Ketilept 200 mg

Package leaflet: Information for the user

Ketilept 25 mg, coated tablets
Ketilept 100 mg, coated tablets
Ketilept 200 mg, coated tablets
Ketilept 300 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, 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. See section 4.

Contents of the leaflet:

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

1. What Ketilept is and what it is used for

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

• Bipolar disorder and severe depressive episodes in the course of depressive disorders, when the patient experiences profound sadness or despair, feelings of guilt, lack of energy and appetite, or difficulties in falling asleep.
• Mania, when the patient may be highly excited, agitated, over-enthusiastic, excessively active, or have impaired critical judgment, including aggressive behavior or destructive actions.
• Schizophrenia, when the patient hears or feels non-existent voices and sensations, has delusions, is excessively suspicious, fearful, anxious, confused, or experiences feelings of guilt, tension, or depression.

Your doctor may recommend continuing treatment with Ketilept even when you feel better.
It may be helpful for you to inform your friends and family about your symptoms and ask them to read this leaflet. You may ask them to inform you if they notice that your symptoms worsen or if worrying changes in your behavior occur.

2. Important information before using Ketilept

When not to use Ketilept

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking or has recently taken any of the following medicines:
  • certain medicines used to treat 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 to the patient, Ketilept must not be used.
If in doubt, consult a doctor or pharmacist before using Ketilept.
Warnings and precautions
Before starting Ketilept, consult a doctor or pharmacist:

• if the patient has or has had heart problems such as irregular heartbeat, weakened or inflamed heart muscle, or if the patient is taking medicines that may affect heart rhythm,
• if the patient has low blood pressure,
• if the patient has had a stroke, especially if the patient is elderly,
• if the patient has liver problems,
• if the patient has ever had seizures (fits) in the past,
• if the patient has diabetes or is prone to high blood sugar levels (diabetes in medical history or high blood glucose during pregnancy). In this case, the doctor may recommend monitoring blood glucose levels during treatment with Ketilept,
• if the patient has pancreatitis or has risk factors for pancreatitis, such as gallstones or high levels of triglycerides (fats in the blood),
• if the patient has depression or other conditions treated with antidepressants. Taking these medicines together with Ketilept may lead to serotonin syndrome, a potentially life-threatening condition (see “Ketilept and other medicines”),
• if the patient has previously had low levels of white blood cells, whether or not related to taking other medicines,
• if the patient is elderly with dementia (loss of brain function). In this case, Ketilept must not be used, as medicines in the class to which Ketilept belongs may increase the risk of stroke and, in some cases, risk of death in elderly patients with dementia,
• if the patient is elderly and has Parkinson’s disease / parkinsonism.
• if the patient or someone in their family has had venous thrombosis, as taking medicines in this class may increase the risk,
• if the patient has or has previously had breathing problems such as brief periods of stopped breathing during sleep (known as sleep apnoea syndrome) and is taking medicines that slow down or suppress normal brain function,
• if the patient has or has previously had difficulty completely emptying the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These problems may sometimes be caused by medicines (so-called anticholinergic agents) that affect nerve function to treat certain conditions.
• if the patient has or has had problems with alcohol or drug abuse.

If the patient is admitted to hospital, it is important to inform the medical staff that the patient is taking Ketilept.
Contact the doctor immediately if any of the following symptoms occur:

• Fever, muscle stiffness, sweating, or reduced level of consciousness (a condition called neuroleptic malignant syndrome). Immediate medical help may be needed.
• Involuntary movements, especially of the face or tongue.
• Dizziness, feeling very sleepy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures.
• Prolonged and painful erection (priapism).
• Fast or irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained tiredness. 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 in this therapeutic class.
Contact the doctor as soon as possible if:

• Fever, flu-like symptoms, sore throat, or any other infection occur, as these may be signs of very low white blood cell count, which may require stopping Ketilept and/or appropriate treatment.
• Constipation with persistent abdominal pain or constipation unresponsive to treatment, as this may lead to more serious intestinal obstruction.

Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks or sometimes longer to take effect. These thoughts may also worsen if treatment is suddenly stopped.
The risk of suicidal thoughts, thoughts of self-harm, or suicide attempts is higher if:

• the patient has previously had suicidal thoughts or self-harm,
• the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask family or friends to inform them if they notice worsening depression or concerning changes in behaviour.
Severe cutaneous adverse reactions (SCARs)
Very rarely, severe cutaneous adverse reactions (SCARs) have been reported during treatment with quetiapine, which may be life-threatening or lead to death. These usually present as:

• Stevens-Johnson syndrome (SJS), widespread blistering rash and peeling skin, particularly around the mouth, nose, eyes, and genitals,
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin detachment,
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzyme activity),
• Acute Generalized Exanthematous Pustulosis (AGEP), small pustules filled with pus,
• Erythema Multiforme (EM), skin rash with itchy-red irregular patches.

