Leaflet: information for the user

Quetiapine pensa 200 mg film-coated tablets

quetiapine

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. 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 Quetiapine Pensa is and what it is used for

2. What you need to know before you start taking Quetiapine Pensa

3. How to take Quetiapine Pensa

4. Possible side effects

5. Storage of Quetiapine Pensa

6. Contents of the pack and additional information

Quetiapina Pensa containsa substance called quetiapina. It belongsto a group of medicines called antipsychotics. Quetiapina Pensa can be used to treat several illnesses, such as:

?Bipolar depression: by which you feel sad. You may findthat you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.

• Mania: by which you may feel extremely excited, euphoric, agitated, enthusiastic or hyperactive or present poor judgment which includes being aggressive or violent.

?Schizophrenia: by 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.

Your doctor may continue prescribing Quetiapina Pensa even when you feel better.

Do not take Quetiapina Pensa:

?if you are allergic (hypersensitive) to quetiapina 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)

Do not take Quetiapina Pensa if the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Quetiapina Pensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Pensa if:youor a family member has 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.

?You have low blood pressure.

?You have had a stroke, especially if you are elderly.

?You have liver problems.

?You have had a seizure (convulsion).

?You have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking quetiapina.

?You know that you have had low white blood cell counts (which may or may not have been caused by other medicines).

?You are an elderly person with dementia (loss of brain function). If so, do not take quetiapina because the group of medicines to which quetiapina belongs may increase the risk of stroke or, in some cases, death in these people.

?You or a family member has a history of blood clots, as medicines like these have been associated with blood clot formation.

• If you have depression or other conditions treated with antidepressants. The use of these medicines with quetiapina may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapina Pensa").

Inform your doctor immediately if after taking Quetiapina Pensa you experience any of the following:

?A combination of fever, intense muscle stiffness, sweating or a decrease in consciousness (a condition known as "neuroleptic malignant syndrome"). You may need immediate medical treatment.

?Uncontrolled movements, mainly of your face or tongue.

?Dizziness or you feel very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.

?Seizures (convulsions).

?Prolonged and painful erection (priapism).

•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.

These conditions may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to flu, sore throat, or any other infection, as it may be a consequence of a very low white blood cell count and require discontinuation of quetiapina 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 when you first start treatment, as all these medicines 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 thoughts of suicide and/or suicidal behaviour in young adults under 25 with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close relative 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.

Weight gain

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

Children and adolescents

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

Other medicines and Quetiapina Pensa

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

Do not take Quetiapina Pensa 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)

• Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium) such as diuretics (medicines to help you urinate) or certain antibiotics (medicines to treat infections).

?Medicines that may cause constipation.

• Antidepressants. These medicines may interact with quetiapina 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.

Taking Quetiapina Pensa with food, drinks and alcohol

?Quetiapina Pensa can be taken with or without food.

?Be careful about the amount of alcohol you drink. This is because the combined effect of Quetiapina Pensa and alcohol may make you drowsy.

?Do not take grapefruit juice while taking Quetiapina Pensa. It may affect how the medicine works.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant. Your doctor may need to adjust your treatment.

Do not take Quetiapina Pensa during pregnancy, unless your doctor has advised you to. Do not use Quetiapina Pensa if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapina in the last trimester (last three months of pregnancy): shivering, 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.

Quetiapina Pensa contains lactose.

Inform your doctor if you have been told you have an intolerance to some sugars. Consult your doctor before taking this medicine.

Effect on drug detection tests in urine

If you are having a drug detection test in urine, taking quetiapina may produce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when using some testing 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 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 150 mg and 800 mg.

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

Swallow your tablets whole with the help of water.

You can take the tablets with or without food.

Do not take grapefruit juice while taking Quetiapina Pensa. 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 adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

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

Taking more Quetiapina Pensa than prescribed

If you take more Quetiapina Pensa than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats.Contact your doctor or the nearest hospital immediately.

Carry the Quetiapina Pensa tablets with you.

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

Missing a dose of Quetiapina Pensa

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.

Stopping treatment with Quetiapina Pensa

If you stop taking Quetiapina Pensa 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.

