Ketrel xr

Patient Information Leaflet

KETREL XR, 150 mg, prolonged-release tablets
Quetiapinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What KETREL XR is and what it is used for

The active substance in KETREL XR is quetiapine, which belongs to a group of medicines called antipsychotics. KETREL XR may be used in the treatment of the following conditions:

• Schizophrenia: the patient may hear or feel things that do not exist, believe things that are not true, or experience unusual suspiciousness, anxiety, confusion, feelings of guilt, tension, and depression.
• Mania: the patient may be highly excited, elated, overactive, overly enthusiastic, have impaired judgment, and may become aggressive or display destructive behaviors.
• Bipolar disorder and major depressive episodes in the course of severe depressive disorders: the patient experiences sadness. The patient may feel depressed, guilty, lack energy and appetite, and have difficulty sleeping.

When KETREL XR is used in the treatment of major depressive episodes in the course of severe depressive disorders, it is used as an add-on to another medicine prescribed for this condition. Your doctor may decide to continue treatment with KETREL XR even if you are feeling better.

2. Important information before using KETREL XR

When not to use KETREL XR:

• if the patient is allergic (hypersensitive) 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,
• azoles (antifungal medicines),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

If any of the situations listed above apply to the patient, KETREL XR must not be used. If in doubt, consult a doctor or pharmacist before using KETREL XR.

Warnings and precautions
Before starting treatment with KETREL XR, consult a doctor, pharmacist, or nurse:

• 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 elderly;
• if the patient has liver problems;
• if the patient has ever had seizures (fits);
• if the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may recommend regular blood sugar tests during treatment with KETREL XR;
• if the patient has ever had a low white blood cell count (which may or may not have been caused by other medicines);
• if the patient is an elderly person with dementia (loss of brain function). In such cases, KETREL XR should not be used, as the class of medicines to which it belongs may increase the risk of stroke or, in some cases, risk of death in elderly patients with dementia;
• if the patient is an elderly person with Parkinson's disease/parkinsonism;
• if the patient or someone in their family has had venous thrombosis (blood clots), as treatment with medicines such as this one has been associated with blood clot formation;
• if the patient has or has had a condition involving brief interruptions in breathing during normal sleep at night (so-called sleep apnoea) and is taking medicines that slow down brain function ("depressants");
• if the patient has or has had difficulty completely emptying the bladder (urinary retention), benign prostatic hyperplasia, intestinal obstruction, or increased intraocular pressure. These symptoms may sometimes be caused by medicines (so-called anticholinergic medicines) used to treat certain conditions and which affect nerve cell function;
• if the patient has or has had problems with alcohol or drug abuse.

Immediately inform the doctor if the patient experiences any of the following symptoms after taking KETREL XR:

• Fever, severe muscle stiffness, sweating, or reduced level of consciousness (a condition called neuroleptic malignant syndrome). Immediate medical help may be required.
• Uncontrolled movements, mainly of the face or tongue.
• Dizziness or 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.

These symptoms may be related to taking this type of medicine.
Inform the doctor as soon as possible if any of the following occur:

• Fever, flu-like symptoms, sore throat, or any other infection, as these may be signs of a very low white blood cell count, which may require discontinuation of KETREL XR 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
Patients with depression may sometimes have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment, as these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may also increase if treatment is suddenly stopped. The likelihood of such thoughts is higher in young adults. Data from clinical trials indicate an increased risk of suicidal thoughts and/or suicidal behaviour in young adults under 25 years of age with depression.
If the patient experiences thoughts of self-harm or suicide, seek immediate medical help or go to hospital. It may be helpful to inform friends and family about the depression and its symptoms, and ask them to read this leaflet and inform you if they think the depression has worsened or if there are worrying changes in the patient's behaviour.

Severe cutaneous adverse reactions (SCAR)
Very rarely, severe skin adverse reactions (SCAR), which may be life-threatening or lead to death, have been reported during treatment with this medicine. Symptoms of these reactions include:

• Stevens-Johnson syndrome (SJS), widespread blistering rash and peeling skin, particularly around the mouth, nose, eyes, and genital areas;
• Toxic epidermal necrolysis (TEN), a more severe form of rash causing extensive skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS), flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzyme activity).

If any of these symptoms occur, stop taking KETREL XR immediately and contact a doctor without delay.

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

Children and adolescents
KETREL XR is not intended for use in children and adolescents under 18 years of age.

