Patient Information Leaflet

Quetiapina Stada 50 mg prolonged-release tablets EFG

Quetiapina Stada 150 mg prolonged-release tablets EFG

Quetiapina Stada 200 mg prolonged-release tablets EFG

Quetiapina Stada 300 mg prolonged-release tablets EFG

Quetiapina Stada 400 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 the same symptoms as 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 Stada is and what it is used for

2.What you need to know before you start taking Quetiapina Stada

3.How to take Quetiapina Stada

4.Possible side effects

5.Storage of Quetiapina Stada

6.Contents of the pack and additional information

Quetiapina Stada contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat several illnesses, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: for which you 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, it will be taken in addition to another medicine that is being used to treat this illness.

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

Do not takeQuetiapina Stada

• 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 Stada:

• If you, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness or inflammation of the heart, or if you are taking any medicine that may affect your heart rhythm.
• If you have low blood pressure.
• If you have had a stroke, especially if you are an elderly patient.
• If you have liver problems.
• If you have ever had a seizure (convulsion).
• If you have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking quetiapine.
• If you know that you have had low white blood cell counts (which may or may not have been caused by other medicines).
• If you are an elderly 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.
• If you are an elderly patient with Parkinson's disease or parkinsonism
• If you or a family member has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
• If you have or have had a condition in which your breathing is interrupted for short periods of time during normal sleep (called "sleep apnea") and are taking medicines that decrease normal brain activity ("depressants").
• If you have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, an intestinal obstruction, 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.
• If you have a history of alcohol or drug abuse.
• 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 Stada").

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 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 elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast 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 conditions may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and may require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as it 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 medicines 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 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 can ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Drug reaction with eosinophilia and systemic symptoms (DRESS)

Generalised rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS).

If you develop these symptoms, stop using quetiapine 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

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

Other medicines andQuetiapina Stada

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:

• 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) such as diuretics (medicines for urination) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work, 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 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.

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

TakingQuetiapina Stadawith 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 about the amount of alcohol you drink. This is because the combined effect of quetiapine and alcohol may make you drowsy.
• Do not take grapefruit juice while taking quetiapine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist 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, respiratory problems, and feeding difficulties. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

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

Quetiapina Stadacontains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before starting to take this medicine.

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 antidepressant medicines 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. 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 usually 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 quetiapina. 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

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

If you take moreQuetiapina Stadathan you should

If you take more quetiapina than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately or call the Toxicological Information Service, phone: 91 562 04 20. Bring the quetiapina tablets with you.

If you forget to takeQuetiapina Stada

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for the missed dose.

If you interrupt the treatment withQuetiapina Stada

If you stop taking quetiapina 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 interrupting treatment.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Very common (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 quetiapine) (which may lead to falls).
• Discontinuation 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 stiff without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol) in the blood.

Common (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 cause dizziness or fainting (which 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.
• Increased levels of liver enzymes measured in the blood.

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

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

- In women, not having a menstrual period or having irregular periods.

Rare (may affect up to 1 in 100 people):

Very rare (may affect up to 1 in 10,000 people):

Unknown (frequency cannot be estimated from available data):

- Stroke

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

Some side effects are only observed when blood tests are 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, increased levels of liver enzymes, decreased numbers of certain types of blood cells, decreased number of red blood cells, increased levels of creatine phosphokinase in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased levels of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to:

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):

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

- In girls, not having a menstrual period or having irregular periods.

• • Increased appetite.
  • Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling restless or stiff without pain.
• Increased blood pressure.

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

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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 storage conditions.

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

Composition ofQuetiapina Stada

• • The active ingredient is quetiapine.
  • Quetiapina Stada 50 mg tablets contain 50 mg of quetiapine (as quetiapine fumarate).
• Quetiapina Stada 150 mg tablets contain 150 mg of quetiapine (as quetiapine fumarate).
• Quetiapina Stada 200 mg tablets contain 200 mg of quetiapine (as quetiapine fumarate).
• Quetiapina Stada 300 mg tablets contain 300 mg of quetiapine (as quetiapine fumarate).
• Quetiapina Stada 400 mg tablets contain 400 mg of quetiapine (as quetiapine fumarate).
• • The other components are:

Tablet core: lactose, copolymer of methacrylic acid - ethyl acrylate (1:1), crystalline maltose Type A, 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 package

The 50 mg prolonged-release tablets are white or off-white, biconvex, round, 7.1 mm in diameter, and 3.2 mm in height, and have "50" engraved on one face.

The 150 mg prolonged-release tablets are white or off-white, biconvex, oblong, 13.6 mm in length, 6.6 mm in width, and 4.2 mm in height, and have "150" engraved on one face.

The 200 mg prolonged-release tablets are white or off-white, biconvex, oblong, 15.2 mm in length, 7.7 mm in width, and 4.8 mm in height, and have "200" engraved on one face.

The 300 mg prolonged-release tablets are white or off-white, biconvex, oblong, 18.2 mm in length, 8.2 mm in width, and 5.4 mm in height, and have "300" engraved on one face.

The 400 mg prolonged-release tablets are white or off-white, biconvex, oval, 20.7 mm in length, 10.2 mm in width, and 6.3 mm in height, and have "400" engraved on one face.

Quetiapina Stada is packaged in PVC/PCTFE-aluminum foil blisters, packaged in the following package sizes:

50 mg: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 tablets.

150 mg: 10, 20, 30, 60, 90, 100, 120, 180, and 200 tablets.

200 mg: 10, 20, 30, 60, 90, 100, 120, 180, and 200 tablets.

300 mg: 10, 20, 30, 60, 90, 100, 120, 180, and 200 tablets.

400 mg: 10, 20, 30, 60, 90, 100, 120, 180, and 200 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

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

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

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

AustriaQuetiapin STADA 50/150/200/300 mg Retardtabletten

BelgiumQuetiapine Retard EG 50/150/200/300 mg tabletten met verlengde afgifte

GermanyBiquetan 50/150/200/300 mg Retardtabletten

DenmarkBiquetan

IrelandSeropia XR 50/150/200/300 mg prolonged-release tablets

ItalyQUETIAPINA EG STADA

SpainQuetiapina Stada 50/150/200/300 mg comprimidos de liberación prolongada EFG

RomaniaBiquetan 50/150/200/300 mg comprimate cu eliberare prelungita

Last review date of this leaflet: August 2024.

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