Ketrel Xr

Leaflet accompanying the packaging: patient information

KETREL XR, 150 mg, prolonged-release tablets

Quetiapine

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, consult a doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

The active substance of KETREL XR is quetiapine, which belongs to a group of medicines called antipsychotics. KETREL XR may be used to treat diseases such as:

• Schizophrenia: the patient may hear or feel things that do not exist, believe in things that are not true, or experience unusual suspicion, anxiety, disorientation, guilt, tension, and depression.
• Mania: the patient may be very excited, agitated, stimulated, enthusiastic, overactive, or have limited critical judgment, and may also be aggressive or exhibit destructive behavior.
• Bipolar disorder and episodes of major depression in severe depressive disorders: the patient feels sad. The patient may feel depressed, have a sense of guilt, lack energy and appetite, and have difficulty sleeping.

When KETREL XR is used to treat episodes of major depression in severe depressive disorders, it is used in addition to another medicine used to treat this disease. The doctor may prescribe continued use of KETREL XR even if the patient feels better.

2. Important information before taking KETREL XR

When not to take KETREL XR:

• azoles (antifungal medicines),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

If any of the above situations apply to the patient, do not take KETREL XR. In case of doubts, consult a doctor or pharmacist before taking KETREL XR.

Warnings and precautions

Before starting treatment with KETREL XR, consult a doctor, pharmacist, or nurse:

Inform your doctor immediately if you experience any of the following symptoms after taking KETREL XR:

• Fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary.
• Uncontrolled movements, mainly of the face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures.
• 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, refer the patient to a cardiologist immediately.

These symptoms may be related to taking medicines of this type. Inform your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat, or other infections, as these symptoms may be due to a very low white blood cell count, which may require discontinuation of KETREL XR and/or appropriate treatment.
• Constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to more severe intestinal obstruction.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes think about self-harm or suicide. Such thoughts may intensify at the beginning of treatment, as these medicines require time to start working, usually about two weeks, but sometimes longer. Such thoughts may also intensify if the medicine is stopped abruptly. The likelihood of such thoughts is higher in young adults. Information from clinical trials indicates an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age suffering from depression. If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately. It may be helpful to inform friends and family about their depression and its symptoms and ask them to read this leaflet and inform them if they think the patient's depression has worsened or if there are any worrying changes in the patient's behavior.

Severe skin reactions (SCAR)

During treatment with this medicine, very rare severe skin reactions (SCAR) have been reported, which can be life-threatening or lead to death. The symptoms of these reactions include:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals;
• Toxic epidermal necrolysis (TEN), a more severe form of rash causing widespread skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS), symptoms including flu-like symptoms with a rash, fever, swelling of lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity).

If such symptoms occur, discontinue KETREL XR and contact a doctor immediately.

Weight gain

Patients taking KETREL XR may experience weight gain. Regularly check your weight yourself or with your doctor.

Children and adolescents

KETREL XR is not intended for use in children and adolescents under 18 years of age.

KETREL XR and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Do not take KETREL XR if you are taking any of the following medicines:

• certain medicines used to treat HIV,
• azoles (antifungal medicines),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

Tell your doctor if you are taking any of the following medicines:

• medicines used to treat epilepsy (e.g., 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 action, such as those that can cause electrolyte imbalance (low potassium or magnesium levels), such as diuretics (diuretic medicines) or certain antibiotics (medicines used to treat infections),
• medicines that can cause constipation,
• medicines used to treat certain diseases, affecting the activity of nerve cells (so-called anticholinergic medicines).

Before stopping any of the medicines you are taking, consult your doctor.

KETREL XR with food, drink, and alcohol

• Food may affect KETREL XR, so take this medicine at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you consume, as the combined effect of KETREL XR and alcohol may cause drowsiness.
• Do not consume grapefruit juice while taking KETREL XR, as it may affect the way this medicine works.

Pregnancy, breastfeeding, and fertility

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. Do not take KETREL XR during pregnancy, unless discussed with your doctor. Do not take KETREL XR during breastfeeding. In newborns whose mothers took quetiapine in the last trimester of pregnancy (last 3 months of pregnancy), the following withdrawal symptoms may occur: shaking, muscle stiffness, and/or weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If you notice any of these symptoms in your child, consult a doctor.

Driving and using machines

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

KETREL XR contains lactose

KETREL XR contains lactose, a type of sugar. If you have been informed by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

KETREL XR contains sodium

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

Effect on urine drug tests

In patients undergoing urine tests for drugs, taking KETREL XR may cause positive results for methadone or certain antidepressants called tricyclic antidepressants, using some methods, even if the patient is not taking methadone or tricyclic antidepressants. In such cases, a more accurate test can be performed.

3. How to take KETREL XR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. The doctor will decide on the initial dose. The maintenance dose (daily dose) depends on the disease and the patient's needs, but it is usually between 150 mg and 800 mg.

• Take the tablets once a day.
• Do not divide, chew, or crush the tablets.
• Swallow the tablets whole, with water.
• Take the tablets on an empty stomach (at least one hour before a meal or before bedtime, as your doctor will inform you).
• Do not consume grapefruit juice while taking KETREL XR, as it may affect the way this medicine works.
• Do not stop treatment without consulting your doctor, even if you feel better.

Liver function disorders

The doctor may recommend changing the dose of KETREL XR if you have liver function disorders.

Elderly patients

The doctor may recommend changing the dose of KETREL XR for elderly patients.

Use in children and adolescents

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

Taking a higher dose of KETREL XR than recommended

If you take a higher dose of KETREL XR than prescribed by your doctor, you may experience drowsiness, dizziness, and heart rhythm disturbances. Contact your doctor or go to the nearest hospital immediately. Take KETREL XR with you.

