ROCOZ 100 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Rocoz100 mgfilm-coated tablets EFG

Quetiapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.,keep this leaflet. You may need to read it again..

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rocoz and what is it used for
2. What you need to know before you take Rocoz
3. How to take Rocoz
4. Possible side effects
5. Storing Rocoz
6. Contents of the pack and other information

1. What is Rocoz and what is it used for

Rocoz contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat several diseases, such as:

• Bipolar depression: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or can't sleep.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or show poor judgment including being aggressive or violent.
• Schizophrenia: where 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 to prescribe quetiapine to you even when you are feeling better.

2. What you need to know before you take Rocoz

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
  • azole-type medicines (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression).

If you are in any doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rocoz:

• if you, or someone in your family, have or have had heart problems, such as problems with the heartbeat, weakening of the heart muscle or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• 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 getting diabetes. If so, your doctor may check your blood sugar levels while you are taking quetiapine.
• if you know you have had low white blood cell counts in the past (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, you should not take quetiapine because the group of medicines that quetiapine belongs to may increase the risk of stroke, or in some cases the risk of death, in these people.
• if you are an elderly person with Parkinson's disease/parkinsonism.
• if you or a family member have a history of blood clots, as medicines like this one have been associated with the formation of blood clots.
• if you have or have had a condition where your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and are taking medicines that reduce normal brain activity ("depressants").
• if you have or have had a condition where you cannot empty your bladder completely (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eye. These conditions can sometimes 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. Using these medicines with quetiapine may cause a condition called serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Rocoz").

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

• A combination of fever, severe muscle stiffness, sweating, or a decrease in consciousness level (a disorder called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should check your heart and, if necessary, refer you to a cardiologist immediately.

These disorders can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and may require stopping treatment with quetiapine and/or additional treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more severe bowel blockage.
• Thoughts of suicide and worsening of your depression

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

If at any time you think about harming yourself or committing suicide, contact your doctor or go to the hospital immediately. It may help to tell a relative or close 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 worried about changes in your behavior.

• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug 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.

Weight gain

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

Children and adolescents

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

Taking Rocoz with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take quetiapine if you are using any of the following medicines:

• Some medicines for HIV.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Neafazodone (for depression).

Tell 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 heartbeat, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• Antidepressants. These medicines can interact with quetiapine and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if 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 with the amount of alcohol you drink. This is because the combined effect of quetiapine and alcohol can make you drowsy.
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take quetiapine during pregnancy, unless you have discussed this with your doctor. You should not use quetiapine if you are breastfeeding.

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

Driving and using machines

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

Rocoz contains lactose

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

Effect on urine drug tests

If you are having a urine drug test, taking quetiapine may produce positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs) when some analysis methods are used, even if you are not taking methadone or TCAs. If this happens, a more specific test can be performed.

3. How to take Rocoz

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

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 a glass of water.
• You can take the tablets with or without food.
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medicine 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.

Elderly people

If you are elderly, 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 has prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the quetiapine tablets with you. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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 forgotten doses.

If you stop taking Rocoz

If you stop taking quetiapine abruptly, you may be unable to sleep (insomnia), or you may feel nauseous, 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Frequent:may affect more than 1 in 10 people

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

• Feeling of drowsiness (which may disappear over time, as you continue taking quetiapine), (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is advised.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Frequent:may affect up to 1 in 10 people

• Fast heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disorder of speech and language.
• Suicidal thoughts 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. The increases in prolactin hormone may, in rare cases, lead to the following:
• • Both in men and women, having swollen breasts and unexpected milk production.
  • In women, not having menstrual periods or having irregular periods.

Uncommon:may affect up to 1 in 100 people

• Seizures or convulsions.
• Allergic reactions that can include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on the ECG (prolongation of the QT interval).
• Slower than normal heart rate that can 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 disorder called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swollen breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can 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 you are asleep.
• Decrease in body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") in which you may have a combination of three or more of the following effects: increased fat around your abdomen, decrease in "good" cholesterol (HDL-C), increase in a type of fat in the blood called triglycerides, increase in blood pressure, and increase in blood sugar.
• A combination of fever, flu-like symptoms, 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 can cause difficulty breathing or shock.
• Rapid 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).
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Unknown: frequency cannot be estimated from the available data

• Skin rash with irregular red spots (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs may cause heart rhythm problems that can be serious and, in severe cases, may be fatal.

Some adverse effects are only observed when a blood test is performed. 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, decreases in the number of certain types of blood cells, decrease in the number of red blood cells, increase in creatine phosphokinase in the blood (a substance found in muscles), decrease in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone may, in rare cases, lead to the following:

• Both in men and women, having swollen breasts and unexpected milk production.
• In women, not having menstrual periods or having irregular periods.

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

Adverse Effects in Children and Adolescents

The same adverse effects that can occur in adults can also occur in children and adolescents.

The following adverse effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very Frequent:may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. The increases in prolactin hormone may, in rare cases, lead to the following:
• • Both in boys and girls, having swollen breasts and unexpected milk production.
  • In girls, not having menstrual periods or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Frequent: may affect up to 1 in 10 people

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rocoz

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofRocoz

The active ingredient is quetiapine. Each tablet contains 100 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose, calcium phosphate dibasic dihydrate, povidone K30, sodium starch glycolate (Type A) potato, and calcium stearate.

Coating of the tablet: Hypromellose, titanium dioxide (E171), and triacetin.

Appearance of the Product and Package Contents

The tablets are white, biconvex, and round.

They are presented in white opaque PVC and aluminum blisters, in packages of 60 tablets.

Marketing Authorization Holder and 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

Date of the Last Revision of this Leaflet: June 2024

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