Ketilept retard

Leaflet accompanying the packaging: information for the user

Ketilept Retard, 50 mg, prolonged-release tablets

Ketilept Retard, 150 mg, prolonged-release tablets

Ketilept Retard, 200 mg, prolonged-release tablets

Ketilept Retard, 300 mg, prolonged-release tablets

Ketilept Retard, 400 mg, prolonged-release tablets

Quetiapine

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ketilept Retard and what is it used for
• 2. Important information before taking Ketilept Retard
• 3. How to take Ketilept Retard
• 4. Possible side effects
• 5. How to store Ketilept Retard
• 6. Contents of the packaging and other information

1. What is Ketilept Retard and what is it used for

Ketilept Retard contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Ketilept Retard can be used to treat diseases such as:

• Bipolar affective disorder and episodes of severe depression in the course of severe depressive disorders, when the patient feels intense sadness or depression, has a sense of guilt, lack of energy and appetite, or difficulty sleeping.
• Mania, when the patient may be very agitated, excited, elated, overactive, or has limited critical judgment, including being aggressive or exhibiting destructive behavior.
• Schizophrenia, when the patient hears or feels non-existent voices and things, is overly suspicious, feels anxiety, unease, disorientation, has a sense of guilt, tension, or depression.

In the case of treating episodes of severe depression associated with severe depressive disorder, Ketilept Retard will be used in combination with another medicine. The doctor may recommend continued use of Ketilept Retard, even if the patient's condition improves.

2. Important information before taking Ketilept Retard

When not to take Ketilept Retard

• certain medicines used to treat HIV infection,
• azole medicines (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 Ketilept Retard. In case of doubts, the patient should consult their doctor or pharmacist before taking Ketilept Retard.

Warnings and precautions

Before starting treatment with Ketilept Retard, the patient should discuss the following with their doctor or pharmacist:

The patient should immediately inform their doctor if they experience any of the following symptoms after taking Ketilept Retard:

• Fever, muscle stiffness, increased sweating, or altered consciousness (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary.
• Involuntary movements, mainly of the face or tongue.
• Dizziness, excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures.
• Prolonged and painful erections (priapism).
• Rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient to a cardiologist immediately.

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

• Fever, flu-like symptoms, sore throat, or other infections, as these symptoms may be due to a very low white blood cell count, which may require discontinuation of Ketilept Retard and/or appropriate treatment.
• Constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to severe intestinal obstruction.

Suicidal thoughts and depression

People with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the start of treatment with antidepressant medicines, as these medicines usually start working after 2 weeks, and sometimes later. Such thoughts may also worsen if the patient suddenly stops taking the medicine. The likelihood of such thoughts may be higher in young adults. Data from clinical trials indicate an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression. If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform the family or friends about the depression and ask them to read this leaflet. The patient may ask them to inform them if they notice that the depression has worsened or if there are worrying changes in their behavior. Severe skin reactions (SCAR) have been very rarely reported during treatment with quetiapine, which can be life-threatening or fatal. They usually manifest as:

• Toxic epidermal necrolysis (TEN), a more severe form causing intense skin peeling,
• Drug reaction with eosinophilia and systemic symptoms (DRESS) including flu-like symptoms with rash, fever, swelling of lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme activity).
• Acute generalized exanthematous pustulosis (AGEP), small blisters filled with pus.
• Erythema multiforme (EM), a skin rash with red, irregular patches. If such symptoms occur, the patient should stop taking Ketilept Retard and seek medical attention immediately.

Weight gain

Patients taking Ketilept Retard have experienced weight gain. The patient should regularly check their weight themselves or with their doctor.

Children and adolescents

Ketilept Retard is not recommended for use in children and adolescents under 18 years of age.

Ketilept Retard and other medicines

The patient should tell their doctor or pharmacist 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 Ketilept Retard if they are taking:

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

In particular, the patient should tell their doctor if they are taking:

• antiepileptic medicines (such as phenytoin or carbamazepine),
• antidepressant medicines. These medicines may interact with Ketilept Retard and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, the patient should consult their doctor.
• antihypertensive medicines,
• barbiturates (medicines used to treat sleep disorders),
• thioridazine or lithium (another antipsychotic medicine),
• medicines that affect heart rhythm, such as medicines that disrupt electrolyte balance (decreased potassium or magnesium levels), such as diuretics (medicines that increase urine production) or certain antibiotics (medicines used to treat infections),
• medicines that may cause constipation,
• medicines (so-called anticholinergic preparations) that affect nerve function to treat certain conditions.

