Ketrel

Package leaflet: Information for the patient

Ketrel, 25 mg, coated tablets
Ketrel, 100 mg, coated tablets
Ketrel, 200 mg, coated tablets
Quetiapine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Contents of the leaflet:

1. What Ketrel is and what it is used for
2. What you need to know before taking Ketrel
3. How to take Ketrel
4. Possible side effects
5. How to store Ketrel
6. Contents of the pack and other information

1. What Ketrel is and what it is used for

Ketrel contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics.
Ketrel is used to treat conditions such as:

• Schizophrenia, when the patient hears or sees unreal voices and images, believes in things that are not real, is excessively suspicious, anxious, confused, tense, feels guilty, or is depressed;
• Depressive episodes in bipolar disorder, when the patient feels sad, depressed, lacks energy, loses appetite, feels guilty, or cannot sleep;
• Mania, when the patient is highly excited, overactive, overly enthusiastic, has impaired judgment, or is aggressive or troublesome.

Your doctor may continue to prescribe Ketrel even after your condition improves in order to prevent relapse.

2. Important information before using Ketrel

When not to take Ketrel

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• if the patient is currently taking any of the following medicines:
  • protease inhibitors (some medicines used in HIV infection),
  • azole antifungals (used in fungal infections),
  • erythromycin or clarithromycin (antibiotics used in infections),
• nefazodone (used to treat depression).

If any of the above situations apply, Ketrel must not be used.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting Ketrel, discuss with your doctor or pharmacist if:

• The patient or a family member has or has had any heart problems, such as irregular heartbeat, weakened heart, or myocarditis, or if the patient 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 elderly.
• The patient has liver problems.
• The patient has ever had seizures (epilepsy).
• The patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor the patient's blood sugar levels during treatment with Ketrel.
• The patient has previously had a low white blood cell count (which may or may not have been caused by other medicines).
• The patient is an elderly person with dementia (impaired brain function). In this case, Ketrel should not be used, as medicines of this class have been associated with an increased risk of stroke and sometimes even death in elderly patients with dementia.
• The patient or a family member has a history of blood clots; use of medicines like Ketrel may increase the risk of thrombosis.
• The patient has depression or other conditions treated with antidepressants. Taking these medicines together with Ketrel may lead to serotonin syndrome, a potentially life-threatening condition (see "Ketrel with other medicines").

Immediately inform the doctor if the patient experiences any of the following after taking Ketrel:

• fever, muscle stiffness, excessive sweating, altered mental status (a condition known as neuroleptic malignant syndrome); immediate treatment may be required.
• involuntary movements, especially of the facial muscles or tongue.
• dizziness or severe drowsiness; these effects may increase the risk of accidental injury (falls) in elderly patients.
• seizures (epilepsy).
• prolonged painful erection (priapism).
• rapid or irregular heartbeat, even at rest, palpitations, shortness of breath, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient immediately to a cardiologist.

All of these symptoms may occur during treatment with medicines of this therapeutic class.
Immediately inform the doctor if the patient experiences:

• fever together with flu-like symptoms, sore throat, or any other signs of infection, which may result from a very low number of white blood cells in the blood. In such cases, Ketrel should be discontinued and/or appropriate treatment initiated.
• constipation accompanied by persistent abdominal pain or persistent constipation despite treatment, as this may lead to serious intestinal obstruction.

Suicidal thoughts or worsening depression
Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen during the initial phase of treatment, as all antidepressants take time to work, usually after two weeks or sometimes longer. Such thoughts may also worsen after abrupt discontinuation of the medicine. Young adults are more likely to experience these thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behavior in individuals under 25 years of age with depression.
If the patient ever experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to a hospital. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. You may also ask these individuals to inform the patient if they notice worsening of depressive symptoms or other concerning behavioral changes.

Weight gain
Weight gain has been observed in patients taking Ketrel. The patient and doctor should regularly monitor the patient's body weight.

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

Ketrel with other medicines
Tell the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Do not take Ketrel if the patient is taking any of the following medicines:

• certain medicines used to treat HIV,
• azole antifungals (used in fungal infections),
• erythromycin or clarithromycin (used in infections),
• nefazodone (used to treat depression).

Tell the doctor if the patient is taking:

• antiepileptic medicines (such as phenytoin or carbamazepine),
• antihypertensive medicines,
• barbiturates (medicines used for sleep disorders),
• thioridazine or lithium salts (other antipsychotics),
• medicines affecting heart rhythm, for example, medicines that may disturb electrolyte balance (reducing potassium and magnesium levels), such as diuretics (causing increased urine output) or certain antibiotics (used to treat infections),
• medicines that may 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, tremor, increased reflexes, muscle rigidity, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor immediately.

Do not stop taking any medicine without first consulting a doctor.

