Ketilept 100 mg

Leaflet attached to the packaging: information for the user

Ketilept 25 mg, coated tablets

Ketilept 100 mg, coated tablets

Ketilept 200 mg, coated tablets

Ketilept 300 mg, coated tablets

Quetiapine

You should carefully read the contents of the 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.
• In case of any doubts, you should consult a 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 any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Ketilept and what is it used for

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

• Bipolar disorder and severe depressive episodes in the course of 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, enthusiastic, 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, has hallucinations, is overly suspicious, fearful, anxious, confused, has a sense of guilt, tension or depression.

The doctor may recommend continuing treatment with Ketilept even when the patient feels better.
It may be helpful for the patient to inform friends and family about their symptoms and ask them to read this leaflet. The patient may ask them to inform them if they notice that the symptoms have worsened or worrying changes in behavior have occurred.

2. Important information before taking Ketilept

When not to take Ketilept

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

Warnings and precautions

Before starting treatment with Ketilept, the patient should consult a doctor or pharmacist:

If the patient is hospitalized, it is essential to inform the medical staff about taking Ketilept.
The patient should immediately inform their doctor if they experience symptoms such as:

• Fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary.
• Involuntary movements, especially 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, immediately refer the patient to a cardiologist.

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 and/or administration of appropriate treatment.
• Constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to more severe intestinal obstruction.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, and sometimes later. Such thoughts may also worsen if the medicine is stopped abruptly.
The occurrence of suicidal thoughts, self-harm thoughts, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past,
• the patient is a young adult. Information from clinical trials indicates an increased risk of
• suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm thoughts, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friends about depression and ask them to read this leaflet. The patient may ask their relatives or friends to inform them if they notice that the depression has worsened or worrying changes in behavior have occurred.

Severe skin reactions (SCARs)

During treatment with quetiapine, very rare severe skin reactions (SCARs) have been reported, which can be life-threatening or fatal. They usually manifest as:

• 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 causing intense peeling of the skin,
• 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 itchy, red, irregular patches.

If such symptoms occur, the patient should stop taking Ketilept and immediately contact their doctor or seek medical attention.

Weight gain

Patients taking Ketilept may experience weight gain. The patient should regularly check their weight with their doctor.

Children and adolescents

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

Ketilept 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 Ketilept if they are taking:

• certain medicines used to treat HIV,
• 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),
• antidepressants. These medicines may interact with Ketilept and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, 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 diseases.

The patient should not stop taking these medicines without first talking to their doctor.

Taking Ketilept with food, drink, and alcohol

Ketilept can be taken with or without food.
The patient should be cautious when consuming alcoholic beverages. The patient should tell their doctor before taking Ketilept if they regularly drink alcohol. Taking Ketilept and alcohol at the same time may cause drowsiness.
The patient should not consume grapefruit juice while taking Ketilept. This may affect how 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 before taking this medicine.
Ketilept should not be taken during pregnancy unless discussed with the doctor.
Ketilept should not be taken during breastfeeding.
In newborns whose mothers took Ketilept during the last trimester (last 3 months of pregnancy), the following withdrawal symptoms may occur: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, difficulty breathing, and feeding difficulties. If the patient notices such symptoms in their child, they should consult their doctor.

Driving and using machines

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

Ketilept contains lactose and sodium

In case of lactose intolerance, it should be noted that each Ketilept 25 mg, 100 mg, 200 mg, and 300 mg coated tablet contains 4.42 mg, 17.05 mg, 34.1 mg, and 50.94 mg of lactose, respectively.
If the doctor has informed the patient that they have an intolerance to some sugars, the patient should contact their doctor before taking this medicinal product.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Effect on urine drug tests

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

3. How to take Ketilept

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will determine the initial dose, which may be gradually increased. There are different dosing schedules depending on the indication.
The maintenance dose (daily dose) depends on the disease and the patient's needs, usually ranging from 150 mg to 800 mg per day.

• The medicine should be taken once a day before bedtime or twice a day, depending on the disease.
• The tablets should be swallowed whole, with a glass of water.
• The tablets can be taken with or without food.
• The patient should not consume grapefruit juice while taking Ketilept. It may affect how the medicine works.
• Even if the patient feels better, they should not stop taking the medicine unless their doctor decides to do so.

Patients with liver function disorders

The doctor may recommend changing the dose of Ketilept in patients with liver function disorders.

Elderly patients

The doctor may recommend changing the dose of Ketilept in elderly patients.

Use in children and adolescents

Ketilept should not be taken by children and adolescents under 18 years of age.