Before stopping these medicines, the patient should first talk to their doctor.

Taking Ketilept Retard with food, drink, and alcohol

• Food may interfere with the action of the medicine, so Ketilept Retard should be taken at least 1 hour before a meal or before bedtime.
• The patient should be cautious when consuming alcoholic beverages. Taking Ketilept Retard and alcohol at the same time may cause drowsiness.
• The patient should not drink grapefruit juice while taking Ketilept Retard, as it may affect the way the medicine works.

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. The patient should not take Ketilept Retard during pregnancy, unless it has been discussed with their doctor. The patient should not take Ketilept Retard while breastfeeding. In newborns of mothers who took Ketilept Retard during the last trimester of pregnancy (the last 3 months of pregnancy), the following withdrawal symptoms may occur: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the child experiences any of these symptoms, medical consultation may be necessary.

Driving and using machines

Ketilept Retard may cause drowsiness. The patient should not drive or operate machinery until they are sure how the medicine affects them.

Effect on urine tests for drugs

In patients undergoing urine tests for drugs, taking Ketilept Retard may cause positive test results for methadone or certain antidepressant medicines (tricyclic antidepressants) using some methods, even if the patient is not taking methadone or tricyclic antidepressants. In such cases, a more specific test can be performed.

Ketilept Retard contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicinal product.

3. How to take Ketilept Retard

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will determine the initial dose. The usual daily dose of Ketilept Retard is between 150 mg and 800 mg, depending on the patient's symptoms and needs.

• 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 in the evening, as recommended by the doctor).
• The patient should not drink grapefruit juice while taking Ketilept Retard, as it may affect the way the medicine works.
• Even if the patient feels better, they should not stop taking the medicine unless their doctor decides to do so.

Liver function disorders

The doctor may recommend a dose change in patients with liver function disorders.

Elderly patients

The doctor may recommend a dose change in elderly patients.

Use in children and adolescents

Ketilept Retard should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Ketilept Retard than recommended

If the patient takes a higher dose of Ketilept Retard than recommended by their doctor, they may experience drowsiness, dizziness, irregular heartbeat. The patient should immediately consult their doctor or go to the nearest hospital. The patient should take the Ketilept Retard tablets with them.

Missing a dose of Ketilept Retard

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, 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 Ketilept Retard

If the patient suddenly stops taking Ketilept Retard, 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 doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketilept Retard can cause side effects, although not everybody gets them. Very common(may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth.
• Drowsiness (may resolve during continued treatment with Ketilept Retard) (may lead to falls).
• Withdrawal symptoms (symptoms that may occur after stopping Ketilept Retard), including difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop the medicine over a period of 1-2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Changes in the levels of certain fats (e.g., triglycerides and total cholesterol) in the blood.

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

• Increased heart rate.
• Palpitations, rapid heartbeat, or skipped heartbeats.
• Constipation, indigestion.
• Weakness.
• Swelling of hands or feet.
• Low blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Vivid dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased white blood cell count.
• Increased liver enzyme activity in the blood.
• Increased prolactin levels in the blood, which may rarely cause:
• Breast swelling and unexpected milk production in both men and women.
• Absence or irregular menstrual periods in women.

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

• Seizures.
• Allergic reactions, including hives and blisters on the skin, swelling of the skin and mouth area.
• Unpleasant sensations in the lower limbs (restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual function disorders.
• Diabetes.
• Changes in the electrical activity of the heart observed in ECG (QT interval prolongation).
• Slower than normal heart function, which may occur at the start of 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.
• Disorientation.

Rare(may affect up to 1 in 1,000 people):

• The simultaneous occurrence of symptoms such as high fever (fever), increased sweating, muscle stiffness, and altered consciousness or fainting (a condition called malignant neuroleptic syndrome).
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erections (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Blood clots, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the patient should immediately consult their doctor.
• Sleepwalking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called metabolic syndrome) in which three or more of the following symptoms coexist: increased fat around the waist, decreased "good" cholesterol (HDL), increased triglyceride levels, high blood pressure, and increased blood sugar levels.
• The simultaneous occurrence of fever, flu-like symptoms, sore throat, or other infections with a very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase (a substance derived from muscles) in the blood.

