Ketrel Xr

Leaflet attached to the packaging: patient information

KETREL XR, 50 mg, prolonged-release tablets

KETREL XR, 200 mg, prolonged-release tablets

KETREL XR, 300 mg, prolonged-release tablets

KETREL XR, 400 mg, prolonged-release tablets

Quetiapine

You should read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What KETREL XR prolonged-release tablets are and what they are used for
• 2. Important information before taking KETREL XR prolonged-release tablets
• 3. How to take KETREL XR prolonged-release tablets
• 4. Possible side effects
• 5. How to store KETREL XR prolonged-release tablets
• 6. Contents of the pack and other information

1. What KETREL XR prolonged-release tablets are and what they are used for

What they are used for
The active substance of KETREL XR prolonged-release tablets is quetiapine.
Quetiapine belongs to a group of medicines called antipsychotics. KETREL XR prolonged-release tablets may be used to treat the following conditions:

• Schizophrenia: when the patient hears and feels things that do not exist; believes in things that are not true or shows unusual suspicion, anxiety, disorientation, guilt, tension, and depression.
• Mania: when the patient is very excited, elated, enthusiastic, overactive, or has limited critical judgment, including being aggressive or showing destructive behavior.
• Bipolar disorder and severe depressive episodes in depressive disorders, when the patient feels intense sadness or depression, has a sense of guilt, lack of energy and appetite, or difficulty sleeping.

In the case of treatment of severe depressive episodes in major depression, KETREL XR prolonged-release tablets will be used with other medicines. The doctor may decide to continue taking KETREL XR even if the patient feels better.

2. Important information before taking KETREL XR prolonged-release tablets

Contraindications

When not to take KETREL XR prolonged-release tablets

• 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,
• medicines from the azole group (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

If any of the above situations apply to the patient, they should not take KETREL XR prolonged-release tablets. Before taking KETREL XR prolonged-release tablets, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with KETREL XR prolonged-release tablets, the patient should discuss it with their doctor

• if the patient or someone in their family has a heart condition, such as arrhythmia, weakness, or inflammation of the heart muscle, or if the patient is taking medicines that can affect heart rhythm,
• if the patient has low blood pressure,
• if the patient has had a stroke, especially if they are elderly,
• if the patient has liver problems,
• if the patient has had seizures (convulsions),
• if the patient has diabetes or an increased risk of developing diabetes. If the patient is at risk, the doctor may order a blood sugar test while taking KETREL XR prolonged-release tablets,
• if the patient has ever had a low white blood cell count (regardless of whether it was caused by taking other medicines or not),
• if the patient is elderly with dementia (reduced brain function). Such a person should not take KETREL XR prolonged-release tablets, as medicines in the same group as KETREL XR may increase the risk of stroke and sometimes the risk of death in elderly people with dementia,
• if the patient is elderly with Parkinson's disease/parkinsonism,
• if the patient or someone in their family has had blood clots, as taking medicines in this group is associated with the formation of clots,
• if the patient has or has had a condition characterized by short pauses in breathing during normal sleep at night (so-called sleep apnea) and is taking medicines that slow down brain function,
• if the patient has or has had a condition characterized by inability to completely empty the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. Such symptoms may be caused by medicines (so-called anticholinergic medicines) used to treat certain diseases and affecting nerve cell function,
• if the patient has or has had problems with alcohol or drug abuse.

The patient should immediately inform their doctor if they experience any of the following symptoms after taking KETREL XR prolonged-release tablets:

• combined fever, muscle stiffness, excessive sweating, decreased consciousness (so-called malignant neuroleptic syndrome). Immediate medical attention may be necessary,
• involuntary movements, especially of the face or tongue,
• dizziness or a feeling of intense drowsiness. This can increase the risk of accidental injury (fall) in elderly patients,
• seizures (convulsions),
• prolonged 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.

All these symptoms can occur during treatment with medicines in this therapeutic group.
The patient should see their doctor as soon as possible if they experience:

• fever, flu-like symptoms, sore throat, or other infection, as they may be caused by 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 it can lead to severe intestinal obstruction.

Suicidal thoughts or worsening of depression.

