Ketrel

Leaflet attached to the packaging: patient information

Ketrel, 25 mg, coated tablets

Ketrel, 100 mg, coated tablets

Ketrel, 200 mg, coated tablets

Quetiapine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Ketrel and what is it used for
• 2. Important information before taking Ketrel
• 3. How to take Ketrel
• 4. Possible side effects
• 5. How to store Ketrel
• 6. Package contents and other information

1. What is Ketrel and what is it used for

Ketrel contains the active substance quetiapine. It belongs to a group of antipsychotic medicines.
Ketrel is used to treat diseases such as:

• Schizophrenia, when the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, worried, confused, tense, has a sense of guilt or is depressed;
• Depressive episodes in bipolar disorder, when the patient feels sad, depressed, lacks energy, loses appetite, has a sense of guilt or cannot sleep;
• Mania, when the patient is very excited, enthusiastic, or overly active, or has impaired critical judgment, is aggressive or troublesome.

The doctor may recommend taking Ketrel even if the patient's condition improves, to prevent relapse.

2. Important information before taking Ketrel

When not to take Ketrel

• If the patient is allergic to quetiapine or any other ingredient of this medicine (listed in section 6).
• If the patient is taking any of the following medicines at the same time:
• Protease inhibitors (some medicines used to treat HIV infection),
• Azole drugs (used to treat fungal infections),
• Erythromycin or clarithromycin (antibiotics used to treat infections),
• Nefazodone (used to treat depression).

If any of the above situations apply to the patient, they should not take Ketrel.
In case of doubts, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Ketrel, the patient should discuss it with their doctor or pharmacist if:

• The patient or someone in their family has or has had any heart problems, such as arrhythmias, heart muscle weakness or inflammation, or is taking or has taken medicines that may affect heart function
• The patient has low blood pressure
• The patient has had a stroke, especially if they are elderly
• The patient has liver problems
• The patient has ever had a seizure (epilepsy)
• The patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may check the patient's blood sugar levels during treatment with Ketrel
• The patient has ever had a decreased white blood cell count (which may or may not have been caused by other medicines)
• The patient is elderly with dementia (impairment of brain function). In this case, Ketrel should not be taken, as medicines in the same class as Ketrel may increase the risk of stroke and even death in elderly patients with dementia
• The patient or their family members have had blood clots; the use of such medicines is associated with the formation of blood clots.
• The patient has depression or other conditions that are treated with antidepressants. Taking these medicines with Ketrel may lead to the development of serotonin syndrome, a life-threatening condition (see "Ketrel and other medicines")

The patient should immediately inform their doctor if they experience:

• Fever, muscle stiffness, excessive sweating, consciousness disorders (a condition called malignant neuroleptic syndrome); immediate treatment may be necessary
• Involuntary movements, especially of the face or tongue
• Dizziness or severe drowsiness; these changes may increase the risk of accidental injury (fall) in elderly patients
• Seizures (epilepsy)
• Prolonged and painful erections (priapism)
• Rapid and irregular heartbeat, even at rest, palpitations, breathing difficulties, 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 may occur during treatment with medicines in this therapeutic class.
The patient should immediately inform their doctor if they experience:

• Simultaneously: fever, flu-like symptoms, sore throat, or any other infection, which may be a consequence of a very low white blood cell count in the blood. Then, the patient should stop taking Ketrel and (or) receive appropriate treatment.
• Constipation combined with persistent abdominal pain or persistent constipation despite treatment, as it may lead to serious bowel obstruction.

Suicidal thoughts or worsening depression

Patients with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviors may worsen during the initial phase of treatment, as all antidepressant medicines start to work after some time, usually after two weeks, sometimes later. These thoughts may worsen after sudden withdrawal of the medicine. Young adults are more likely to have such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and (or) suicidal behaviors in patients under 25 years of age with depression.
If the patient has ever had suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. The patient can also ask these people to tell them if they notice any worsening of depressive symptoms or other worrying changes in behavior.