If any of these symptoms occur, stop taking Ketilept immediately and contact a doctor or seek medical help without delay.
Weight gain
Weight gain has been observed in patients taking Ketilept. Body weight should be monitored regularly by the patient or together with the doctor.
Children and adolescents
Ketilept is not recommended for use in children and adolescents under 18 years of age.
Ketilept and other medicines
Inform the doctor about all medicines currently taken, recently taken, or planned to be taken.
Do not take Ketilept if the patient is taking:

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

In particular, inform the doctor if the patient is taking:

• antiepileptic medicines (such as phenytoin or carbamazepine),
• antidepressants. These medicines may interact with Ketilept and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact the doctor,
• antihypertensive medicines,
• barbiturates (medicines used for sleep disorders),
• thioridazine or lithium (another antipsychotic medicine),
• medicines that affect heart rhythm, for example, medicines that disturb electrolyte balance (low potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (medicines used in infections),
• medicines that may cause constipation,
• medicines (so-called anticholinergic agents) that affect nerve function to treat certain conditions.

Do not stop taking any of these medicines without first talking to the doctor.
Taking Ketilept with food, drink and alcohol
Ketilept may be taken with or without food.
Exercise caution when consuming alcoholic beverages. Inform the doctor before taking Ketilept if the patient regularly drinks alcohol. Taking Ketilept together with alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Ketilept. It may affect how the medicine works.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Do not use Ketilept during pregnancy unless discussed with a doctor.
Do not use Ketilept during breastfeeding.
Newborns whose mothers took Ketilept during the third trimester (last 3 months of pregnancy) may experience withdrawal symptoms such as tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact the doctor.
Driving and operating machinery
Ketilept may cause drowsiness. Do not drive or operate machinery until the patient knows how the medicine affects them.
Ketilept contains lactose and sodium
In case of lactose intolerance, consider that each coated tablet of Ketilept 25 mg, 100 mg, 200 mg and 300 mg contains respectively: 4.42 mg, 17.05 mg, 34.1 mg and 50.94 mg of lactose.
If the doctor has informed the patient of an intolerance to certain sugars, the patient should consult the doctor before taking this medicinal product.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
Effect on urine drug screening tests
In patients undergoing urine drug screening tests, taking Ketilept may cause false positive results for methadone or certain antidepressants known as tricyclic antidepressants, when using certain testing methods, even if the patient is not taking methadone or tricyclic antidepressants. In such cases, a different, more specific test can be performed.

3. How to use Ketilept

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Your doctor will determine the initial dose, which may be gradually increased. Different dosing
regimens exist depending on the indication.
The maintenance dose (daily dose) depends on the disease and individual patient needs and is
usually between 150 mg and 800 mg per day.

• This medicine should be taken once daily before bedtime or twice daily, depending on the 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 Ketilept. It may affect how the medicine works.
• Even if the patient feels better, do not stop taking this medicine unless instructed by the doctor.

Patients with hepatic impairment
The doctor may recommend adjusting the dose of Ketilept in patients with impaired liver function.
Elderly patients
The doctor may recommend adjusting the dose of Ketilept in elderly patients.
Use in children and adolescents
Ketilept should not be used in children and adolescents under 18 years of age.
Taking more Ketilept than prescribed
If an overdose of Ketilept is taken, the patient may experience drowsiness, dizziness, or irregular heartbeat.
Seek immediate medical advice or go to the nearest hospital. Take the medicine pack with you.
Missed dose of Ketilept
If the patient forgets to take a dose, it should be taken as soon as possible. If it is almost time for the
next dose, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Ketilept
Do not stop taking the tablets without consulting your doctor. If Ketilept is stopped suddenly,
difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, or irritability may occur.
Your doctor may advise gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Very common (may affect more than 1 in 10 people):

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (may diminish with continued use of Ketilept) (may lead to falls).
• Withdrawal symptoms (symptoms which may occur after stopping Ketilept), including difficulty falling asleep (insomnia), nausea, headaches, diarrhoea, vomiting, dizziness or irritability and weight gain. Gradual discontinuation of the medicine over 1–2 weeks is recommended.
• Increase in body weight.
• Abnormal muscle movements. These include, among others, difficulty initiating muscle movements, tremors, motor restlessness or painless muscle stiffness.
• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• Increased heart rate.
• Palpitations, rapid heartbeat or sensation of missed heartbeats.
• Constipation, indigestion.
• Weakness.
• Swelling of hands or feet.
• Low blood pressure upon standing. This may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Strange dreams and nightmares.
• Increased feeling of hunger.
• Feeling of irritability.
• Speech and language disturbances.
• Suicidal thoughts and worsening of depression. Seek immediate medical attention or go to hospital!
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in blood.
• Decreased number of certain types of blood cells.
• Increased liver enzyme activity in blood.
• Increased levels of prolactin hormone in blood. Elevated prolactin levels may, in rare cases, lead to the following symptoms:
  • Breast enlargement and unexpected milk production in both men and women.
  • Absence of menstruation or irregular periods in women.

