Package Leaflet: Information for the Patient

quetiapine cinfa 150 mg prolonged-release tablets EFG

Read this leaflet carefully before you start to take 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 similar symptoms to 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.

This medication contains a substance called quetiapina. It belongs to a group of medications called antipsicotics. This medication may be used to treat several diseases, such as:

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

Your doctor may continue prescribing quetiapina cinfa even when you are feeling better.

Do not take quetiapine cinfa

• 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).

Do not take quetiapine cinfa if the above applies to you. If you are unsure, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Consult 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, irregular heart rhythm, heart muscle weakness 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 an elderly patient.
• If you have liver problems.
• If you have ever had a seizure (convulsion).
• If you have depression or other conditions that are treated with antidepressants. The use of these medicines 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. Your doctor may monitor your blood sugar levels while you are taking quetiapine.
• 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 patient 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 elderly patients with dementia.
• If you are an elderly patient 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 brief 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, a bowel 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 doctor immediatelyif you experience any of the following after taking quetiapine:

• 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).
• Prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor will 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 experience:

• Fever, pseudogripal syndrome, sore throat, or any other infection that may be the result of low white blood cell counts, which may require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, which may lead to more serious bowel blockage problems.

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 years old 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)

With the use of this medicine, very rarely reported severe skin reactions (SCARs) have been noted, which may put your life at risk or be fatal. These typically manifest as:

• Stevens-Johnson syndrome (SSJ), a generalized 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 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).
• Generalized acute pustular psoriasis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

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 regularly monitor your weight.

Children and adolescents

Quetiapine is not indicated for use in children or adolescents under 18 years old.

Other medicines and quetiapine cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may 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 falling asleep).
• Thioridazine or lithium (other antipsychotic medicines).
• Antidepressants. These medicines may interact with quetiapine 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 body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.
• 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 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.

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

Quetiapine cinfa 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 grapefruit juice while taking quetiapine. 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 or pharmacist 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 the newborn, whose mothers have taken quetiapine in the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby develops any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

Quetiapine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and 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.

Effect on urine drug detection tests

If you are undergoing a urine drug detection test, quetiapine 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.

Quetiapine cinfa contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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 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.

Patients with liver problems

If you have liver problems, your doctor may change your dose.

Older patients

If you are an older patient, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the quetiapina cinfa tablets with you.

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 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 interrupting 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.

If you experience any of the following serious side effects, stop taking quetiapina and go to your doctor or the nearest hospital:

Frequent side effects(may affect up to 1 in 10 people):

•Thoughts of suicideand worsening of your depression.

Less frequent side effects(may affect up to 1 in 100 people):

•Sudden fever, especially withirritated throatand otherflu-like symptoms. It may be due to an abnormal low white blood cell count.

•Skin reactionssuch as skin rash, urticaria, hives, redness, itching, possibly withswelling of the face, eyelids, and lips. It may also cause difficulty breathing, dizziness, or shock.

•Seizuresorconvulsions.

•Uncontrolled movements, mainly of the face or tongue (tardive dyskinesia).

•A feeling thatthe heart is poundingor beating rapidly alongwith dizziness or fainting. They may be symptoms of serious heart rhythm problems and in severe cases could be fatal.

Rare side effects(may affect up to 1 in 1,000 people):

•Sharp painand/orswellingand rednessin a leg;sharp chest painthat may reach the left arm orabrupt lack of breathing. It may be due to blood clots in the veins.

•Sharp pain in the upper stomach, which may reach the back, causing nausea and vomiting in some cases. It may be a symptom of pancreatitis.

•Constipationwithpersistent abdominal painor constipation that does not respond to treatment and may lead to a more serious intestinal blockage.

•Yellow skin and eyes (jaundice), dark urine, along with unusual fatigue or fever (symptom of hepatitis).

•Long-lasting and painful erection.

•A combination offever, sweating, muscle stiffness, feeling very dizzy or weak (a condition called “neuroleptic malignant syndrome”).

Very rare side effects(may affect up to 1 in 10,000 people):

•Severe skin reactions with rash or blisters, irregular red patches, and/or skin peeling, around the mouth, eyes, or genitals, often withsudden fever or flu-like symptoms. These reactions can appear quickly.

•Unexpected muscle pain, sensitivity, or weakness. These may be the first symptoms of a severe muscle degeneration.