Weight gain

Patients taking Ketrel have been observed to gain weight. The patient and their doctor should regularly check the patient's weight.

Children and adolescents

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

Ketrel 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 if they are taking any of the following medicines:

• Certain medicines used to treat HIV,
• Azole drugs (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:

• Antiepileptic drugs (such as phenytoin or carbamazepine),
• Antihypertensive drugs,
• Barbiturates (drugs used to treat sleep disorders),
• Thioridazine or lithium salts (other antipsychotic medicines),
• Medicines that affect heart rhythm, such as those that can disrupt electrolyte balance (decrease potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (which fight infections),
• Medicines that can cause constipation.
• Antidepressants. These medicines may interact with Ketrel and 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, the patient should consult their doctor.

Before stopping treatment with any medicine, the patient should consult their doctor.

Taking Ketrel with food, drinks, and alcohol

• Ketrel can be taken with or without food.
• During treatment with Ketrel, the patient should avoid consuming alcoholic beverages. Concurrent use of Ketrel and alcohol may cause drowsiness.
• While taking Ketrel, the patient should not consume grapefruit juice. It 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 before taking Ketrel. The patient should not take Ketrel during pregnancy without first discussing it with their doctor.
Ketrel should not be taken during breastfeeding.
Newborns of mothers who took Ketrel during the last trimester of pregnancy (the last three months of pregnancy) may experience the following symptoms, which may indicate withdrawal syndrome: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient's child experiences any of these symptoms, they should contact their doctor.

Driving and operating machinery

Ketrel may cause drowsiness. The patient should not drive vehicles or operate machinery until they know how the medicine affects them.

Effect on urine tests for drug presence

In patients taking Ketrel, some urine tests for drug presence may show the presence of methadone or tricyclic antidepressants (TCAs), even if the patient is not taking them. It is recommended to perform these tests using other methods to confirm the results.

The medicine contains lactose, orange yellow (Ketrel 25 mg), and sodium

Lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Orange yellow

Ketrel 25 mg contains orange yellow. The medicine may cause allergic reactions.

Sodium

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

3. How to take Ketrel

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The initial dose and the method of taking the medicine on subsequent days of treatment will be determined by the doctor. The usual dose of Ketrel is between 150 mg and 800 mg, depending on the patient's symptoms and needs.

• The medicine should be taken once a day, before bedtime, or twice a day, depending on the patient's disease.
• The tablets should be swallowed whole, with a glass of water.
• The tablets can be taken with or without food.
• While taking Ketrel, the patient should not consume grapefruit juice. It may affect the action of the medicine.
• The patient should not stop taking the tablets even if they feel better, unless their doctor decides to do so.

Liver function disorders

The doctor may recommend changing the dosage regimen in patients with liver function disorders.

Elderly patients

The doctor may recommend changing the dosage regimen in elderly patients.

Use in children and adolescents

Ketrel should not be used in patients under 18 years of age.

Taking a higher dose of Ketrel than recommended

If a higher dose of Ketrel than recommended is taken, the patient may experience drowsiness, dizziness, irregular heartbeat. The patient should immediately consult their doctor or go to the nearest hospital. The patient should take the Ketrel packaging with them.

Missing a dose of Ketrel

If a dose of Ketrel is missed, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should 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

If treatment with Ketrel is stopped suddenly, the patient may experience difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.

4. Possible side effects

Like all medicines, Ketrel can cause side effects, although not everyone will experience them.

Very common side effects (occurring in more than 1 in 10 treated patients):

• Dizziness (may lead to falls), headache, dry mouth,
• Drowsiness (may resolve during treatment with Ketrel); may lead to falls,
• Withdrawal symptoms (symptoms that occur after stopping treatment with Ketrel): difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over a period of at least 1-2 weeks;
• Weight gain,
• Involuntary muscle contractions; this may be difficulty starting movement, tremors, restlessness, or muscle stiffness without pain,
• Changes in blood levels of certain fatty substances (triglycerides and total cholesterol).

