Kvetaplex Xr

Package Leaflet: Information for the Patient

Kwetaplex XR, 150 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, please 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 strong 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, and may be aggressive or exhibit destructive behavior.
• Schizophrenia, when the patient hears or feels non-existent voices and things, takes non-existent things for real, 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

nefazodone (used for depression). If in doubt, consult your doctor or pharmacist before taking Kwetaplex XR.

Warnings and precautions

Before starting treatment with Kwetaplex XR, discuss with your doctor if:

you or a family member have or have had heart disease, such as arrhythmias, heart muscle weakness or myocarditis, you are taking medicines that may cause changes in heart rhythm; you have low blood pressure; you have had a stroke, especially if you are elderly; you have liver problems; you have ever had a seizure (epilepsy); you have diabetes or are at risk of developing diabetes. In this case, your doctor may recommend glucose level tests during treatment with Kwetaplex XR; you have ever had a low white blood cell count (regardless of whether it was caused by taking other medicines or not); you are an elderly person with senile dementia (impairment of 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 you are an elderly person with Parkinson's disease/parkinsonism; if you or a family member have a history of blood clots, as taking medicines in this group can cause them to form; if you have or have had conditions during which breathing stops for short periods during normal nighttime sleep (so-called sleep apnea) and take medicines that slow down normal brain activity (so-called depressants); if you have or have had problems with complete emptying of the bladder (urinary retention), have an enlarged prostate, intestinal obstruction or increased eye pressure. These symptoms are sometimes caused by medicines taken to treat certain diseases that affect the functioning of nerve cells (so-called anticholinergic products); if you have or have had a problem with alcohol or drug abuse; if you have 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"). You should immediately inform your doctor if you experience symptoms such as: fever, significant muscle stiffness, sweating or decreased level of consciousness (a disease 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. You should inform 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) initiation of appropriate treatment; constipation with persistent abdominal pain or constipation that does not improve with treatment. This can lead to serious intestinal obstruction.

Suicidal thoughts and depression

People 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 can also worsen after sudden discontinuation of the medicine. The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if the patient is a young adult. Data from clinical trials indicate an increased risk of suicidal thoughts and (or) suicidal behavior in young adults under 25 years of age with depression. If you experience suicidal thoughts or thoughts of self-harm, you should immediately contact your doctor or go to the hospital. It may be helpful to inform your relatives or friends about your depression and ask them to read this leaflet. You can ask your relatives or friends for help and ask them to inform you if they notice that your depression has worsened or if there are any worrying changes in your 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 fatal. They usually occur as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling of the skin, especially in 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 number of white blood cells (eosinophilia) and liver enzymes)

If you experience these symptoms, you should discontinue treatment with Kwetaplex XR and immediately contact your doctor or seek medical attention.

Weight gain

Patients taking Kwetaplex XR have experienced weight gain. You should regularly check your weight yourself or with your 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 taking now or have taken recently, as well as any medicines you plan to take. Do not take Kwetaplex XR if you are taking: certain medicines for HIV, azole group medicines (used for fungal infections), erythromycin or clarithromycin (used for infections), nefazodone (used for depression). Tell your doctor if you are taking: antiepileptic medicines (such as phenytoin or carbamazepine), antihypertensive medicines, barbiturates (medicines used for 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 (medicines used for infections), antacids, medicines (called "anticholinergic medicines") that affect the functioning of nerve cells 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, body temperature above 38°C (serotonin syndrome). If such symptoms occur, you should consult your doctor. Do not stop taking other medicines without consulting your 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. You should be careful when drinking alcoholic beverages. Taking Kwetaplex XR and alcohol at the same time may cause drowsiness. You should 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 your doctor recommends it. Kwetaplex XR should not be used during breastfeeding. In newborns and mothers who have taken 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 your child experiences any of these symptoms, you may need to consult your doctor.

Driving and using machines

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

Effect on urine drug tests

If you are taking quetiapine and undergo urine tests for drugs, some test methods may show a positive result for methadone or TCA (tricyclic antidepressants) even if you have not taken them. In such a case, more detailed tests should be performed.

Kwetaplex XR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Kwetaplex XR

This medicine should always be taken as directed by your doctor. If you are unsure, consult 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. The medicine should be taken once a day. The tablets should not be divided, chewed, or crushed. The tablets should be swallowed whole, with water. The tablets should be taken without food (at least 1 hour before a meal or before bedtime, as directed by your doctor). You should not consume grapefruit juice while taking Kwetaplex XR, as it may affect the way the medicine works. Even if you feel better, you should not stop taking the medicine unless your doctor decides to do so.