Patients with depression may sometimes think about self-harm or suicide. Such symptoms or behaviors may worsen during the initial phase of treatment, as these medicines usually start working after 2 weeks, sometimes later. Suicidal thoughts may worsen in patients who have suddenly stopped taking their medicines. The likelihood of such thoughts is higher in young patients. Data from clinical trials indicate an increased risk of suicidal thoughts and/or behaviors in young people under 25 with depression.
If the patient has ever had suicidal thoughts or suicidal thoughts, they should immediately contact their doctor or go to the hospital. It may be helpful to inform friends and family about the depression and ask them to read this leaflet. You can also ask them to tell the patient if they notice any worsening of depressive symptoms or other worrying changes in behavior.

Severe skin reactions (SCAR)

During treatment with this medicine, very rare severe skin reactions have been reported, which can be life-threatening or fatal. 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 similar to flu with a rash, fever, swelling of the glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity).

If such symptoms occur, the patient should stop taking KETREL XR and immediately contact their doctor.

Weight gain

Patients taking KETREL XR prolonged-release tablets have been observed to gain weight. The patient should regularly check their weight themselves or with their doctor.

Children and adolescents

KETREL XR prolonged-release tablets are not intended for use in children and adolescents under 18 years of age.

KETREL XR prolonged-release tablets 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.
The patient should not take KETREL XR prolonged-release tablets if they are taking any of the following medicines:

• certain medicines used to treat HIV,
• medicines from the azole group (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

The patient should tell their doctor if they are taking any of the following medicines:

• medicines used to treat epilepsy (such as phenytoin or carbamazepine),
• medicines used to treat high blood pressure,
• barbiturates (medicines used to treat sleep disorders),
• thioridazine or lithium (medicines used to treat psychotic disorders),
• medicines that affect heart rhythm, such as medicines that disrupt electrolyte balance (reducing potassium or magnesium levels), such as diuretics (diuretics) or certain antibiotics (medicines used to treat infections),
• medicines that can cause constipation,
• medicines used to treat certain diseases, affecting nerve cell function (so-called anticholinergic medicines).

The patient should not stop taking other medicines without consulting their doctor.

KETREL XR prolonged-release tablets, food, drink, and alcohol

• Taking food can affect the action of the medicine, so KETREL XR prolonged-release tablets should be taken at least 1 hour before a meal or before bedtime.
• The patient should be careful with the amount of alcohol they consume. Taking KETREL XR prolonged-release tablets and alcohol at the same time can cause drowsiness.
• The patient should not drink grapefruit juice if they are taking KETREL XR prolonged-release tablets. Grapefruit juice can affect the action of the medicine.

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.
KETREL XR prolonged-release tablets should not be taken during pregnancy, unless agreed with the doctor.
The patient should not breastfeed while taking KETREL XR prolonged-release tablets.
In newborns whose mothers took KETREL XR in the last trimester of pregnancy (last 3 months of pregnancy), the following withdrawal symptoms may occur: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, difficulty breathing, and feeding difficulties. If the patient notices any of these symptoms in their child, they should contact their doctor.

Driving and using machines

KETREL XR prolonged-release tablets can cause drowsiness. The patient should not drive or operate machinery until they know how they react to the medicine.

KETREL XR contains lactose.

KETREL XR prolonged-release tablets contain lactose, which is a type of sugar.
If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

KETREL XR contains sodium

KETREL XR prolonged-release tablets contain less than 1 mmol (23 mg) of sodium per tablet, which means that these products are considered "sodium-free".

Urinary tests for drugs

Taking KETREL XR may result in a positive test result for methadone and certain antidepressants, so-called tricyclic antidepressants (TCA), even if the patient has not taken them. In such a case, more detailed tests should be performed.

3. How to take KETREL XR prolonged-release tablets

This medicine should always be taken as directed by the doctor.
If the patient is unsure, they should contact their doctor or pharmacist.
The initial dose will be determined by the doctor.
The maintenance dose (daily) depends on the disease and the patient's needs and is usually between 150 mg and 800 mg

• The medicine should be taken once a day.
• Tablets should not be divided, chewed, or crushed.
• Tablets should be swallowed whole, with water.
• 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 drink grapefruit juice while taking KETREL XR prolonged-release tablets. It may affect the action of the medicine.
• The patient should not stop taking KETREL XR without consulting their doctor, even if they feel better.