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

• Severe skin rash, blisters, red spots on the skin.
• Severe allergic reaction (anaphylactic reaction) that can cause breathing difficulties or shock.
• Rapidly developing swelling of the skin, usually around the eyes, mouth, or throat (angioedema).
• A severe condition characterized by the formation of blisters in the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome) (see section 2).
• Abnormal secretion of the hormone that regulates urine output.
• Muscle breakdown and muscle pain (rhabdomyolysis).

Unknown(cannot be estimated from the available data)

• Heart muscle disorders (cardiomyopathy).
• Myocarditis.
• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Sudden appearance of areas of red skin with small blisters (acute generalized exanthematous pustulosis (AGEP)). See section 2.
• A severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling (toxic epidermal necrolysis (see section 2).
• 2)
• Drug reaction with eosinophilia and systemic symptoms (DRESS) including flu-like symptoms with rash, fever, swelling of lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme activity) (see section 2).
• Vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple spots.
• Withdrawal symptoms in newborns of mothers who took quetiapine during pregnancy.
• Stroke.

Medicines in the same group as Ketilept Retard may cause heart function disorders, which can be severe and life-threatening. Some side effects are only observed in blood test results. These include changes in the levels of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme activity in the blood, decreased white blood cell count, decreased red blood cell count, increased creatine phosphokinase (a substance derived from muscles) in the blood, decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels may rarely cause:

• Breast swelling and unexpected milk production in both men and women.
• Absence or irregular menstrual periods in women.

The doctor may recommend regular check-ups.

Additional side effects in children and adolescents

The same side effects as in adults can also occur in children and adolescents. The following side effects were observed more frequently in children and adolescents than in adults: Very common(may affect more than 1 in 10 people)

• Increased prolactin levels in the blood. In rare cases, this may cause:
• breast swelling and unexpected milk production in both boys and girls
• absence or irregular menstrual periods in girls
• Increased appetite
• Vomiting
• Abnormal muscle movements, including difficulty starting movement, tremors, restless legs syndrome, and muscle stiffness without pain
• Increased blood pressure

Common(may affect up to 1 in 10 people)

• Feeling weak, fainting (may lead to falls)
• Feeling stuffy
• Feeling irritable

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ketilept Retard

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 packaging. The expiry date refers to the last day of the stated month. Ketilept Retard does not require special storage conditions. 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. Contents of the packaging and other information

What Ketilept Retard contains

The active substance of the medicine is quetiapine. Ketilept Retard prolonged-release tablets contain 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg of quetiapine (in the form of quetiapine fumarate). The other ingredients are: Tablet core: lactose anhydrous, methacrylic acid-ethyl acrylate copolymer (1:1), type A, crystalline maltose, magnesium stearate, talc. Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1), type A, triethyl citrate.

What Ketilept Retard looks like and contents of the pack

Ketilept Retard, 50 mg, prolonged-release tablets: white or almost white, round, biconvex tablets with a diameter of 7.1 mm and a thickness of 3.2 mm, with the inscription "50" on one side. Ketilept Retard, 150 mg, prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 13.6 mm, width of 6.6 mm, and thickness of 4.2 mm, with the inscription "150" on one side. Ketilept Retard, 200 mg, prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 15.2 mm, width of 7.7 mm, and thickness of 4.8 mm, with the inscription "200" on one side. Ketilept Retard, 300 mg, prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 18.2 mm, width of 8.2 mm, and thickness of 5.4 mm, with the inscription "300" on one side. Ketilept Retard, 400 mg, prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 20.7 mm, width of 10.2 mm, and thickness of 6.3 mm, with the inscription "400" on one side. Ketilept Retard prolonged-release tablets are available in PVC/PCTFE/Aluminum blisters, packaged in a cardboard box. The pack sizes are 30, 50, 60, and 100 prolonged-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

EGIS Pharmaceuticals PLC, Keresztúri út 30-38, H-1106 Budapest, Hungary

Manufacturer

Pharmathen International S.A, Sapes Industrial Park Block 5, 69300 Rodopi, Greece, Pharmathen S.A, 6, Dervenakion str., 153 51 Pallini, Attiki, Greece, EGIS Pharmaceuticals PLC, Bökényföldi út 118-120, H-1165 Budapest, Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Ketilept Prolong, Hungary: Ketilept Prolong, Poland: Ketilept Retard, Slovakia: Ketilept Prolong

Date of last revision of the leaflet:19.06.2024