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

Quetiapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Ketilept Retard is and what it is used for
• 2. What you need to know before you take 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. This belongs to a group of medicines called antipsychotics. Ketilept Retard can be used to treat several illnesses, such as:

• Bipolar depression and major depressive episodes in major depressive disorder, when you have feelings of sadness, or you feel empty, or you lose interest in things around you, and you have the following symptoms: you feel hopeless, you feel guilty, you lose your appetite or can't sleep, you feel tired, you have difficulty concentrating, or you think about death or suicide.
• Mania, where you may feel very excited, agitated, or irritable, or have little need for sleep, or have a lot of energy, or have a lot of ideas, or have trouble concentrating.
• Schizophrenia, where you may hear or see things that are not there, or believe things that are not true, or feel unusually suspicious, or feel unusually anxious, or feel that other people are against you, or feel that other people can read your thoughts or control your thoughts.

When Ketilept Retard is used to treat major depressive episodes, it will be used in addition to another medicine.

2. What you need to know before you take Ketilept Retard

Do not take Ketilept Retard

• if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6),
• if you are taking any of the following medicines:
• certain medicines for HIV,
• certain antifungal medicines,
• erythromycin or clarithromycin (medicines used to treat infections),
• nefazodone (a medicine used to treat depression).

If any of the above applies to you, do not take Ketilept Retard. If you are not sure, talk to your doctor or pharmacist before taking Ketilept Retard.

Warnings and precautions

Before you start taking Ketilept Retard, your doctor will ask you about your medical history. Tell your doctor if you have or have had any of the following:

• heart problems, such as heart failure, heart attack, or abnormal heart rhythm,
• low blood pressure,
• stroke or "mini-stroke", especially if you are elderly,
• liver problems,
• seizures (fits),
• diabetes or if you have a risk factor for developing diabetes,
• increased levels of fats (triglycerides and cholesterol) in the blood,
• depression or feelings of suicide,
• thoughts of suicide or self-harm,
• low white blood cell count,
• if you are elderly and have dementia (a loss of mental ability),
• if you have Parkinson's disease or a condition called "parkinsonism",
• if you have a history of blood clots, or if you have a family history of blood clots,
• if you have a history of breathing problems during sleep (sleep apnea),
• if you have a history of urinary retention (difficulty passing urine), or an enlarged prostate, or narrowing of the intestine, or increased pressure in the eye.

Special warnings about possible serious side effects

Very rarely, the following serious side effects have been reported:

• Fever, stiff muscles, feeling confused, or changes in mental state, with a rapid heart rate and sweating (a condition called neuroleptic malignant syndrome). You may need urgent medical treatment.
• Unusual movements of the tongue, mouth, and face (tardive dyskinesia),
• Seizures (fits),
• Long-lasting and painful erection (priapism),
• Irregular heart rhythm (including a condition called Torsades de Pointes),

Other possible serious side effects that have been reported with Ketilept Retard include:

• Thoughts of suicide or self-harm,
• Severe allergic reactions (anaphylaxis),
• Swelling of the skin and mucous membranes (angioedema),

Increased risk of stroke or death in elderly people with dementia

There is an increased risk of stroke or death in elderly people who are prescribed antipsychotics, including Ketilept Retard, for the treatment of dementia.

Increased risk of blood clots

There is an increased risk of blood clots in the legs or lungs when antipsychotics, including Ketilept Retard, are used.

Weight gain

Weight gain has been seen in patients taking Ketilept Retard, so your weight should be checked regularly.

Children and adolescents

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

Other medicines and Ketilept Retard

Do not take Ketilept Retard if you are taking any of the following medicines:

• Medicines for HIV,
• Medicines for fungal infections,
• Erythromycin or clarithromycin (medicines used to treat infections),
• Neafazodone (a medicine used to treat depression).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines for epilepsy,
• Medicines for depression,
• Medicines for high blood pressure,
• Barbiturates (medicines for sleep disorders),
• Thioridazine or lithium (other antipsychotic medicines),
• Medicines that affect the heart rhythm (such as certain antibiotics),
• Medicines that can cause constipation,
• Medicines that affect the brain (such as anticholinergic medicines).

