Ketyalix 25 mg/ml oral suspension

Package leaflet: Information for the patient

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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ketyalix is and what it is used for

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

• Bipolar depression: when you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: when you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or violent.
• Schizophrenia: when you may hear or sense 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 Ketyalix even after you start feeling better.

2. What you need to know before you start taking Ketyalix

Do not take Ketyalix:

• if you are allergic to quetiapine or to any of the other components of this medicine (listed in section 6).
• if you are taking any of the following medicines:
  • Some medicines for HIV.
  • Azole-type medicines (for fungal infections).
  • Erythromycin or clarithromycin (for infections).
  • Nefazodone (for depression).

If in doubt, consult your doctor or pharmacist before starting to take Ketyalix.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ketyalix:

• if you, or a family member, have or have had any heart problems, for example, irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heart rhythm.
• if you have low blood pressure.
• if you have had a stroke, especially if you are elderly.
• if you have liver problems.
• if you have ever had a seizure (epileptic fit).
• if you have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking Ketyalix.
• if you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain functions). In this case, you should not take Ketyalix because the group of medicines to which Ketyalix belongs may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
• if you are an elderly person with Parkinson’s disease/parkinsonism.
• if you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
• if you have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).
• if you have or have had a condition in which you cannot completely empty your bladder (urinary retention), an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.
• if you have depression or other conditions treated with antidepressants. Using these medicines together with Ketyalix may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Ketyalix”).

Inform your doctor immediately if, after taking Ketyalix, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “neuroleptic malignant syndrome”). Immediate medical treatment may be necessary.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• Seizures (fits).
• Prolonged and painful erection (Priapism).
• Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

These disorders may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low white blood cell count and may require stopping treatment with Ketyalix and/or additional treatment.
• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.
• Suicidal thoughts and worsening of your depression.

If you are depressed, you may sometimes think about harming yourself or committing suicide. This risk may increase at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also increase if you suddenly stop taking your medication. You may be more likely to have such thoughts if you are a young adult. Data from clinical trials have 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 about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may also ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Serious skin adverse reactions (SCARs)

Very rarely, serious skin adverse reactions (SCARs), which may be life-threatening or fatal, have been reported with this medicine. These commonly present as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by 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 eruptions with irregular red, itchy spots.

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

Weight gain

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

Children and adolescents

Ketyalix must 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 need to take any other medicines.

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

• Some medicines for HIV.
• Azole-type medicines (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 heart rhythm, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (medicines to increase urine production) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
• Antidepressants. These medicines may interact with Ketyalix and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

Do not stop taking any of your medicines without first consulting your doctor.

Taking Ketyalix with food, drinks, and alcohol

• Ketyalix should be taken with a glass of water.
• Ketyalix may be taken with or without food.
• Be cautious about the amount of alcohol you drink. This is because the combined effect of Ketyalix and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Ketyalix. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not take Ketyalix during pregnancy unless advised by your doctor. You should not use Ketyalix if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns whose mothers have taken quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

Ketyalix may make you feel drowsy. Do not drive or operate tools or machinery until you know how this medicine affects you.

Ketyalix contains sodium benzoate

This medicine contains 1.0 mg of sodium benzoate per ml.

Ketyalix contains sorbitol

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

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the body cannot break down fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Ketyalix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; i.e., essentially “sodium-free”.

Ketyalix contains glycerol

This medicine contains 29.25 mg of glycerol per ml.

It may cause headache, stomach discomfort, and diarrhea.

Effect on urine drug screening tests

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

3. How to take Ketyalix

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide your starting dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

• This medicine contains 25 mg of quetiapine in 1 ml of suspension. You will take this medicine once daily at bedtime or twice daily, depending on your condition.
• Take this medicine by mouth.
• Always shake the bottle before taking it.
• Always use the syringe and dosing cup provided in the package.
• It can be taken with or without food and with a glass of water.
• Do not drink grapefruit juice while taking Ketyalix. It may affect how the medicine works.
• Do not stop taking this medicine 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 insert it into the opening of the adapter (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 push the plunger up to remove any possible air bubbles (Figure 3B). Finally, pull the plunger down to the graduation mark corresponding to the amount in millilitres prescribed by your doctor. This is indicated in ml (Figure 3C).
5. Turn the bottle back to its normal upright position.
6. Remove the syringe from the adapter. Place the tip of the syringe into your mouth and slowly push the plunger to take the medicine.
7. Wash the syringe with water and allow it to dry before reusing.
8. Close the bottle with the plastic screw cap.
9. Store the syringe in its original box. The syringe must only be used for this medicine.