Common side effects (occurring in less than 1 in 10 treated patients):

• Increased heart rate,
• Feeling that the heart is pounding, rapid heartbeat, or pauses in heart rhythm
• Constipation, stomach upset (indigestion),
• Weakness,
• Swelling of hands or feet,
• Decreased blood pressure when standing up. This may cause dizziness or fainting (may lead to falls),
• Increased blood glucose levels,
• Blurred vision,
• Vivid dreams and nightmares,
• Increased appetite,
• Irritability,
• Speech and language disorders,
• Suicidal thoughts and worsening depression,
• Shortness of breath,
• Vomiting (mainly in elderly patients),
• Fever,
• Changes in thyroid hormone levels in the blood,
• Decreased levels of certain types of blood cells,
• Increased levels of liver enzymes in the blood,
• Increased levels of the hormone prolactin in the blood; increased prolactin levels may lead to:
• Breast enlargement in both men and women, and unexpected milk production,
• Lack of or irregular menstrual periods in women.

Uncommon side effects (occurring in less than 1 in 100 treated patients):

• Seizures,
• Allergic reactions, such as blisters (bubbles), skin swelling, and swelling around the mouth,
• Unpleasant sensations in the lower limbs (also known as restless legs syndrome),
• Difficulty swallowing,
• Involuntary movements, especially of the face or tongue,
• Sexual dysfunction,
• Diabetes,
• Changes in the electrical activity of the heart visible on an ECG (QT interval prolongation),
• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with decreased blood pressure and fainting,
• Difficulty urinating,
• Fainting (may lead to falls),
• Stuffy nose,
• Decreased red blood cell count,
• Decreased sodium levels in the blood.

Rare side effects (occurring in less than 1 in 1,000 treated patients):

• Simultaneous occurrence of high body temperature (fever), sweating, muscle stiffness, and drowsiness or near-fainting (a condition called malignant neuroleptic syndrome),
• Yellowing of the skin and eyes (jaundice),
• Hepatitis,
• Prolonged and painful erections (priapism),
• Breast enlargement and unexpected milk production,
• Menstrual disorders,
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg); a fragment of the clot can move with the blood flow to the lungs, causing chest pain and breathing difficulties; if the patient notices any of these symptoms, they should immediately consult their doctor or go to the hospital,
• Sleepwalking, talking, eating, or performing other activities while asleep,
• Pancreatitis,
• A condition (known as "metabolic syndrome") in which there is a combination of three or more of the following features: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides in the blood, high blood pressure, and increased blood glucose levels,
• Simultaneous occurrence of fever, flu-like symptoms, sore throat, or any other infection, which may be a consequence of a very low white blood cell count in the blood (a condition known as agranulocytosis),
• Bowel obstruction,
• Increased creatine kinase levels in the blood (a substance derived from muscles).

Very rare side effects (occurring in less than 1 in 10,000 treated patients):

• Severe rash, blisters, or red spots on the skin,
• Severe allergic reactions (anaphylactic reaction) with symptoms such as difficulty breathing or shock,
• Rapidly developing swelling of the skin, usually around the eyes and mouth, as well as the throat (angioedema),
• Severe skin disorder with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• Inappropriate secretion of the hormone that regulates urine volume,
• Muscle breakdown and muscle pain (rhabdomyolysis),
• Worsening of existing diabetes.

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

• Skin rash with irregular red spots (erythema multiforme),
• Rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (rash with eosinophilia and systemic symptoms is also known as DRESS or drug hypersensitivity syndrome). If the patient experiences these symptoms, they should stop taking Ketrel and immediately consult their doctor or seek medical attention;
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis),
• Withdrawal symptoms (may occur in newborns of mothers who took Ketrel during pregnancy)
• Heart muscle disorders (cardiomyopathy)
• Myocarditis
• Vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple spots.

