Kwexyma

Patient Information Leaflet

Kwexyma, 25 mg/mL, oral suspension
quetiapine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult 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 adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Kwexyma is and what it is used for

Kwexyma contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Kwexyma may be used in the treatment of several conditions, such as:

• Depressive episodes in bipolar disorder: a condition causing the patient to feel sadness, low mood, guilt, lack of energy and appetite, and (or) difficulty in falling asleep.
• Mania: the patient may be highly excited, agitated, and overactive, may have impaired perception of reality, and may display aggressive behavior or cause disturbances.
• Schizophrenia: the patient may hear or sense things that do not exist; believe in things that are not true; or experience unusual suspicion, anxiety, disorientation, guilt, tension, and depression.

Your doctor may advise you to continue taking Kwexyma even if you feel better.

2. Important Information Before Taking Kwexyma

When not to take Kwexyma:

• 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 in fungal infections);
  • erythromycin or clarithromycin (antibiotics used in infections);
  • nefazodone (used to treat depression).

If the patient has any doubts, they should speak to their doctor or pharmacist before
taking Kwexyma.
Warnings and precautions
Before taking Kwexyma, discuss with the doctor or pharmacist:

• if the patient suffers from depression or another condition treated with antidepressant medicines. Using these medicines together with Kwexyma may lead to serotonin syndrome, a potentially life-threatening condition (see "Kwexyma with other medicines");
• if the patient has or has had heart problems, either personally or in their family, 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 a seizure (fits);
• if the patient has diabetes or is at increased risk of developing diabetes. If the patient is at risk, the doctor may order blood glucose monitoring during treatment with Kwexyma;
• if the patient has ever had a low white blood cell count (which may or may not have been related to taking other medicines);
• if the patient is an elderly person with dementia (reduced mental function). Kwexyma should not be used in such patients, as medicines in the class to which Kwexyma belongs may increase the risk of stroke or, in some cases, risk of death in these individuals;
• if the patient is elderly and has Parkinson's disease or parkinsonism;
• if the patient or someone in their family has had blood clots in the past, as medicines like this have been associated with blood clot formation;
• if the patient has or has had episodes of stopped breathing during normal sleep (so-called "sleep apnea") and is taking medicines that slow brain function ("antidepressants");
• if the patient has or has had difficulty passing urine (urinary retention), an enlarged prostate gland, intestinal obstruction, or increased intraocular pressure. These conditions may sometimes be caused by medicines ("anticholinergics") that affect nerve cell function used to treat certain conditions;
• if the patient has previously abused alcohol or psychoactive substances.

The doctor should be informed immediately if any of the following symptoms occur after taking Kwexyma:

• a group of symptoms including fever, muscle stiffness, excessive sweating, reduced level of consciousness (a condition called neuroleptic malignant syndrome). Immediate medical help may be required;
• uncontrolled movements, especially of the face or tongue;
• dizziness or pronounced drowsiness. This may increase the risk of accidental injury (falls) in elderly patients;
• seizures or fits;
• 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 these symptoms may occur during treatment with medicines in this class.
The patient should contact their doctor as soon as possible if they experience:

• fever, flu-like symptoms, sore throat, or any infection, as this may be due to a very low white blood cell count, which may require stopping Kwexyma and/or specific treatment;
• constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to severe intestinal obstruction;
• suicidal thoughts or worsening depression. Patients with depression may sometimes think about self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment, as these medicines usually take about 2 weeks, or sometimes longer, to start working. Suicidal thoughts may increase in patients who abruptly stop taking their medication. The risk of such thoughts is higher in younger patients. Clinical trial data indicate an increased risk of suicidal thoughts and/or behaviors in young people under 25 years of age with depression. If the patient experiences thoughts of self-harm or suicidal thoughts, they should contact their doctor immediately or go to a hospital. It may be helpful to inform friends and family about the patient's condition and ask them to read this leaflet. They may also be asked to inform the patient's doctor if symptoms of depression worsen or if other worrying changes in behavior occur.

