Quetiapine Stada 300 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quetiapine Stada 50 mg prolonged-release tablets EFG

Quetiapine Stada 150 mg prolonged-release tablets EFG

Quetiapine Stada 200 mg prolonged-release tablets EFG

Quetiapine Stada 300 mg prolonged-release tablets EFG

Quetiapine Stada 400 mg prolonged-release tablets EFG

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 must not be given 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 these are effects not listed in this leaflet. See Section 4.

Contents of the leaflet

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

1. What Quetiapina Stada is and what it is used for

Quetiapina Stada 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 and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: where you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have impaired judgment, which may include aggressive or violent behavior.
• Schizophrenia: where you may hear or sense 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 is taken in addition to another medicine you are already taking for this condition.

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

2. What you need to know before taking Quetiapina Stada

DO NOT take Quetiapina Stada

• 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:

- some medicines for HIV

- azole-type medicines (for fungal infections)

- erythromycin or clarithromycin (for infections)

- nefazodone (for depression)

If you have any doubts, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Quetiapina Stada:

• If you, or a family member, have or have had any heart problems, for example, irregular heartbeat, weakened heart muscle, 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. In such cases, 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 (which may or may not have been 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, the 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 for short periods during normal nighttime sleep (called “sleep apnea”) and you are taking medicines that reduce 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, 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 or a family member has 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 Quetiapina Stada”).

Contact 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 necessary.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Rapid or irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. 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.

Contact 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 treatment with quetiapine and/or additional treatment.
• Constipation along 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. You may be more likely to have such thoughts 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 ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Drug rash with eosinophilia and systemic symptoms (DRESS).

Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS).

If you develop 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

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

Other medicines and Quetiapina Stada

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

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:

• 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, 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 muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, 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 Quetiapina Stada with food, drinks, and alcohol

• Quetiapine may be affected by food, so you should take your tablets at least one hour before a meal or before bedtime.
• 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 are planning 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 if you are breastfeeding.

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

Quetiapina Stada contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before starting 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 known as tricyclic antidepressants (TCAs), when certain testing methods are used, even though you may not be taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Quetiapine Stada

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine 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 daily.
• Do not split, chew, or crush the tablets.
• Swallow the 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 adjust your dose.

Elderly patients

If you are an elderly patient, 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 Stada than you should

If you take more quetiapine than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately or call the Toxicology Information Service at: 91 562 04 20. Take the quetiapine tablets with you.

If you forget to take Quetiapine 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 forgotten doses.

If you stop taking Quetiapine Stada

If you stop taking quetiapine suddenly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhoea, vomiting, dizziness, or irritability.

Your doctor may recommend gradually reducing 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 decrease 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), feeling nauseous, headache, diarrhoea, 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 restless, or painless muscle rigidity.
• Changes in the levels of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.

• Feeling like 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 the levels of thyroid hormones in the blood.

• Decrease in the number of certain types of blood cells.

• Increases in liver enzyme levels measured in blood.

• Increases in the level of prolactin hormone in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both men and women, breast enlargement and unexpected milk production.

• In women, absence of menstrual periods or irregular periods.

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

• Seizures or fits.
• 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.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the electrical activity of the heart seen on ECG (prolongation of 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 passing urine.
• Fainting (could lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in blood.
• Decrease in the amount of sodium in blood.
• Worsening of pre-existing diabetes.

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 disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the 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”) where you may experience a combination of 3 or more of the following effects: increased abdominal fat, decreased “good cholesterol” (HDL-C), increased levels of a type of fat in the blood 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 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 condition affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Not known (frequency cannot be estimated from available data):

• Skin rashes with irregular red spots (erythema multiforme).

• Sudden and severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis).

• Withdrawal symptoms may occur in newborns of mothers who 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 consisting of small red or purple spots.

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

Some adverse effects are only detected through blood tests. These include changes in the levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in your blood, increased liver enzymes, decreases in the number of certain types of blood cells, decrease in red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decrease in blood sodium levels, and increases in blood prolactin hormone levels. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both men and women, breast enlargement and unexpected milk production.
• 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 have not been observed in adults:

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

• Increase in the level of a hormone called prolactin in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both boys and girls, breast enlargement and unexpected milk production.

• In girls, absence of menstrual periods or irregular periods.

  • • Increased appetite.
    • Vomiting.
  • Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quetiapine Stada

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 refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapina Stada

• • The active substance 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, methacrylic acid-ethyl acrylate copolymer (1:1), crystalline maltose Type A, magnesium stearate and talc.

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

Appearance of the product and contents of the pack

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

The 150 mg prolonged-release tablets are white or almost white, biconvex, oblong, 13.6 mm long, 6.6 mm wide and 4.2 mm high, with "150" engraved on one side.

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 high, with "200" engraved on one side.

The 300 mg prolonged-release tablets are white or almost white, biconvex, oblong, 18.2 mm long, 8.2 mm wide and 5.4 mm high, with "300" engraved on one side.

The 400 mg prolonged-release tablets are white or almost white, biconvex, oval, 20.7 mm long, 10.2 mm wide and 6.3 mm high, with "400" engraved on one side.

Quetiapina Stada is available in PVC/PCTFE-aluminum foil blisters, packed in the following pack 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 pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

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

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 European Economic Area (EEA) Member States under the following names:

Austria Quetiapin STADA 50/150/200/300 mg Retardtabletten

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

Germany Biquetan 50/150/200/300 mg Retardtabletten

Denmark Biquetan

Ireland Seropia XR 50/150/200/300 mg prolonged-release tablets

Italy QUETIAPINA EG STADA

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

Romania Biquetan 50/150/200/300 mg comprimate cu eliberare prelungita

Date of the most recent revision of this leaflet: August 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/