Ketilept Retard with food, drink, and alcohol

• Food can affect the way Ketilept Retard works. Take Ketilept Retard at least one hour before a meal or before bedtime.
• Be careful when drinking alcohol while taking Ketilept Retard, as it may make you feel drowsy.
• Do not drink grapefruit juice while taking Ketilept Retard, as it may affect the way the medicine works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ketilept Retard may make you feel drowsy. Do not drive or use any tools or machines until you know how Ketilept Retard affects you.

Tests for other medicines

Ketilept Retard may affect the results of some tests for other medicines. If you are having tests, tell your doctor that you are taking Ketilept Retard.

Ketilept Retard contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ketilept Retard

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• Take Ketilept Retard once a day.
• Do not split, chew, or crush the tablets.
• Swallow the tablets whole with a glass of water.
• Take Ketilept Retard without food (at least one hour before a meal or at bedtime).
• Do not drink grapefruit juice while taking Ketilept Retard.
• Do not stop taking Ketilept Retard unless your doctor tells you to.

Patients with liver problems

Your doctor may need to adjust your dose if you have liver problems.

Elderly patients

Your doctor may need to adjust your dose if you are elderly.

Children and adolescents

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

If you take more Ketilept Retard than you should

If you take more Ketilept Retard than you should, you may feel drowsy, dizzy, or have a fast heart rate. Contact your doctor or go to the nearest hospital immediately.

If you forget to take Ketilept Retard

If you forget to take a dose, take it as soon as you remember. Then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Ketilept Retard

Do not stop taking Ketilept Retard suddenly. If you need to stop, your doctor will gradually reduce your dose over a period of at least one to two weeks.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking the medicine), including difficulty sleeping, nausea, headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may need to gradually reduce your dose over a period of at least one to two weeks.
• Weight gain.
• Abnormal movements of the muscles (extrapyramidal symptoms), including difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Changes in the levels of certain fats (triglycerides and total cholesterol) in the blood.

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

• Fast heart rate.
• Palpitations (feeling like your heart is racing or pounding).
• Constipation.
• Feeling weak.
• Swelling of the hands or feet.
• Low blood pressure when standing up (which may lead to falls).
• High blood sugar.
• Blurred vision.
• Abnormal dreams or nightmares.
• Increased appetite.
• Feeling irritable.
• Speech or language problems.
• Suicidal thoughts or worsening of depression.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased levels of certain types of blood cells.
• Increased levels of liver enzymes in the blood.
• Increased levels of a hormone called prolactin in the blood, which may cause:
• Enlargement of the breasts in men and women, and unexpected production of milk.
• Irregular menstrual periods or absence of menstrual periods in women.

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

• Seizures (fits).
• Allergic reactions, including swelling of the skin and mucous membranes (angioedema),
• Unpleasant feelings in the legs (restless legs syndrome),
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual problems.
• Diabetes.
• Changes in the electrical activity of the heart (prolonged QT interval),
• Slow heart rate, which may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty passing urine.
• Fainting (which may lead to falls).
• Blocked nose.
• Decreased levels of sodium in the blood.
• Worsening of existing diabetes.
• Disorientation.