Severe cutaneous adverse reactions (SCAR)
Severe cutaneous adverse reactions (SCAR), which may be life-threatening or fatal, have been very rarely reported during treatment with this medicine.
Symptoms of these reactions include:

• Stevens-Johnson syndrome (SJS), widespread blistering rash and peeling skin, especially around the mouth, nose, eyes, and genitals;
• 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 elevated liver enzymes);
• acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus;
• erythema multiforme (EM), skin rash with irregular, itchy red patches.

If any of these symptoms occur, stop taking Kwexyma and contact a doctor or seek immediate medical help.
Weight gain
Weight gain has been observed in patients taking Kwexyma. Body weight should be monitored regularly by the patient or together with the doctor.
Children and adolescents
Kwexyma is not intended for use in children and adolescents under 18 years of age.
Kwexyma with other medicines
Tell the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take Kwexyma if the patient is taking any of the following medicines:

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

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

• antidepressants. These medicines may interact with Kwexyma and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling 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;
• antiepileptic medicines (such as phenytoin or carbamazepine);
• antihypertensive medicines;
• barbiturates (medicines used for sleep disorders);
• thioridazine or lithium (other antipsychotic medicines);
• medicines that affect heart rhythm, 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 (called "anticholinergics") that affect nerve cell function used to treat certain conditions.

Do not stop taking other medicines without consulting the doctor.
Kwexyma with food, drink, and alcohol

• Kwexyma can be taken with or without food.
• Be cautious about alcohol consumption. The combined effect of Kwexyma and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Kwexyma. Grapefruit juice may affect the medicine's action.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor before taking this medicine. Do not take Kwexyma during
pregnancy unless discussed with the doctor. Do not take Kwexyma if the patient is breastfeeding.
Newborns of mothers who took Kwexyma during the third trimester (last three months of
pregnancy) may experience symptoms indicating withdrawal syndrome: tremor, muscle stiffness
and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties.
If these symptoms occur in the child, contact the doctor.
Driving and operating machinery
Quetiapine may cause drowsiness. Do not drive or operate tools
and machinery until the patient knows how this medicine affects them.
Kwexyma contains sodium benzoate
This medicine contains 0.3 mg of sodium benzoate per mL.
Kwexyma contains sorbitol (E420)
This medicine contains 30 mg of sorbitol per mL. Sorbitol is a source of fructose. If the patient has previously been diagnosed with hereditary intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should contact their doctor before taking this medicine.
Kwexyma contains propylene glycol (E1520)
This medicine contains 22.5 mg of propylene glycol per mL.
Kwexyma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per mL, meaning the medicine is considered "sodium-free".
Kwexyma contains methyl 4-hydroxybenzoate (E218)
The medicine may cause allergic reactions (including delayed-type reactions).
Effect on urine drug screening tests
In patients undergoing urine drug screening tests, taking Kwexyma may
lead to 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 more specific test should be performed.

3. How to take Kwexyma

This medicine should always be taken as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist. The recommended dose is given in section "How much medicine to take".

Taking this medicine

• This medicine contains 25 mg of quetiapine in each 1 mL of suspension.
• This medicine is for oral use. Always shake the bottle for 15 seconds before use.
• Always use the syringe or dosing cup provided in the package. For doses of 5 mL or less, use the syringe; for doses greater than 5 mL, use the dosing cup.
• Kwexyma can be taken with or without food.
• Do not drink grapefruit juice while taking Kwexyma. It may affect the medicine's action.
• Do not stop taking this medicine, even if the patient feels better, unless instructed otherwise by the doctor.

