed as soon as possible if 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 may lead to serious intestinal obstruction.

• Suicidal thoughts and depression worseningPeople with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as they usually start working after 2 weeks, and sometimes later. Such thoughts may also worsen after sudden discontinuation of the medicine. The occurrence of suicidal thoughts, thoughts of self-harm, or suicidal behavior is more likely if the patient is a young adult. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression. If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that the depression has worsened or if there are worrying changes in their behavior.

Severe skin reactions

During treatment with this medicine, very rare severe skin reactions (SCAR, severe cutaneous adverse reactions) have been reported, which can be life-threatening or lead to death. They usually occur as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling of the skin, especially in the areas 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 an increased white blood cell count (eosinophilia) and liver enzymes)

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

Weight gain

Patients taking Kwetaplex XR have experienced weight gain. The patient should regularly check their weight, either alone or with their doctor.

Children and adolescents

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

Kwetaplex XR and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Kwetaplex XR should not be taken if the patient is taking: certain medicines for HIV infection, azole antifungals, erythromycin or clarithromycin (used to treat infections), or nefazodone (used to treat depression). The patient should tell their doctor if they 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 (diuretics) or certain antibiotics (used to treat infections), laxatives, medicines (called anticholinergic medicines) that affect the way nerve cells work to treat certain diseases. Antidepressants. These medicines may interact with Kwetaplex XR and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, the doctor should be consulted. Other medicines should not be discontinued without consulting a doctor.

Kwetaplex XR with food, drinks, 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. The patient should be cautious when drinking alcoholic beverages. Taking Kwetaplex XR and alcohol at the same time may cause drowsiness. The patient should not consume grapefruit juice while taking Kwetaplex XR, as it may affect the way the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Kwetaplex XR should not be taken during pregnancy, unless the doctor recommends it. Kwetaplex XR should not be taken during breastfeeding. In newborns and mothers who took quetiapine during the last trimester of pregnancy (the 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. The patient should not drive vehicles or operate machines until they are sure how the medicine affects them.

Effect on urine drug tests

If the patient is taking Kwetaplex XR and undergoes urine tests for drugs, some test methods may show a positive result for methadone or tricyclic antidepressants (TCA), even if they have not been taken. In such a case, 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. This corresponds to 1.28% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Kwetaplex XR

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. The initial dose will be determined by the doctor. The usual daily maintenance dose of Kwetaplex XR is between 150 mg and 800 mg, depending on the patient's symptoms and needs. The medicine should be taken once a day. The tablets should not be divided, chewed, or crushed. The tablets should be swallowed whole, with a glass of water. The tablets should be taken without food (at least 1 hour before a meal or before bedtime, as directed by the doctor). The patient should not consume grapefruit juice while taking Kwetaplex XR, as it may affect the way the medicine works. Even if the patient feels better, they should not stop taking the medicine unless the doctor decides to do so.

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

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

Taking a higher dose of Kwetaplex XR than recommended

In case of taking a higher dose of Kwetaplex XR than recommended, the patient may experience drowsiness, dizziness, or irregular heartbeat. The patient should immediately contact their doctor or go to the nearest hospital. They should take Kwetaplex XR with them.

Missing a dose of Kwetaplex XR

If the patient forgets to take a dose, they should take it as soon as possible. If it is almost time for the next dose, they should take the medicine at the usual time. The patient should not take a double dose of the medicine to make up for the missed dose.

Stopping Kwetaplex XR treatment

If the patient suddenly stops taking Kwetaplex XR, they may experience difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before ending treatment. In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Kwetaplex XR 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 with the medicine) (may cause falls); withdrawal symptoms (symptoms that may occur after stopping treatment with the medicine), including difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over 1-2 weeks; weight gain; abnormal movements of the muscles. Difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain; changes in the 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 the hands or feet; drops in blood pressure when standing up. These may 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 worsening; 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 may 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; 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). decreased 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 blood creatine phosphokinase activity; worsening of existing diabetes.

Rare side effects (may affect up to 1 in 1000 people):

very high body temperature (fever), increased 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 (galactorrhea); absence or 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 any of these symptoms occur, the doctor should be consulted immediately; sleepwalking, talking, or eating during sleep; low body temperature (hypothermia); pancreatitis; "metabolic syndrome", which includes a combination of three or more symptoms, such as: central obesity, decreased "good" cholesterol (HDL-C), increased triglycerides, increased blood pressure, and elevated blood sugar; fever, flu-like symptoms, sore throat, or other infections with a very low white blood cell count in the blood (so-called agranulocytosis); intestinal obstruction; increased creatine phosphokinase activity in the blood.

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

severe skin 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 that regulates urine volume; muscle breakdown and muscle pain (rhabdomyolysis)

Unknown frequency (cannot be estimated from the available data):

skin 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 an increased white blood cell count (eosinophilia) and liver enzymes). See section 2; in newborns whose mothers took quetiapine during pregnancy, withdrawal symptoms may occur; stroke; heart muscle disorders (cardiomyopathy); myocarditis; vasculitis (inflammation of blood vessels), 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, life-threatening.

Side effects in children and adolescents

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

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

increased prolactin levels, which may 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 movements of the muscles, 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 side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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, phone: 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, more information can be collected on the safety of the medicine.

5. How to store Kwetaplex XR

The medicine should be stored out of sight and reach of children. There are no special storage temperature recommendations for the medicine. The medicine should be stored in its original packaging to protect it from light and moisture. The medicine should not be taken after the expiry date stated on the carton and blister after the EXP mark. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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