KETYALIX 25 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Ketyalix 25 mg/ml Oral Suspension

Quetiapine

Read all of this leaflet carefully before you start 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 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

1. What Ketyalix 25 mg/ml Oral Suspension is and what it is used for
2. What you need to know before you take Ketyalix 25 mg/ml Oral Suspension
3. How to take Ketyalix 25 mg/ml Oral Suspension
4. Possible side effects
5. Storage of Ketyalix 25 mg/ml Oral Suspension
6. Contents of the pack and other information

1. What Ketyalix 25 mg/ml Oral Suspension is and what it is used for

Ketyalix contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat several diseases, such as:

• Bipolar depression: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or can't sleep.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment, including being aggressive or violent.
• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel abnormally suspicious, anxious, confused, guilty, tense or depressed.

Your doctor may continue to prescribe quetiapine for you even when you are feeling better.

2. What you need to know before you take Ketyalix 25 mg/ml Oral Suspension

Do not take Ketyalix:

• 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:
• • Some medicines for HIV.
  • Medicines of the azole type (for fungal infections).
  • Erythromycin or clarithromycin (for infections).
  • Nefazodone (for depression).

If in doubt, consult your doctor or pharmacist before taking Ketyalix.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• you, or someone in your family, have or have had any heart problems, such as problems with the heartbeat, weakening of the heart muscle or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• you have low blood pressure.
• you have had a stroke, especially if you are elderly.
• you have liver problems.
• you have ever had a seizure (convulsion).
• you have diabetes or are at risk of developing diabetes. If so, your doctor may need to check your blood sugar levels while you are taking quetiapine.
• you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• you are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine because the group of medicines to which quetiapine belongs may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
• you are an elderly person with Parkinson's disease/parkinsonism.
• you or a family member have a history of blood clots, as medicines like these have been associated with the formation of blood clots.
• you have or have had a condition where your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and are taking medicines that reduce normal brain activity ("depressants").
• you have or have had a condition where you cannot empty your bladder completely (urinary retention), have an enlarged prostate, a blockage in your intestine, or high pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect how nerve cells work to treat certain medical conditions.
• you have a history of alcohol or drug abuse.
• you have depression or other conditions that are treated with antidepressants. The use of these medicines with quetiapine may cause a condition called serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Ketyalix").

Tell your doctor immediately if, after taking quetiapine, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or a decrease in consciousness level (a disorder called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injury (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (Priapism).
• Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it could be a consequence of a very low count of white blood cells and may require interruption of treatment with Ketyalix and/or treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more serious blockage of the intestine.
• Thoughts of suicide and worsening of your depression.

If you are depressed, you may sometimes think of harming or killing yourself. This can increase when you first start treatment, as all these medicines take time to work, usually around two weeks but sometimes longer. These thoughts can also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you think of harming or killing yourself, contact your doctor or go to a hospital immediately. It may help to tell a relative or close friend that you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Severe skin reactions (SCARs)

With the use of this medicine, very rare severe skin reactions (SCARs) have been reported, which can be life-threatening or fatal. These are commonly manifested as:

• Stevens-Johnson syndrome (SSJ), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes extensive peeling of the skin.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including an increase in the number of white blood cells (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using Ketyalix and contact your doctor or seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking quetiapine. You and your doctor should regularly check your weight.

Children and adolescents

Quetiapine should not be used in children and adolescents under 18 years of age.

Other medicines and Ketyalix

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take Ketyalix if you are using any of the following medicines:

• Some medicines for HIV.
• Medicines of the azole type (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Tell your doctor if you are using any of the following medicines:

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or Lithium (other antipsychotic medicines).
• Medicines that affect your heartbeat, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work to treat certain medical conditions.
• Antidepressants. These medicines can interact with Ketyalix and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C (serotonin syndrome). Contact your doctor when you experience these symptoms.

Before stopping any of your medicines, consult your doctor first.

