Leaflet: information for the patient

quetiapine cinfa 400 mg prolonged-release tablets EFG

Quetiapine

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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking quetiapine cinfa

3. How to take quetiapine cinfa

4. Possible side effects

5. Storage of quetiapine cinfa

6. Contents of the pack and additional information

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

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

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

Do not take quetiapina cinfa

• if you are allergic to quetiapina or 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).

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

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 inflammation of the heart, or if you are taking any medicine that may affect your heart rate.
• if you have low blood pressure.
• if you have had a stroke, especially if you are an older patient.
• 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 cinfa.
• 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 older patient with dementia (loss of brain function). If so, do not take quetiapina cinfa because the group of medicines to which quetiapina cinfa belongs may increase the risk of stroke, or in some cases the risk of death, in older patients with dementia.
• if you are an older 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 (called "sleep apnea") and are taking medicines that decrease the normal activity of the brain ("depressants").
• if you have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, a blockage in your intestine, or high pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect the way nerve cells work, 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 supposed after taking quetiapina cinfa:

• Combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition called "neuroleptic malignant syndrome").May require immediate medical treatment.
• 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.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feels very drowsy. This may increase the risk of accidental injuries (falls) in older patients.
• Seizures (convulsions).
• Prolonged and painful erection (priapism).

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 could be the result of low white blood cell count, which may require discontinuation of quetiapina cinfa 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, sometimes you may 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. Clinical trial information has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 years with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to the 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, severe skin reactions (SCARs) have been rarely reported, which may put your life at risk or be fatal. These usually 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 (NET), a more severe form that causes extensive skin peeling.
• Medication 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 rash 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 regularly monitor your weight.

Children and adolescents

Quetiapina cinfa is not indicated for use in children or adolescents under 18 years.

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 cinfa 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 falling asleep).
• Thioridazine or Lithium (other antipsychotic medicines).
• 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 core temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.
• Medicinesthat affect your heart rate, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics(medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called “anticholinergics”) that affect the way nerve cells work, to treat certain medical conditions.

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

Quetiapina cinfa with food, drinks, and alcohol

• Quetiapina cinfa 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 quetiapina cinfa and alcohol may make you drowsy.
• Do not take grapefruit juice while taking quetiapina cinfa. It may affect the way the medicine works.

Pregnancy and breastfeeding

If you are pregnantor inbreastfeeding,believe you may be pregnant or intend to become pregnant,consult your doctor before using this medicine. Do not take quetiapina cinfa during pregnancy, unless you have consulted your doctor. Do not use quetiapina cinfa if you are breastfeeding.

The following symptoms that may represent withdrawal symptoms, may occur in the newborn, whose mothers have taken quetiapina in thethird 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

Quetiapina cinfa may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying illness, may make it difficult for you 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 drug detection tests in urine

If you are undergoing a urine drug detection test, quetiapina cinfa mayproduce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when using some analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Quetiapina 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 of this medication as indicated by your doctor.In case of doubt, consult again withyour doctor or pharmacist. Your doctor will decide your initial dose. The maintenance dose (daily dose)will depend on your illness and your needs but will normally 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, yourdoctor will tell you when).
• Do not take grapefruit juice while taking quetiapina cinfa. It may affect the way 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 patients

If you arean older patientyour doctor may change your dose.

Use in children and adolescents

quetiapina cinfa should not be used by children and adolescents under 18 years of age.

If you take more quetiapina cinfa than you should

If you take more quetiapina cinfa than your doctor prescribed, you may feel drowsy, feelnauseous and experience abnormal heartbeats.In case of overdose or accidental ingestion,consultimmediately with your doctor or pharmacist or call the Toxicological Information Service, Telephone 915 620 420,indicating the medication and the amount ingested. Bring with you the quetiapina cinfa tablets.

If you forgot to take quetiapina cinfa

If you forget to take a dose, take it as soon as you remember. If it is almost time to take thenext 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 cinfa abruptly, you may be unable to sleep (insomnia), or you mayfeel nauseous, 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 doubts 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.Some people may not experience any side effects at all.

If you experience any of the following serious side effects, stop taking quetiapina cinfa and seek medical attention immediately:

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

• Thoughts of suicide and worsening of depression.This is a serious side effect that requires immediate medical attention.

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

• Sudden fever, especially withirritated throat and otherflu-like symptoms.This may be due to an abnormal low white blood cell count.
• Skin reactions such as rash, urticaria, hives, redness, itching, and swelling of the face, eyelids, and lips.This may cause difficulty breathing, dizziness, or shock.
• Seizures orconvulsions.
• Uncontrolled movements, mainly of the face or tongue (tardive dyskinesia).
• Sensation of arapid or irregular heartbeatalong with dizziness or fainting.This may be a sign of serious heart rhythm problems and in severe cases, it could be fatal.