Measuring the dose
Instructions for using the syringe (for doses of 5 mL or less):

1. To open the bottle, press down on the cap and turn it counterclockwise
   (figure 1).

2. Attach the syringe adapter to the neck of the bottle (figure 2).
3. Take the syringe and insert it into the adapter (figure 2).
4. Turn the bottle upside down (figure 3).
5. Fill the entire syringe by pulling the plunger down (figure 4A). Then push the plunger all the way up (the entire medicine will return to the bottle). This is to remove any air bubbles. Next, pull the plunger down to the mark corresponding to the dose prescribed by the doctor, indicated in mL (figure 4C).
6. Turn the bottle right-side up.
7. Remove the syringe from the adapter. Place the tip of the syringe into the mouth and slowly push the plunger back in to administer the medicine.
8. Wash the syringe with water and leave it to dry before reuse.
9. Close the bottle with the plastic cap, leaving the adapter in the neck of the bottle.
10. The syringe should be used only with this medicine.

Instructions for using the dosing cup (for doses greater than 5 mL)

1. To open the bottle, press down on the cap and turn it counterclockwise.
2. Pour the medicine into the dosing cup up to the mark indicating the required dose. For certain doses, the dosing cup may need to be used twice.
3. Wash the dosing cup with water and leave it to dry before reuse.
4. Close the bottle with the plastic cap.

How much medicine to take

• Your doctor will determine the starting dose of the medicine. The maintenance dose (daily dose) depends on the condition being treated and the individual patient’s needs, and usually ranges from 150 mg (6 mL) to 800 mg (32 mL).
• The medicine should be taken once daily before bedtime or twice daily, depending on the condition.

The table below will help measure the exact dose prescribed by your doctor:
Dose equivalents for the syringe:

Warning: the total volume of the syringe is 5 mL.
Dose equivalents for the dosing spoon:

Warning: the total volume of the dosing cup is 20 mL.
Liver function disorders
In case of liver function disorders, the physician may recommend a dose adjustment.
Elderly patients
The physician may adjust the dose of the medicine in elderly patients.
Use in children and adolescents
Kwexyma must not be used in children and adolescents under 18 years of age.
Taking more Kwexyma than recommended
If a higher dose of Kwexyma is taken than prescribed by the physician, drowsiness, dizziness, and heart rhythm disturbances may occur. Contact a physician immediately or go to the nearest hospital. Bring this medicine with you.
Missing a dose of Kwexyma
If the patient forgets to take a dose, it should be taken as soon as remembered. If it is almost time for the next dose, the patient should wait until then. Do not take a double dose to make up for the missed dose.
Stopping treatment with Kwexyma
If treatment with Kwexyma is stopped suddenly, difficulties in sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, or irritability may occur. The physician may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

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

Very common: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Somnolence (may diminish over time as treatment with Kwexyma continues) (may lead to falls).
• Withdrawal symptoms (symptoms occurring after discontinuation of Kwexyma) include difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness, or painless muscle stiffness.
• Changes in levels of certain lipids (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Sensation of heart pounding, racing, or skipped beats.
• Constipation, upset stomach (dyspepsia).
• Weakness.
• Swelling of arms or legs.
• Low blood pressure upon standing. This may cause dizziness or fainting (may lead to falls).
• Increased blood glucose levels.
• Blurred vision.
• Unusual dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disturbances.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in thyroid hormone levels in blood.
• Decreased number of certain types of blood cells.
• Increased liver enzyme activity measured in blood.
• Increased prolactin levels in blood. Increased prolactopenia levels may rarely lead to the following symptoms:
• Breast swelling in men and women and unexpected milk production.
• Absence of menstruation or irregular menstruation in women.

Uncommon: may affect up to 1 in 100 people

• Seizures.
• Allergic reactions, which may include raised lumps (blisters), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in electrical activity of the heart visible 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 pre-existing diabetes.
• Disorientation.

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

• Concurrent occurrence of: high body temperature (fever), sweating, muscle stiffness, extreme drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis (liver inflammation).
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhoea).
• Menstrual disorders.
• Blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, medical advice should be sought immediately.
• Walking, talking, eating, or performing other activities during sleep.
• Low body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") in which 3 or more of the following symptoms occur simultaneously: increased abdominal fat, decreased levels of "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood glucose levels.
• Concurrent occurrence 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 creatine kinase levels in blood (a substance derived from muscles).

