Package Leaflet: Information for the User

quetiapine cinfa 50 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 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.

quetiapina cinfa contains a substance called quetiapina. It belongs to a group of medicines called antipsicotics. Quetiapina cinfa can be used to treat several diseases, such as:

• Bipolar depression: when you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.
• Mania: when you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or present poor judgment which includes 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 quetiapina even when you are feeling better.

Do not take quetiapina cinfa:

If you are unsure, consult your doctor or pharmacist before taking quetiapina cinfa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take quetiapina cinfa:

• 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 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 depression or other conditions treated with antidepressants. The use of these medicines with quetiapina cinfa may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and quetiapina cinfa").
• if you have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking quetiapina.
• if you know 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 quetiapina because the group of medicines to which quetiapina 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 blood clot formation.
• if you have or have had a condition in which your breathing is interrupted by brief periods of time during normal sleep (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.

Inform your doctorimmediately if after taking quetiapina 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 quetiapina 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 work, 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, rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count and elevated liver enzymes).
• Generalized 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 quetiapina and contact your doctor or seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking quetiapina. You and your doctor should monitor your weight regularly.

Children and adolescents

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

Other medicines and quetiapina cinfa

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

Do not take quetiapina 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).

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).
• Antidepressants. These medicines may interact with quetiapina cinfa 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.
• 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 for urination) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work to treat certain medical conditions.

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

Taking quetiapina cinfa with food, drinks, and alcohol

Quetiapina can be taken with or without food.

• Be careful about the amount of alcohol you drink. This is because the combined effect of quetiapina and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking quetiapina. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine. Do not take quetiapina during pregnancy, unless your doctor has advised you to. Do not use quetiapina if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapina in the last trimester (last three months of 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

Quetiapina may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Quetiapina cinfa contains lactose.

If your doctor has told you that you have a lactose intolerance, consult them before taking this medicine.

Quetiapina cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Effect on drug detection tests in urine

If you are undergoing a urine drug detection test, taking quetiapina may produce positive results for methadone or certain antidepressants 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 your needs, but it 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. The groove is only for breaking the tablet if it is difficult to swallow it whole, but not for dividing it into equal doses.
• You can take the tablets with or without food.
• Do not take grapefruit juice while taking quetiapina. 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 should not be used in children and adolescents under 18 years of age.

If you take more quetiapina cinfa than you should

If you take more quetiapina than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take quetiapina cinfa

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 the treatment with quetiapina cinfa

If you stop taking quetiapina 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 patients):

• Dizziness (which could lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to take quetiapine) (which could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine) that include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to taper off over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless or stiff without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• 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 make you feel dizzy or faint (which could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• 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.
• 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. Increases in prolactin hormone may, in rare cases, lead to the following:

• Swelling of the breasts and unexpected milk production in both men and women.
• Women not having a menstrual period or having irregular periods.

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

• 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 the electrical activity of the heart 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 (which could lead to falls).
• Stuffy nose.
• Decreased number of red blood cells in the blood.
• Decreased amount of sodium in the blood.
• Worsening of pre-existing diabetes.

Rare (may affect up to 1 in 1,000 patients):

• 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).
• Swelling of the breasts 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 attention immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• 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 substance found in muscles).

Very rare (may affect 1 in 10,000 patients):

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (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 (rupture of muscle fibers and pain in the muscles).

Frequency not known (cannot be estimated from available data):

• Rashes on the skin with irregular red spots (erythema multiforme). See Section 2.
• Rapid appearance of areas of red skin with small white or yellow pustules (small blisters filled with liquid) known as Pustulosis Exanthemática Generalizada Aguda (AGEP). See Section 2.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis). See Section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS, for its English acronym), 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.
• Effects of withdrawal in newborns of mothers who have used quetiapine during pregnancy.
• Stroke.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with a rash of small red or purple spots.

Medication reaction with eosinophilia and systemic symptoms (DRESS, for its English acronym):

Generalized rash, high body temperature, elevated liver enzymes, abnormal blood test results (eosinophilia), swollen lymph nodes, and other organs involved (medication reaction 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..

The class of medicines to which quetiapine 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 substance found in muscles), decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• Swelling of the breasts and unexpected milk production in both men and women.
• 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 patients):

-Increased amount of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• Swelling of the breasts and unexpected milk production in both boys and girls
• Girls not having a menstrual period or having irregular periods.

-Increased appetite.

-Vomiting.

-Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or stiff without pain.

-Increased blood pressure.

Common (may affect up to 1 in 10 patients)

• Feeling weak, fainting (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.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of 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 quetiapine cinfa

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

The other components are:

Tablet core: povidone, anhydrous calcium hydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethylcellulose (type A) (from potato), lactose monohydrate, and magnesium stearate.

Tablet coating: Opadry white OY-L28900 (contains lactose monohydrate, hypromellose, titanium dioxide (E-171), and macrogol 4000).

Appearance of the product and content of the packaging

quetiapine cinfa 50 mg arecover-encapsulated tabletsof white color, cylindrical, biconvex, scored on one face and marked with the code “Q5” on the other.

It is presented in packs of 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: June 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/86669/P_86669.html

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