Package Insert: Information for the User

Quetiapina Teva-ratio 150 mg Extended-Release Tablets EFG

quetiapine

Read this package insert carefully before starting to take this medication,because it contains important information for you.

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

1. What isQuetiapina Teva-ratio and for what it is used

2. What you needto know before starting to take Quetiapina Teva-ratio

3. Howto take Quetiapina Teva-ratio

4. Possible adverse effects

5. Storage ofQuetiapina Teva-ratio

6. Contents of the package and additional information

Quetiapina Teva-ratio contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quetiapina Teva-ratio may be used to treat several diseases, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: for which you may 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 Quetiapina Teva-ratioextended-release tabletsto treat major depressive episodes in major depressive disorder, this will be taken in addition to another medication that is being used to treat this disease.

Your doctor may continue prescribing Quetiapina Teva-ratioeven when you are feeling better.

Do not takeQuetiapina Teva-ratio:

• if you are allergic to quetiapine or any of the other ingredients in this medicine,(see section 6).
• if you are taking any of the following medicines:

-Some medicines for HIV

-Azole-type medicines (for fungal infections)

-Erythromycin or clarithromycin (for infections)

-Nefazodone (for depression).

If you are unsure, consult your doctor or pharmacist before taking Quetiapina Teva-ratio.

Warnings and precautions

Consult your doctoror pharmacistbefore starting to take Quetiapina Teva-ratio:

• if you, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness or heart inflammation, 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 elderly.
• if you have liver problems.
• if you have ever had a seizure (convulsion).
• 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 “Use of Quetiapina Teva-ratio with other medicines”).
• 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 person with dementia (loss of brain function). If so, do not take quetiapine,because the group of medicines to which Quetiapina Teva-ratio belongs may increase the risk of stroke, or in some cases the risk of death, in these people with dementia.
• 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 these have been associated with the formation of blood clots.
• if you have or have had a condition in which your breathing is interrupted by 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, a bowel 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.

Inform your doctor immediately if after taking Quetiapina Teva-ratioyou 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.
• Fast 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.

• 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).

These conditions 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 it may be a consequence of very low white blood cell counts and 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 bowel obstruction.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or taking your own life. This may be more likely when you first start treatment, as these medicines take time to become effective, 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 behaviour in young adults under 25 with depression.

If you ever think about harming yourself or taking your own life, 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 tell you if they think your depression is getting worse, or if they are concerned about changes in your behaviour.

Severe skin reactions (SCARs)

Very rarely, severe skin reactions (SCARs) have been reported with the use of this medicine, which may put your life at risk or be fatal. These usually manifest as:

• Stevens-Johnson syndrome (SSJ), a generalised rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (NET), 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 eosinophilia and elevated liver enzymes).
• Generalised acute pustular psoriasis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using Quetiapina Teva-ratio 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 Teva-ratioshould not be used in children and adolescents under 18 years of age.

Use of Quetiapina Teva-ratiowith other medicines

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

Do not take Quetiapina Teva-ratio 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).

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).
• Antidepressants. These medicines may interact with Quetiapina Teva-ratio 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 a body temperature above 38 °C (serotonin syndrome). Contact your doctor when you experience these symptoms.
• Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium levels) 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.

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

Taking Quetiapina Teva-ratiowith food, drinks, and alcohol

• Quetiapina Teva-ratiomay be affected by food, so take your tablets at least one hour before a meal or before going to bed.
• Be careful about the amount of alcohol you drink. This is because the combined effect ofQuetiapina Teva-ratioand alcohol may make you drowsy.
• Do not take grapefruit juice while takingQuetiapina Teva-ratio. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Do not takeQuetiapina Teva-ratioduring pregnancy, unless you have consulted your doctor. Do not useQuetiapina Teva-ratioif you are breastfeeding.

The following symptoms,which may represent withdrawal symptoms,may appear in newborn babies of mothers who have used quetiapine in the last trimester (last three months of their pregnancy): tremor, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating 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 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 some analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Quetiapina Teva-ratio contains sodium

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

Follow exactly the administration instructions of 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 your needs, but it will normally be between 150mg and 800mg.

• 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 Teva-ratio. 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 Teva-ratioshould not be used in children and adolescents under 18 years of age.

If you take moreQuetiapina Teva-ratiothan you should

If you take moreQuetiapina Teva-ratiothan your doctor prescribed, you mayfeel drowsy, feel dizzyand experience abnormal heartbeats. Contact your doctoror the nearest hospital immediately. Bring your Quetiapina Teva-ratiotablets with you.

You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to takeQuetiapina Teva-ratio

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 interrupt treatment withQuetiapina Teva-ratio

If you stop taking Quetiapina Teva-ratio abruptly,you may be unable to fall asleep (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 stopping treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you have any of the following serious side effects, stop taking Quetiapina Teva-ratio and seek medical attention immediately:

Frequent side effects(may affect up to 1 in 10 people)

• Thoughts of suicideand worsening of your depression.

Less frequent side effects(may affect up to 1 in 100 people)

• Sudden fever, especially withthroat painandflu-like symptoms. They may be

signs of a very low white blood cell count.

• Signs ofskin reactionssuch as skin rash, urticaria, hives, redness, itching, possibly withswelling of the face, eyelids, and lips. This could also cause difficulty breathing, dizziness, or shock.
• Seizuresorconvulsions.
• Uncontrollable movements, mainly of your face or tongue (tardive dyskinesia).
• Sensation that your heart isbeating very fast or beating very rapidlyalong withdizziness or fainting. This can be a sign of serious heart rhythm problems and in severe cases can be fatal.