Missing a dose of KETREL 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 KETREL XR

If you stop taking KETREL XR abruptly, you may experience sleep problems (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, and irritability. The doctor may recommend gradually reducing the dose before stopping treatment. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, KETREL XR can cause side effects, although not everybody gets them.

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

• Dizziness (which may cause falls), headache, dry mouth.
• Drowsiness (which may resolve during continued treatment with quetiapine) (may cause falls).
• Withdrawal symptoms (symptoms that may occur after stopping quetiapine), including sleep problems (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop the medicine over a period of 1-2 weeks.
• Weight gain.
• Abnormal muscle movements, including difficulty starting movements, tremors, restlessness, or muscle stiffness without pain.
• Changes in the levels of some fats (triglycerides and total cholesterol).

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

• Rapid heartbeat.
• Palpitations, rapid heartbeat, or skipped heartbeats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of hands or feet.
• Low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls).
• High blood sugar levels.
• Blurred vision.
• Vivid dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased number of certain types of blood cells.
• Increased liver enzyme activity in the blood.
• Increased prolactin levels in the blood. Increased prolactin levels may rarely lead to:
• breast swelling and unexpected milk production (in men and women),
• missed periods or irregular periods (in women).

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

• Seizures.
• Allergic reactions, which may include skin blisters, skin swelling, and swelling around the mouth.
• 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 electrical activity of the heart visible on an ECG (prolonged QT interval).
• Slow heart rate at the beginning of treatment, which may be related to low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Stuffy nose.
• Decreased red blood cell count.
• Decreased sodium levels in the blood.
• Worsening of existing diabetes.

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

• A syndrome of symptoms: high fever, sweating, muscle stiffness, feeling very drowsy or fainting (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 in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• Walking, talking, eating, and performing other activities while asleep.
• Low body temperature (hypothermia).
• Pancreatitis.
• A disorder (so-called metabolic syndrome) in which a combination of three or more symptoms occurs: increased fat around the waist, decreased "good" cholesterol (HDL-C), increased triglyceride levels in the blood, high blood pressure, and increased blood sugar levels.
• A combination of fever, flu-like symptoms, sore throat, or other infections with a very low white blood cell count (so-called agranulocytosis).
• Intestinal obstruction.
• Increased creatine kinase activity in the blood (a substance from muscles).

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

• Severe rash, blisters, or red spots on the skin.
• A severe allergic reaction (so-called anaphylaxis) that can cause difficulty breathing or shock.
• Sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious blistering skin disease, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of the hormone that controls urine volume.
• Muscle breakdown and muscle pain (rhabdomyolysis).

Frequency not known (cannot be estimated from the available data)

• A skin rash with irregular red spots (erythema multiforme).
• A severe, sudden allergic reaction with symptoms such as fever, blisters on the skin, and peeling skin (toxic epidermal necrolysis) See section 2.
• A drug reaction with eosinophilia and systemic symptoms (DRESS), including symptoms such as flu-like symptoms with a rash, fever, swelling of lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity). See section 2.
• Withdrawal symptoms in newborns whose mothers took KETREL XR during pregnancy.
• Stroke.
• Heart muscle disorders (cardiomyopathy)
• Myocarditis
• Vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple spots.

The group of medicines to which KETREL XR belongs may cause heart rhythm disturbances, which can be serious and, in severe cases, even life-threatening. Some side effects are only visible in blood test results. These include: increased levels of some 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 kinase activity in the blood (a substance from muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels may rarely lead to:

• breast swelling and unexpected milk production (in men and women),
• missed periods or irregular periods (in women).

The doctor may recommend regular blood tests.

Additional side effects in children and adolescents

The same side effects as in adults may also occur in children and adolescents. The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

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

• Increased prolactin levels in the blood. Increased prolactin levels may rarely lead to:
• breast swelling and unexpected milk production (in boys and girls),
• missed periods or irregular periods (in girls).
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting movements, tremors, restlessness, or muscle stiffness without pain.
• Increased blood pressure.

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

• Weakness, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, consult your doctor or 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, 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.

5. How to store KETREL XR

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label, box, blister, and bottle after: EXP. The expiry date refers to the last day of the month stated.
• Bottle: use within 100 days of first opening.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
• No special precautions for storage are necessary.

6. Contents of the packaging and other information

What KETREL XR contains

• The active substance of KETREL XR is quetiapine. Each tablet contains 150 mg of quetiapine (in the form of quetiapine fumarate).
• The other ingredients are: Tablet core: lactose monohydrate, hypromellose 3550, hypromellose 100, sodium chloride, povidone K-30, microcrystalline cellulose, talc, and magnesium stearate.

Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What KETREL XR looks like and contents of the pack

KETREL XR 150 mg: white or almost white, biconvex, film-coated tablets in the shape of a capsule with the inscription "AB2" on one side and smooth on the other. The tablet is approximately 17.4 mm long and 6.7 mm wide. Available in packs of 10, 30, 50, 60, and 100 tablets in white non-transparent PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters. Packs of 60 and 100 tablets in HDPE bottles with PP closure with child-resistant closure. Not all pack sizes may be marketed.

Marketing authorization holder

Celon Pharma S.A., Ogrodowa 2A, Kiełpin, 05-092 Łomianki

Manufacturer/Importer

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, HA1 4HF Middlesex, United Kingdom, Wessling Hungary Kft., Fóti út 56, 1047 Budapest, Hungary, GAP SA, 46, Agissilaou str., Agios Dimitrios, 17341 Athens, Greece, Accord Healthcare Polska Sp. z o.o., ul. Lutomierska 50, 95-200 Pabianice, Accord UK Limited, Whiddon Valley, Barnstaple, Devon EX32 8NS, United Kingdom, Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 08.2022