Instructions for using the dosing 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 from 6 ml to 16 ml, squeeze the bottle and pour the medicine into the dosing cup up to the required dosage mark (Figure 2).
3. Wash the cup with water and allow it to dry before reuse.
4. Close the bottle with the plastic screw cap.
5. Store the cup in its original box. The cup must only be used for this medicine.

How much to take

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

• A usual dose is typically between 150 mg and 800 mg per day. This will depend on your condition and individual needs.
• Depending on your condition, you should take the medicine:
  • once daily – at bedtime
  • twice daily – your doctor will tell you when to take your doses.

The following table provides the equivalence between doses in mg and doses in ml, and indicates whether the syringe or dosing cup should be used for each dose. Each ml contains 25 mg of quetiapine.

Quetiapine dose (mg)	Dosing device	Dosage volume (ml)
25	Syringe - 5 ml	1 ml
50	2 ml
75	3 ml
100	4 ml
150	Cup - 20 ml	6 ml
200	8 ml
250	10 ml
300	12 ml
400	16 ml

Liver problems

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

Elderly patients

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

Use in children and adolescents

Ketyalix must not be used in children and adolescents under 18 years of age.

If you take more Ketyalix than you should

If you take more Ketyalix than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or go to the nearest hospital. Take the medicine with you.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ketyalix

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 missed dose.

If you stop taking Ketyalix

If you stop taking Ketyalix abruptly, you may have difficulty sleeping (insomnia), feel nauseous, or experience headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

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

4. Possible adverse effects

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

Very common: may affect more than 1 in 10 people

• Dizziness (could lead to falls), headache, dry mouth.
• Drowsiness (which may decrease over time as you continue taking quetiapine), (could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless, or painless muscle rigidity.
• Changes in levels of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Feeling as if your heart is pounding, racing, or having irregular beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may make you feel dizzy or faint (could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Decreased number of certain types of blood cells.
• Increases in liver enzyme levels measured in blood.
• Increases in prolactin hormone levels in blood. Elevated prolactin levels may, in rare cases, lead to the following:
  • Breast enlargement and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

Uncommon: may affect up to 1 in 100 people

• Epileptic seizures or convulsions.
• Allergic reactions which may include raised itchy rashes (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen 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 (could lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in blood.
• Decrease in the amount of sodium in 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, and extreme drowsiness or dizziness (a condition called “neuroleptic malignant syndrome”).
• Yellowing of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorder.
• Blood clots in the 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 difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatic inflammation.
• A condition (called “metabolic syndrome”) in which you may have a combination of 3 or more of the following: increased abdominal fat, decreased “good cholesterol” (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased 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 known as agranulocytosis.
• Intestinal obstruction.
• Increased blood creatine phosphokinase (a substance 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 difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious blistering condition affecting 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).

Not known: frequency cannot be estimated from available data

• Skin rashes with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid known as acute generalized exanthematous pustulosis (AGEP)). See section 2.
• Sudden and severe 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), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple spots.

The class of medicines to which Ketyalix belongs may cause problems with heart rhythm that can be serious and, in severe cases, may be fatal.

Some adverse effects are only detected through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in your blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased number of red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in blood, and increased levels of the hormone prolactin in blood. Elevated prolactin levels may, in rare cases, lead to the following:

• Breast enlargement and unexpected milk production in both men and women.
• In women, absence of menstrual periods or irregular periods.

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

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 in adults:

Very common: may affect more than 1 in 10 people

• Increased levels of a hormone called prolactin in blood. Elevated prolactin levels may, in rare cases, lead to the following:
  • Breast enlargement and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness, or painless muscle rigidity.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketyalix

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use more than 50 days after first opening.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ketyalix

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

What Ketyalix looks like and contents of the pack

Ketyalix is a white, homogeneous oral suspension when mixed.

Pack sizes: 1 or 2 bottles of 50 ml of suspension.

Only certain pack sizes may be marketed.

Dosage devices:

• 5 ml syringe with markings every 0.2 ml.
• 20 ml dosing cup with markings at 6 ml, 8 ml, 10 ml, 12 ml and 16 ml.

Marketing Authorization Holder

ITALFARMACO, S.A.

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

Tel.: 916572323

Manufacturer

ITALFARMACO, S.A.

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

Tel.: 916572323

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

Netherlands: AQUETIA 25 mg/ml suspensie voor oraal gebruik

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 suspensión oral

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: August 2025

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