Package Insert: Information for the Patient

Rocoz 50 mg Film-Coated Tablets

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 only for you, 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 any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this package insert. See Section 4.

Rocoz contains a substance called quetiapine. It belongs to a group of medications called antipsychotics.Quetiapinecan be used to treat various diseases, such as:

• Bipolar depression: for which you 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.

Your doctor may continue prescribing youquetiapineeven when you are feeling better.

Do not takeRocoz

• if you are allergic to quetiapine or 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.
  • medicines of the azole type (for fungal infections).
  • erythromycin or clarithromycin (for infections).
  • nefazodone (for depression).

If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeRocoz:

• if you, or a family member, have or have had any heart problems, for example, irregular heart rhythm, weakening of the heart muscle, or inflammation of the heart, 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 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 quetiapine belongs may increase the risk of stroke or, in some cases, death in these people.
• 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 at night (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.
• 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 "Other medicines and Rocoz").

Inform your doctor immediately if after taking this medicine you experience any of the following:

• a combination of fever, intense muscle stiffness, sweating, or a decrease in level of 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.
• seizures (convulsions).
• a prolonged and painful erection (priapism).
• rapid 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 medicine.

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 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 committing suicide. This may increase at the beginning of treatment, as all these medicines 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 obtained from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in adults under 25 years of age 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 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 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 peeling of the skin, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes extensive peeling of the skin.
• 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 increase in white blood cell count (eosinophilia) and elevated liver enzymes).
• Generalised Acute 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 regularly monitor your weight.

Children and adolescents

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

Taking Rocoz with other medicines

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

Do not takequetiapineif you are taking any of the following medicines:

• some medicines for HIV.
• medicines of the azole type (for fungal infections).
• erythromycin or clarithromycin (for infections).
• nefazodone (for depression).

Inform your doctor if you are taking any of the following medicines:

• medicines for epilepsy (such as phenytoin or carbamazepine).
• medicines for high blood pressure.
• barbiturates (for difficulty falling asleep).
• 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 levels) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• medicines that may cause constipation.
• medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• antidepressants. These medicines 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 a 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 Rocoz with food, drinks, and alcohol

• Quetiapine can be taken with or without food.
• Be careful about the amount of alcohol you drink. This is because the combined effect of quetiapine and alcohol may make you drowsy.
• Do not take grapefruit juice while taking quetiapine. It may affect how the medicine 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 medicine. Do not takequetiapineduring pregnancy, unless you have consulted your doctor. Do not use quetiapine if 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 their pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

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

Rocoz contains lactose and sodium

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

This medicine containsless than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free"

Effect on Drug Detection Tests in Urine

If you are having a drug detection test in urine, takingquetiapinemay produce positive results for methadone or certain antidepressants 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.

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 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 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.

Older adults

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

Use in children and adolescents

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

If you take more Rocoz than you should

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

If you forget to take Rocoz

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 doses.

If you interrupt treatment with Rocoz

If you stop taking quetiapine 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 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:may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Sensation of 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. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, 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 heart rate.
• Feeling like your heart is beating strongly, beating rapidly, or having irregular heartbeats.
• Constipation, indigestion.
• Sensation of weakness.
• 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.
• 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. 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.
• 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 activity 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.
• Worsening of pre-existing diabetes.

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 called "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 help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "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 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 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). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis (muscle fiber rupture and muscle pain).

Unknown: the frequency cannot be estimated from available data

• Rashes on the skin with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of areas of skin with red spots and 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 (toxic epidermal necrolysis). See section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS, for its acronym in English), which consists of 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
• Withdrawal symptoms may occur in newborns of mothers who have taken quetiapine during pregnancy.
• Stroke.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with skin rash with small red or purple spots

The class of medicines to which quetiapine belongsmay cause heart rhythm problems that can be serious 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 blood sugar, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreases in the number of certain types of blood cells, decreases in the number of red blood cells, increased 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. 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.

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 amount 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 initiating muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common:may affect up to 1 in 10 people

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

Reporting 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 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 this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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 Rocoz

The active ingredient is quetiapine. Each tablet contains 50 mg of quetiapine (as quetiapine fumarate).

The other components are:

• Tablet core: Lactose monohydrate, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, povidone, sodium carboxymethylcellulose from potato (Type A) and calcium stearate.
• Tablet coating: : Opadry OY-S 7322 (hypromellose, titanium dioxide (E171) and triacetin).

Appearance of the product and contents of the packaging:

The tablets are white, round, biconvex, and scored on one side.

The tablet can be divided into equal doses.

They are presented in PVC-aluminum blisters consisting of a white opaque PVC layer and an aluminum layer, in packs of 60 tablets.

Marketing authorization holder and responsible manufacturer:

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Last review date of this leaflet: 06/2024

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 /.