Not known(the frequency cannot be estimated from the available data)

• Rapid appearance of red skin patches with small white/yellow-filled blisters (Pustulosis Exantemática Generalizada Aguda (AGEP)). See section 2.
• Red skin rash with irregular patches (erythema multiforme).
• Heart muscle disorder (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Blood flow deficiency in the brain (stroke). Typical signs may be sudden facial drooping, weakness in the arms, difficulty speaking, and inability to move or feel on one side of the body.

Drug reaction with eosinophilia and systemic symptoms (DRESS):Generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS).If you develop these symptoms, stop using quetiapina and contact your doctor or seek medical attention immediately.

Do not worry if you see a tablet in your stoolafter taking quetiapina. As the tablet passes through the gastrointestinal tract, quetiapina is released slowly. The tablet shape remains intact and is eliminated in the stool. Therefore, even if you see a tablet in your stool, your quetiapina dose has been absorbed.

Other possible side effects:

Frequent side effects(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 quetiapina) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapina), including inability to sleep (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. This includes difficulty initiating muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Decreased hemoglobin levels (protein in red blood cells that carries oxygen).
• Increased levels of certain fats (triglycerides and total cholesterol).

Frequent side effects(may affect up to 1 in 10 people)

• Fast heart rate.
• Sensation that the heart is pounding, beating rapidly, or has irregular beats.
• Constipation, indigestion (stomach upset).
• Sensation of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorder.
• Difficulty breathing.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Changes in the number of certain blood cells.
• Increased levels of liver enzymes in the blood.
• Increased levels of prolactin hormone in the blood. This increase in prolactin may, in rare cases, lead to:

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

Frequent side effects(may affect up to 1 in 100 people)

• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• Diabetes.
• 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.
• Decreased sodium levels in the blood.
• Worsening of pre-existing diabetes.
• Confusion.

Rare side effects(may affect up to 1 in 1,000 people)

• Swelling of the breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Walking, talking, eating, or other activities while asleep.
• Low body temperature (hypothermia).
• A condition (called “metabolic syndrome”) where you may have a combination of 3 or more of the following assumed: increased abdominal fat, decreased “good” cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, high blood pressure, and increased blood sugar levels.
• Increased creatine phosphokinase levels in the blood (a substance originating from muscles).

Very rare side effects(may affect up to 1 in 10,000 people)

• Incorrect secretion of a hormone that controls urine volume.

Not known(the frequency cannot be estimated from the available data)

• Withdrawal symptoms may occur in newborns of mothers who used quetiapina during pregnancy.
• Inflammation of blood vessels (vasculitis), often with skin rash with small red or purple spots.

Some side effects are only observed when a blood test is performed. These include changes in the levels of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in thyroid hormone levels in the blood, increased liver enzymes, decreased levels of certain types of blood cells, decreased hemoglobin levels, increased levels of creatine phosphokinase in the blood, decreased sodium levels in the blood, and increased levels of prolactin hormone in the blood. The increases in prolactin hormone may, in rare cases, lead to:

• Swelling of the breasts and unexpected milk production in both men and women.
• In women, not having a menstrual period or 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:

Frequent side effects(may affect more than 1 in 10 people)

• Increased levels of a hormone called prolactin in the blood. The increases in prolactin may, in rare cases, lead to:
• • Swelling of the breasts and unexpected milk production in both boys and girls.
  • In girls, not having a menstrual period or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. This includes difficulty initiating muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

Frequent side effects(may affect up to 1 in 10 people)

• Sensation of weakness, fainting (may lead to falls).
• Stuffy nose.
• Sensation of irritability.

Reporting 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 after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

After the first opening of the HDPE bottle, the product must be used within 60 days.

Medications should not be disposed of through drains or trash. Deposit the containers 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 containers 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 quetiapine cinfa tablet contains 150 mg of quetiapine (as quetiapine fumarate).
• The other components (excipients) are:

• Core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, and magnesium stearate.
• Coating: titanium dioxide (E 171), hypromellose, macrogol, and polisorbate 80.

Appearance of the product and contents of the packaging

quetiapine cinfa are film-coated tablets, white in color, biconvex, oblong, and engraved with “Q150” on one face.

They are presented in PVC/PVDC-Aluminum blisters in packs of 10, 20, 30, 30×1 (unit dose with perforated blister), 50, 56 (calendar pack), 60, 60×1 (unit dose with perforated blister), 90, or 100 prolonged-release tablets.

HDPE bottles with polypropylene screw caps containing 60 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

CarreteraOlaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)- Spain

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143Blaubeuren

Germany

Last review date of this leaflet: July 2024

Detailed information about 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 the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/81154/P_81154.html

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