KETREL XR and other medicines
Tell the 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 KETREL XR if the patient is taking any of the following medicines:

• certain medicines used to treat HIV,
• azoles (antifungal medicines),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

Tell the doctor if the patient is taking any of the following medicines:

• medicines used to treat epilepsy (e.g. phenytoin or carbamazepine),
• medicines used to treat high blood pressure,
• barbiturates (used for sleep disorders),
• thioridazine or lithium (other antipsychotic medicines),
• medicines that affect heart function, for example medicines that may cause electrolyte imbalance (low potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (medicines used to treat infections),
• medicines that may cause constipation,
• medicines used to treat certain conditions that affect nerve cell function (so-called anticholinergic medicines).

Do not stop taking any of the medicines being used without first talking to the doctor.

KETREL XR with food, drink and alcohol

• Food may affect KETREL XR, so the medicine should be taken at least one hour before a meal or before bedtime.
• Be cautious with alcohol consumption, as the combined effect of KETREL XR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking KETREL XR. This may affect how the medicine works.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Do not use KETREL XR during pregnancy unless discussed with the doctor. Do not use KETREL XR during breastfeeding.

Newborns whose mothers have taken quetiapine during the third trimester of pregnancy (last 3 months of pregnancy) may experience the following withdrawal symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms are observed in the newborn, consult a doctor.

Driving and operating machinery
This medicine may cause drowsiness. Do not drive or operate machinery until the patient knows how the medicine affects them.

KETREL XR contains lactose
KETREL XR contains lactose, which is a type of sugar. If the patient has been told by a doctor that they have an intolerance to certain sugars, consult the doctor before taking this medicine.

KETREL XR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the product is considered "sodium-free".

Effect on urine drug screening tests
In patients undergoing urine drug screening tests, taking KETREL XR may lead to false-positive results for methadone or certain antidepressants called tricyclic antidepressants, when certain testing methods are used, even if the patient is not taking methadone or tricyclic antidepressants. In such cases, a different, more accurate test can be performed.

3. How to take KETREL XR

This medicine should always be taken as instructed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The doctor will decide the initial dose. The maintenance dose (daily dose) depends on the
condition and individual needs of the patient, but usually ranges from 150 mg to 800 mg.

• Take tablets once daily.
• Do not divide, chew or crush the tablets.
• Swallow tablets whole with water.
• Take tablets on an empty stomach (at least one hour before a meal or before bedtime; the doctor will inform the patient accordingly).
• Do not consume grapefruit juice during treatment with KETREL XR. Grapefruit juice may affect how this medicine works.
• Do not stop treatment without consulting your doctor, even if you feel better.

Liver function disorders
The doctor may adjust the dose of the medicine if the patient has liver function disorders.
Elderly patients
The doctor may adjust the dose of the medicine in elderly patients.
Use in children and adolescents
KETREL XR must not be used in children and adolescents under 18 years of age.
Taking more KETREL XR than prescribed
If a patient takes more than the prescribed dose of KETREL XR, they may experience drowsiness, dizziness and heart rhythm disturbances. Seek immediate medical advice or go to the nearest hospital. Bring the KETREL XR medicine with you.
Missed dose of KETREL XR
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, take the medicine at the usual time. Do not take a double dose to make up for a missed dose.
Stopping KETREL XR
If KETREL XR is stopped abruptly, problems such as difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness and irritability may occur.
The doctor may recommend 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 reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Somnolence (may diminish during continued use of quetiapine) (may lead to falls).
• Withdrawal symptoms (symptoms which may occur after stopping quetiapine), including difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation of the medicine over a period of 1–2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements, including difficulty initiating movement, tremors, restlessness or muscle stiffness without pain.
• Changes in levels of certain lipids (triglycerides and total cholesterol).

Common (may occur in 1 in 10 people):

• Fast heartbeat.
• Palpitations, rapid heartbeat or sensation of missed heartbeats.
• Constipation, indigestion (dyspepsia).
• Feeling of weakness.
• Swelling of hands or feet.
• Low blood pressure upon standing. This may cause dizziness or fainting (which may lead to falls).
• Increased blood glucose levels.
• Blurred vision.
• Unusual dreams and nightmares.
• Increased feeling of hunger.
• Feeling irritable.
• Speech disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Change in thyroid hormone levels in blood.
• Decrease in number of certain types of blood cells.
• Increased liver enzyme activity in blood.
• Increased prolactin levels in blood. Elevated prolactin levels may rarely lead to:
• Breast enlargement and unexpected milk production (in both men and women),
• Absence of menstruation or irregular menstruation (in women).