Liver function disorders

The doctor may recommend changing the dose of the medicine in patients with liver function disorders.

Elderly patients

The doctor may change the dose of the medicine in elderly patients.

Use in children and adolescents

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

Taking a higher dose of KETREL XR prolonged-release tablets than recommended

If the patient takes a higher dose of KETREL XR than recommended, they may experience drowsiness, dizziness, or irregular heartbeat. The patient should immediately contact their doctor or go to the nearest hospital. The patient should take the packaging of KETREL XR prolonged-release tablets with them.

Missing a dose of KETREL XR prolonged-release tablets

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 wait and take the medicine at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with KETREL XR prolonged-release tablets

If the patient suddenly stops taking KETREL XR prolonged-release tablets, they may experience difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.
If the patient has any further questions about taking this medicine, they should contact their doctor, pharmacist, or nurse.

4. Possible side effects

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

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

• dizziness (which can lead to falls), headache, and dry mouth;
• drowsiness (this symptom may disappear after some time of taking KETREL XR) (may lead to falls);
• withdrawal symptoms (symptoms that occur after stopping KETREL XR prolonged-release tablets): difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability; it is recommended to gradually stop taking the medicine over a period of at least 1-2 weeks;
• weight gain;
• abnormal muscle movements. These include: difficulty starting movement, tremors, feeling anxious or muscle stiffness without pain.
• changes in the levels of some lipids (triglycerides and total cholesterol)

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

• rapid heartbeat,
• feeling of palpitations or rapid and irregular heartbeat,
• constipation, upset stomach (indigestion),
• feeling weak,
• swelling of hands and feet,
• low blood pressure. This can cause dizziness and fainting, which can lead to falls,
• increased blood sugar levels,
• blurred vision,
• unusual dreams and nightmares,
• increased appetite,
• feeling irritable,
• speech disorders and difficulty speaking,
• suicidal thoughts and worsening of depression,
• shortness of breath,
• vomiting (mainly in elderly patients),
• fever,
• changes in thyroid hormone levels in the blood,
• decrease in the number of certain types of blood cells,
• increase in liver enzyme activity in the blood,
• increase in prolactin levels in the blood; increased prolactin levels can rarely lead to:
• breast swelling and unexpected milk production in men and women,
• cessation or irregular menstrual periods in women.

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

• seizures (convulsions),
• allergic reactions, which can include blistering of the skin, skin swelling, and swelling around the mouth,
• unpleasant sensations in the lower limbs (also known as restless legs syndrome),
• difficulty swallowing,
• involuntary movements, mainly of the face or tongue,
• sexual disorders,
• diabetes,
• changes in the electrical activity of the heart visible on an ECG (QT interval prolongation),
• slower than normal heartbeat, which can occur when starting treatment and be associated with low blood pressure and fainting,
• difficulty urinating,
• fainting (which can lead to falls),
• stuffy nose,
• decrease in red blood cell count,
• decrease in 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 (fever), sweating, muscle stiffness, feeling of intense drowsiness 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 (galactorrhoea),
• 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 blood vessels to the lungs, causing chest pain and difficulty breathing. If the patient experiences any of these symptoms, they should immediately seek medical attention,
• walking, talking, eating, or performing other activities while asleep,
• decreased body temperature (hypothermia),
• pancreatitis,
• a condition called "metabolic syndrome", in which there is a combination of three or more of the following features: increased fat around the waist, decreased "good" HDL cholesterol, increased triglycerides in the blood, high blood pressure, and increased blood sugar levels.
• combined fever, flu-like symptoms, sore throat, or other infection with a very low white blood cell count (so-called agranulocytosis).
• intestinal obstruction,
• increased activity of the enzyme creatine phosphokinase in the blood (an enzyme produced in muscles, among others).

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

• severe skin rash, blisters, or red spots on the skin,
• severe allergic reaction (anaphylaxis), which can cause difficulty breathing or shock,
• sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema),
• severe skin reaction with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) (see section 2),
• abnormal secretion of the hormone that controls urine volume,
• muscle breakdown and muscle pain (rhabdomyolysis).