Taking a higher dose of Ketilept than recommended

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

Missing a dose of Ketilept

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

The patient should not stop taking the tablets without consulting their doctor. If the patient stops taking Ketilept abruptly, they may experience difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may advise 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 can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):

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

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

• Increased heart rate.
• Feeling of palpitations, rapid heartbeat, or skipped heartbeats.
• Constipation, indigestion.
• Weakness.
• Swelling of the 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.
• Strange dreams and nightmares.
• Increased appetite.
• Irritability.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression. The patient should immediately consult their doctor or go to the hospital!
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased levels of some types of blood cells.
• Increased liver enzyme activity in the blood
• Increased prolactin levels in the blood. Increased prolactin levels may rarely lead to the following symptoms: o Breast swelling and unexpected milk production in men and women. o 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, skin swelling, and swelling around the mouth.
• 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 (prolonged QT interval).
• Slower than normal heart function, which may occur when starting treatment and which 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 1000 people):

• Simultaneous occurrence of symptoms such as high fever (fever), sweating, muscle stiffness, and decreased level of consciousness (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 in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, the patient should immediately consult their doctor.
• Walking, talking, eating, or performing other activities while sleeping.
• 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) levels, increased triglyceride levels, high blood pressure, and increased blood sugar levels.
• Coexistence 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 levels of creatine phosphokinase (a substance derived from muscles) in the blood.

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

• Severe rash, blisters, red spots on the skin.
• Severe allergic reaction (anaphylactic), which can cause difficulty breathing or shock.
• Rapidly developing swelling of the skin, usually around the eyes, mouth, or throat (angioedema).
• Severe skin disease, mouth, eyes, and genital areas with blistering (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of the hormone that regulates urine volume.
• Muscle breakdown and muscle pain (rhabdomyolysis).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Heart muscle disorders (cardiomyopathy).
• Heart muscle inflammation.
• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Sudden appearance of areas of reddened skin with small blisters (small blisters filled with a white-yellow fluid called acute generalized exanthematous pustulosis (AGEP). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling (toxic necrolysis). See section 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.
• Newborns whose mothers took Ketilept during pregnancy may experience withdrawal symptoms.
• Stroke.

Medicines in the same group as Ketilept may disrupt heart rhythm, which can be a serious condition and, in individual cases, even fatal.
Some side effects are only visible after blood tests have been performed. These include changes in the levels of some fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzyme activity, decreased levels of some types of blood cells, decreased red blood cell count, increased creatine phosphokinase levels in the blood, and decreased sodium levels in the blood, as well as increased prolactin levels in the blood. Increased prolactin levels may rarely lead to the following symptoms:

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

The doctor may recommend performing control tests.

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 have been observed more frequently in children and adolescents or have not occurred in adults:
Very common (may affect more than 1 in 10 people)

• Increased levels of the hormone prolactin in the blood. In rare cases, this may lead to
• breast swelling and unexpected milk production in boys and girls,
• absence or irregular menstrual periods in girls
• Increased appetite
• Vomiting
• Abnormal movements of the muscles, including difficulties in starting muscle movements, tremors, restlessness, and muscle stiffness without pain.
• Increased blood pressure

Common (may affect up to 1 in 10 people)

• Feeling of weakness, fainting (may cause falls)
• Feeling of a stuffy nose
• Irritability.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Ketilept

Store in a temperature below 25°C.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
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 contains

The active substance of Ketilept is quetiapine hemifumarate. Each 25 mg, 100 mg, 200 mg, and 300 mg coated tablet contains 28.78 mg, 115.13 mg, 230.26 mg, and 345.4 mg of quetiapine hemifumarate, respectively.
The other ingredients are:

Ketilept 25 mg, coated tablets

magnesium stearate, silica colloidal anhydrous, povidone K-90, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, macrogol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).

Ketilept 100 mg, coated tablets

magnesium stearate, silica colloidal anhydrous, povidone K-90, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, macrogol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).

Ketilept 200 mg, coated tablets

magnesium stearate, silica colloidal anhydrous, povidone K-90, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, macrogol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).
Opadry II 33G24283 Pink (iron oxide yellow (E172), iron oxide red (E172), triacetin, macrogol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).

Ketilept 300 mg, coated tablets

magnesium stearate, silica colloidal anhydrous, povidone K-90, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, macrogol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).

What Ketilept looks like and contents of the pack

Ketilept 25 mg, coated tablets: white or almost white, odorless or almost odorless, round, biconvex coated tablets with the inscription "201" on one side and a stylized letter "E" on the other side.
Ketilept 100 mg, coated tablets: white or almost white, odorless or almost odorless, round, biconvex coated tablets with the inscription "E202" on one side.
Ketilept 200 mg, coated tablets: pink, odorless or almost odorless, round, biconvex coated tablets with the inscription "E204" on one side.
Ketilept 300 mg, coated tablets: white or almost white, odorless or almost odorless, round, biconvex coated tablets with the inscription "E205" on one side.

Packaging:

30, 50, 60, 70, 80, 90, or 100 coated tablets in colorless, transparent PVC/PVDC/Aluminum blisters, placed in a cardboard box

Marketing authorization holder

PROTERAPIA Spółka z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary

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

Hungary:
Ketilept 25/100/150/200/300 mg film-coated tablets
Czech Republic: Ketilept
Lithuania: Ketilept 25/100/150/200/300 mg tablets
Latvia:
Ketilept 25/100/150/200/300 mg film-coated tablets
Poland
Ketilept 25/100/200/300 mg
Slovakia:
Ketilept 25/100/150/200/300 mg

Date of last revision of the leaflet: 17.06.2024