Leaflet: information for the user

Quetiapine ratio 25 mg film-coated tablets EFG

quetiapine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What isQuetiapine ratioand what it is used for

2.What you need to know before starting to takeQuetiapine ratio

3.How to takeQuetiapine ratio

4.Possible side effects

5.Storage ofQuetiapine ratio

6.Contents of the pack and additional information

Quetiapina ratio contains a substance called quetiapina. It belongs to a group of medications called antipsychotics. Quetiapina ratio may be used to treat various conditions, such as:

• Bipolar depression: for which you may feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.
• Mania: for which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or exhibit poor judgment, which may include being aggressive or violent.
• Schizophrenia: for 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.

Your doctor may continue prescribing Quetiapina ratio even when you are feeling better.

Do not take Quetiapina ratio:

• if you are allergic to quetiapina or any of the other ingredients of this medication (listed in section 6).
• if you are taking any of the following medications:
• • Some HIV medications
  • Azole-type medications (for fungal infections)
  • Erythromycin or clarithromycin (for infections)
  • Nefazodone (for depression)

If you have any doubts, consult your doctor or pharmacist before taking quetiapina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take quetiapina:

• if you, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness, or heart inflammation, or if you are taking any medication that may affect your heart rate.
• if you have low blood pressure.
• if you have had a stroke, especially if you are elderly.
• if you have liver problems.
• if you have ever had a seizure (convulsion).
• if you have depression or other conditions treated with antidepressants. The use of these medications with quetiapina may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapina ratio").
• if you have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking quetiapina.
• if you know you have had low white blood cell counts (which may or may not have been caused by other medications).
• if you are an elderly person with dementia (loss of brain function). If so, do not take Quetiapina ratio because the group of medications to which quetiapina belongs may increase the risk of stroke or, in some cases, death in these individuals.
• if you are an elderly person with Parkinson's disease or parkinsonism
• if you or a family member has a history of blood clots, as medications 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 nighttime sleep (called "sleep apnea") and are taking medications that decrease normal brain activity ("depressants").
• if you have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.

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

• A combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Rapid 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 medication.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it may be a consequence of a very low white blood cell count and require discontinuation of quetiapina treatment and/or additional treatment.

• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as it may lead to a more severe intestinal blockage.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medications take time to be effective, 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 suicidal thoughts and/or 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 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 medication, very rare severe skin reactions (SCARs) have been reported, 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 (NET), a more severe form that causes extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count and elevated liver enzymes).
• Generalized Acute Exanthematous Pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using quetiapina and contact your doctor or seek medical attention immediately.

Weight gain

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

Children and adolescents

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

Other medications and Quetiapina ratio

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

Do not take quetiapina if you are using any of the following medications:

• Some HIV medications.
• Azole-type medications (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Inform your doctor if you are using any of the following medications:

• Medications for epilepsy (such as phenytoin or carbamazepine).
• Medications for high blood pressure.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or Lithium (other antipsychotic medications).
• Antidepressants. These medications may interact with Quetiapina ratio and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.
• Medications that affect your heart rate, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medications to urinate) or certain antibiotics (medications to treat infections).
• Medications that may cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.

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

Taking Quetiapina ratio with food, drinks, and alcohol

• Quetiapina ratio can be taken with or without food.
• Be careful with the amount of alcohol you consume. This is because the combined effect of Quetiapina ratio and alcohol may cause drowsiness.
• Do not take grapefruit juice while taking Quetiapina ratio. It may affect how the medication works.

Pregnancy and breastfeeding

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

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapina in the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

This medication may cause drowsiness. Do not drive or operate tools or machines until you know how the medication affects you.

This medication containslactose, sodium, and Yellow iron oxide (E110)

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

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

It may cause allergic reactions.

Effect on Drug Detection Tests in Urine

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your illness and needs, but will normally be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your illness.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not take grapefruit juice while taking Quetiapina ratio. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

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

Older adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

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

If you take more Quetiapina ratio than you should

If you take more quetiapina than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring your Quetiapina ratio tablets with you. You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Quetiapina ratio

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 tablet.