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

• Painintense and oswellingand rednessin one of your legs;Pain severeabruptly in the chestthat can reach the left arm ordifficulty breathingabruptly. These may be signs of blood clots in the veins.
• Pain severe in the upper stomach, often radiating to the back, sometimes withnausea and vomiting. This can be a sign of pancreatitis.
• Constipationalong withpersistent abdominal painor constipation that has not responded to treatment, as this can lead to a more severe intestinal blockage.
• Yellowish discoloration of the skin and eyes(jaundice), dark urine, especially along with unusual fatigue or fever (signs of hepatitis).
• Aprolonged erectionandpainful.
• A combination offever, sweating, rigid muscles, feeling of drowsiness or fainting (a condition called "neuroleptic malignant syndrome").

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

• Severe skin rash, blisters, or red spots on the skin.
• Severe allergic reaction (anaphylaxis) that can cause difficulty breathing or shock.
• Quick 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.
• Abnormal secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and pain in the muscles (rhabdomyolysis).

Unknown side effects(frequency cannot be estimated from available data)

• Red, irregular patches on the skin (erythema multiforme). See section 2.
• Rapid appearance of red skin patches with small white or yellow pustules (Pustulosis Exanthemática Generalizada Aguda (AGEP). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Cardiomyopathy (heart muscle disorder)
• Myocarditis (inflammation of the heart muscle)
• Stroke

Drug reaction with eosinophilia and systemic symptoms (DRESS). A generalized rash, elevated body temperature, elevated liver enzymes, abnormal blood tests (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.

Other possible side effects

Do not worry if you see a tablet in your stoolafter taking Quetiapina Teva-ratio. As the tablet passes through your gastrointestinal tract, quetiapine is released slowly. The tablet shape remains intact and is eliminated in the stool. Therefore, although you may see a tablet in your stool, your quetiapine dose has been absorbed..

Frequent side effects(may affect more than 1 in 10 people)

• Dizziness (could lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to take quetiapine),(could lead to falls).
• Symptoms of withdrawal (symptoms that occur when you stop taking quetiapine), which include being unable to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability.It is recommended to taper off over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Decrease in hemoglobin levels (proteins in red blood cells that carry oxygen).
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Frequent side effects(may affect up to 1 in 10 people)

• Fast heart rate.
• Sensation that your heart isbeating very fast or beating very rapidlyalong withdizziness or fainting.
• Constipation, indigestion (stomach upset).
• Sensation of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This can make you feel dizzy or faintor (could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorder.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Changes in the number of certain types of blood cells.
• Increases in liver enzymes measured in the blood.
• Increases in prolactin hormone levels in the blood. Elevated prolactin levels may, in rare cases, lead to:

• Both in men and women having breast swelling and unexpected milk production.
• In women not having a menstrual period or having irregular periods.

Less frequent side effects(may affect up to 1 in 100 people)

• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• Diabetes.
• Slower than normal heart rate, which may occur at the start 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 the blood.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes
• Confusion

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

• Swelling of the breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Walking, talking, eating, or other activities while you are asleep.
• Decreased body temperature (hypothermia).
• A condition (called “metabolic syndrome”) where you may experience a combination of 3 or more of the following effects: increased belly fat, decreased “good” cholesterol (HDL-C), increased triglycerides in the blood, increased blood pressure, and increased blood sugar levels.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

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

• Abnormal secretion of a hormone that controls urine volume.

Unknown(frequency cannot be estimated from available data)

• Symptoms of withdrawal may occur in newborns of mothers who have used quetiapine during pregnancy.
• Inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots.

Some side effects are only observed when a blood test is performed. These include changes in the amount of certain fats (triglycerides and total cholesterol) or blood sugar levels, 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-phosphocinase in the blood (a substance found in muscles), decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to:

• Both in men and women having breast swelling and unexpected milk production.
• Women not having a menstrual period or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

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:

Frequent side effects(may affect more than 1 in 10 people)

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

-Both in children and girls having breast swelling and unexpected milk production.

-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 muscle stiffness without pain.
• Increased blood pressure.

Frequent side effects(may affect up to 1 in 10 people)

• Sensation of weakness, fainting (could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: 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 and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Quetiapina Teva-ratiodoes not require any special storage temperature.

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

Composition of Quetiapina Teva-ratio

The active ingredient is quetiapine. Quetiapina Teva-ratio tablets contain 150mg of quetiapine (as quetiapine fumarate).

The other components are:

Tablet core:hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate.

Tablet coating:titanium dioxide (E171), hypromellose, macrogol/PEG 400, polysorbate 80.

Appearance of Quetiapina Teva-ratio and packaging contents

The tablets are white, biconvex, oblong, coated, and engraved with “Q 150” on one side.

They are presented in packaging of 10, 20, 30, 50, 50x1 (perforated single-dose blister) (hospital packaging), 56 (calendar packaging), 60, 90, 100, and 100x1 (perforated single-dose blister) tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Manufacturer responsible

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

Teva Operations Poland SP Z.O.O.

ul. Mogilska 80. 31-546, Krakow

Poland

Teva Pharma, S.L.U.

C/C, n. 4, Industrial Estate Malpica, 50016 Zaragoza

Spain

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Last review date of this leaflet:July 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/82292/P_82292.html