Taking Ketrel with food, drink, and alcohol

• Ketrel may be taken with or without food.
• During treatment with Ketrel, alcoholic beverages should be avoided. Taking Ketrel with alcohol may increase drowsiness.
• Grapefruit juice must not be consumed during treatment with Ketrel, as it may affect the medicine's action.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult a doctor before taking Ketrel. Ketrel should not be taken during pregnancy without first discussing it with a doctor. Ketrel should not be used during breastfeeding.

Newborns of mothers who took Ketrel during the third trimester of pregnancy (last three months) may experience the following symptoms, which may indicate withdrawal syndrome: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the newborn, contact a doctor.

Driving and operating machinery
Ketrel may cause drowsiness. Do not drive or operate machinery until the patient knows how this medicine affects them.

Effect on urine drug screening tests
In patients taking Ketrel, certain urine drug screening tests may show positive results for methadone or tricyclic antidepressants (TCAs), even though the patient has not taken these medicines. It is recommended to confirm test results using alternative methods.

Ketrel contains lactose, sunset yellow (Ketrel 25 mg), and sodium

Lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sunset yellow
Ketrel 25 mg contains sunset yellow. This ingredient may cause allergic reactions.

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

3. How to take Ketrel

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
The initial dose and method of administration during subsequent days of treatment will be determined by the attending physician. The usual dose of Ketrel ranges from 150 mg to 800 mg, depending on the patient's symptoms and needs.

• Take the medicine once daily, before bedtime, or twice daily, depending on the patient's condition.
• Swallow the tablets whole with water.
• The tablets may be taken with or without food.
• Grapefruit juice should not be consumed during treatment with Ketrel, as it may affect the medicine's action.
• Do not discontinue treatment even if symptoms improve, unless instructed by the physician.

Liver function disorders
The physician may adjust the dosing regimen in patients with impaired liver function.
Elderly patients
The physician may adjust the dosing regimen in elderly patients.
Use in children and adolescents
Ketrel should not be used in patients under 18 years of age.
Overdose of Ketrel
If an overdose of Ketrel is taken, symptoms such as drowsiness, dizziness, or irregular heartbeat may occur. Seek immediate medical advice or go to the nearest hospital. Bring the Ketrel packaging with you.
Missed dose of Ketrel
If a dose has been missed, take it as soon as possible. If it is almost time for the next dose, take the medicine at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Ketrel treatment
If Ketrel is stopped abruptly, difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, or irritability may occur. The physician may recommend gradually reducing the dose before discontinuing treatment.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.

Very common adverse reactions (in more than 1 out of 10 patients treated):

• dizziness (may lead to falls), headache, dry mouth,
• somnolence (may decrease during Ketrel treatment); may lead to falls,
• withdrawal symptoms (symptoms occurring after discontinuation of Ketrel): difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation of Ketrel over a period of at least 1–2 weeks is recommended;
• weight gain,
• abnormal muscle contractions; this may include difficulty initiating movement, tremor, motor restlessness or painless muscle stiffness,
• changes in blood levels of certain lipids (triglycerides and total cholesterol).

Common adverse reactions (in less than 1 out of 10 patients treated):

• increased heart rate,
• sensation of heart pounding, rapid heartbeat or irregular heart rhythm (palpitations),
• constipation, stomach irritation (dyspepsia),
• weakness,
• swelling of hands or feet,
• low blood pressure upon standing. This may cause dizziness or fainting (may lead to falls),
• increased blood glucose levels,
• blurred vision,
• unusual dreams and nightmares,
• increased appetite,
• irritability,
• speech and language disorders,
• suicidal thoughts and worsening of depression,
• shortness of breath,
• vomiting (mainly in elderly patients),
• fever,
• changes in blood levels of thyroid hormones,
• decreased number of certain types of blood cells,
• increased levels of liver enzymes in blood,
• increased blood levels of the hormone prolactin; elevated prolactin levels may lead to:
  • breast enlargement in both men and women, and unexpected milk production,
  • absence or irregular menstruation in women.

Uncommon adverse reactions (in less than 1 out of 100 patients treated):

• seizures,
• allergic reactions such as blisters (vesicles), 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 facial muscles or tongue,
• sexual dysfunction,
• diabetes,
• changes in the electrical activity of the heart seen on ECG (prolongation of QT interval),
• slower than usual heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting,
• difficulty urinating,
• fainting (may lead to falls),
• nasal congestion,
• decreased number of red blood cells in blood,
• decreased sodium levels in blood.

Rare adverse reactions (in less than 1 out of 1,000 patients treated):

• seizures,
• concurrent occurrence of high body temperature (fever), sweating, muscle stiffness, drowsiness or near-fainting (a condition known as neuroleptic malignant syndrome),
• yellowing of the skin and eyes (jaundice),
• hepatitis (liver inflammation),
• prolonged and painful penile erection (priapism),
• breast enlargement and unexpected milk discharge (galactorrhea),
• menstrual cycle disturbances,
• formation of blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the limb); a fragment of the clot may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties; if any of these symptoms occur, the patient should seek immediate medical attention from a doctor or hospital,
• sleepwalking, talking, eating or performing other activities during sleep,
• pancreatitis,
• a condition (referred to as "metabolic syndrome") involving a combination of 3 or more of the following: increased abdominal fat, reduced levels of "good cholesterol" (HDL-C), increased blood lipid levels (triglycerides), high blood pressure, and elevated blood glucose levels,
• concurrent occurrence of fever, flu-like symptoms, sore throat, or presence of any other infection with a very low number of white blood cells in blood (a condition known as agranulocytosis),
• intestinal obstruction,
• increased blood levels of creatine kinase (a substance derived from muscles).