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

• skin rash with accompanying irregular spots on the skin (erythema multiforme),
• severe, sudden allergic reaction with symptoms such as fever, blisters on the skin, and peeling of the skin (toxic epidermal necrolysis) (see section 2),
• drug reaction with eosinophilia and systemic symptoms (DRESS), including symptoms such as flu-like symptoms with a rash, fever, swelling of the 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 prolonged-release tablets during pregnancy.
• stroke.
• heart muscle disorders (cardiomyopathy)
• heart muscle inflammation
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots

Medicines in the same group as KETREL XR prolonged-release tablets may cause heart rhythm disorders, which can be severe and, in severe cases, fatal.
Some side effects are only visible in blood test results. These include: changes in the levels of certain fats (triglycerides and total cholesterol) or sugar in the blood, 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 activity of the enzyme creatine phosphokinase in the blood (an enzyme produced in muscles, among others), 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 women and men,
• cessation or irregular menstrual periods in women.

The doctor may recommend regular blood tests.

Additional side effects that occur in children and adolescents

The same side effects as in adults can 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, which can rarely lead to:
• breast swelling and unexpected milk production in both boys and girls,
• in girls, it may lead to cessation or irregular menstrual periods.
• increased appetite,
• vomiting,
• abnormal muscle movements, including difficulty starting movement, tremors, feeling anxious, or muscle stiffness without pain,
• increased blood pressure.

Common (may affect up to 1 in 10 people)

• feeling weak, fainting (which can lead to falls);
• stuffy nose;
• feeling irritable.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 201 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of this medicine.

5. How to store KETREL XR prolonged-release tablets

• The medicine should be stored out of sight and reach of children.
• The medicine should not be taken after the expiration date stated on the carton and blister pack after: EXP. The expiration date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
• There are no special precautions for storing the medicine.

6. Contents of the pack and other information

What KETREL XR prolonged-release tablets contain

• The active substance of the medicine is quetiapine. Each prolonged-release tablet contains 50, 200, 300, or 400 mg of quetiapine (in the form of quetiapine fumarate).
• The medicine also contains: Tablet core: lactose monohydrate, hypromellose, sodium chloride, povidone K30, talc, and magnesium stearate. In addition, 50 mg tablets contain microcrystalline cellulose silanized.

Tablet coating: titanium dioxide (E 171), macrogol 400.
50 mg tablets also contain polyvinyl alcohol, talc, and iron oxide red (E 172).
50, 200, and 300 mg tablets also contain iron oxide yellow (E 172).
200, 300, and 400 mg tablets also contain hypromellose 6 cP.

What KETREL XR prolonged-release tablets look like and what the pack contains

KETREL XR prolonged-release tablets, 50 mg: peach-colored, round, biconvex, film-coated tablets with the symbol "Q50" embossed on one side and smooth on the other.
KETREL XR prolonged-release tablets, 200 mg: yellow, round, biconvex, film-coated tablets with the symbol "I2" embossed on one side and smooth on the other. The tablet diameter is approximately 9.6 mm.
KETREL XR prolonged-release tablets, 300 mg: light yellow, round, biconvex, film-coated tablets with the symbol "Q300" embossed on one side and smooth on the other. The tablet diameter is approximately 11.2 mm.
KETREL XR prolonged-release tablets, 400 mg: white, round, biconvex, film-coated tablets with the symbol "I4" embossed on one side and smooth on the other. The tablet diameter is approximately 12.8 mm.
PVC/PVDC/Aluminum blisters: packaging containing 10, 30, 50, 60, and 100 tablets are registered for 200, 300, and 400 mg.
PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters: packaging containing 6, 10, 20, 28, 30, 50, 60, 90, and 100 tablets is registered for 50 mg.
Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer/Importer:

Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
GAP S.A.
46, Agissialou, str.
Agios Dimitrios,
17341 Athens
Greece
For KETREL XR 50 mg prolonged-release tablets:
ARROW GENERIQUES- LYON,
26 avenue Tony Garnier, LYON, 69007,
France
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