Medicines in the same class as Ketrel may cause heart rhythm disorders, which can be dangerous and, in severe cases, may lead to death.
Some side effects can only be detected by laboratory blood tests. These include changes in levels of certain fatty substances (triglycerides and total cholesterol) or glucose in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme levels in the blood, decreased levels of certain types of blood cells, decreased red blood cell count, increased creatine kinase levels in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased prolactin levels may lead to:

• Breast enlargement in both men and women, and unexpected milk production,
• Lack of or irregular menstrual periods in women.

The doctor may recommend regular check-ups.

Side effects in children and adolescents

The same side effects that occur in adults may also occur in children and adolescents.
The following side effect has been observed more frequently or exclusively in children and adolescents:

Very common side effects (occurring in more than 1 in 10 treated patients):

• Increased levels of the hormone prolactin in the blood. This may rarely lead to:
• Breast enlargement and unexpected milk production in boys and girls,
• In girls, lack of or irregular menstrual periods,
• Increased appetite,
• Vomiting,
• Involuntary muscle contractions, including difficulty starting movement, tremors, restlessness, or muscle stiffness without pain,
• Increased blood pressure.

Common side effects (occurring in less than 1 in 10 treated patients):

• Feeling weak, fainting (may lead to falls),
• Stuffy nose,
• Irritability.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: Al. Jerozolimskie 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ketrel

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not use the medicine if signs of opening or damage are visible.
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.

6. Package contents and other information

What Ketrel contains

• The active substance of the medicine is quetiapine.

Ketrel 25 mg: each tablet contains 25 mg of quetiapine in the form of quetiapine fumarate.
Ketrel 100 mg: each tablet contains 100 mg of quetiapine in the form of quetiapine fumarate.
Ketrel 200 mg: each tablet contains 200 mg of quetiapine in the form of quetiapine fumarate.

• Other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, lactose monohydrate, copovidone, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, orange yellow lake (Ketrel 25 mg), yellow lake (Ketrel 100 mg), Opadry HP White.

What Ketrel looks like and what the package contains

Ketrel 25 mg are orange, round, biconvex coated tablets.
Ketrel 100 mg are yellow, round, biconvex coated tablets.
Ketrel 200 mg are white, round, biconvex coated tablets.
Available packages:

• Packaging containing 20, 30, 40, 60, or 120 coated tablets of 25 mg, in a 30 mL polyethylene container with a polypropylene cap containing a desiccant, with a tamper-evident ring, in a cardboard box or PVC/PVDC/Aluminum blisters in a cardboard box.
• Packaging containing 60 coated tablets of 100 mg, in a 30 mL polyethylene container with a polypropylene cap containing a desiccant, with a tamper-evident ring, in a cardboard box or PVC/PVDC/Aluminum blisters in a cardboard box.
• Packaging containing 60 coated tablets of 200 mg, in a 75 mL polyethylene container with a polypropylene cap containing a desiccant, with a tamper-evident ring, in a cardboard box or PVC/PVDC/Aluminum blisters in a cardboard box.

Not all package types may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Celon Pharma S.A.
Ogrodowa 2A, Kiełpin
05-092 Łomianki
phone: (22) 751 59 33
email: info@celonpharma.com

Manufacturer:

Celon Pharma S.A.
Marymoncka 15
05-152 Kazuń Nowy
To obtain more detailed information, the patient should contact the marketing authorization holder:
Celon Pharma S.A.
Ogrodowa 2A, Kiełpin
05-092 Łomianki
phone: (22) 751-59-33,
email: info@celonpharma.com
To protect the medicine from unauthorized access and children, the packaging cap is equipped with a seal and a child-resistant opening mechanism.
Follow the instructions below to properly open the packaging:
 PRESS THE CAP FIRMLY
 WITH THE CAP PRESSED, TURN IT HALF A TURN

Date of last update of the leaflet: