Ketilept retard

Package leaflet: 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
Quetiapinum
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Ketilept Retard is and what it is 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 pack and other information

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

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

• Bipolar affective disorder and major depressive episodes associated with major depressive disorder, when the patient experiences profound sadness or despair, feelings of guilt, lack of energy and appetite, or difficulty falling asleep.
• Mania, when the patient may be highly stimulated, excited, euphoric, excessively active, or have impaired critical judgment, including aggressive behavior or destructive actions.
• Schizophrenia, when the patient hears or senses non-existent voices or things, is excessively suspicious, feels anxiety, restlessness, disorientation, guilt, tension, or depression.

In the treatment of major depressive episodes associated with major depressive disorder, Ketilept Retard will be used in combination with another medicine.
Your doctor may recommend continuing treatment with Ketilept Retard even if your condition improves.

2. Important information before using Ketilept Retard

When not to use Ketilept Retard

• 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 any of the following medicines:
• certain medicines used to treat HIV infection,
• azole antifungals (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

If any of the above situations apply, do not take Ketilept Retard. If in doubt, consult a doctor or pharmacist before taking Ketilept Retard.

Warnings and precautions

Before starting Ketilept Retard, discuss with your doctor or pharmacist:

• if the patient has or has had heart problems, such as irregular heartbeat, weakened heart function, or myocarditis, either personally or in their family, or if the patient is taking medicines that may cause changes in 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 function disorders,
• if the patient has ever had a seizure (epilepsy),
• if the patient has diabetes or an increased risk of developing diabetes. In such cases, the doctor may recommend glucose monitoring during treatment with Ketilept Retard,
• if the patient has pancreatitis or risk factors for pancreatitis, such as gallstones or high levels of triglycerides (a type of fat) in the blood,
• if the patient has depression or other conditions treated with antidepressants. Taking these medicines together with Ketilept Retard may lead to serotonin syndrome, a potentially life-threatening condition (see "Ketilept Retard and other medicines"),
• if the patient has ever had a low white blood cell count (regardless of whether it was caused by other medicines or not),
• if the patient is elderly and has dementia (impaired brain function). In such cases, Ketilept Retard should not be used, as medicines in the class to which Ketilept Retard 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 a family member has had or has blood clots, as medicines in this class may increase the risk of clot formation,
• if the patient has or has had breathing problems involving 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 had difficulty completely emptying the bladder (urinary retention), 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.

Immediately inform the doctor if the following symptoms occur after taking Ketilept Retard:

• Fever, muscle stiffness, excessive sweating, or altered consciousness (a condition called neuroleptic malignant syndrome). Immediate medical help may be required.
• Involuntary movements, especially of the facial muscles or tongue.
• Dizziness, feeling of extreme drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures.
• Prolonged and 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 in this therapeutic class. Inform the doctor as soon as possible if any of the following occur:

• Fever, flu-like symptoms, sore throat, or other signs of infection, as these 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 unresponsive to treatment, as this may lead to severe intestinal obstruction.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to take effect.
Such thoughts may also worsen if treatment is suddenly stopped.
The likelihood of such thoughts may be higher in young adults. Clinical trial data indicate an increased risk of suicidal thoughts and/or behaviors in young adults under 25 years of age with depression.
If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact a doctor immediately or go directly to a 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 them to inform them if they notice worsening depression or concerning changes in behavior.

Serious skin reactions (SCAR)

Very rarely, serious skin reactions (SCAR), which may be life-threatening or lead to death, have been reported during treatment with quetiapine. These usually present as:

• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling,
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, lymph node swelling, 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), a skin rash with itchy-red, irregular patches.
  If any of these symptoms occur, stop taking Ketilept Retard and contact a doctor or seek medical help immediately.

Weight gain

Weight gain has been observed in patients taking Ketilept Retard. Body weight should be monitored regularly, either by the patient or together with the 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

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Ketilept Retard if the patient is taking:

• certain medicines used to treat HIV infection,
• azole antifungals (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat 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 Retard and may 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 to treat 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 your doctor.

Taking Ketilept Retard with food, drink and alcohol

• Food may interfere with the action of the medicine; therefore, Ketilept Retard should be taken at least one hour before a meal or immediately before bedtime.
• Be cautious with the amount of alcohol consumed. Taking Ketilept Retard together with alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Ketilept Retard. This 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 have a baby, she should consult a doctor or pharmacist before taking this medicine.
Do not take Ketilept Retard during pregnancy unless discussed with a doctor.
Do not take Ketilept Retard while breastfeeding.
Newborns of mothers who took Ketilept Retard during the third trimester of pregnancy (last 3 months) may experience withdrawal symptoms such as tremor, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the baby, medical advice may be needed.

Driving and operating machinery

Ketilept Retard may cause drowsiness. Do not drive or operate machinery until the patient knows how the medicine affects them.

Effect on drug screening tests in urine

In patients undergoing urine drug screening tests, taking Ketilept Retard may cause false-positive results for methadone or certain antidepressants (tricyclic antidepressants) when tested by certain methods, even if the patient is not taking methadone or tricyclic antidepressants. In such cases, a different, more specific test can be performed.

Ketilept Retard contains lactose

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

3. How to use Ketilept Retard

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.

The treating doctor will determine the initial dose. The usual daily dose of Ketilept Retard
typically ranges from 150 mg to 800 mg, depending on the patient's symptoms and needs.

• The medicine should be taken once daily.
• Tablets must not be divided, chewed, or crushed.
• Tablets should be swallowed whole with water.
• Tablets should be taken on an empty stomach (at least one hour before a meal or in the evening, as directed by the doctor).
• Grapefruit juice must not be consumed during treatment with Ketilept Retard, as it may affect the medicine's action.
• Even if the patient feels better, the medicine should not be discontinued unless advised by the doctor.

Liver function disorders
The doctor may recommend adjusting the dose in patients with impaired liver function.
Elderly patients
The doctor may recommend adjusting the dose in elderly patients.
Use in children and adolescents
Ketilept Retard must not be used in children and adolescents under 18 years of age.
Taking more Ketilept Retard than prescribed
If a higher than prescribed dose of Ketilept Retard is taken, the patient may experience drowsiness, dizziness, or irregular heartbeat. Immediate contact with a doctor or admission to the nearest hospital is required. Bring the Ketilept Retard tablets along.
Missed dose of Ketilept Retard
If a dose is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped and the next dose taken at the usual time. A double dose must not be taken to make up for a missed dose.
Stopping Ketilept Retard
If treatment with Ketilept Retard 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.
If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

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

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may diminish during continued treatment with Ketilept Retard) (may lead to falls).
• Withdrawal symptoms (symptoms that may occur after stopping Ketilept Retard), including difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation over a period of 1–2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include, among others, difficulty initiating movement, tremor, motor restlessness or painless muscle stiffness.
• Changes in blood levels of certain lipids (e.g. triglycerides and total cholesterol).

Common (may occur in 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 glucose levels.
• Blurred vision.
• Strange dreams and nightmares.
• Increased feeling of hunger.
• Feeling of irritability.
• Speech and articulation disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in blood levels of thyroid hormones.
• Decreased number of certain types of blood cells.
• Increased liver enzyme activity in blood.
• Increased blood levels of the hormone prolactin, which may rarely cause:
  • Breast enlargement and unexpected milk production in both men and women.
  • Absence of menstruation or irregular menstruation in women.

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

• Seizures.
• Hypersensitivity reactions, including skin nodules and blisters, swelling of the skin and area 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 the heart's electrical activity 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 blood sodium levels.
• Worsening of pre-existing diabetes.
• Disorientation.

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

• Concurrent occurrence of symptoms such as high body temperature (fever), excessive sweating, muscle stiffness, pronounced drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis (liver inflammation).
• Prolonged and painful penile erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorders.
• Blood clots in veins, particularly in the legs (symptoms include swelling, pain and redness of the leg), 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 (inflammation of the pancreas).
• 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 triglycerides, high blood pressure and increased blood glucose levels.
• Concurrent occurrence of fever, flu-like symptoms, sore throat or other infection with very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased blood levels of creatine phosphokinase (a substance derived from muscles).

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

• Severe rash, blisters, red spots on the skin.
• Severe hypersensitivity reaction (anaphylactic), which may cause breathing difficulties or shock.
• Rapid swelling of the skin, usually around the eyes, mouth or throat (angioedema).
• Severe condition with blister formation on the skin, inside the mouth, eyes and genital organs (Stevens-Johnson syndrome) (see section 2).
• Abnormal secretion of the hormone regulating urine volume.
• Muscle fibre breakdown and muscle pain (rhabdomyolysis).

Unknown frequency (cannot be estimated from available data):

• Disorders of the heart muscle (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Sudden appearance of red skin areas with small pustules (small blisters filled with whitish-yellow fluid) known as acute generalized exanthematous pustulosis (AGEP). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever, blistering of 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 quetiapine during pregnancy.
• Stroke.

Medicines of the class to which Ketilept Retard belongs may cause disturbances in heart function, which may be markedly intensified and, in severe cases, may result in death.

Some adverse effects are only observed in blood test results. These include changes in blood levels of certain lipids (triglycerides and total cholesterol) or blood glucose, changes in blood levels of thyroid hormones, increased liver enzyme activity, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase activity (a substance derived from muscles) in blood, decreased blood sodium levels and increased blood levels of the hormone prolactin. Increased prolactin levels may rarely 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 periodic 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 than in adults:

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

• Increased blood levels of the hormone called prolactin. In rare cases, this may cause:
  • breast enlargement and unexpected milk production in both boys and girls
  • absence or irregular menstruation in girls
• Increased appetite
• Vomiting
• Abnormal muscle movements, including difficulty initiating movement, tremor, restless legs syndrome and painless muscle stiffness
• Increased blood pressure

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

• Feeling of weakness, fainting (may cause falls)
• Feeling of nasal congestion
• Feeling of irritability

Reporting of adverse effects

If any adverse effects occur, including any 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 49 21 301, fax: +48 22 49 21 309, 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 Retard

Keep this 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.
No special storage conditions are required for Ketilept Retard.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ketilept Retard contains
The active substance is quetiapine. Ketilept Retard prolonged-release tablets contain
50 mg, 150 mg, 200 mg, 300 mg, and 400 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core: anhydrous lactose, methacrylic acid and ethyl acrylate copolymer (1:1), type A,
crystalline maltose, magnesium stearate, talc.
Tablet coating: methacrylic acid and 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 thickness of 3.2 mm, embossed with "50" on one side.
Ketilept Retard 150 mg prolonged-release tablets: white or almost white, oblong, biconvex tablets, 13.6 mm in length, 6.6 mm in width, and 4.2 mm thick, embossed with "150" on one side.
Ketilept Retard 200 mg prolonged-release tablets: white or almost white, oblong, biconvex tablets, 15.2 mm in length, 7.7 mm in width, and 4.8 mm thick, embossed with "200" on one side.
Ketilept Retard 300 mg prolonged-release tablets: white or almost white, oblong, biconvex tablets, 18.2 mm in length, 8.2 mm in width, and 5.4 mm thick, embossed with "300" on one side.
Ketilept Retard 400 mg prolonged-release tablets: white or almost white, oval, biconvex tablets, 20.7 mm in length, 10.2 mm in width, and 6.3 mm thick, embossed with "400" on one side.
Ketilept Retard prolonged-release tablets are available in PVC/PCTFE/Aluminum blisters packed in cardboard boxes.
Pack sizes: 30, 50, 60, and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
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 authorised in the European Economic Area under the following names:
Czech Republic: Ketilept Prolong
Hungary: Ketilept Prolong
Poland: Ketilept Retard
Slovakia: Ketilept Prolong