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

• Sharp pain and/or swellingand rednessin a leg;sharp painin the chest that may radiate to the left arm orshortness of breaththat occurs suddenly. This may be due to blood clots in the veins.
• Acute pain in the upper abdomen, which may radiate to the back, causing nausea and vomiting in some cases.This may be a sign of pancreatitis.
• Constipation with persistent abdominal pain orconstipationthat does not respond to treatment and may lead to a more serious intestinal blockage.
• Yellowing of the skin and eyes(jaundice), dark urine, along with unusual fatigue or fever (sign of hepatitis).
• Prolonged and painful erection.
• A combination offever, sweating, muscle stiffness,feeling extremely 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 orflu-like symptoms.This may occur rapidly.
• Unexpected muscle pain, sensitivity, or weakness.This may be the first sign of a severe muscle degeneration.

Unknown frequency(frequency cannot be estimated from available data)

• Rapid appearance of red spots on the skin with small white or yellowish pustules (Generalized Acute Exanthematous Pustulosis, or AGEP). See section 2.
• Red skin rash with irregular patches (erythema multiforme). See section 2.
• Cardiac muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Cerebral blood flow deficiency (stroke). Typical signs may include 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): A generalized rash, high body temperature, elevated liver enzymes, abnormal blood counts (eosinophilia), swollen lymph nodes, and other affected organs (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 cinfa. As the tablet passes through the gastrointestinal tract, the quetiapine is released slowly. The tablet remains intact and is eliminated in the stool. Therefore, even if you see a tablet in your stool, your quetiapine dose has been absorbed.

Other possible side effects:

Very common 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 takequetiapina cinfa) (may lead to falls).
• Symptoms of withdrawal (symptoms that occur when you stop taking quetiapinacinfa) include inability to sleep (insomnia), feeling nauseous, headache, diarrhea,vomiting, dizziness, and irritability. It is recommended to taper off gradually over a period of at least 1to 2 weeks.
• 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).

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

• Fast heart rate.
• Sensation of a rapid or irregular heartbeat.
• Constipation, indigestion.
• Sensation of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause dizziness orfainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorders.
• Difficulty breathing.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Changes in certain blood cell counts.
• 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.
  • Irregular menstrual periods or absence of menstruation in women.

Less common 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 heart ratethan normal that may occur when treatment begins and may be associated with low blood pressure andfainting.
• 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).
• Irregular menstrual periods.
• 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:
• • Increased belly fat, decreased "good" cholesterol (HDL-C), increased triglycerides in your blood, high blood pressure, and increased blood sugar levels.
• Increased creatine phosphokinase levels in the blood (a substance from muscles).

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

• Incorrect secretion of a hormone that controls urine volume.

Unknown frequency(frequency cannot be estimated from available data)

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

Some side effects are only observed when blood tests are performed. These include changes in the levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzymes, decreased levels of certain blood cells, decreased red blood cell count, increased creatine phosphokinase levels in the blood, and decreased sodium levels 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.
• Irregular menstrual periods or absence of menstruation in women.

Your doctor may ask you to have blood tests from time to time.

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 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.
  • Irregular menstrual periods or absence of menstruation in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. This includes difficulty initiating muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

Common 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

Ifyou experience any type ofside effect, consult your doctor or pharmacist,even if it is a possible side effect thatdoes not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more informationon 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 in the blister pack 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of quetiapine cinfa

• The active ingredient is quetiapine. Quetiapine cinfa tablets contain 400 mg of quetiapine(as quetiapine fumarate).

• The other components (excipients) are:

Core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate.Coating: titanium dioxide (E171), hypromellose, macrogol/PEG 400 and polysorbate 80.

Appearance of the product and contents of the package

Quetiapine cinfa 400 mg prolonged-release tablets EFG

They are coated tablets, white in color, biconvex, oblong, and engraved with “Q 400” on one side.

Packages of 10, 20, 30, 50, 50x1(blister single-dose perforated)(hospital package), 56 (calendar package), 60, 90 and 100 tablets.

HDPE bottles containing 60 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

CarreteraOlaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra)- Spain

Responsible manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, H-4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5,P.O. Box 552 NL2003 RN Haarlem

Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305,Building No80 Small OSD and Building No 881NOSD

74770 Opava-Komarov

Czech Republic

TEVA OPERATIONS POLAND SP.Z.O.O.

ul. Mogilska 80. 31-546, Krakow

Poland

Teva Pharma, S.L.U.

C/C, n. 4, Industrial Estate Malpica, 50016 Zaragoza

Spain

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Last review date of thisleaflet:June 2024

Detailed and updated information on this medication is available on the website of theSpanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medication 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/75503/P_75503.html

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