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

• Seizures.
• Hypersensitivity reactions, including skin nodules and blisters, skin swelling and swelling around the mouth.
• Unpleasant sensations in the lower limbs (so-called restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of facial muscles or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in electrical activity of the heart observed 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.
• Decreased sodium levels in blood.
• Worsening of existing diabetes.
• Disorientation.

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

• Simultaneous occurrence of symptoms such as high temperature (fever), sweating, muscle stiffness, intense drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Blood clots, particularly in the lower limbs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If any of these symptoms occur, consult a doctor immediately.
• Walking, talking, eating or performing other activities during sleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called “metabolic syndrome”) in which 3 or more of the following symptoms may coexist: increased abdominal fat, decreased levels of “good cholesterol” (HDL), increased levels of a fat called triglycerides, high blood pressure and increased blood sugar levels.
• Coexistence of fever, flu-like symptoms, sore throat or other infection with a very low number of white blood cells, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased levels of creatine phosphokinase (a substance derived from muscles) in 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 may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, mouth or throat (angioedema).
• Severe skin disease involving the mouth, eyes and genital organs, with blister formation (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of the hormone regulating urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

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

• Heart muscle disorders (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Skin rash with irregular red spots (erythema multiforme). See section 2.
• Sudden appearance of red skin areas with small pustules (small blisters filled with whitish-yellow fluid called acute generalized exanthematous pustulosis (AGEP)). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blister formation on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzyme activity). See section 2.
• Inflammation of blood vessels (vasculitis), often with skin rash presenting as small red or purple nodules.
• Withdrawal symptoms in newborns of mothers who used Ketilept during pregnancy.
• Stroke.

Medicines in the group to which Ketilept belongs may disturb heart rhythm, which can be a serious condition and, in rare cases, may even lead to death.

Some adverse effects are detectable only through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in levels of thyroid hormones in blood, increased liver enzyme activity, decreased number of certain types of blood cells, decreased number of red blood cells, increased levels of creatine phosphokinase (a substance derived from muscles) in blood, decreased sodium levels in blood and increased levels of prolactin hormone in blood. Increased prolactin levels may, in rare cases, lead to the following symptoms:

• Breast enlargement and unexpected milk production in both women and men.
• Absence or irregular menstruation in women.

Your doctor may recommend regular monitoring tests.

Additional adverse effects in children and adolescents

The same adverse effects as in adults may also occur in children and adolescents. The following adverse effects have been observed more frequently in children and adolescents or did not occur in adults:

Very common (may affect more than 1 in 10 people):

• Increased levels of a hormone called prolactin in blood. In rare cases, this may cause:
  • Breast enlargement and unexpected milk production in boys and girls.
  • Absence or irregular menstruation in girls.
• Increased appetite.
• Vomiting.
• Unusual muscle movements, including difficulty initiating movement, tremors, restless legs syndrome and painless muscle stiffness.
• Increased blood pressure.

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

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

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ketilept

Store below 25°C.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Ketilept contains
The active substance is quetiapine hemifumarate. Each 25 mg, 100 mg, 200 mg and 300 mg film-coated tablet contains 28.78 mg, 115.13 mg, 230.26 mg and 345.4 mg of quetiapine hemifumarate, respectively.
Other ingredients are:
Ketilept 25 mg, film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium carboxymethylstarch (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, polyethylene glycol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).
Ketilept 100 mg, film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium carboxymethylstarch (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, polyethylene glycol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).
Ketilept 200 mg, film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium carboxymethylstarch (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, polyethylene glycol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).
Opadry II 33G24283 Pink (iron oxide yellow (E172), iron oxide red (E172), triacetin, polyethylene glycol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).
Ketilept 300 mg, film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium carboxymethylstarch (type A), lactose monohydrate, microcrystalline cellulose
Coating: Opadry II 33G28523 White (triacetin, polyethylene glycol 3350, lactose monohydrate, titanium dioxide (E171), hypromellose).

What Ketilept looks like and contents of the pack
Ketilept 25 mg, film-coated tablets: white or almost white, odourless or nearly odourless, round, biconvex film-coated tablets engraved with the code "201" on one side and a stylized letter "E" on the other.
Ketilept 100 mg, film-coated tablets: white or almost white, odourless or nearly odourless, round, biconvex film-coated tablets engraved with the code "E202" on one side.
Ketilept 200 mg, film-coated tablets: pink, odourless or nearly odourless, round, biconvex film-coated tablets engraved with the code "E204" on one side.
Ketilept 300 mg, film-coated tablets: white or almost white, odourless or nearly odourless, round, biconvex film-coated tablets engraved with the code "E205" on one side.

Packaging:
30, 50, 60, 70, 80, 90 or 100 film-coated tablets in colourless, transparent PVC/PVDC/Aluminium blisters, placed in a cardboard carton.

Marketing Authorisation Holder
PROTERAPIA Spółka z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Poland

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Hungary: Ketilept 25/100/150/200/300 mg filmtabletta
Czech Republic: Ketilept
Lithuania: Ketilept 25/100/150/200/300 mg plévele dengtos tabletés
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