Ketrel

Package leaflet: Information for the patient

Ketrel, 25 mg, coated tablets
Ketrel, 100 mg, coated tablets
Ketrel, 200 mg, coated tablets
Quetiapinum
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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• 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 and sees unreal voices and images, believes in non-existent things, is excessively suspicious, anxious, confused, tense, feels guilt or is depressed;
• depressive episodes in bipolar disorder, when the patient feels sadness, depression, lack of energy, loss of appetite, guilt or is unable to sleep;
• mania, when the patient is highly excited, elated, enthusiastic or excessively active, has impaired critical judgment, or is aggressive or troublesome.

Your doctor may recommend continuing treatment with Ketrel even after your condition improves 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 situations listed above 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 such cases, Ketrel should not be used, as medicines of the class to which Ketrel belongs may increase the risk of stroke and sometimes even death in elderly patients with dementia.
• The patient or a family member has had blood clots; use of medicines such as this one may be associated with blood clot formation.
• 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 consciousness (a condition known as neuroleptic malignant syndrome); immediate treatment may be required.
• involuntary movements, especially of the face 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, difficulty breathing, 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 contact the doctor if the patient experiences:

• fever together with flu-like symptoms, sore throat, or any other infection, which may be due to a very low number of white blood cells in the blood. In such cases, Ketrel must 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 about two weeks or sometimes longer. These thoughts may also worsen if the medicine is stopped abruptly. Young adults are more likely to experience such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behavior in people under 25 years of age with depression.
If the patient ever experiences suicidal thoughts or thoughts of self-harm, seek immediate medical help by contacting a doctor or going 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 worrying changes in behavior.

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 your doctor about all medicines the patient is currently taking, has recently taken, or 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 antipsychotic medicines),
• medicines affecting heart rhythm, for example medicines that may disturb electrolyte balance (lowering potassium and magnesium levels), such as diuretics (causing increased urine production) or certain antibiotics (used to treat infections),
• medicines that may cause constipation,
• antidepressants. These medicines may interact with Ketrel and may cause symptoms such as involuntary rhythmic muscle contractions, including eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor immediately.

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

Taking Ketrel with food, drink, and alcohol

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before taking Ketrel. The patient should not take Ketrel during pregnancy without first discussing this with her doctor.
Ketrel should not be taken 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 difficulty feeding. If the patient's baby shows any of these symptoms, contact a doctor.

Driving and operating machinery
Ketrel may cause drowsiness. The patient should not drive or operate machinery until they know how this medicine affects them.

Effect on urine drug screening tests
In patients taking Ketrel, certain urine drug screening tests may show the presence of methadone or antidepressants known as tricyclic antidepressants (TCA), 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 previously been 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 medicine may cause allergic reactions.

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

3. How to use Ketrel

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The initial dose and the way the medicine is taken during the following days of treatment will be determined by the treating doctor.
The usual dose of Ketrel ranges from 150 mg to 800 mg, depending on the patient's symptoms and needs.

• The medicine should be taken once daily, before bedtime, or twice daily, depending on the patient's condition.
• Tablets should be swallowed whole with water.
• 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 stop taking the tablets even if you feel better, unless instructed by your doctor.

Liver function disorders
The doctor may recommend adjusting the dosage regimen in patients with impaired liver function.
Elderly patients
The doctor may recommend adjusting the dosage regimen in elderly patients.
Use in children and adolescents
Ketrel should not be used in patients under 18 years of age.
Taking more Ketrel than prescribed
If an overdose of Ketrel is taken, symptoms such as drowsiness, dizziness, and irregular heartbeat may occur.
Seek immediate medical advice from a doctor or go to the nearest hospital. Bring the medicine pack 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 doctor may recommend gradually reducing the dose before stopping 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 in 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 movements; 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 in 10 patients treated):

• increased heart rate,
• sensation of heart pounding (palpitations), rapid heartbeat or irregular heartbeat rhythm,
• 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 blood levels of liver enzymes,
• 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 in 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, particularly of facial muscles or tongue,
• sexual dysfunction,
• diabetes,
• changes in the heart's electrical activity seen on ECG (prolongation of QT interval),
• slower than normal 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 in 1000 patients treated):

• 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,
• prolonged and painful penile erection (priapism),
• breast enlargement and unexpected milk discharge (galactorrhoea),
• 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 while asleep,
• pancreatitis,
• a condition (known as “metabolic syndrome”) involving a combination of 3 or more of the following features: increased abdominal fat, decreased levels of “good cholesterol” (HDL-C), increased blood lipid levels (triglycerides), high blood pressure, and increased blood glucose levels,
• concurrent occurrence of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count (a condition known as agranulocyt游戏副本),
• intestinal obstruction,
• increased blood levels of creatine kinase (a substance derived from muscles).

Very rare adverse reactions (in less than 1 in 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 skin swelling, 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,
• 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), enlarged 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 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 by 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 blood levels of liver enzymes, 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. Increased levels of this hormone may lead to:

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

Your doctor may recommend periodic monitoring tests.

Adverse reactions in children and adolescents

The same adverse reactions observed 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 in 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, tremor, restlessness or muscle stiffness without associated pain,
• increased blood pressure.

Common (in less than 1 in 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 of 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 to provide more information on the safety of the medicine.

5. How to store Ketrel

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 any 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ketrel contains

• The active substance 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 lake (Ketrel 25 mg), quinoline yellow lake (Ketrel 100 mg), Opadry HP White.

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

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 seal, 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 seal, 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 seal, 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 correctly open the container:
 PUSH HARD ON THE CAP  WHILE PUSHING, TURN THE CAP BY HALF A TURN