QUETIAPINE QUALIGEN FARMA 150 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Quetiapine Qualigen Farma

Do not take Quetiapine Qualigen Farma:

• If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine Qualigen Farma (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 Qualigen Farma if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Quetiapine Qualigen Farma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine Qualigen Farma if:

• You, or a family member, have or have had any heart problems, such as problems with your heart rhythm, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medication that may affect your heart rate.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have ever had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking quetiapine.
• You know that you have had low white blood cell counts in the past (which may or may not have been caused by other medications).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine, because the group of medicines that Quetiapine Qualigen Farma belongs to may increase the risk of stroke, or in some cases the risk of death, in these people.

If you are an elderly person with Parkinson's disease/parkinsonism.

• You or a family member have a history of blood clots, as medicines like this one have been associated with the formation of blood clots.

If you have or have had a disorder in which you stop breathing for short periods during normal nighttime sleep (called "sleep apnea") and are taking medications that slow down normal brain activity ("depressants").

• You have or have had a disorder in which you cannot empty your bladder completely (urinary retention), enlarged prostate, intestinal obstruction, or increased eye pressure. These disorders are sometimes caused by medications (called "anticholinergics") that affect the functioning of nerve cells and are used to treat certain diseases.
• You have a history of alcoholism or drug abuse.
• If you suffer from depression or other conditions that are treated with antidepressants.

The use of these medications with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see Other medicines and Quetiapine Qualigen Farma).

Tell your doctor immediately if, after taking Quetiapine Qualigen Farma, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or a decrease in level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
  • Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. 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.

Tell your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and may require interruption of treatment with quetiapine and/or additional treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more serious bowel obstruction.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think of harming or killing yourself. This may increase when you first start treatment, as all these medications take time to work, 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 from clinical trials has 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 think of harming or killing yourself, contact your doctor or go to a hospital immediately. It may help to tell a relative or close 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 worried about changes in your behavior.

Weight gain

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

Children and adolescents

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

Other medicines and Quetiapine Qualigen Farma

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

Do not take Quetiapine Qualigen Farma if you are using any of the following medicines:

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

Tell 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).
• Medicines that affect your heart rate, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.

Medicines (called "anticholinergics") that affect the functioning of nerve cells and are used to treat certain diseases.

Antidepressants. These medicines may interact with quetiapine, and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles 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 if you experience these symptoms.

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

Taking Quetiapine Qualigen Farma with food, drinks, and alcohol

• Quetiapine Qualigen Farma may be affected by food, and therefore you should take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Quetiapine Qualigen Farma and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Qualigen Farma. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take Quetiapine Qualigen Farma during pregnancy, unless your doctor has advised you to do so. You should not use Quetiapine Qualigen Farma if you are breastfeeding.

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

Driving and using machines

These tablets may make you feel drowsy. Do not drive or operate tools or machines until you know how the tablets affect you.

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 some analysis methods are used, even if you are not taking methadone or TCAs. If this happens, a more specific test can be performed.

Quetiapine Qualigen Farma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking the medicine.

3. How to take Quetiapine Qualigen Farma

Follow exactly the administration instructions of this medicine given 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 disease and needs but will normally be between 150 mg and 800 mg.

• Take the tablets once a day.
• Do not split, 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 at bedtime, your doctor will indicate when).
• Do not drink grapefruit juice while taking Quetiapine Qualigen Farma. 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 change your dose.

Elderly patients

If you are an elderly patient, your doctor may change your dose.

Use in children and adolescents

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

If you take more Quetiapine Qualigen Farma than you should

If you take more Quetiapine Qualigen Farma than your doctor has prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring the Quetiapine Qualigen Farma tablets with you. You can also call the Toxicology Information Service, Tel: 915620420, indicating the medicine and the amount taken.

If you forget to take Quetiapine Qualigen Farma

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 forgotten tablet.

If you stop taking Quetiapine Qualigen Farma

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Dizziness (which may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time as you continue taking quetiapine), (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, 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 starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common Adverse Effects (may affect up to 1 in 10 people):

• Fast heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disorder of speech and language.
• Suicidal thoughts 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. The increases in prolactin hormone could, in rare cases, lead to the following:

o In both men and women, having swollen breasts and unexpected milk production.

o In women, not having menstrual periods or having irregular periods.

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• Seizures or convulsions.
• Allergic reactions that can include swollen hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on the ECG (prolongation of the QT interval).
• Slower heart rate than normal, which can occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which 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.

Rare Adverse 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 disorder called "neuroleptic malignant syndrome").
• Yellowish color of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swollen breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• Walking, talking, eating, or other activities while you are asleep.
• Decreased body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") where you may suffer from a combination of 3 or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased triglycerides, increased blood pressure, and increased blood sugar.
• 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 substance found in muscles).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

Unknown Frequency (cannot be estimated from available data):

• Red spots on the skin with irregular edges (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug rash 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.

Stroke

Heart muscle disorder (cardiomyopathy).

Heart muscle inflammation (myocarditis).

Blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which Quetiapina Qualigen belongs can cause heart rhythm problems that can be serious and, in severe cases, potentially fatal.

Some adverse effects are only observed when a blood test is performed. 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, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both men and women having swollen breasts and unexpected milk production.
• Women not having menstrual periods or having irregular periods.

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

Adverse Effects in Children and Adolescents

The same adverse effects that can occur in adults can 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 amount of a hormone called prolactin in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:
  • Both boys and girls having swollen breasts and unexpected milk production.
  • Girls not having menstrual periods or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common Adverse Effects (may affect up to 1 in 10 people):

• Feeling of weakness, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritated.

Reporting Adverse Effects

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

5. Storage of Quetiapina Qualigen Farma

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

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

This medicine does not require special storage conditions. Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of

The active ingredient is quetiapine. The tablets contain 50 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

Core of the tablet: lactose, methacrylic acid - ethyl acrylate copolymer (1:1), crystalline maltose type A, magnesium stearate, and talc.

Coating of the tablet: Methacrylic acid - ethyl acrylate copolymer (1:1), type A, triethyl citrate.

Appearance of Quetiapina Qualigen Farma and Package Contents

The 50 mg prolonged-release tablets are white or almost white, round, biconvex, with "50" engraved on one side, 7.1 mm in diameter, and 3.2 mm in thickness.

They are presented in aluminum/PVC/PCTFE blisters in a cardboard box.

The package sizes are: 10, 30, 50, 60, 100, and 180 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Manufacturer

Pharmathen International, S.A.

Industrial Park Sapes Rodopi Prefecture Block Nº 5

Rodopi 69300

Greece

or

Pharmathen, S.A.

Dervenakion 6

Pallini Attiki, 15351

Greece

or

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Date of the Last Revision of this Leaflet: June 2024

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