PATIENT INFORMATION LEAFLET

Quetiapina Pharma Combix 400 mg prolonged-release tablets EFG

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See Section 4.

1.What Quetiapina Pharma Combix is and what it is used for

2.What you need to know before taking Quetiapina Pharma Combix

3.How to take Quetiapina Pharma Combix

4.Possible side effects

5.Storage of Quetiapina Pharma Combix

6.Contents of the pack and additional information

Quetiapina Pharma Combix contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapina Pharma Combix may be used to treat several conditions, 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 Pharma Combix,to treat major depressive episodes in major depressive disorder, this will be taken in addition to another medicine that is already being used to treat this condition.

Your doctor may continue prescribing Quetiapina Pharma Combix,even when you are feeling better.

Do not takeQuetiapina Pharma Combix:

• If you are allergic (hypersensitive) to quetiapine or to any of the other components of Quetiapina Pharma Combix,(including 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 Quetiapina Pharma Combix,if the above-mentioned applies to you. If you have any doubts, consult your doctor or pharmacist before taking Quetiapina Pharma Combix.

Warnings and precautions

Consult your doctoror pharmacistbefore starting to take Quetiapina Pharma Combix,if:

• You, or a family member, have or have had any heart problems, for example, heart rhythm problems, heart muscle weakness, or heart inflammation, or if you are taking any medication that may affect your heart rate.
• 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. If so, your doctor may monitor your blood sugar levels while taking quetiapine.
• You know that you have had low white blood cell counts (which may or may not have been caused by other medications).
• You are an elderly person with dementia (loss of brain function). If so, do not take quetiapine,because the group of medications to which Quetiapina Pharma Combix 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 medications like these have been associated with blood clot formation.
• You have depression or other conditions treated with antidepressants.

The use of these medications with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Quetiapina Pharma Combix with other medications").

Inform your doctor immediately if after taking Quetiapina Pharma Combix 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 feeling 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, respiratory problems, chest pain, or unexplained fatigue. Your doctor will examine your heart and, if necessary, refer you to a cardiologist immediately.

These conditions may be caused by this type of medication.

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 more severe intestinal blockage.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medications take time to take effect, usually around two weeks but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to the hospital immediately. It may help to tell a close family member or friend that you are depressed, and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Weight gain

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

Children and adolescents

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

Use of Quetiapina Pharma Combix with other medications

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

Do not take Quetiapina Pharma Combix 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).
• Antidepressants. These medications may interact with quetiapine and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C (serotonin syndrome). Contact your doctor when you experience these symptoms.

Inform 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, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medications for urination) or certain antibiotics (medications for treating infections).
• Medications that may cause constipation.

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

Taking Quetiapina Pharma Combix with food, drinks, and alcohol

• Quetiapina Pharma Combix may be affected by food, so take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you consume. This is because the combined effect ofQuetiapina Pharma Combixand alcohol may make you drowsy.
• Do not take grapefruit juice while takingQuetiapina Pharma Combix. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Do not takeQuetiapina Pharma Combixduring pregnancy, unless you have consulted your doctor. Do not useQuetiapina Pharma Combixif you are breastfeeding.

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

Driving and operating machinery

Quetiapine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Effect on Drug Detection Tests in Urine

If you are undergoing a urine drug detection test, taking quetiapine may produce positive results for methadone or certain antidepressant medications known as tricyclic antidepressants (TCAs) when using certain analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions 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 Pharma Combix. 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 Pharma Combixshould not be used in children and adolescents under 18 years of age.

If you take moreQuetiapina Pharma Combixthan you should

If you take moreQuetiapina Pharma Combixthan your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring your Quetiapina Pharma Combix tablets with you.

You can also call the Toxicological Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to takeQuetiapina Pharma Combix

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

If you interrupt treatment withQuetiapina Pharma Combix

If you stop taking Quetiapina Pharma Combix abruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before interrupting treatment.

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

Like all 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 (which may lead to falls), headache, dry mouth.
• Feeling drowsy (which may disappear over time as you continue to take quetiapine), (which 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, tremor, feeling restless or muscle stiffness 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 beating strongly, rapidly, or irregularly.
• Constipation, indigestion.
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause you to feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• 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 the amount of 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:

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

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

• Seizures or convulsions.

• Allergic reactions that may include hives, swelling of the skin, 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 the electrical activity of the heart 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 (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.

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

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

• Yellowish discoloration of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).

• Breast swelling 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.
• 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 fat around your abdomen, decreased "good" cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, 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):

• A severe rash, blisters, or red spots on the skin.

• Severe allergic reaction (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.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

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

• Rashes on the skin with irregular red spots (erythema multiforme).
• Generalized rash, high body temperature, elevated liver enzymes, abnormal blood tests (eosinophilia), enlarged lymph nodes, and other organs involved (drug eruption 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.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Symptoms of withdrawal in newborns of mothers who have used quetiapine during pregnancy.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a rash of small red or purple spots.

The class of medicines to which Quetiapina Pharma Combix belongs may cause serious heart rhythm problems that can be life-threatening in severe cases.

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, increased liver enzymes, decreased numbers of certain types of blood cells, decreased 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. Elevated prolactin levels may, in rare cases, lead to:

• Both men and women experiencing 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:

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

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

Both boys and girls experiencing 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.

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

• Feeling weak, fainting (which 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 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 medicine.

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.

For the presentation in a bottle: discard the product 60 days after opening the packaging.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from humidity.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofQuetiapina Pharma Combix

• The active ingredient is quetiapine. Each prolonged-release tablet contains 400 mg of quetiapine (as fumarate).
• The other components (excipients) are: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate, titanium dioxide (E171), macrogol 400, polysorbate 80.

Appearance of the product and contents of the packaging

The tablets of this medication are white, capsule-shaped, film-coated, and engraved with “Q 400” on one face and smooth on the other.

The available packaging are:

Aluminum/PVC/PVDC blister. Packets containing 60 tablets.

White opaque high-density polyethylene bottle with a white opaque polypropylene cap and desiccant. Pack containing 60 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

Last review date of the leaflet: July 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/