Very rare adverse reactions (in less than 1 out of 10,000 patients treated):

• severe rash, blisters or red spots on the skin,
• severe hypersensitivity reactions (anaphylactic reaction) manifesting as difficulty breathing or shock,
• rapidly developing swelling of the skin, usually around the eyes, mouth and throat (angioedema),
• severe condition with blister formation on the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome),
• inappropriate secretion of the hormone regulating urine volume (inappropriate antidiuretic hormone secretion),
• muscle fibre breakdown and muscle pain (rhabdomyolysis),
• worsening of pre-existing diabetes.

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

• skin rash with irregular red patches (erythema multiforme),
• rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (rash with eosinophilia and systemic symptoms is also known as DRESS or drug hypersensitivity syndrome). If these symptoms occur in a patient, Ketrel should be discontinued immediately and the patient should contact their doctor or seek medical help without delay;
• severe, sudden allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis),
• withdrawal symptoms (may occur in newborns of mothers who took Ketrel during pregnancy),
• heart muscle disorders (cardiomyopathy),
• inflammation of the heart muscle (myocarditis),
• inflammation of blood vessels (vasculitis), often with skin rash presenting as small red or purple nodules.

Medicines of the class to which Ketrel also belongs may cause disturbances in heart rhythm, which may be dangerous and, in severe cases, may lead to death.

Some adverse reactions can only be detected through laboratory blood tests. These include changes in blood levels of certain lipids (triglycerides and total cholesterol) or glucose, changes in blood levels of thyroid hormones, increased levels of liver enzymes in blood, decreased number of certain types of blood cells, decreased number of red blood cells, increased blood levels of creatine kinase (a substance derived from muscles), decreased sodium levels in blood, and increased blood levels of the hormone prolactin. Elevated prolactin levels may lead to:

• breast enlargement in both men and women, and unexpected milk production,
• absence or irregular menstruation in women.

The doctor may recommend periodic monitoring tests.

Adverse reactions in children and adolescents

The same adverse reactions occurring in adult patients may also occur in children and adolescents.

The following adverse reactions have been observed more frequently or exclusively in children and adolescents:

Very common adverse reactions (in more than 1 out of 10 patients treated):

• increased blood levels of the hormone prolactin. In rare cases, this may lead to:
  • breast enlargement and unexpected milk discharge in boys and girls,
  • in girls, absence or irregular menstruation,
• increased appetite,
• vomiting,
• abnormal muscle contractions, including difficulty initiating intended movement, tremors, restlessness or muscle stiffness without accompanying pain,
• increased blood pressure.

Common (in less than 1 out of 10 patients treated):

• feeling of weakness, fainting (may lead to falls),
• nasal congestion,
• feeling of irritability.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ketrel medicine

Keep the medicine 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 stated month.
Do not store above 25°C.
Do not use the medicine if signs of tampering or damage are visible.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ketrel contains

• The active substance in Ketrel is quetiapine.

Ketrel 25 mg: each tablet contains 25 mg of quetiapine as quetiapine fumarate.
Ketrel 100 mg: each tablet contains 100 mg of quetiapine as quetiapine fumarate.
Ketrel 200 mg: each tablet contains 200 mg of quetiapine as quetiapine fumarate.

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

What Ketrel looks like and contents of the pack
Ketrel 25 mg are round, biconvex, film-coated tablets, orange in colour.
Ketrel 100 mg are round, biconvex, film-coated tablets, yellow in colour.
Ketrel 200 mg are round, biconvex, film-coated tablets, white in colour.

Available pack sizes:

• Pack containing 20, 30, 40, 60 or 120 film-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/Aluminium blisters in a cardboard box.
• Pack containing 60 film-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/Aluminium blisters in a cardboard box.
• Pack containing 60 film-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/Aluminium blisters in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Celon Pharma S.A.
ul. Ogrodowa 2A, Kiełpin
05-092 Łomianki
tel.: (22) 751 59 33
e-mail: [email protected]

Manufacturer:
Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy

For further information, please contact the Marketing Authorisation Holder:
Celon Pharma S.A.
Ogrodowa 2A, Kiełpin
05-092 Łomianki
tel.: (22) 751-59-33,
e-mail: [email protected]

To protect the medicine from access by unauthorized persons and children, the container cap is equipped with a seal and a child-resistant closure mechanism.
Follow the instructions in the figures below to open the container correctly:
 PRESS DOWN FIRMLY  WHILE PRESSING, TURN THE CAP
HALF A TURN