Uncommon (may occur in 1 in 100 people):

• Seizures.
• Allergic reactions, which may include skin rashes (blisters), skin swelling and swelling around the mouth.
• Unpleasant sensations in the legs (called restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in electrical activity of the heart seen on ECG (prolongation of QT interval).
• Slowing of heart rate at the beginning of treatment, which may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Nasal congestion.
• Decrease in number of red blood cells.
• Decreased sodium levels in blood.
• Worsening of pre-existing diabetes.

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

• Convulsions.
• Syndrome of symptoms: high temperature (fever), sweating, muscle stiffness, feeling very sleepy or fainting (a disorder called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorders.
• Blood clots in veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If any of these symptoms occur, seek medical help immediately.
• Walking, talking, eating or performing other activities during sleep.
• Low body temperature (hypothermia).
• Pancreatitis.
• A disorder (called "metabolic syndrome") involving a combination of three or more of the following: increased abdominal fat, decreased levels of "good cholesterol" (HDL-C), increased blood triglyceride levels (a type of fat), high blood pressure and increased blood glucose levels.
• Combination of fever, flu-like symptoms, sore throat or other infection with very low white blood cell count (so-called agranulocytosis).
• Intestinal obstruction.
• Increased creatine kinase activity in blood (a substance derived from muscles).

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

• Severe rash, blisters or red spots on the skin.
• Severe allergic reaction (called anaphylaxis), which may cause breathing difficulties or shock.
• Sudden swelling of the skin, usually around the eyes, lips and throat (angioedema).
• Serious blistering disease affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone regulating urine volume.
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Frequency not known (cannot be estimated from available data):

• Skin rash with irregular red patches (erythema multiforme).
• Severe, sudden allergic reaction with symptoms such as fever, skin blisters and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including symptoms such as: flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzyme activity). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who used KETREL XR during pregnancy.
• Stroke.
• Heart muscle disorders (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of blood vessels (vasculitis), often with a skin rash consisting of small red or purple nodules.

The group of medicines to which KETREL XR belongs may cause heart rhythm disturbances, which may be serious and, in severe cases, even fatal.

Some adverse reactions are detectable only through blood tests. These include: increased levels of certain lipids (triglycerides and total cholesterol) or blood glucose, changes in thyroid hormone levels in blood, increased liver enzyme activity, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine kinase activity in blood (a substance present in muscles), decreased sodium levels in blood, and increased prolactin levels in blood. Elevated prolactin levels may rarely lead to:

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

Your doctor may recommend periodic blood tests.

Additional adverse reactions in children and adolescents

The same adverse reactions as in adults may also occur in children and adolescents.

The following adverse reactions have been observed more frequently in children and adolescents, or were not observed in adults:

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

• Increased prolactin (hormone) levels in blood. Elevated prolactin levels may rarely lead to:
• Breast enlargement and unexpected milk production (in boys and girls),
• Absence of menstruation or irregular menstruation (in girls).
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include: difficulty initiating movement, tremors, restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common (may occur in 1 in 10 people):

• Weakness, fainting (may lead to falls).
• Nasal congestion.
• Feeling irritable.

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor, pharmacist or nurse. Adverse reactions 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

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store KETREL XR

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label, carton, blister, or bottle after: EXP. The expiry date refers to the last day of the stated month.
• Bottle: use within 100 days after first opening.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
• No special storage conditions apply.

6. Contents of the pack and other information

What KETREL XR contains

• The active substance is quetiapine. Each tablet contains 150 mg of quetiapine (as quetiapine fumarate).
• Other ingredients are:
  Tablet core: Lactose monohydrate, hypromellose 3550, hypromellose 100, sodium chloride, povidone K-30, microcrystalline cellulose, talc, and magnesium stearate.
  Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What KETREL XR looks like and contents of the pack
KETREL XR 150 mg: white or almost white, capsule-shaped, biconvex film-coated tablets with the imprint "AB2" on one side and smooth on the other. The tablet is approximately 17.4 mm in length and 6.7 mm in width.
Pack sizes of 10, 30, 50, 60, and 100 tablets in white opaque blisters of PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum.
Pack sizes of 60 and 100 tablets in HDPE bottles with PP closure and child-resistant safety cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Celon Pharma S.A.
ul. Ogrodowa 2A, Kiełpin
05-092 Łomianki
Poland

Manufacturer/Importer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, HA1 4HF Middlesex
United Kingdom
Wessling Hungary Kft.
Fóti út 56
1047 Budapest
Hungary
GAP SA
46, Agissilaou str., Agios Dimitrios
17341 Athens
Greece
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland
Accord UK Limited
Whiddon Valley
Barnstaple; Devon EX32 8NS
United Kingdom
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names: