QUETIAPINE AUROVITAS PHARMA 200 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Quetiapine Aurovitas Pharma 200 mg prolonged-release tablets EFG

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 and other information

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

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

Quetiapine Aurovitas Pharma 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 and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or cannot sleep.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or show 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.

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

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

2. What you need to know before you take Quetiapine Aurovitas Pharma

Do not take Quetiapine Aurovitas Pharma

• 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.
  • azole-type medicines (for fungal infections).
  • erythromycin or clarithromycin (for infections).
  • nefazodone (for depression).

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

Warnings and precautions

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

• If you are suffering from depression or other conditions that are treated with antidepressants. The use of these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapine Aurovitas Pharma").
• You, or a family member, have or have had any heart problems, such as heart rhythm problems, heart muscle weakness or heart inflammation, or if you are taking any medicine that may affect your heart beat.
• You have low blood pressure.
• You have had a stroke, especially if you are an elderly patient.
• You have liver problems.
• You have ever had a seizure (convulsion).
• You suffer from diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking quetiapine.
• You know that you have had low white blood cell counts 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 these people.
• 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 in which 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 in which 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 or have had problems with alcohol or drug abuse.

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"). Immediate medical treatment may be necessary.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This may increase the risk of accidental injury (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Rapid and irregular heartbeats, even when 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 may 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 white blood cell count and may require interruption of treatment with quetiapine and/or additional 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 may increase when you first start taking 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 suicidal thoughts and/or suicidal behavior in young adults under 25 years with depression.

If at any time you have thoughts 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 (SCAR)

Very rarely, severe skin reactions (SCARs) have been reported, which can be life-threatening or fatal.

These are very rare with this medicine treatment. They are commonly characterized by:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes widespread peeling of the skin.
• Drug reaction with eosinophilia and systemic symptoms (DRESS): symptoms similar to flu, with skin rash, fever, swelling of the lymph nodes, and abnormal blood test results (increased white blood cells (eosinophilia) and liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled bumps.
• ERYthema multiforme (EM), skin rash with irregular red patches that itch.

Stop using Quetiapine Aurovitas Pharma if you have these symptoms and contact your doctor or seek medical attention immediately.

Weight gain

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

Children and adolescents

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

Other medicines and Quetiapine Aurovitas Pharma

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

Do not take quetiapine 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:

• Antidepressants. These medicines may interact with quetiapine 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, tremor, exaggerated reflexes, increased muscle tone, 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 sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, 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.

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

Taking Quetiapine Aurovitas Pharma with food, drinks, and alcohol

• Quetiapine may be affected by food and should be taken 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 drink grapefruit juice while taking quetiapine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 breastfeeding.

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 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 using machines

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

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 test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

Quetiapine Aurovitas Pharma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Quetiapine Aurovitas Pharma

Follow exactly the administration instructions of this medicine given 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 disease and needs, but will normally be between 150 mg and 800 mg.

• You will take your tablets once a day.
• Do not split, chew, or crush the tablets.
• Swallow your tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when).
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medicine 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.

Elderly patients

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

Use in children and adolescents

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

If you take more Quetiapine Aurovitas Pharma than you should

If you take more quetiapine than your doctor has 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring the Quetiapine Aurovitas Pharma tablets with you.

If you forget to take Quetiapine 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 forgotten tablet.

If you stop taking Quetiapine Aurovitas Pharma

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 further questions on 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 all people suffer from them.

Very Common(may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling of drowsiness that may disappear over time, as you continue taking quetiapine (may lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking quetiapine), which include inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is advised.
• 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 heart rate.
• Feeling like your heart is beating strongly, quickly, or skipping 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 (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 swollen breasts and unexpected milk production.
  • 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 an ECG (prolongation of the QT interval).
• Slower heart rate than normal that can occur at the start of treatment and can be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in the amount of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.
• 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").
• Yellowish color in the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swollen breasts and unexpected milk production (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 blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Decrease in body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") where you may suffer from a combination of 3 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). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Frequency Not Known(cannot be estimated from the available data):

• Skin rash with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of areas of red skin with small blisters (small blisters filled with white/yellow liquid called 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 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.
• Heart muscle disorder (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Blood vessel inflammation (vasculitis), often with skin rash with small red or purple spots.

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

Some adverse effects are only observed 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, increase in liver enzymes, decrease in the number of certain types of blood cells, decrease in the amount 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 swollen breasts and unexpected milk production.
• In women, not having menstrual periods or having 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 can occur in adults can also occur in children and adolescents.

The following adverse 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 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 swollen breasts and unexpected milk production.
  • 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 (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of Adverse Effects

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

5. Storage of Quetiapina Aurovitas Pharma

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines 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 medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapina Aurovitas Pharma

• The active ingredient is quetiapine. Each tablet contains 200 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:

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

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

Appearance of the Product and Package Contents

The 200 mg prolonged-release tablets are white or almost white, biconvex, oblong, 15.2 mm long, 7.7 mm wide, and 4.8 mm thick, with the mark "200" on one face.

They are presented in PVC/PCTFE-aluminum blister packs. The pack sizes are 10, 20, 30, 50, 60, and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

60314 Frankfurt

Germany

Date of the Last Revision of this Leaflet: June 2024

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