Taking quetiapine with food, drinks, and alcohol

• Quetiapine should be administered with a glass of water.
• Quetiapine can be administered with or without food.
• Be careful with the amount of alcohol you drink. This is because the combined effect of quetiapine and alcohol can make you drowsy.
• Do not drink grapefruit juice while taking quetiapine. It may affect how 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 for advice before taking this medicine. You should not take quetiapine during pregnancy, unless you have discussed this with your doctor. You should not use quetiapine if you are breast-feeding.

The following symptoms, which may represent a withdrawal syndrome, may appear in newborns of mothers who have used quetiapine in the last trimester (last three months of their pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

Quetiapine can make you feel drowsy. Do not drive or use tools or machines until you know how the tablets affect you.

Ketyalix contains sodium benzoate

This medicine contains 1.0 mg of sodium benzoate in each ml.

Ketyalix contains sorbitol

This medicine contains 384.2 mg of sorbitol (E420) in each ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with a rare genetic disorder called hereditary fructose intolerance (HFI), consult your doctor before taking this medicine.

Sorbitol can cause gastrointestinal upset and a mild laxative effect.

Ketyalix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; this is essentially "sodium-free".

Ketyalix contains glycerol

This medicine contains 29.25 mg of glycerol in each ml.

It can cause headaches, stomach upset, and diarrhea.

Effect on urine drug screening tests

If you are having a urine drug screening test, taking quetiapine may produce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when some analysis methods are used, even if you are not taking methadone or TCAs. If this happens, a more specific test can be performed.

3. How to take Ketyalix 25 mg/ml oral suspension

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide on your initial dose. The maintenance dose (daily dose) will depend on your illness and needs but is usually between 150 mg and 800 mg.

• This medication contains 25 mg of quetiapine in 1 ml of suspension. You will take your tablets once a day, at bedtime or twice a day, depending on your illness.
• Take this medication orally.
• Always shake the bottle before taking it.
• Always use the syringe and measuring cup that come with the packaging.
• It can be taken with or without food and with a glass of water.
• Do not take grapefruit juice while taking Ketyalix. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Measuring your dose

Instructions for using the syringe (for doses less than 5 ml):

1. To open the bottle, press the cap down and turn it counterclockwise (figure 1).
2. Take the syringe and place it in the adapter opening (figure 2).
3. Turn the bottle upside down (figure 2).
4. Fill the syringe with a small amount of solution by pulling the plunger down (figure 3A). Then press the plunger up to eliminate any possible bubbles (figure 3B). Finally, pull the plunger down to the graduation mark corresponding to the amount in milliliters prescribed by your doctor. This is given in ml (figure 3C).
5. Turn the bottle back to its normal position.
6. Remove the syringe from the adapter. Place the end of the syringe in your mouth and push the plunger slowly to take the medication.
7. Wash the syringe with water and let it dry before reusing it.
8. Close the bottle with the plastic screw cap.
9. Keep the syringe in its original box. The syringe should only be used for this medication.

Instructions for using the measuring cup (for doses greater than 5 ml):

1. To open the bottle, press the cap down and turn it counterclockwise (figure 1).
2. For doses of 6 ml to 16 ml, squeeze the bottle and pour the medication into the measuring cup up to the required dosing mark (figure 2).
3. Wash the cup with water and let it dry before reusing it.
4. Close the bottle with the plastic screw cap.
5. Keep the cup in its original box. The cup should only be used for this medication.

How much to take

Your doctor will decide on the starting dose and may gradually increase it.

• A normal dose is usually between 150 mg and 800 mg per day. This will depend on your illness and needs.
• Depending on your illness, you should take the medication:
• • once a day - at bedtime
  • twice a day - your doctor will indicate when to take your doses.

The following table provides the equivalence between doses in mg and doses in ml and the indication of the syringe or measuring cup to be used for each dose. Each ml contains 25 mg of quetiapine.

Liver problems

If you have liver problems, your doctor may change your dose.

Elderly people

If you are elderly, your doctor may change your dose.

Use in children and adolescents

Quetiapine should not be used in children and adolescents under 18 years of age.

If you take more quetiapine than you should

If you take more quetiapine than your doctor has prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or go to the nearest hospital. Bring the medication with you.

