Package Insert: Information for the Patient

Quentiax 100 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Quentiaxcontains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quentiaxmay be used to treat several conditions, such as:

Your doctor maycontinue prescribing Quentiax even when you are feeling better.

Do not takeQuentiax

• If you are allergic to quetiapine or any of the other components of this medication (listed in section 6)
• If you are taking any of the following medications:
• Certain medications for HIV treatment.
• Azole-type antifungal agents (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

If you are unsure, consult your doctor or pharmacist before takingQuentiax.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quentiax if:

• You, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness, or heart inflammation, or if you are taking any medication that may affect your heart rate.
• You have low blood pressure.
• You have had a stroke, especially if you are an older person.
• You have liver problems.
• You have had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking Quentiax.
• You know that you have had low white blood cell counts (which may or may not have been caused by other medications).
• You are an older person with dementia (loss of brain function). If so, do not take Quentiax because the group of medications to which Quentiax belongs may increase the risk of stroke or, in some cases, death in these people.
• You are an older person with Parkinson's disease or parkinsonism.
• You or a family member has a history of blood clots, as medications like these have been associated with blood clot formation.
• You have or have had a condition in which your breathing is interrupted by short periods of time during normal nighttime sleep (called "sleep apnea") and are taking medications that decrease normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• You have a history of alcohol or drug abuse.

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

• A combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment. Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feel very drowsy. This may increase the risk of accidental injuries (falls) in older patients.
• Seizures (convulsions).
• A long-lasting and painful erection (priapism).
• Rapid and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders may be caused by this type of medication.

Inform your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be the result of low white blood cell counts, which may require that treatment with quetiapine be interrupted and/or other treatment be given.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as this may lead to a more severe intestinal blockage.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medications take time to take effect, usually around two weeks but sometimes longer. These thoughts may 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 obtained from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to the 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 ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Severe cutaneous adverse reaction (SCAR)

Severe cutaneous adverse reactions (SCARs), which may put your life at risk or be fatal, have been reported very rarely with quetiapine treatment. These have manifested frequently by:

• Stevens-Johnson syndrome (SSJ), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe condition that causes extensive skin peeling.
• 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 eosinophilia and elevated liver enzymes).
• Acute generalized pustular psoriasis (AGPP), small pus-filled blisters.
• Erythema multiforme (EM), a skin rash with irregular red patches that itch.

Stop using Quentiax if you develop these symptoms and contact your doctor or seek medical attention immediately.

Weight gain

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

Children and adolescents

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

Other medications and Quentiax

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not takeQuentiaxif you are taking any of the following medications:

• Certain HIV medications.
• Azole-type antifungal agents (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Inform your doctor if you are using any of the following medications:

• Antiepileptic medications (such as phenytoin or carbamazepine).
• Antihypertensive medications.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or lithium (another antipsychotic medication).
• Medications that affect your heart rate, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medications for urination) or certain antibiotics (medications for treating infections).
• Medications that may cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.

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

Quentiax with food, drinks, and alcohol

• Quentiax can be taken with or without food.
• Be careful about the amount of alcohol you consume. This is because the combined effect of Quentiax and alcohol may cause drowsiness.
• Do not take grapefruit juice while taking Quentiax. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Quentiax during pregnancy, unless you have consulted your doctor.

Do not useQuentiaxif you are breastfeeding.

The following symptoms that may represent withdrawal syndrome may occur in newborn babies, of mothers who have used quetiapine in the last trimester (last three months of pregnancy): tremors, muscle stiffness, or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby experiences any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

Quentiaxmay cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Quentiax contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmolof sodium (23 mg) per tablet; it is essentially "sodium-free".

Effect on Drug Detection Tests in Urine

If you are undergoing a drug detection test in urine, taking Quentiax may produce positive results for methadone or certain antidepressant medications called tricyclic antidepressants (TCAs) when using certain analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and your needs, but it will usually be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your disease.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not take grapefruit juice while taking Quentiax. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

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

Older adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

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

If you take more Quentiax than you should

If you take more Quentiax than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring your Quentiax tablets with you.

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

If you forget to take Quentiax

If you forget to take Quentiax, take your corresponding dose 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 doses.

If you interrupt treatment with Quentiax

If you stop taking Quentiax abruptly, you may be unable to sleep (insomnia) or experience nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before interrupting treatment.

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

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to take Quentiax) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Quentiax) include insomnia, nausea, headache, diarrhea, 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 initiating muscle movements, tremor, feeling of restlessness or muscle rigidity without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• Fast heart rate.
• Feeling like your heart is beating strongly, rapidly, or irregularly.
• Constipation, indigestion.
• Sensation of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This may make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorder.
• 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 liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both in men and women, breast swelling and unexpected milk production.
• In women, not having a menstrual period or having irregular periods.

Uncommon side effects(may affect 1 in 100 people):

• Seizures or convulsions.
• Allergic reactions that may include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in heart activity seen on an ECG (prolongation of the QT interval).
• Slower than normal heart rate that may occur at the start of treatment and may 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.

Rare side effects(may affect 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs) that may travel to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar levels.
• 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.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

Very rare side effects(may affect 1 in 10,000 people):

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that may cause difficulty breathing or shock.
• Quick 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). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis (muscle fiber rupture and pain).

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

• Rashes on the skin with irregular red spots (erythema multiforme). See section 2.
• Appearance of rapid areas of red skin with small pustules (small blisters filled with white/yellow liquid called pustulosis exanthematosa aguda generalizada (PEAG). See section 2.

• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.

• Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen lymph nodes, and altered blood test results (including increased white blood cell count and liver enzymes). See section 2.

• Withdrawal symptoms may occur in newborns of mothers who have used Quentiax during pregnancy.
• Stroke.
• Cardiomyopathy (heart muscle disorder).
• Miocardiitis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with skin rash with small red or purple spots.

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

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, increases in liver enzymes, decreases in the number of certain types of blood cells, decreases in the number of red blood cells, increases in creatine phosphokinase in the blood (a substance found in muscles), decreases in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both in men and women, breast swelling and unexpected milk production.
• Women may not have a menstrual period or have irregular periods.

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

Side effects in children and adolescents

The same side effects that may occur in adults may 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 side effects(may affect more than 1 in 10 people):

• Increased amount of a hormone called prolactin in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both in boys and girls, breast swelling and unexpected milk production.
• Girls may not have a menstrual period or have irregular periods.

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling of restlessness or muscle rigidity without pain.
• Increased blood pressure.

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medicationafter the expiration date indicated on the carton, container, and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Quentiax

The active ingredient is quetiapine. Each film-coated tablet contains 100 mg of quetiapine (as quetiapine hemifumarate).

The other components are:

Core tablet: lactose monohydrate (lactose), calcium dihydrate phosphate, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A) from potato (potato starch), magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172). See section 2 “Quentiax contains lactose and sodium”.

Appearance of the product and contents of the package

The 100 mg film-coated tablets are round, yellow-brown in color.

They are presented in aluminum/PVC blisters of 60 tablets per pack.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Or

KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/Anabel segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet: December 2021

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/