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

• A severe skin rash, with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• A severe allergic reaction (anaphylaxis), which may cause difficulty breathing or a rapid heart rate.
• A severe skin rash, with blistering of the skin, and peeling of the skin (toxic epidermal necrolysis),
• Abnormal heart rhythm (Torsades de Pointes),
• Severe liver damage (liver failure),
• Long-lasting and painful erection (priapism),
• Enlargement of the breasts in men and women, and unexpected production of milk (galactorrhoea),
• Irregular menstrual periods or absence of menstrual periods in women (amenorrhoea),
• Blood clots in the legs or lungs (thrombosis),
• Walking, talking, eating, or other activities while asleep (somnambulism),
• Low body temperature (hypothermia),
• Inflammation of the pancreas (pancreatitis),
• A condition where you have a combination of three or more of the following: increased fat around the abdomen, high blood sugar, high levels of a type of fat called triglycerides, low levels of "good" cholesterol, and high blood pressure (metabolic syndrome),
• A severe decrease in the number of white blood cells in the blood (agranulocytosis),
• Blockage of the intestine (intestinal obstruction),
• Increased levels of a substance called creatine phosphokinase in the blood, which is a sign of muscle damage.

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

• A severe skin rash, with blistering of the skin, and peeling of the skin (toxic epidermal necrolysis),
• A severe allergic reaction (anaphylaxis), which may cause difficulty breathing or a rapid heart rate.
• A severe skin rash, with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• Abnormal heart rhythm (Torsades de Pointes),
• Severe liver damage (liver failure),
• Long-lasting and painful erection (priapism),
• Enlargement of the breasts in men and women, and unexpected production of milk (galactorrhoea),
• Irregular menstrual periods or absence of menstrual periods in women (amenorrhoea),
• Blood clots in the legs or lungs (thrombosis),
• Walking, talking, eating, or other activities while asleep (somnambulism),
• Low body temperature (hypothermia),
• Inflammation of the pancreas (pancreatitis),
• A condition where you have a combination of three or more of the following: increased fat around the abdomen, high blood sugar, high levels of a type of fat called triglycerides, low levels of "good" cholesterol, and high blood pressure (metabolic syndrome),
• A severe decrease in the number of white blood cells in the blood (agranulocytosis),
• Blockage of the intestine (intestinal obstruction),
• Increased levels of a substance called creatine phosphokinase in the blood, which is a sign of muscle damage.

Not known(frequency cannot be estimated from the available data):

• Heart muscle damage (cardiomyopathy),
• Inflammation of the heart muscle (myocarditis),
• A skin rash with irregular red patches (erythema multiforme),
• A severe skin rash, with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• A severe allergic reaction (anaphylaxis), which may cause difficulty breathing or a rapid heart rate.

Additional side effects in children and adolescents

The same side effects that may occur in adults may also occur in children and adolescents.

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

• Increased levels of a hormone called prolactin in the blood, which may cause:
• Enlargement of the breasts in boys and girls, and unexpected production of milk.
• Irregular menstrual periods or absence of menstrual periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal movements of the muscles (extrapyramidal symptoms), including difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• High blood pressure.

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

• Feeling weak or faint (which may lead to falls).
• Blocked nose.
• Feeling irritable.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Ketilept Retard

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

Ketilept Retard does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ketilept Retard contains

The active substance is quetiapine. Each prolonged-release tablet contains 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

Core: lactose anhydrous, methacrylic acid - ethyl acrylate copolymer (1:1), type A, crystalline maltose, magnesium stearate, talc.

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 "50" engraved on one side.

Ketilept Retard 150 mg prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 13.6 mm, a width of 6.6 mm, and a thickness of 4.2 mm, with "150" engraved on one side.

Ketilept Retard 200 mg prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 15.2 mm, a width of 7.7 mm, and a thickness of 4.8 mm, with "200" engraved on one side.

Ketilept Retard 300 mg prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 18.2 mm, a width of 8.2 mm, and a thickness of 5.4 mm, with "300" engraved on one side.

Ketilept Retard 400 mg prolonged-release tablets: white or almost white, oval, biconvex tablets with a length of 20.7 mm, a width of 10.2 mm, and a thickness of 6.3 mm, with "400" engraved on one side.

Ketilept Retard prolonged-release tablets are available in blisters of PVC/PCTFE/Aluminum, packaged in a cardboard box.

Available pack sizes: 30, 50, 60, and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised 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