Very rare: may affect up to 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.
• Rapidly developing skin swelling, usually around the eyes, lips, and throat (angioedema).
• Severe blistering disorder affecting the skin, mouth, eyes, and genital organs (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of the hormone regulating urine volume.
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Frequency not known: frequency cannot be estimated from available data

• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Rapid appearance of areas of red skin with small pustules (small blisters filled with white or 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 skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with rash, fever, lymph node swelling, 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 Kwexyma during pregnancy.
• Stroke.
• Heart muscle disorders (cardiomyopathy).
• Inflammation of the heart muscle.
• Inflammation of blood vessels, often with a skin rash consisting of small red or purple nodules.

The class of medicines to which Kwexyma belongs may cause disturbances in heart rhythm, which may be
serious and, in severe cases, fatal.
Some adverse effects can only be detected by blood tests. These include:
changes in 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 erythrocytes, increased
creatine kinase activity in blood (an enzyme present in muscles), decreased
sodium levels in blood, and increased prolactin levels in blood. Increased prolactin levels in blood
may rarely lead to:

• breast swelling in men and women and unexpected milk production,
• absence of menstruation or irregular menstruation in women.

Your doctor may occasionally request blood tests.

Additional adverse effects in children and adolescents
The same adverse effects that may occur in adults may also occur in children
and adolescents.
The following adverse effects have been observed more frequently in children and adolescents or were not observed at all in adults:

Very common: may affect more than 1 in 10 people

• Increased prolactin levels in blood. Increased prolactin levels may rarely lead to the following symptoms:
  • Breast swelling in boys and girls and unexpected milk production;
  • Absence of menstruation or irregular menstruation in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness, or painless muscle stiffness.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

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

Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can also be
reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Kwexyma medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the stated month.
Kwexyma medicine can be used for up to 4 months after the first opening of the bottle. After 4 months, any unused solution must be discarded. To help remember the date when the 4 months have passed, the date of opening should be written in the designated space on the carton.
Do not store at temperatures above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Kwexyma contains

• The active substance is quetiapine. Each 1 mL contains 25 mg of quetiapine (as fumarate).
• The other ingredients are: sodium benzoate (E211), methylparaben (E218), sodium saccharin (E954), disodium phosphate (E339), 70% sorbitol solution (E420), propylene glycol (E1520), glycerol (E422), microcrystalline cellulose-collodial silica, sodium carboxymethylcellulose (E466), xanthan gum (E415), poloxamer 188, macrogol 400 (E1521), sucralose (E955), cherry flavour, water.

What Kwexyma looks like and contents of the pack
Kwexyma is a white oral suspension supplied in glass or polyethylene terephthalate (PET) bottles with a child-resistant PP cap, packed in a cardboard carton.
Dosage devices: a PE syringe with a capacity of 5 mL, marked in 0.5 mL increments, and a PP dosing cup with a capacity of 20 mL.
Plastic bottle adapter.
Pack sizes: 60 mL and 120 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka Street 8
01-748 Warsaw
e-mail: [email protected]

Manufacturer
LABORATORIOS LICONSA S.A.
Avenida De Miralcampo 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Austria Zenaxel
Belgium Quexima 25 mg/ml suspensie voor oraal gebruik
Quexima 25 mg/ml suspension buvable
Quexima 25 mg/ml Suspension zum Einnehmen
Czech Republic Equilion
Finland Zenaxel
France Queliva 25 mg/mL, suspension buvable
Spain Zenaxel
Luxembourg Zenaxel 25 mg/ml suspension buvable
Zenaxel 25 mg/ml Suspension zum Einnehmen
Germany Zenaxel 25 mg/ml Suspension zum Einnehmen
Norway Zenaxel
Poland Kwexyma
Portugal Zenaxel
Slovakia Zenaxel
Sweden Zenaxel
Italy Yadina