QUETIAPINE SANDOZ 200 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Quetiapine Sandoz 50 mg prolonged-release tablets EFG

Quetiapine Sandoz 150 mg prolonged-release tablets EFG

Quetiapine Sandoz 200 mg prolonged-release tablets EFG

Quetiapine Sandoz 300 mg prolonged-release tablets EFG

Quetiapine Sandoz 400 mg prolonged-release tablets EFG

quetiapine

Read the entire patient information leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Patient Information Leaflet

1. What Quetiapine Sandoz is and what it is used for
2. What you need to know before taking Quetiapine Sandoz
3. How to take Quetiapine Sandoz
4. Possible side effects
5. Storage of Quetiapine Sandoz
6. Package contents and additional information

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

Quetiapine Sandoz contains the active substance quetiapine. It belongs to a group of medications called antipsychotics. Quetiapine can be used to treat several diseases, 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 have difficulty sleeping.
• Mania: for which you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or exhibit poor judgment, including 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 medication used to treat this disease.

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

2. What you need to know before taking Quetiapine Sandoz

Do not take Quetiapine Sandoz

• If you are allergic to quetiapine or any of the other components of this medication (listed in section 6).
• If you are taking any of the following medications:

• some HIV medications,
• azole-type medications (for fungal infections),
• erythromycin or clarithromycin (for infections),
• nefazodone (for depression).

Do not take quetiapine if the above applies to you. If you have any doubts, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if 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 medication that may affect your heart rate,
• 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 (convulsion),
• 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 had low white blood cell counts in the past (which may or may not have been caused by other medications),
• if you are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine because the group of medications to which quetiapine belongs may increase the risk of stroke, or in some cases the risk of death, in these individuals,
• if you are an elderly person with Parkinson's disease/parkinsonism,
• if you or a family member have a history of blood clots, as medications like this have been associated with the formation of blood clots,
• if 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 medications that decrease normal brain activity ("depressants"),
• if you have or have had a condition in which you cannot empty your bladder completely (urinary retention), have an enlarged prostate, a bowel obstruction, or increased pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions,
• if you have a history of alcohol or drug abuse.

Tell your doctor immediately if, after taking Quetiapine Sandoz, 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 injuries (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 fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders may be caused by this type of medication.

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 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 severe intestinal blockage.

• Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase when you first start treatment, as all these medications 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 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 be helpful to tell a family member 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 concerned about changes in your behavior.

Severe skin reactions (SCARs)

With the use of this medication, very rare but severe skin reactions (SCARs) have been reported, which can be life-threatening or fatal. These are commonly manifested as:

• Stevens-Johnson syndrome (SSJ), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including an increased number of 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 patches that itch.

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

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

Other medications and Quetiapine Sandoz

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

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

• Some HIV medications.
• Azole-type medications (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

In particular, tell your doctor if you are using any of the following medications:

• Medications for epilepsy (such as phenytoin or carbamazepine).
• Medications for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medications).
• Medications that affect your heart rate, such as medications that can cause an imbalance in electrolytes (low potassium or magnesium levels) such as diuretics (medications to urinate) or certain antibiotics (medications to treat infections).
• Medications that can cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.

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

Taking Quetiapine Sandoz with food, drinks, and alcohol

• Quetiapine may be affected by food, and therefore, you should take your tablets at least one hour before a meal or at bedtime.
• Be careful with 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 medication 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 medication.

You should not take quetiapine during pregnancy, unless you have discussed it 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): tremors, 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 operate tools or machines until you know how the tablets affect you.

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 medications called tricyclic antidepressants (TCAs) when using some analysis methods, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

Quetiapine Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Quetiapine Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, 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 it is usually 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 the help of water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will indicate when).
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

If you have liver problems, your doctor may change your dose.

Elderly

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

Use in children and adolescents(under 18 years of age)

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

If you take more Quetiapine Sandoz than you should

If you take more quetiapine than prescribed by your doctor, you may feel drowsy, dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring the Quetiapine Sandoz tablets with you.

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 medication and the amount ingested.

If you forget to take Quetiapine Sandoz

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 Sandoz

If you stop taking quetiapine abruptly, you may experience insomnia, nausea, or headache, diarrhea, vomiting, dizziness, or irritability.

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

If you have any other questions about the use of this medication, 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 (which may lead to falls), headache, or dry mouth.
• Feeling of drowsiness (which may disappear over time as you continue taking quetiapine) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhea, 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 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 heartbeat.
• Feeling like your heart is beating strongly, quickly, or has skipped beats.
• Constipation or 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 (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• 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. Increases in prolactin hormone may, 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 than normal heart rate that can occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.
• Confusion.

