Patient Information Leaflet

Quetiapina Aurovitas Pharma 150 mg prolonged-release tablets EFG

Read 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See Section 4.

1.What Quetiapina Aurovitas Pharma is and what it is used for

2.What you need to know before you start taking Quetiapina Aurovitas Pharma

3.How to take Quetiapina Aurovitas Pharma

4.Possible side effects

5.Storage of Quetiapina Aurovitas Pharma

6.Contents of the pack and additional information

Quetiapina Aurovitas Pharma contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat various diseases, such as:

•Bipolar depression and major depressive episodes in major depressive disorder: for which you may feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.

•Mania: for which you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or present poor judgment, which includes being aggressive or violent.

•Schizophrenia: for which 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.

When using quetiapine to treat major depressive episodes in major depressive disorder, this will be taken in addition to another medicine that is being used to treat this disease.

Your doctor may continue prescribing quetiapine even when you are feeling better.

Do not take Quetiapina Aurovitas Pharma

•if you are allergic to quetiapine or any of the other ingredients in this medicine (listed in section 6).

•if you are taking any of the following medicines:

-some HIV medicines.

-azole-type medicines (for fungal infections).

-erythromycin or clarithromycin (for infections).

-nefazodone (for depression).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Aurovitas Pharma if:

•You have depression or other conditions that are treated with antidepressants. The use of these medicines with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapina Aurovitas Pharma").

•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 medicine that may affect your heart rhythm.

•You have low blood pressure.

•You have had a stroke, especially if you are an older patient.

•You have liver problems.

•You have ever 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 quetiapine.

•You know that you have had low white blood cell counts (which may or may not have been caused by other medicines).

•You are an older patient with dementia (loss of brain function). If so, do not take quetiapine because the group of medicines to which quetiapine belongs may increase the risk of stroke or, in some cases, death in these patients.

•You are an older patient with Parkinson's disease/parkinsonism.

•You or a family member has a history of blood clots, as medicines 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 sleep (called "sleep apnea") and are taking medicines that decrease the normal activity of the brain ("depressants").

•You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, a bowel obstruction, or high pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect the way nerve cells work, to treat certain medical conditions.

•You have or have had problems with alcohol or drug abuse.

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

•A combination of fever, intense muscle stiffness, sweating, or a decrease in level of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.

•Uncontrolled movements, mainly of your face or tongue.

•Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in older patients.

•Seizures (convulsions).

•Prolonged and painful erection (priapism).

•Fast and irregular heartbeats, even when at rest, palpitations, breathing problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These conditions 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 it could be a consequence of very low white blood cell counts and require discontinuation of quetiapine treatment and/or additional treatment.

Thoughts of suicide and worsening of depression

If you are depressed, sometimes you may think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medicines take time to work, 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 from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 years with depression.

If you ever 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 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 reactions (SCARs)

Very rarely, severe cutaneous adverse reactions (SCARs) that may be life-threatening or fatal have been reported with the treatment of this medicine.

These are commonly manifested by:

• Stevens-Johnson syndrome (SJS), a generalised rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS): consists of flu-like symptoms, skin rash, fever, lymph node inflammation, and abnormal blood test results (eosinophilia and elevated liver enzymes).
• Acute Generalized Exanthematous Pustulosis (AGEP), small pus-filled blisters.
• Erythema Multiforme (EM), a skin rash with irregular red patches that cause itching.

Stop using Quetiapina Aurovitas Pharma if you experience these symptoms 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 monitor your weight regularly.

Children and adolescents

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

Other medicines and Quetiapina Aurovitas Pharma

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

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

•Some HIV medicines.

•Azole-type medicines (for fungal infections).

•Erythromycin or clarithromycin (for infections).

•Nefazodone (for depression).

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

•Antidepressants. These medicines may interact with quetiapine and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.

•Medicines for epilepsy (such as phenytoin or carbamazepine).

•Medicines for high blood pressure.

•Barbiturates (for difficulty falling asleep).

•Thioridazine or lithium (other antipsychotic medicines).

•Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medicines for urination) or certain antibiotics (medicines for treating infections).

•Medicines that may cause constipation.

•Medicines (called "anticholinergics") that affect the way nerve cells work, to treat certain medical conditions.

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

Taking Quetiapina Aurovitas Pharma with food, drinks, and alcohol

•Quetiapine may be affected by food, so take your tablets at least one hour before a meal or before bedtime.

•Be careful with the amount of alcohol you drink. This is because the combined effect of quetiapine and alcohol may make you drowsy.

•Do not take orange juice while taking quetiapine. It may affect the way the medicine works.

Pregnancy and breastfeeding

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

Do not take quetiapine during pregnancy, unless you have consulted your doctor. Do not use quetiapine if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapine in the last trimester (last three months of pregnancy): tremor, 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 operating machines

These tablets may make you feel drowsy. Do not drive or operate tools or machines until you know how the tablets affect you.

Effect on Drug Detection Tests in Urine

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

Quetiapina Aurovitas Pharma contains lactose

If your doctor has told you that you have a lactose intolerance, consult him before starting to take this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 illness and needs, but will normally be between 150 mg and 800 mg.

•You will take your tablets once a day.

•Do not break, chew, or crush the tablets.

•Swallow your tablets whole with the help of water.

•Take the tablets without food (at least one hour before a meal or before going to bed, your doctor will tell you when).

•Do not take grapefruit juice while taking quetiapine. 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 patients

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

Use in children and adolescents

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

If you take more Quetiapina Aurovitas Pharma than you should

If you take more quetiapine than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the Quetiapina Aurovitas Pharma tablets with you.

If you forgot to take Quetiapina Aurovitas Pharma

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 tablet.

If you interrupt the treatment with Quetiapina Aurovitas Pharma

If you stop taking quetiapine abruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability.

Your doctor may suggest reducing the dose gradually before stopping treatment.

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

Like all medicines, this medicine can cause side 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.

•Sensation of drowsiness that may disappear over time as you continue to take quetiapine (may lead to falls).

•Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which 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 starting muscle movements, tremors, feeling restless or rigid without pain.

•Changes in the amount of certain fats (triglycerides and total cholesterol).

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

•Fast heart rate.

•Feeling like your heart is beating strongly, rapidly, or irregularly.

•Constipation, indigestion.

•Feeling weak.

•Swelling of arms or legs.

•Low blood pressure when standing. This may cause dizziness or fainting (may lead to falls).

•Increased blood sugar levels.

•Blurred vision.

•Abnormal dreams and nightmares.

•Increased hunger.

•Feeling irritable.

•Speech and language disorders.

•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.

•Decreased number of certain types of blood cells.

•Increases in liver enzymes measured in blood.

•Increases in prolactin hormone in blood. Elevated prolactin levels may, in rare cases, lead to:

-Swelling of breasts and unexpected milk production in both men and women.

-Irregular or absent menstrual periods in women.

Uncommon(may affect up to 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).

•Dysphagia.

•Involuntary movements, mainly of the face or tongue.

•Sexual dysfunction.

•Diabetes.

•Change in heart activity seen on ECG (prolongation of 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 (may lead to falls).

•Blocked nose.

•Decreased number of red blood cells in blood.

•Decreased sodium levels 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, feeling very drowsy or dizzy (a condition known as "neuroleptic malignant syndrome").

•Yellowish discoloration of skin and eyes (jaundice).

•Inflammation of the liver (hepatitis).

•Prolonged and painful erection (priapism).

•Swelling of breasts and unexpected milk production (galactorrhea).

•Menstrual disorders.

•Clots in veins, especially in legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.

•Walking, talking, eating, or other activities while asleep.

•Decreased body temperature (hypothermia).

•Inflammation of the pancreas.

•A condition (called "metabolic syndrome") where you may experience 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 blood called triglycerides, increased blood pressure, and increased blood sugar levels.

•A combination of fever, symptoms similar to the flu, sore throat, or any other infection with a very low white blood cell count, a condition known as agranulocytosis.

•Intestinal obstruction.

•Increased creatine phosphokinase in 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 (anaphylaxis) that may cause difficulty breathing or shock.

•Rapid skin swelling, 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.

•Abnormal secretion of a hormone that controls urine volume.

•Rhabdomyolysis (muscle fiber rupture and muscle pain).

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

•Rash with irregular red spots (erythema multiforme).See Section 2.

•Appearance of rapid areas of skin redness with small pustules (Pustulosis Exantemática Generalizada Aguda (PEGA). See Section 2.

•Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (necrólisis epidérmica tóxica).See Section 2.

•Drug rash with eosinophilia and systemic symptoms (DRESS)consists of symptoms similar to the flu, with skin rash, fever, lymph node inflammation, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes).See Section 2.

•Withdrawal symptoms may occur in newborns of mothers who have used quetiapine 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 medications to which quetiapine belongs can cause heart rhythm problems that may be severe and in severe cases.

Some side effects are only seen when a blood test is performed. 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 blood (a substance found in muscles), decreases in sodium levels in blood, and increases in prolactin hormone in blood. Elevated prolactin levels may, in rare cases, lead to:

•Swelling of breasts and unexpected milk production in both men and women.

•Irregular or absent menstrual periods in women.

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 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(may affect more than 1 in 10 people):

•Increased levels of a hormone called prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to:

-Swelling of breasts and unexpected milk production in both boys and girls.

-Irregular or absent menstrual periods in girls.

•Increased appetite.

•Vomiting.

•Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling restless or rigid without pain.

•Increased blood pressure.

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

•Feeling weak, fainting (may lead to falls).

•Blocked 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 the 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 medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Quetiapina Aurovitas Pharma

-The active ingredient is quetiapine. Each tablet contains 150 mg of quetiapine (as quetiapine fumarate).

-The other components are:

Tablet core:lactose, copolymer of methacrylic acid-ethyl acrylate (1:1), Type A, crystalline maltose, magnesium stearate, and talc.

Tablet coating:copolymer of methacrylic acid-ethyl acrylate (1:1), Type A, triethyl citrate.

Appearance of the product and contents of the packaging

The prolonged-release tablets of 150 mg are white or off-white, biconvex, oblong, 13.6 mm in length, 6.6 mm in width, and 4.2 mm in thickness, with the mark “150” on one face.

They are presented in PVC/PCTFE-aluminum foil blisters. The packaging sizes are 10, 20, 30, 50, 60, and 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

Pharmathen International S.A.

Sapes Industrial Block 5

69300 Rodopi

Greece

or

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini, Athens

Greece

or

Salutas Pharma GmbH

Otto Von Guericke Alle, 1

D-39179 Barleben

Germany

or

G.L. Pharma GmbH

Schlossplatz, 1

8502 Lannach

Austria

or

Hormosan Pharma GmbH

Hanauer Landstrasse 139-143

6031 Frankfurt

Germany

Last review date of this leaflet:June 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).