Quetiapine Aurovitas 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

QuetiapineAurovitas50 mg film-coated tablets

Read the entire 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Quetiapine Aurovitas contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapine 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 highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.

? Schizophrenia: when you may hear or feel things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

Your doctor may continue prescribing quetiapine to you even after you start feeling better.

2. What you need to know before taking Quetiapine Aurovitas

Do not take Quetiapine Aurovitas:

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

? If you are taking any of the following medicines:

• certain HIV medications
• 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

Talk to your doctor or pharmacist before starting Quetiapine Aurovitas:

? If you, or a family member, have or have had any heart problems, such as heart rhythm disorders, weakened heart muscle, or heart inflammation, or if you are taking any medicine that may affect your heartbeat.

? 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 quetiapine.

? If you know you have previously had low levels of white blood cells (either with or without being caused by other medicines).

? If you are an elderly person with dementia (loss of brain function). In this case, you should not take quetiapine, as the group of medicines to which quetiapine belongs may increase the risk of stroke or, in some cases, risk of death in these patients.

? 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 briefly during normal sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).

? If you have or have had a condition where you cannot fully empty your bladder (urinary retention), have 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 quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapine Aurovitas”).

Inform your doctor immediately if, after taking quetiapine, 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 required.

? Uncontrollable movements, mainly of the face or tongue.

? Dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.

? Seizures (convulsions).

? A prolonged and painful erection (priapism).

? Fast or irregular heartbeats, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. 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 count of white blood cells and may require stopping quetiapine treatment 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 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. This may be more likely if you are a young adult. Clinical trial data 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 let you know 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 and potentially life-threatening or fatal skin reactions (SCARs) have been reported with this medicine. These commonly include:

• 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 pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red spots that itch.

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

Weight gain

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

Children and adolescents

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

Other medicines and Quetiapine Aurovitas

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

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

? Certain HIV medications
? 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:

? Medicines for epilepsy (such as phenytoin or carbamazepine).
? Medicines for high blood pressure.
? Barbiturates (for difficulty sleeping).
? Thioridazine or lithium (other antipsychotic medicines).
? Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (medicines to increase urination) 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 quetiapine and you may experience symptoms such as involuntary and rhythmic muscle contractions, including eye movement control, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

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

Taking Quetiapine Aurovitas with food, drinks, and alcohol

? Quetiapine can be taken with or without food.

? Be cautious about the amount of alcohol you consume. 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should not take quetiapine during pregnancy unless advised by your doctor. You should not use quetiapine while breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns of mothers who have used 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

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

Quetiapine Aurovitas contains sodium

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

Quetiapine Aurovitas contains lactose

This medicine contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking quetiapine may produce positive results for methadone or certain antidepressant medicines 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 Quetiapine Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. 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.

? You will take your tablets once a day, at bedtime, or twice a day, depending on your condition.

? Swallow the tablets whole with water.

? You may take the tablets with or without food.

? 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 adjust your dose.

Elderly patients

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

Use in children and adolescents

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

If you take more Quetiapine Aurovitas than you should

If you take more Quetiapine Aurovitas than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take your Quetiapine Aurovitas tablets with you.

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

If you forget to take Quetiapine Aurovitas

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 stop taking Quetiapine Aurovitas

If you stop taking quetiapine suddenly, you may have difficulty sleeping (insomnia), or feel nauseous, or experience headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce 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 disappear 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 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, restlessness, 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 beating irregularly.

? 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 blood levels of the hormone prolactin. 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 the 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 blood sodium levels.

• 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 feeling very drowsy or dizzy (a disorder known as "neuroleptic malignant syndrome").

? Yellowing of the skin and eyes (jaundice).

? Inflammation of the liver (hepatitis).

? Prolonged and painful erection (priapism).

? Breast enlargement and unexpected milk production (galactorrhoea).

? Menstrual disorders.

? 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 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 abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a type of blood fat 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 levels of 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 disease affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.

? Inappropriate secretion of a hormone that controls urine volume.

? Rupture of muscle fibres 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 spotted 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), which consists of 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 have 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 quetiapine belongs can cause heart rhythm problems that may be serious and, in severe cases, could be fatal.

Some adverse effects are only detected by 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, increases in liver enzymes, decreases in certain types of blood cells, decreased number of red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased blood sodium levels, and increased blood levels of the hormone prolactin. 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

? Increase in blood levels of a hormone called prolactin. 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 or pharmacist, 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 Quetiapine Aurovitas

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 is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Aurovitas 50 mg

• The active substance is quetiapine. Each film-coated tablet contains 50 mg of quetiapine (as quetiapine fumarate).
• The other components are:

Tablet core: calcium hydrogen phosphate dihydrate, lactose monohydrate, microcrystalline cellulose (Grade-101 and Grade-102), sodium carboxymethyl starch (Type A), povidone (K-30), colloidal anhydrous silica, talc, magnesium stearate.

Tablet coating: hypromellose (6cp), macrogol 400, titanium dioxide, black printing ink containing shellac and black iron oxide.

Appearance of the product and contents of the pack

Quetiapine Aurovitas 50 mg film-coated tablets:

[Size: Approximately 6.6 mm]

White, round, biconvex, film-coated tablets marked “F84” on one side and smooth on the other.

Quetiapine Aurovitas 50 mg film-coated tablets are available in blister packs and HDPE bottles.

Pack sizes:

Blister pack: 6, 10, 20, 30, 50, 60, 90, 100, 120, 180, 240 film-coated tablets.

HDPE bottle: 60, 100, 250, 500, 1,000 film-coated tablets.

Only certain 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:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Belgium: Quetiapine AB 25 mg / 100 mg / 200 mg / 300 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Germany: Quetiapin PUREN 50 mg/200 mg/300 mg/400 mg Filmtabletten

Poland: Quetiapine Aurovitas

Portugal: Quetiapina Ritisca

Spain: Quetiapina Aurovitas 50 mg comprimidos recubiertos con pelicula

Date of the most recent review of this leaflet: October 2024

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