Quetiapine CINFA 150 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quetiapine cinfa 150 mg prolonged-release tablets EFG

Read the entire 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 they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

• Bipolar depression and major depressive episodes in major depressive disorder: in which you may feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: in which you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or violent behavior.
• Schizophrenia: in 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 quetiapine cinfa is used to treat major depressive episodes in major depressive disorder, it is taken in addition to another medicine you are already using to treat this condition.

Your doctor may continue prescribing this medicine 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:
  • Some medicines for HIV.
  • Azole-type medicines (for fungal infections).
  • Erythromycin or clarithromycin (for infections).
  • Nefazodone (for depression).

Do not take Quetiapine cinfa if any of the above applies to you. If you have any doubts, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Quetiapine cinfa:

• if you, or a family member, have or have had any heart problems, for example, heart rhythm disorders, weakened 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 an elderly patient.
• 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. Taking 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 this case, 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 patient with dementia (loss of brain function). In this case, you should not take quetiapine, as the group of medicines to which quetiapine belongs may increase the risk of stroke, or in some cases, the risk of 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 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 completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.

Inform your doctor immediately if you experience any of the following after taking quetiapine:

• 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.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very sleepy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (fits).
• Prolonged and painful erection (priapism).
• Fast or irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

These disorders may be caused by this type of medicine.

Inform your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection that could result from a low white blood cell count, which may require stopping treatment with quetiapine and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, which could lead to serious intestinal blockage problems.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This risk may increase at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer.

These thoughts may also increase if you suddenly stop taking your medication.

This 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 also 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) have been reported with this medicine, which may be life-threatening or fatal. These commonly present as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering and peeling of the skin, 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 cells (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with irregular red patches that itch.

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 is not indicated for use in children or adolescents under 18 years of age.

Other medicines and Quetiapine cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• 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 tone, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.
• Medicines that affect your heartbeat, for example, medicines that may cause 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 may be affected by food, and therefore you should take your tablets at least one hour before a meal or before bedtime.
• 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 or pharmacist before using this medicine.

You should not take quetiapine during pregnancy unless advised by your doctor. You should not use quetiapine while breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns whose mothers have taken quetiapine during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and difficulty feeding. If your baby 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 blurred vision, and may reduce your reaction ability. These effects, as well as your underlying illness, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Effect on urine drug screening tests

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

Quetiapine cinfa contains sodium.

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

3. How to take Quetiapine cinfa

Follow exactly the instructions given by your doctor or pharmacist 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.
• Do not split, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will tell you when).
• 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.

Patients with 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

This medicine 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: 91 562 04 20, stating the medicine and the amount taken. Take the Quetiapine cinfa tablets with you.

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), feel nauseous, or experience headache, diarrhoea, vomiting, dizziness, or irritability.

Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

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

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

Common adverse effects (may affect up to 1 in 10 people):

• Suicidal thoughts and worsening of your depression.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Sudden fever, especially with sore throat and other flu-like symptoms. This may be due to an abnormally low concentration of white blood cells.
• Skin reactions such as rash, hives, lumps, redness, itching, possibly with swelling of the face, eyelids, and lips. These may also cause difficulty breathing, dizziness, or shock.
• Seizures or convulsions.
• Uncontrolled movements, mainly of the face or tongue (tardive dyskinesia).
• Feeling that the heart is pounding or beating rapidly, together with dizziness or fainting. These may be symptoms of serious heart rhythm problems and, in severe cases, could be fatal.

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

• Sudden severe pain and/or swelling and redness in one leg; sudden sharp chest pain that may radiate to the left arm or sudden shortness of breath. This may be due to blood clots in the veins.
• Severe pain in the upper abdomen, possibly radiating to the back, sometimes causing nausea and vomiting. This may be a symptom of pancreatitis.
• Constipation with persistent abdominal pain or constipation unresponsive to treatment, which may lead to a more serious intestinal blockage.
• Yellowing of the skin and eyes (jaundice), dark urine, together with unusual tiredness or fever (symptoms of hepatitis).
• Prolonged and painful erection.
• A combination of fever, sweating, muscle rigidity, feeling very dizzy or weak (a disorder called "neuroleptic malignant syndrome").

Very rare adverse 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 accompanied by sudden fever or flu-like symptoms. These reactions may develop rapidly.

  • Severe allergic reaction (called anaphylaxis) which may cause difficulty breathing or shock.

• Unexpected muscle pain, tenderness, or weakness. These may be the first symptoms of severe muscle breakdown.

Frequency not known (cannot be estimated from available data)

• 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.
• Skin rash with irregular red spots (erythema multiforme).
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Condition involving insufficient blood flow to the brain (stroke). Typical signs may include sudden facial drooping, arm weakness, difficulty speaking, and inability to move or feel on one side of the body.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.

Do not be alarmed if you see a tablet in your faeces after taking quetiapine. As the tablet passes through the gastrointestinal tract, quetiapine is slowly released. The tablet shell remains undissolved and is eliminated in the faeces. Therefore, even if you see a tablet in your faeces, your dose of quetiapine has been absorbed.

Other possible adverse effects:

Very common adverse effects (may affect more than 1 in 10 people)

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may decrease over time as you continue taking quetiapine) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. This includes difficulty initiating muscle movements, tremor, restlessness, or painless muscle rigidity.
• Decreased levels of haemoglobin (the protein in red blood cells that carries oxygen).
• Increase in certain fats (triglycerides and total cholesterol).

Common adverse effects (may affect up to 1 in 10 people)

• Rapid heartbeat.

• Sensation of heart palpitations, rapid or irregular heartbeat.

• Constipation, upset stomach (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.

• Increased appetite.

• Feeling irritable.

• Speech and language disorders.

• Difficulty breathing.

• Vomiting (mainly in elderly patients).

• Fever.

• Changes in the amount of thyroid hormones 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 could, in rare cases, lead to the following:

• Breast swelling and unexpected production of breast milk in both men and women.

• In women, absence of menstrual periods or irregular periods.

Uncommon adverse effects (may affect up to 1 in 100 people)

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

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

• Breast swelling and unexpected milk production (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating, or other activities during sleep.
• Decreased body temperature (hypothermia).
• A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased blood fats called triglycerides, high blood pressure, and increased blood sugar.
• Increased blood creatine phosphokinase (a substance derived from muscles).

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

• Inappropriate secretion of a hormone that controls urine volume.

Frequency not known (cannot be estimated from available data)

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

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, increased liver enzymes, decreased numbers of certain blood cells, reduced red blood cell count, increased blood creatine phosphokinase (a substance found in muscles), decreased blood sodium levels, and increased blood prolactin levels. Increased prolactin levels could, in rare cases, lead to the following:

• Breast swelling 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 have not been observed in adults:

Very common adverse effects (may affect more than 1 in 10 people)

• Increased levels of a hormone called prolactin in the blood. Increased prolactin levels could, in rare cases, lead to the following:
  • Breast swelling and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. This includes difficulty initiating muscle movements, tremors, restlessness, or painless muscle rigidity.
• Increased blood pressure.

Common adverse effects (may affect up to 1 in 10 people)

• Feeling weak, fainting (may 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 packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature conditions.

For HDPE bottles only:

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

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

6. Contents of the pack and other information

Composition of Quetiapine cinfa

• The active substance 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 polysorbate 80.

Appearance of the medicinal product and contents of the pack

Quetiapine cinfa are white, biconvex, oblong, film-coated tablets marked with “Q150” on one side.

It is available 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 cap containing 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

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

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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