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

?Dizziness (may lead to falls), headache, dry mouth.

?Drowsiness (which may disappear over time as you continue to take quetiapine) (may lead to falls).

?Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include insomnia, nausea, 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 rigid without pain.

?Changes in the amount of certain fats (triglycerides and total cholesterol).

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

?Fast heart rate

?Feeling like your heart is pounding, racing, or skipping beats.

?Constipation, indigestion

?Feeling weak

?Swelling of arms or legs

?Low blood pressure when standing. This may make you feel dizzy or faint (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.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
• • Swelling of the breasts and unexpected milk production in both men and women.
  • Irregular or absent menstrual periods in women.

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

• Seizures or convulsions.

?Reactions to the medication that may include hives, skin swelling, and swelling around the mouth.

?Unpleasant sensations in the legs (also known as restless leg syndrome).

?Difficulty swallowing

?Uncontrolled movements, mainly of the face or tongue.

• Sexual dysfunction.
• Diabetes.
• Change in heart rhythm seen on an ECG (prolongation of the QT interval).
• Slower than normal heart rate that may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (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.

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

?A combination of high temperature (fever), sweating, muscle stiffness, feeling extremely drowsy or dizzy (a condition known as "neuroleptic malignant syndrome").

?Yellowing of the skin and eyes (jaundice).

?Inflammation of the liver (hepatitis).

?Prolonged and painful erection (priapism).

?Swelling of the breasts and unexpected milk production (galactorrhea).

?Menstrual disorders

• 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 medical attention immediately.
• Sleepwalking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (known as "metabolic syndrome") in which you may have a combination of 3 or more of the following effects: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides in the blood, increased blood pressure, and increased blood sugar levels.

• 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 creatine phosphokinase in the blood (a substance found in muscles).

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

?Severe rash, blisters, or red spots on the skin

?Severe allergic reaction (known as anaphylaxis) that may 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).
• Incorrect secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

?Worsening of pre-existing diabetes.

Unknown (frequency cannot be estimated from available data)

• Rashes on the skin with irregular red patches (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).

?Birth defects in babies born to mothers who have used quetiapine during pregnancy.

• Medication rash with eosinophilia and systemic symptoms (DRESS, for its English acronym). Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (medication rash 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.
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots.

This class of medications to which Quetiapine Pensa belongs may cause heart rhythm problems that can be severe and, in severe cases, fatal.

Some side effects are only seen when a blood test is done. 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, increases in liver enzymes, decreases in the number of certain types of blood cells, decreases in the number of red blood cells, increases in the amount of creatine phosphokinase in the blood (a substance found in muscles), decreases in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following:

?Both men and women may have breast swelling and unexpected milk production.

Women may have irregular or absent menstrual 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 followingside effects have been observed more frequently in children and adolescents ornot observed in adults:

Very common 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 the following:
• • Both boys and girls may have breast swelling and unexpected milk production.
  • Girls may have irregular or absent menstrual periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling restless or rigid without pain.
• Increased blood pressure.

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

• Feeling weak, fainting (may 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 theSpanish 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 thismedicine.

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.

No special storage conditions are required.

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 of Quetiapina Pensa

The active ingredient is quetiapine. The tablets contain 200 mg of quetiapine (as quetiapine fumarate).

? The other components are:

Core of the tablet: povidone K30 (E1201); microcrystalline cellulose (E460); dihydrogen phosphate of calcium dihydrate, sodium glycolate of corn type C (cornstarch); colloidal anhydrous silica; magnesium stearate (E572).

Coating of the tablet : hypromellose (E464); lactose monohydrate (lactose); macrogol 3350, triacetin; titanium dioxide (E171).

Appearance of the product and content of the container

The tablets are round, biconvex, and white.

They are presented in PVC-Al blisters in containers

of 60 or 90 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Zaklady Farmaceutyczne Polpharma S.A.,

(Pharmaceutical Works Polpharma SA)

ul. Pelplinska 19,

83-200 Starogard Gdanski,

Poland.

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Quetiapina Pensa 200 mg, film-coated tablets EFG

Date of the last review of this leaflet: May 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/