Leaflet: information for the user

Rocoz Prolong 50 mg prolonged-release tablets EFG

Rocoz Prolong 150 mg prolonged-release tablets EFG

Rocoz Prolong 200 mg prolonged-release tablets EFG

Rocoz Prolong 300 mg prolonged-release tablets EFG

Rocoz Prolong 400 mg prolonged-release tablets EFG

Quetiapina

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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isRocoz Prolongand what it is used for

2. What you need to know before starting to takeRocoz Prolong

3. How to takeRocoz Prolong

4. Possible side effects

5. Storage ofRocoz Prolong

6. Contents of the pack and additional information

Rocoz Prolong contains a substance called quetiapina. It belongs to a group of medications called antipsicotics. Rocoz Prolong can be used to treat several diseases, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: 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.

When using Rocoz Prolong to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medication that is being used to treat this disease.

Your doctor may continue prescribing Rocoz Prolong even when you are feeling better.

Do not take Rocoz Prolong:

• if you are allergic to quetiapine or any of the other ingredients in 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 are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take quetiapine:

• 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 any medicine that may affect your heart rate.
• 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 this medicine.
• 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, intestinal 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 quetiapine 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.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should 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 may 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 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 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 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 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 skin peeling, particularly around the mouth, nose, eyes, and genitals.

•Toxic epidermal necrolysis (TEN), a more severe form that causes extensive skin peeling.

•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 cells (eosinophilia) and elevated liver enzymes).

•Generalized Acute Exanthematous Pustulosis (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 prolonged-release 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 should not be used in children and adolescents under 18 years of age.

Other medicines and Rocoz Prolong

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

Do not take Quetiapine Alter 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 falling asleep).
• Thioridazine or Lithium (other antipsychotic medicines).
• Medicines that affect your heart rate, 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 Prolong with food, drinks, and alcohol

• Quetiapine 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 drink. This is because the combined effect of quetiapine and alcohol may make you drowsy.
• Do not take orange juice while taking this medicine. 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 take quetiapine during 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 this medicine in the last trimester (last three months of their 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

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

Rocoz Prolong contains lactose

Rocoz Prolong contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Effect on drug detection tests in urine

If you are having a drug detection test in urine, taking Rocoz Prolong may 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 usually be between 150 mg and 800 mg.

• 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 this medication. 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 Prolong 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 nearest hospital immediately. Bring your Quetiapine tablets with you. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Rocoz Prolong

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 Rocoz Prolong

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 rigidity 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.
• Feeling weak.
• 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 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.
• 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:

orBoth men and women may experience breast swelling and unexpected milk production.

orWomen may not have a menstrual period or have 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.
• 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).
• Breast swelling and unexpected milk production (galactorrhea).
• 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, or other activities while asleep.
• Decrease in 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, 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 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 (anaphylaxis) that may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe skin blistering condition (Stevens-Johnson syndrome).
• Abnormal secretion of a hormone that controls urine volume.
• Rhabdomyolysis, a condition where muscle fibers break down and cause 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 appearanceof areas of skin with red spots and small white/yellow-filled blisters (Pustulosis Exantemática 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), which includes symptoms similar to the flu, 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 newborn babies of mothers who have taken quetiapine during pregnancy.
• Stroke.
• Cardiomyopathy, a disorder of the heart muscle.
• Myocarditis, inflammation of the heart muscle.
• Vasculitis, inflammation of the blood vessels, often with a rash of small red or purple spots.

The class of medicines to which quetiapine belongs can cause heart rhythm problems that may 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 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, decreases in the number of red blood cells, increases in 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 may experience breast swelling and unexpected milk production.
• Women may not have a menstrual period or have 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 amount of a hormone called prolactin in the blood. Prolactin increases may, in rare cases, lead to the following:

orBoth boys and girls may experience breast swelling and unexpected milk production.

orGirls may not have a menstrual period or have irregular periods.

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling of restlessness or muscle rigidity without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (may 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 the 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 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.

Rocoz Prolong does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rocoz Prolong

-The active ingredient is quetiapine. Rocoz Prolong tablets contain 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg of quetiapine (as quetiapine fumarate).

-The other components are:

Tablet core: Copolymer of methacrylic acid and ethyl acrylate (1:1), anhydrous lactose (lactose), crystalline maltose, talc, magnesium stearate

Tablet coating: Copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate

Appearance of Rocoz Prolong and packaging contents

Rocoz Prolong 50 mg tablets are white, round, biconvex, and have “50” engraved on one face

Rocoz Prolong 150 mg tablets are white, oblong, biconvex, and have “150” engraved on one face

Rocoz Prolong 200 mg tablets are white, oblong, biconvex, and have “200” engraved on one face

Rocoz Prolong 300 mg tablets are white, oblong, biconvex, and have “300” engraved on one face

Rocoz Prolong 400 mg tablets are white, oval, biconvex, and have “400” engraved on one face

They are presented in blisters of polychlorotrifluoroethylene and polyvinyl chloride with aluminum

The packaging sizes are:

Rocoz Prolong 50 mg: 10 or 60 tablets

Rocoz Prolong 150 mg: 60 tablets

Rocoz Prolong 200 mg: 60 tablets

Rocoz Prolong 300 mg: 60 tablets

Rocoz Prolong 400 mg: 60 tablets. Some packaging sizes may only be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Responsible manufacturer:

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

or

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attiki,

Greece

Last review date of this leaflet:july 2024

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/