Quetiapine CINFA 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

quetiapine cinfa 50 mg film-coated tablets

Read all of 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is quetiapine cinfa and what is it used for?

quetiapine cinfa contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. quetiapine cinfa 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 extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: when you may hear or sense 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 to you even after you start feeling better.

2. What you need to know before taking quetiapine cinfa

Do not take quetiapine cinfa:

• 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:
  • certain HIV medications
  • 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 quetiapine cinfa.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take quetiapine cinfa:

• if you, or a family member, have or have had any heart problems, for example, heart rhythm disorders, 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 (epileptic fit).
• if you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with quetiapine cinfa may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and quetiapine cinfa").
• 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 (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain functions). In this case, you should not take quetiapine, as the group of medicines to which quetiapine cinfa belongs may increase the risk of stroke, or in some cases the 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 for short periods during normal nighttime 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), an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions may 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.

Inform your doctor immediately if, after taking quetiapine, 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 excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).
• Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. 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 have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low count of white blood cells 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 this could lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts 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. Such thoughts may be more likely if you are a young adult. Clinical trial data have 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 have thoughts of 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 inform you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Serious skin adverse reactions (SCARs)

Very rarely, serious skin adverse reactions (SCARs), which may be life-threatening or fatal, have been reported with this medicine. These commonly manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes).
• Acute Generalized Exanthematous Pustulosis (AGEP), small pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with itchy, irregular red patches.

If you develop any of these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.

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 quetiapine cinfa

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:

• Certain HIV medications.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (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).
• Antidepressants. These medicines may interact with quetiapine cinfa, 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 tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.
• Thioridazine or Lithium (other antipsychotic medicines).
• Medicines that affect your heartbeat, 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.

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

Taking quetiapine cinfa with food, drinks, and alcohol

Quetiapine can 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 you have discussed it with your doctor. You should not use quetiapine while breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns of mothers who have used 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

Quetiapine may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

quetiapine cinfa contains lactose.

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

quetiapine cinfa contains sodium.

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

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 antidepressants known as tricyclic antidepressants (TCAs) when certain analytical 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 quetiapine cinfa

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will determine 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 the tablets whole with water. The score line is intended only to facilitate breaking the tablet if you have difficulty swallowing it whole, but not for dividing it into equal doses.
• 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 quetiapine cinfa than you should

If you take more quetiapine than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take quetiapine 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 a missed dose.

If you stop taking quetiapine cinfa

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

If you have any further questions about 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 everyone will experience them.

Very common (may affect more than 1 in 10 patients):

• Dizziness (which could lead to falls), headache, dry mouth.
• Drowsiness (which may diminish 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), nausea, headache, diarrhea, vomiting, dizziness, and irritability. Gradual discontinuation 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 stiffness.
• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• 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 patients).

• Fever.

• Changes in levels of thyroid hormones in the blood.

• Decreased number of certain types of blood cells.

• Increases in liver enzyme levels measured in blood.

• Increases in blood levels of prolactin hormone. Elevated prolactin levels may, in rare cases, lead to the following:

• Breast enlargement 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 patients):

• Epileptic seizures or convulsions.
• Allergic reactions that may include raised, itchy rashes (hives), skin swelling, or swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the electrical activity of the heart seen on ECG (prolongation of the 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.
• Decreased number of red blood cells in blood.
• Decreased sodium levels in 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, and extreme drowsiness or dizziness (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged, painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhea).
• 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 difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• 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 three 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 patients):

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious blistering condition affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

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

• Skin rashes with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid), known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.
• Sudden, severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who 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 showing small red or purple spots.

Drug reaction 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 reaction with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop taking quetiapine and contact your doctor or seek immediate medical attention.

The class of medicines to which quetiapine belongs can cause heart rhythm problems 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 prolactin hormone. Elevated prolactine levels may, in rare cases, lead to the following:

• Breast enlargement 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.

Additional 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 patients):

• Increased levels of a hormone called prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to the following:

  • Breast enlargement 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 stiffness.

• Increased blood pressure.

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

• 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 quetiapine cinfa

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to 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. Unused medicines and waste materials should be handed over to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of quetiapina cinfa

The active substance 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, colloidal anhydrous silica, sodium carboxymethyl starch (type A) (from potato), lactose monohydrate and magnesium stearate.

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

Appearance of the product and contents of the container

quetiapina cinfa 50 mg are white, film-coated, cylindrical, biconvex tablets, scored on one side and marked with the code "Q5" on the other.

They are supplied in packs of 60 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: June 2024

Detailed 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/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. 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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