If you interrupt treatment with Quetiapina ratio

If you stop taking quetiapina abruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.

• Sensation of drowsiness (which may disappear over time as you continue to take quetiapine), (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include 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. These include difficulty initiating muscle movements, tremor, feeling of restlessness or muscle rigidity without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Palpitations.
• Feeling like your heart is beating strongly, rapidly, or irregularly.
• Constipation, indigestion.
• Feeling weak.
• Swelling of arms or legs.

• Low blood pressure when standing. This may make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorders.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

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

Rare: may affect up to 1 in 1,000 people

• Seizures or convulsions.
• Allergic reactions that may include hives, swelling of the skin, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in heart rhythm seen on an ECG (prolongation of the QT interval).
• Slower than normal heart rate that may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes
• Confusion

Very rare: may affect up to 1 in 10,000 people

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Swelling of the breasts and unexpected milk production (galactorrhea).
• Menstrual disorders.

• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.
• Walking, talking, eating, or other activities while you are asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following effects: increased fat around your abdomen, decrease in "good" cholesterol (HDL-C), increase in a type of fat in the blood called triglycerides, increase in blood pressure, and increase in blood sugar levels.
• A combination of fever, symptoms similar to the flu, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

Not known: the frequency cannot be estimated from available data

• Rashes on the skin with irregular red patches (erythema multiforme). See section 2.
• Rapid appearance of areas of skin with red spots and small pustules (small blisters filled with white/yellow liquid called Pustulosis Exantemática Generalizada Aguda (AGEP). See section 2.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis). See section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS, for its English acronym), which consists of symptoms similar to the flu with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Stroke
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of blood vessels (vasculitis), often with skin rash with small red or purple spots.

This medicine belongs to a class of medicines that can cause heart rhythm problems that can be serious and, in severe cases, fatal.

Some side effects are only seen when a blood test is done. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, increases in liver enzymes, decreases in the number of certain types of blood cells, decreases in the number of red blood cells, increases in creatine phosphokinase in the blood (a substance found in muscles), decreases in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

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

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

Additional side effects in children and adolescents

The same side effects that may occur in adults may also occur in children and adolescents.

The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very common: may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:
• • Taking in children and adolescents swelling of the breasts and unexpected milk production.
  • Girls may not have a menstrual period or have irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling of restlessness or muscle rigidity without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Quetiapina ratio

• The active ingredient is quetiapine. Quetiapina ratio tablets contain 25 mg of quetiapine (as quetiapine fumarate).
• The other components are: Dihydrate calcium hydrogen phosphate, lactose, povidone K-25, microcrystalline cellulose, sodium carboxymethyl starch (from potato), anhydrous colloidal silica, magnesium stearate. The coating contains hypromellose, titanium dioxide (E171), triacetin, lactose, yellow iron oxide (E172), and yellow orange S (E110).

Appearance of the product and content of the container

Quetiapina ratio 25 mg tablets are film-coated, light orange, round, biconvex, and engraved with “25” on one side and smooth on the other.

Quetiapina ratio film-coated tablets are available in:

Transparent white PVC/PVdC-aluminum blister pack.

Blister pack of 6 film-coated tablets.

Blister pack of 60 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13.

Debrecen H-4042

Hungary

PHARMACHEMIE B.V.

Swensweg, 5. P.O. Box 552 (Haarlem) –

NL-2003 RN - Netherlands

TEVA SANTE SA

Rue Bellocier (Sens) - 89107 – France

TEVA CZECH INDUSTRIES S.R.O.

Ostravska 29, c.p. 305, (Opava-Komarov)

747 70 - Czech Republic

TEVA OPERATIONS POLAND SP.Z.O.O.

Ul. Mogilska 80 (Krakow)

31-546 – Poland

Merckle GmbH,

Ludwig-Merckle-Str 3,

89143 Blaubeuren

Germany

Last review date of this leaflet: June 2024

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