Rare(may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a disorder called "neuroleptic malignant syndrome").
• Yellowish color of 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 bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Walking, talking, eating, or other activities while you are asleep.
• Decreased body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") where you may suffer from a combination of three or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased 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 called agranulocytosis.
• Intestinal obstruction.
• Increased 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):

• Red spots on the skin with irregular red patches (erythema multiforme).
• Rapid appearance of areas of red skin with small pus-filled bumps (small blisters filled with white/yellow liquid known as 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).
• Drug reaction with eosinophilia and systemic symptoms (DRESS) which consists of flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may appear in newborns of mothers who have used quetiapine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Inflammation of blood vessels (vasculitis), often with skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs may cause heart rhythm problems that can be serious and, in severe cases, potentially 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, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. Increases in prolactin hormone may, 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.

Other 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. Increases in prolactin hormone may, 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 (which may lead to falls).
• Stuffy nose.
• Feeling irritated.

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 does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Quetiapine Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton after CAD/EXP. The expiry date is the last day of the month shown.

HDPE bottle: after first opening, use before the expiry date shown on the carton after CAD/EXP.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the cartons and any remaining medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapine Sandoz

• The active substance is quetiapine. Each tablet contains 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine (as quetiapine fumarate).

• The other ingredients are:

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

Coating of the tablet: methacrylic acid - ethyl acrylate copolymer (1:1) type A, triethyl citrate.

Appearance of the Product and Package Contents

• Quetiapine Sandoz 50 mg are prolonged-release tablets, white to off-white, round, biconvex, engraved with "50" on one side, and measure 7.1 mm in diameter and 3.2 mm in thickness.
• Quetiapine Sandoz 150 mg are prolonged-release tablets, white to off-white, oblong, biconvex, engraved with "150" on one side, and measure 13.6 mm in length, 6.6 mm in width, and 4.2 mm in thickness.
• Quetiapine Sandoz 200 mg are prolonged-release tablets, white to off-white, oblong, biconvex, engraved with "200" on one side, and measure 15.2 mm in length, 7.7 mm in width, and 4.8 mm in thickness.
• Quetiapine Sandoz 300 mg are prolonged-release tablets, white to off-white, oblong, biconvex, engraved with "300" on one side, and measure 18.2 mm in length, 8.2 mm in width, and 5.4 mm in thickness.
• Quetiapine Sandoz 400 mg are prolonged-release tablets, white to off-white, oval, biconvex, engraved with "400" on one side, and measure 20.7 mm in length, 10.2 mm in width, and 6.3 mm in thickness.

Quetiapine Sandoz is presented in aluminum PVC/PCTFE blister packs inserted in a cardboard box.

Quetiapine Sandoz is also presented in a white opaque HDPE bottle with a child-resistant polypropylene screw cap and an induction-sealed liner.

The pack sizes for the blisters are: 10, 30, 50, 56, 60, and 100 tablets.

The pack sizes for the bottles are: 60 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben, Sachsen-Anhalt

Germany

or

PHARMATHEN INTERNATIONAL S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5

Rodopi 69300

Greece

or

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attiki

Greece

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release tablets

Austria: Quetiapin Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg Retardtabletten

Belgium: Quetiapin Retard Sandoz 50 mg tablets with prolonged release

Quetiapin Retard Sandoz 200 mg tablets with prolonged release

Quetiapin Retard Sandoz 300 mg tablets with prolonged release

Quetiapin Retard Sandoz 400 mg tablets with prolonged release

Germany: Quetiapin HEXAL® 50/150/200/300/400 Retardtabletten

Finland: Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release tablets

France: Quetiapin Sandoz LP 50 mg/300 mg/400 mg, prolonged-release tablets

Ireland: Quetex XR 50 mg/200 mg/300 mg/400 mg Prolonged-release tablets

Iceland: Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release tablets

Italy: Quetiapina Sandoz BV

Netherlands: Quetiapine Sandoz SR 50 mg/150 mg/200 mg/300 mg/400 mg, tablets with prolonged release

Poland: Kvelux SR

Portugal: Quetiapina Sandoz

Sweden: Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release tablets

Slovenia: Kvelux SR 50 mg/150 mg/200 mg/300 mg/400 mg tablets with prolonged release

Slovakia: Quetiapin Sandoz 200 mg/300 mg

United Kingdom: Psyquet XL 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release tablets

Date of Last Revision of this Leaflet:May 2023

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