Rocoz 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rocoz 100 mg film-coated tablets EFG

Quetiapine

Read the entire 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See Section 4.

Contents of the leaflet

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

1. What Rocoz is and what it is used for

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

• Bipolar depression: when you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: when you may feel overly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: when 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 quetiapine even after you start feeling better.

2. What you need to know before taking Rocoz

Do not take Rocoz

• If you are allergic to quetiapine or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
  • some HIV medicines
  • azole-type medicines (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression).

If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rocoz:

• if you, or a family member, have or have had any heart problems, for example, irregular heartbeat, weakened 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 (epileptic fit).
• if you have diabetes or are at risk of developing diabetes. In such cases, your doctor may monitor your blood sugar levels while you are taking quetiapine.
• if you know you have previously had low levels of white blood cells (with or without being caused by other medicines).
• if you are an elderly person with dementia (loss of brain function). In this case, you should not take quetiapine, as the group of medicines to which quetiapine belongs may increase the risk of stroke or, in some cases, risk of death in these individuals.
• 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 this have been associated with blood clot formation.
• if you have or have had a condition in which your breathing stops briefly during normal sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).
• if you have or have had a condition in which you cannot fully empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.
• if you have depression or other conditions treated with antidepressants. Using these medicines together 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, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or feeling very sleepy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).
• Fast or irregular heartbeats, even at rest, palpitations, breathing difficulties, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

These disorders may be caused by this type of medicine.

Inform your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low white blood cell count and may require stopping treatment with quetiapine and/or additional treatment.
• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.
• Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This risk may increase at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also increase if you suddenly stop taking your medication. You may be more likely to have such thoughts if you are a young adult. Evidence 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 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 let you know if they think your depression is getting worse or if they are concerned about changes in your behavior.

• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (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 observed in patients taking quetiapine. You and your doctor should monitor your weight regularly.

Children and adolescents

Quetiapine must 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 need to take any other medicine.

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

• Some HIV medicines.
• 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 electrolyte imbalance (low potassium or magnesium levels), such as diuretics (medicines to increase urination) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called “anticholinergics”) that affect how nerve cells function, used 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 muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, 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 may be taken with or without food.
• Be cautious about the amount of alcohol you consume. This is because the combined effect of quetiapine and alcohol may 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 plan to become pregnant, consult your doctor before using this medicine. You should not take quetiapine during pregnancy unless advised by your doctor. You should not use quetiapine if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns of mothers who have taken quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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 operate tools or machinery until you know how these tablets affect you.

Rocoz contains lactose

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

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking quetiapine may produce positive results for methadone or certain antidepressant medicines known as tricyclic antidepressants (TCAs) when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Rocoz

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide your starting dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

• You will take your tablets once daily at bedtime or twice daily, depending on your condition.
• Swallow your tablets whole with water.
• You may 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 adjust your dose.

Elderly patients

If you are elderly, your doctor may adjust your dose.

Use in children and adolescents

Quetiapine must 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 prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take the quetiapine tablets with you. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating 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 a missed dose.

If you stop taking Rocoz

If you stop taking quetiapine suddenly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Very common: may affect more than 1 in 10 people

• Dizziness (could lead to falls), headache, dry mouth.
• Drowsiness (which may disappear over time as you continue taking quetiapine) (could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness, and irritability. 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, restlessness, or painless muscle rigidity.
• Changes in levels of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Feeling that your heart is pounding, racing, or beating irregularly.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may make you feel dizzy or faint (could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in blood.
• Decrease in number of certain types of blood cells.
• Increases in liver enzyme levels measured in blood.
• Increases in blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to:
  • Swelling of the breasts and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

Uncommon: may affect up to 1 in 100 people

• Seizures or convulsions.
• Allergic reactions which may include raised, itchy rashes (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the heart's electrical activity seen on ECG (prolongation of QT interval).
• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (could lead to falls).
• Stuffy nose.
• Decrease in number of red blood cells in blood.
• Decrease in blood sodium levels.
• Worsening of pre-existing diabetes.

Rare: may affect up to 1 in 1,000 people

• A combination of high temperature (fever), sweating, muscle rigidity, and extreme drowsiness or dizziness (a condition called "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 (galactorrhoea).
• Menstrual disorders.
• Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If you notice any of these symptoms, seek immediate medical help.
• Walking, talking, eating, or other activities while asleep.
• Decreased 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: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a type of blood fat called triglycerides, increased blood pressure, and increased 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 known as agranulocytosis.
• Intestinal obstruction.
• Increased blood levels of creatine phosphokinase (a substance from 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) which may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from available data

• Skin rashes with irregular red spots (erythema multiforme).
• Sudden, severe allergic reaction with symptoms such as fever, skin blisters, 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).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a skin rash consisting of small red or purple spots.

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

Some adverse effects are only detected through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in your blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased blood creatine phosphokinase (a substance found in muscles), decreased blood sodium levels, and increased blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to:

• Swelling of the breasts and unexpected milk production in both men and women.
• In women, absence of menstrual periods or 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 may occur in adults may also occur in children and adolescents.

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

Very common: may affect more than 1 in 10 people

• Increased levels of a hormone called prolactin in blood. Elevated prolactin levels may, in rare cases, lead to:
  • Swelling of the breasts and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness, or painless muscle rigidity.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rocoz

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

The other components are:

Tablet core: Lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate dihydrate, povidone K30, sodium carboxymethylstarch (potato Type A) and calcium stearate.

Tablet coating: Hypromellose, titanium dioxide (E171) and triacetin.

Appearance of the product and contents of the pack

The tablets are white, biconvex and round.

They are presented in opaque white PVC/aluminum blisters, in packs 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 most recent revision of this leaflet: June 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.