Ketrel Xr

Leaflet accompanying 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 is KETREL XR, prolonged-release tablets and what is it 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 packaging and other information

1. What is KETREL XR, prolonged-release tablets and what is it used for

What is it 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 diseases:

• Schizophrenia: when the patient hears and feels things that do not exist; believes in things that are not true or shows unusual suspiciousness, anxiety, disorientation, guilt, tension, and depression.
• Mania: when the patient is very excited, agitated, 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

Before taking the medicine

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 disease, 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 from the group to which KETREL XR belongs 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 from 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 the function of nerve cells,
• 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 level of 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 may 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, immediately refer the patient to a cardiologist.

All these symptoms may occur during treatment with medicines from 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 may lead to severe intestinal obstruction.

Suicidal thoughts or worsening of depression.

Patient 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 increases in young patients. Data from clinical trials indicate an increased risk of suicidal thoughts and/or behaviors in young people under 25 years of age 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 members 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. 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), flu-like symptoms with rash, fever, swelling of 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 the function of nerve cells (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 may 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 may cause drowsiness.
• The patient should not drink grapefruit juice if they are taking KETREL XR, prolonged-release tablets. Grapefruit juice may 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 difficulty feeding. 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 may 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 previously 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

The patient should always take this medicine exactly as their doctor has told them.
If they are not sure, they should ask their doctor or pharmacist.
The doctor will determine the initial dose.
The maintenance dose (daily) depends on the disease and the patient's needs and usually ranges from 150 mg to 800 mg

• 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 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 KETREL XR in patients with liver function disorders.

Elderly patients

The doctor may change the dose of KETREL XR 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, irregular heartbeat. They should immediately contact their doctor or go to the nearest hospital. They 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. They 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 ask their doctor, pharmacist, or nurse.

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 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 movements of the muscles. These include: difficulty starting movement, tremors, feeling anxious or stiff muscles 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 may cause dizziness and fainting, which may 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 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,
• cessation or irregular menstrual periods in women.

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

• seizures (convulsions),
• allergic reactions, which may 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 the ECG (prolonged QT interval),
• slower than normal heartbeat, which may occur when starting treatment and may be associated with low blood pressure and fainting,
• difficulty urinating,
• fainting (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 (fever), sweating, muscle stiffness, feeling very drowsy or fainting (so-called malignant neuroleptic syndrome),
• yellowing of the skin and eyes (jaundice),
• liver inflammation,
• prolonged and painful erection (priapism),
• breast swelling and unexpected milk production,
• 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 abdomen, 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 creatine phosphokinase activity in the blood (an enzyme found in muscles).

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 rash, fever, swelling of glands, 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
• inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple bumps

Medicines from the group to which KETREL XR belongs 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 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 (an enzyme found in muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels in the blood may 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 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, which may 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 movements of the muscles, including difficulty starting movement, tremors, feeling anxious or stiff muscles without pain,
• increased blood pressure.

Common (may affect up to 1 in 10 people)

• feeling weak, fainting (may 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 will 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 patient should not take 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.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.
• There are no special precautions for storing the medicine.

6. Contents of the packaging and other information

What KETREL XR, prolonged-release tablets contain

• The active substance of KETREL XR 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 packaging 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 is registered for 200, 300, and 400 mg strengths.
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 strength.
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