Package Leaflet: Information for the User

Quetiapina Combix 100 mg Film-Coated Tablets

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 only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you take Quetiapina Combix

3. How to take Quetiapina Combix

4. Possible side effects

5. Storage of Quetiapina Combix

6. Contents of the pack and additional information

Quetiapina Combix contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quetiapina Combix can be used to treat various conditions, including:

• 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.
• Mania: for which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or exhibit poor judgment, including aggressive or destructive behaviors.
• Bipolar depression: for which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.

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

Do not take Quetiapina Combix:

• if you are allergic to quetiapine or any of the other ingredients 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).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Combix:

• 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 medications 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 diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking Quetiapina Combix.
• if you know that you have had low white blood cell counts (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, do not take Quetiapina Combix because the group of medications to which it belongs may increase the risk of stroke or, in some cases, death in people with dementia.
• if you are an elderly person with Parkinson's disease or parkinsonism.
• if you or a family member has a history of blood clots, as medications like this have been associated with blood clot formation.
• if you have or have had a condition in which your breathing is interrupted by brief periods of time 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 completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.
• if you have depression or other conditions that are treated with antidepressants.

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

Inform your doctor immediately if after taking Quetiapina Combix you 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.

• 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.
• Seizure (convulsion).
• Prolonged and painful erection (priapism).

These conditions may be caused by this type of medication.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and require discontinuation of Quetiapina Combix 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 be 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 obtained 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 may ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Severe cutaneous adverse reactions (SCARs)

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

• Stevens-Johnson syndrome (SSJ), a generalized 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 rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count and elevated liver enzymes).
• Generalized acute pustular psoriasis (AGEP), small pus-filled blisters.
• Multi-form erythema (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 regularly monitor your weight.

Children and adolescents

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

Other medications and Quetiapina Combix

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

Do not take Quetiapina 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 Quetiapina Combix 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.

Consult your doctor if you are taking 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 rhythm, for example, medications that may cause an imbalance of electrolytes (low potassium and magnesium levels) such as diuretics (medications to urinate), or certain antibiotics (medications to treat infections).
• Medications that may cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.

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

Quetiapina Combix with food, drinks, and alcohol

• Quetiapina Combix can be taken with or without food.
• Be careful about the amount of alcohol you consume. This is because the combined effect of Quetiapina Combix and alcohol may make you drowsy.
• Do not take grapefruit juice while taking Quetiapina Combix. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take Quetiapina Combix during pregnancy, unless you have consulted your doctor. Do not use Quetiapina Combix if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborns of mothers who have used quetiapine in the last trimester (the last three months of pregnancy): tremor, stiffness, and/or muscle 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

These tablets may make you feel drowsy. Do not drive or operate tools or machinery until you know how the tablets affect you.

Quetiapina Combix contains lactose

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

Quetiapina Combix contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially "sodium-free".

Effect on drug detection tests in urine

If you are undergoing a drug detection test in urine, taking Quetiapina Combix may produce positive results for methadone or certain antidepressant medications called 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 for 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 needs, but will usually 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 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 Combix should not be used in children and adolescents under 18 years of age.

If you take more Quetiapina Combix than you should

If you take more Quetiapina Combix than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Keep the Quetiapina Combix tablets with you. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Quetiapina 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 tablet.

If you interrupt treatment with Quetiapina Combix

If you stop taking Quetiapina 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(may affect more than 1 in 10 people):

• Dizziness (which could lead to falls), headache, dry mouth.
• Feeling drowsy (which may disappear over time as you continue to take Quetiapina Combix) (which could lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking Quetiapina Combix) include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremor, feeling restless 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 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 dizziness or fainting (which could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorder.
• 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.
• Decreased number of certain types of blood cells.
• Increased levels of liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:
• • Both men and women having breast swelling and unexpected milk production.
  • Women not having a menstrual period or having irregular periods.

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

• Seizures or convulsions.
• Allergic reactions that may include hives, skin swelling, and swelling around the mouth.
• Dizziness (which could lead to falls).
• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Stuffy nose.
• Diabetes.
• Change in the heart's electrical activity detected on an ECG (prolongation of the QT interval).
• Decreased heart rate that may occur at the start of treatment and may be associated with decreased blood pressure and fainting.
• Difficulty urinating.
• Decreased number of red blood cells in the blood.
• Decreased sodium levels 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 condition known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Menstrual disorder.
• 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 help immediately.
• Walking, talking, eating, and performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Breast swelling and unexpected milk production (galactorrhea).
• 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 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, symptoms similar to the flu, 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 muscle substance).

Very rare(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.
• Rhabdomyolysis (muscle fiber rupture and muscle pain).

Frequency not known (the frequency cannot be estimated from available data)

• Rash on the skin with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of areas of red skin with small white/yellow-filled blisters (pustulosis exanthemática generalizada aguda (AGEP)). See section 2.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (necrólisis epidérmica tóxica). See section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS), which includes symptoms similar to the flu with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes). See section 2.
• Symptoms of withdrawal may occur in newborns of mothers who have used Quetiapina Combix during pregnancy.
• Stroke.
• Cardiomyopathy (heart muscle disorder).
• Miocardiitis (inflammation of the heart muscle).
• Vasculitis (inflammation of the blood vessels), often with skin rash with small red or purple spots.

The class of medicines to which Quetiapina Combix belongs can cause serious heart rhythm problems that may 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 number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a muscle substance), decreased sodium levels in the blood, and increased levels of the prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both 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.

Additional 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(may affect more than 1 in 10 people):

• Increased levels of a hormone called prolactin in the blood. Prolactin increases may, in rare cases, lead to the following:
• • Both boys 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.

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

• Feeling weak, dizziness (which could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish 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 this medicine.

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

No special storage conditions are required.

Do not use Quetiapina Combix after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Quetiapina Combix

The active ingredient is hemifumarate of quetiapine.

Each tablet contains 100 mg of quetiapine (as hemifumarate of quetiapine).

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K30, magnesium stearate (E470b), sodium carboxymethylcellulose of potato (Type A) and dihydrate calcium phosphate.

Tablet coating: hypromellose 6cP, titanium dioxide, macrogol 400 and yellow iron oxide.

Appearance of Quetiapina Combix and contents of the package

Quetiapina Combix 100 mg are round, yellow, biconvex, film-coated tablets, flat on both sides.

Quetiapina Combix 100 mg film-coated tabletsare available in packages of 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Responsible for manufacturing

FUNDACIO DAU,

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009, Greece

This medicinal product is authorized in the Member States of the European Economic Area with the following names

Last review date of this leaflet: October 2024.

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