Patients with liver function disorders

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

Elderly patients

Your doctor may recommend a dose change of Kwetaplex XR if you are an elderly patient. Kwetaplex XR is also available in strengths of 50 mg, 200 mg, 300 mg, and 400 mg.

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 a higher dose of Kwetaplex XR than recommended, you may experience drowsiness, dizziness, or irregular heartbeat. You should immediately contact your doctor or go to the nearest hospital. You should take Kwetaplex XR with you.

Missing a dose of Kwetaplex XR

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

Stopping treatment with Kwetaplex XR

If you suddenly stop taking Kwetaplex XR, 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 (may cause falls), headache, dry mouth. Drowsiness (may improve during continued treatment with this medicine) (may cause falls). Withdrawal symptoms (symptoms that may occur after stopping treatment with this 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, including difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain. Changes in the levels of certain fats (triglycerides, total cholesterol).

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

Increased heart rate. Feeling of palpitations or irregular heartbeat. Constipation, indigestion. Feeling of weakness. Swelling of the hands or feet. Decreased blood pressure when standing up. This can cause dizziness or fainting (may cause falls). Increased blood glucose levels. Blurred vision. Unpleasant dreams and nightmares. Increased appetite. Irritability. Speech disorders. Suicidal thoughts and depression. Shortness of breath. Vomiting (mainly in the elderly). Fever. Changes in thyroid hormone levels in the blood. Decreased number of certain types of blood cells. Increased liver enzyme activity. Increased prolactin levels in the blood. Elevated prolactin levels may rarely lead to: breast swelling and unexpected milk production, both in 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 mouth area. Unpleasant sensations in the legs (so-called restless legs syndrome). Difficulty swallowing. Uncontrolled movements, mainly of the face or tongue. Sexual disorders. Diabetes. Changes in the electrocardiogram (ECG) (prolongation of the QT interval). Decreased heart rate, which may occur at the beginning of treatment and may lead to low blood pressure and loss of consciousness. Difficulty urinating. Fainting (may cause falls). Stuffy nose. Decreased red blood cell count. Decreased sodium levels in the blood. Worsening of existing diabetes. Neutropenia (decreased number of granulocytes).

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). Hepatitis. Prolonged and painful erection (priapism). Breast swelling and unexpected milk production (galactorrhea). Menstrual disorders. Blood clots, 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, you should immediately consult your doctor. 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 elevated blood sugar. Fever, flu-like symptoms, sore throat, 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 rash, blisters, red spots on the skin. Severe allergic reactions (anaphylactic), which can cause difficulty breathing or shock. Rapidly developing 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. Rash with eosinophilia and systemic symptoms (DRESS) including flu-like symptoms with a rash, fever, swelling of the glands, and abnormal blood test results (including an increased number of white blood cells (eosinophilia) and liver enzymes). See section 2. Withdrawal symptoms in newborns of mothers who took quetiapine during pregnancy. Stroke. Heart muscle disorders (cardiomyopathy). Myocarditis. Blood vessel inflammation (vasculitis), often with a skin rash and small red or purple spots. Medicines in the same group as Kwetaplex XR may cause heart rhythm disorders, which can be severe and, in severe cases, fatal. Some side effects become apparent 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 number of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase activity in the blood (a substance in the muscles), decreased sodium levels in the blood, and elevated prolactin levels in the blood. Elevated prolactin levels may rarely lead to: breast swelling and unexpected milk production, both in women and men; absence or irregular menstrual periods in women. Your doctor may recommend regular check-ups.

Additional side effects in children and adolescents

The same side effects 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, both in 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 (may cause falls). Stuffy nose. Feeling of irritation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Medical Devices, and Biocides: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 48 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 gather more information on the safety of this 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 this medicine. Store in the original packaging to protect from light and moisture. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. The "Lot" inscription on the packaging and blister means "Batch number". The "EXP" inscription on the packaging and blister means "Expiry date". 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 150 mg of quetiapine (in the form of quetiapine fumarate).
• Other ingredients are:

Core: hypromellose 2910, hypromellose 2208, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate Coating: titanium dioxide (E 171), hypromellose 2910, macrogol, polysorbate 80.

What Kwetaplex XR looks like and contents of the pack:

Kwetaplex XR 150 mg is a prolonged-release tablet, which is a white, oblong, biconvex tablet with a coating. Kwetaplex XR 150 mg has "Q 150" embossed on one side. PVC/Aclar/Aluminum or PVC/PVDC blisters in a cardboard box containing 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. Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Poland
• 2. Teva Pharma S.L.U., C/C, nº4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
• 3. Merckle GmbH, Ludwig-Merckle-Straβe 3, 89143 Blaubeuren, Germany

Date of last revision of the leaflet:08.2024