Package Insert: Information for the User

Quetiapina TecniGen 200 mg Extended-Release Tablets EFG

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Quetiapina TecniGen contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quediapine can be used to treat various diseases, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: 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 present poor judgment, which includes 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

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

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

Do not take Quetiapina TecniGen

• If you are allergic to quetiapine or any of the other components 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 quetiapine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina TecniGen:

• You have depression or other conditions treated with antidepressants. The use of these medications with Quetiapina TecniGen may cause serotonin syndrome, a potentially fatal condition (see "Use of Quetiapina TecniGen with other medications").
• 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 an elderly patient.
• If you have liver problems.
• If you have ever had a seizure (convulsion).
• 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 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 quetiapine because the class of medications to which quetiapine 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 blood clot formation.
• 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 quetiapine 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"). Immediate medical treatment may be necessary.
• 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).
• Rapid 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.

These disorders 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 could be a consequence of a very low white blood cell count and require discontinuation of quetiapine 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 more.

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 obtained from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 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 can 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

Severe skin reactions that may be life-threatening or life-threatening have been reported in very rare cases with this medication treatment. These typically manifest as:

• Stevens-Johnson syndrome, a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis, a more severe form that causes extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms, rash, fever, lymph node inflammation, and abnormal blood test results (including eosinophilia and elevated liver enzymes).

Stop using quetiapine if you develop these symptoms 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 monitor your weight regularly.

Children and adolescents

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

Other medications and Quetiapina TecniGen

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

Do not take quetiapine 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:

• Antidepressants. These medications may interact with Quetiapina TecniGen 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.
• Antiepileptic medications (such as phenytoin or carbamazepine).
• Blood pressure medications.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or lithium (other antipsychotic medications).
• 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.

Consult your doctor before stopping any of your medications.

Quetiapina TecniGen 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 consume. 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 medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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 newborns of mothers who have used quetiapine in the last trimester (last three months of pregnancy): tremor, 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 using machines

This medication may make you drowsy. Do not drive, operate machines, or engage in other activities that require special attention until you know how this medication affects you.

Quetiapina TecniGen contains lactose

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

Effect on drug detection tests in urine

If you are undergoing a urine drug detection test, taking quetiapine may produce positive results for methadone or certain antidepressant medications 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.

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 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 orange 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 takemore Quetiapina TecniGen 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 the nearest hospital immediately. Bring your quetiapina tablets with you. You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Quetiapina TecniGen

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 dose.

If you interrupt the treatment with Quetiapina TecniGen

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 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 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 side effects: may affect up to 1 in 10 people

• Fast heart rate.
• 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 cause you to 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 the amount of 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:

• In men and women, breast swelling and unexpected milk production.
• In women, absence of menstrual period or irregular periods.

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

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a condition called "neuroleptic malignant syndrome").
• Yellowish discoloration of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling 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 attention immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") where you may experience a combination of 3 or more of the following effects: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, increased blood pressure, and increased blood sugar levels.
• A combination of fever, flu-like symptoms, 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 muscle substance).

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

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (anaphylaxis) that may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe skin blistering, mouth, eyes, and genital areas (Stevens-Johnson syndrome). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Side effects of unknown frequency: cannot be estimated from available data

• Rashes on the skin with irregular red spots (erythema multiforme).
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms, rash, fever, swollen lymph nodes, and abnormal blood test results (including eosinophilia and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have taken quetiapine during pregnancy.
• Stroke.
• Cardiac muscle disorder (cardiomyopathy)
• Cardiac muscle inflammation (myocarditis)
• Inflammation of blood vessels (vasculitis), often with skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs can cause serious heart rhythm problems that may be life-threatening.

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 blood sugar levels, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase in the blood (a muscle substance), decreased sodium levels in the blood, and increased prolactin hormone levels in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• In men and women, breast swelling and unexpected milk production.
• In women, absence of 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:

Very common side effects: 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:

• In boys and girls, breast swelling and unexpected milk production.

• In girls, absence of menstrual period or 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 side effects: may affect up to 1 in 10 people

• Feeling weak, dizziness (may lead to falls).
• Blocked nose.
• Feeling irritable.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the Vigilance 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.

No special storage conditions are required.

Only for the presentation in a bottle:

Do not use Quetiapina TecniGen 60 days after the first opening of the bottle.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Quetiapina TecniGen

- The active ingredient is quetiapine. Each Quetiapina TecniGen tablet contains 200 mg of quetiapine (as quetiapine fumarate).

- The other components are:

• Tablet core: copolymer of methacrylic acid-ethyl acrylate (1:1), type A, anhydrous lactose, crystalline maltose, talc, and magnesium stearate.
• Tablet coating: copolymer of methacrylic acid-ethyl acrylate (1:1), type A, and triethyl citrate.

Appearance of the product and content of the container

Quetiapina TecniGen 200 mg are biconvex, oblong, white to off-white tablets, with dimensions of 15.2±0.2 mm, 7.7±0.2 mm, and 4.8±0.3 mm, engraved with “200” on one face.

Only for the blister presentation

Packages of 10, 30, 50, 60, and 100 tablets.

Only for the bottle presentation

Packages of 10, 30, 50, and 60 tablets.

Some package sizes may only be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

Or

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attiki,

Greece

Atlantic Pharma – Produções Farmacêuticas S.A.

Rua da Tapada Grande, 2, Abrunheira,

2710 – 089 Sintra

Portugal

Last review date of this leaflet:December 2024

Detailed and updated information about this medication is available on the website of theSpanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/