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take quetiapine

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for the forgotten dose.

If you stop taking quetiapine

If you stop taking quetiapine abruptly, you may be unable to sleep (insomnia), or you may feel nauseous, or you may experience headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest gradually reducing the dose before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

Very common: may affect more than 1 in 10 people

• Dizziness (which may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time, as you continue taking quetiapine), (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include being unable to sleep (insomnia), feeling sick (nausea), headache, diarrhea, being sick (vomiting), dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritable.
• Disorder of speech and language.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in the amount of liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:
• • Both in men and women having swelling of the breasts and unexpected production of milk.
  • In women not having menstrual periods or having irregular periods.

Uncommon: may affect up to 1 in 100 people

• Seizures or convulsions.
• Allergic reactions that can include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on the ECG (prolongation of the QT interval).
• Slower than normal heart rate that can occur at the start of treatment and that can be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a disorder called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism)
• Swelling of the breasts and unexpected production of milk (galactorrhea)
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Walking, talking, eating, or other activities while you are asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may have a combination of three or more of the following effects: increased fat around your abdomen, decrease in "good" cholesterol (HDL-C), increase in a type of fat in the blood called triglycerides, increase in blood pressure, and increase in blood sugar.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction
• Increase in creatine phosphokinase in the blood (a substance found in 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) that can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Unknown: frequency cannot be estimated from the available data

• Red spots on the skin with irregular edges (erythema multiforme). See section 2.
• Rapid onset of areas of red skin with small pus-filled bumps (small blisters filled with white/yellow liquid known as Acute Generalized Exanthematous Pustulosis (AGEP)). See section 2.
• Sudden and severe 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 consists of flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of the blood vessels (vasculitis), often with a skin rash with small red or purple spots.

The class of medications that quetiapine belongs to may cause heart rhythm problems that can be serious and, in severe cases, life-threatening.

Some side effects are only seen when a blood test is done. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, increase in liver enzymes, decrease in the number of certain types of blood cells, decrease in the number of red blood cells, increase in creatine phosphokinase in the blood (a substance found in muscles), decrease in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in men and women having swelling of the breasts and unexpected production of milk.
• In women not having menstrual periods or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

Additional side effects in children and adolescents

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

The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very common: may affect more than 1 in 10 people

• Increase in the amount of a hormone called prolactin in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:
• • Both in boys and girls having swelling of the breasts and unexpected production of milk.
  • In girls not having menstrual periods or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling of weakness, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ketyalix 25 mg/ml oral suspension

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use more than 50 days after first opening.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofKetyalix oral suspension

• The active ingredient is quetiapine. Each ml of suspension contains 25 mg of quetiapine (as quetiapine fumarate).
• The other excipients are sodium benzoate (E 211), glycerol, sorbitol (E 420), polysorbate 20, strawberry flavor [containing propylene glycol (E 1520), acetic acid], tragacanth gum (E 413), and purified water.

Appearance ofKetyalix oral suspension and package contents

Ketyalix is a white and homogeneous suspension when mixed.

Format: It is presented in a transparent bottle with 50 ml of suspension.

Dosing devices:

• 5 ml syringe with marks every 0.2 ml.
• 20 ml measuring cup with marks of 6 ml, 8 ml, 10 ml, 12 ml, and 16 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN

Phone: 916572323

Manufacturer

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN

Phone: 916572323

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands: AQUETIA 25 mg/ml suspension for oral use

Belgium: Ketyalix 25 mg/ml Suspension zum Einnehmen

Cyprus: AQUETIA 25 mg/ml π?σιμο εναι?ρημα

Germany: AQUETIA 25 mg/ml Suspension zum Einnehmen

Greece: AQUETIA 25 mg/ml π?σιμο εναι?ρημα

France: QUETIAPINE ITALFARMACO 25 mg/mL, suspension buvable

Italy: AKELYA

Luxembourg: AQUETIA 25 mg/ml Suspension zum Einnehmen

Portugal: AQUETIA 25 mg/ml Suspensão oral

Spain: KETYALIX 25 mg/ml oral suspension

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:August 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/