Quetiapine Qualigen Farma 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine Qualigen Farma 400 mg prolonged-release tablets EFG

Read all of 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Quetiapine Qualigen Farma is and what it is used for
2. What you need to know before taking Quetiapine Qualigen Farma
3. How to take Quetiapine Qualigen Farma
4. Possible side effects
5. How to store Quetiapine Qualigen Farma
6. Contents of the pack and other information

1. What Quetiapina Qualigen Farma is and what it is used for

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

• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: where you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include aggressive or violent behavior.
• Schizophrenia: where you may hear or sense things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

When Quetiapina Qualigen Farma prolonged-release tablets are used to treat major depressive episodes in major depressive disorder, they are taken in addition to another medicine you are already using to treat this condition.

Your doctor may continue prescribing Quetiapina Qualigen Farma even after you start feeling better.

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

Do not take Quetiapine Qualigen Farma:

• If you are allergic (hypersensitive) to quetiapine or to any of the other components 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 have any doubts, consult your doctor or pharmacist before taking Quetiapine Qualigen Farma.

Warnings and precautions

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

• You, or a family member, have or have had any heart problems, for example, irregular heartbeat, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.

• 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 (epileptic fit).

• 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 you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).

• You are an elderly person with dementia (loss of brain function). In this case, you should not take quetiapine, as the group of medicines to which Quetiapine Qualigen Farma belongs may increase the risk of stroke or, in some cases, the risk of death in these individuals.

• 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 have been associated with blood clot formation.

• You have or have had a disorder in which you stop breathing briefly during normal nighttime sleep (called "sleep apnea") and you are taking medicines that slow down normal brain activity ("depressants").

• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), prostate enlargement, intestinal obstruction, or increased eye pressure. These conditions are sometimes caused by medicines (called "anticholinergics") that affect nerve cell function and are used to treat certain diseases.

• You have a history of alcoholism or drug abuse.

• You suffer from depression or other conditions treated with antidepressants.

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

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

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Uncontrollable 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 (epileptic fits).
• A prolonged and painful erection (priapism).
  • Rapid 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.

Tell your doctor as soon as possible if you have:

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

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This 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. You may be more likely to have such thoughts 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 let you know if they think your depression is getting worse or if they are concerned about changes in your behavior.

Weight gain

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

Children and adolescents

Quetiapine Qualigen Farma must 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 need to 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).
• Nefazodone (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 heartbeat, for example, medicines that may cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics ("water pills") or certain antibiotics (medicines to treat infections).

• Medicines that may cause constipation.

• Medicines (called "anticholinergics") that affect nerve cell function and are used to treat certain diseases.

• Antidepressants. These medicines may interact with quetiapine, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, 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, so you should take your tablets at least one hour before a meal or before bedtime.
• Be cautious about the amount of alcohol you consume, as 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 plan to become pregnant, consult your doctor before using this medicine.

You must not take Quetiapine Qualigen Farma during pregnancy unless advised by your doctor. You must not use Quetiapine Qualigen Farma if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborn babies whose mothers have taken quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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 machinery until you know how these tablets affect you.

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking quetiapine may produce positive results for methadone or certain antidepressant medicines called 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 Qualigen Farma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Quetiapine Qualigen Farma

Take this medicine exactly as prescribed by your doctor or pharmacist.
Do not change the dose unless told to do so by your doctor.

Quetiapine Qualigen Farma tablets should be taken with water, swallowed whole, and can be taken with or without food.

The tablets must not be chewed, crushed, or broken.

Your doctor will determine the appropriate dose based on your condition and response to treatment. The dose may be gradually increased at the beginning of treatment.

Continue taking this medicine for as long as your doctor recommends, even if you feel well. Stopping the treatment suddenly may cause withdrawal symptoms. If you wish to discontinue the medication, consult your doctor first.

If you have any doubts about how to take this medicine, ask your doctor or pharmacist.

Follow exactly the instructions for administering this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine your initial dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

• Take the tablets once daily.
• Do not split, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets on an empty stomach (at least one hour before a meal or at bedtime; your doctor will advise you 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 do so.

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

Quetiapine Qualigen Farma must 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 prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the Quetiapine Qualigen Farma tablets with you. You may also call the Toxicology Information Service at telephone number 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 missed tablet.

If you stop taking Quetiapine Qualigen Farma

If you stop taking Quetiapine Qualigen Farma abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further 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 everyone will experience them.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may diminish 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 discontinuation over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness, or painless muscle rigidity.
• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Feeling as if your heart is pounding, racing, or skipping beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in thyroid hormone levels in blood.
• Decreased number of certain types of blood cells.
• Increases in liver enzymes measured in blood.
• Increases in blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to the following:

o Breast enlargement and unexpected milk production in both men and women.

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

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

• Epileptic seizures or convulsions.
• Allergic reactions which may include raised, itchy rashes (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (prolongation of the QT interval).
• 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 number of red blood cells in blood.
• Decreased sodium levels in blood.

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

• A combination of high temperature (fever), sweating, muscle stiffness, and extreme drowsiness or dizziness (a disorder known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, seek immediate medical attention.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may experience a combination of 3 or more of the following: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar.
• A combination of fever, flu-like symptoms, sore throat, or any other infection accompanied by a very low white blood cell count, a condition known as agranulocytosis.
• Intestinal obstruction.
• Increased blood levels of creatine phosphokinase (a muscle substance).

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) which may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious blistering condition affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibres and muscle pain (rhabdomyolysis).

Not known (frequency cannot be estimated from available data):

• Skin rashes with irregular red patches (erythema multiforme).
• Sudden, severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop taking quetiapine and contact your doctor or seek immediate medical attention.

. Stroke

. Heart muscle disorder (cardiomyopathy).

. Inflammation of the heart muscle (myocarditis).

. Inflammation of blood vessels (vasculitis), often with a skin rash consisting of small red or purple spots.

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

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

• Breast enlargement 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.

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 were not observed in adults:

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

• Increased levels of a hormone called prolactin in blood. Elevated prolactin levels may, in rare cases, lead to the following:
  • Breast enlargement and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include 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, pharmacist, or nurse, 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. Conservation of Quetiapine Qualigen Farma

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 is the last day of the month indicated.

This medicine does not require any special storage conditions. Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Quetiapine Qualigen Farma

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

The other components are:

Tablet core: lactose, methacrylic acid – ethyl acrylate copolymer (1:1), crystalline maltose type A, magnesium stearate and talc.

Tablet coating: methacrylic acid – ethyl acrylate copolymer (1:1) type A, triethyl citrate.

Appearance of Quetiapine Qualigen Farma and contents of the pack

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 thick.

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

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

Only some pack 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 latest review of this leaflet: June 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/