Quetiapine Tecnigen 200 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Quetiapine TecniGen 200 mg prolonged-release tablets EFG

Read the entire 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

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

1. What Quetiapina TecniGen is and what it is used for

Quetiapina TecniGen contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapine 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 feel things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

When quetiapine is used to treat major depressive episodes in major depressive disorder, it is taken in addition to another medicine you are already taking for this condition.

Your doctor may continue prescribing quetiapine even after you start feeling better.

2. What you need to know before taking Quetiapina TecniGen

Do not take Quetiapina TecniGen

• If you are allergic to quetiapine 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 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 suffer from depression or other conditions treated with antidepressants. The use of these medicines together with Quetiapina TecniGen may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Quetiapina TecniGen with other medicines").
• If you, or a family member, have or have had any heart problems, for example, heart rhythm disorders, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• 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. If so, your doctor may monitor your blood sugar levels while you are taking quetiapine.
• If you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• If you are an elderly person with dementia (loss of brain functions). In this case, you should not take quetiapine because the group of medicines to which quetiapine belongs may increase the risk of stroke, or in some cases the risk of death, in these individuals.
• If you are an elderly person with Parkinson's disease/parkinsonism.
• If you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
• If you have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and you are taking medicines that reduce 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 increased pressure inside your eye. These conditions can sometimes be caused by medicines (called "anticholinergics") that affect how nerve cells function, used to treat certain medical conditions.
• If you have a history of alcohol or drug abuse.

Contact your doctor immediately if, after taking quetiapine, 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 excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast or irregular heartbeats, even at rest, palpitations, breathing problems, chest pain, or unexplained fatigue. 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.

Inform 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 count of white blood cells and may require discontinuation of quetiapine treatment 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 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 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. 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 about 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 ask them to let you know if they think your depression is getting worse or if they are concerned about changes in your behavior.

Serious skin reactions

Serious, potentially life-threatening or fatal skin reactions have been reported very rarely with this medicine. These commonly manifest as:

• Stevens-Johnson syndrome, a widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals.
• Toxic Epidermal Necrolysis, a more severe form causing extensive skin peeling.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), characterized by flu-like symptoms, rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes).

Stop using quetiapine if you develop these symptoms and contact your doctor or seek immediate medical attention.

Weight gain

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

Children and adolescents

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

Other medicines and Quetiapina TecniGen

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

Do not take quetiapine if you are using any of the following medicines:

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

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

• Antidepressants. These medicines may interact with Quetiapina TecniGen and you may experience symptoms such as involuntary and 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.
• 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 electrolyte imbalance (low potassium or magnesium levels) such as diuretics (medicines to increase urination) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells function, used to treat certain medical conditions.

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

Taking Quetiapina TecniGen with food, drinks, and alcohol

• Quetiapine may be affected by food, and therefore you should take your tablets at least one hour before a meal or before bedtime.
• Be cautious about the amount of alcohol you consume. This is because the combined effect of quetiapine and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking quetiapine. 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 or pharmacist before using this medicine.

You should not take quetiapine during pregnancy unless advised by your doctor. You should not use quetiapine if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns whose mothers have used quetiapine during the third trimester (last three months of pregnancy): tremor, muscle rigidity 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

This medicine may cause drowsiness. Do not drive, operate machinery, or perform other activities requiring special attention until you know how this medicine affects you.

Quetiapina TecniGen contains lactose

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

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 antidepressants 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.

3. How to take Quetiapine TecniGen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

• You will take your tablets once a day.
• Do not split, chew or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will advise you when to take them).
• Do not drink grapefruit juice while taking quetiapine. 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 adjust your dose.

Elderly patients

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

Use in children and adolescents

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

If you take more Quetiapine TecniGen than you should

If you take more quetiapine than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats.

In case of overdose or accidental ingestion, consult your doctor or nearest hospital immediately. Take the tablets with you. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Quetiapine 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 forgotten doses.

If you stop taking Quetiapine TecniGen

If you stop taking quetiapine 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 experiences them.

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

• Dizziness (could lead to falls), headache, dry mouth.
• Drowsiness (may diminish over time as you continue taking quetiapine) (could lead to falls).
• Withdrawal symptoms (symptoms occurring when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. 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, 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 beating irregularly.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Low blood pressure when standing. This may cause dizziness or fainting (could 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 levels of thyroid hormones in the blood.

• Decreased number of certain types of blood cells.

• Increased levels of liver enzymes in blood.

• Increased levels of prolactin hormone in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both men and women: breast enlargement and unexpected milk production.

• 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.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (prolongation of 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 (could lead to falls).
• Stuffy nose.
• Decreased number of red blood cells in blood.
• Decreased sodium levels in blood.
• Worsening of pre-existing diabetes.

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 (galactorrhea).
• Menstrual disorders.
• Blood clots in 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 difficulty breathing. If you experience 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 blood fats called 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, known as agranulocytosis.
• Intestinal obstruction.
• Increased blood 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). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Adverse effects with unknown frequency: cannot be estimated from available data

• Skin rashes with irregular red spots (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), characterized by flu-like symptoms, rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often accompanied by a skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs can cause heart rhythm problems that may be serious and, in severe cases, could 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 the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in blood, and increased levels of prolactin hormone in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both men and women: breast enlargement and unexpected milk production.
• In women: absence of menstrual periods or irregular periods.

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

Additional 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. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both boys and girls: breast enlargement and unexpected milk production.

• 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 (could 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. Storage of Quetiapine TecniGen

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 refers to the last day of the month indicated.

No special storage conditions are required.

Only for the bottle presentation:

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine TecniGen

• The active substance is quetiapine. Each Quetiapine TecniGen tablet contains 200 mg of quetiapine (as quetiapine fumarate).
• The other components are:
  • Tablet core: methacrylic acid-ethyl acrylate copolymer (1:1), type A, anhydrous lactose, crystalline maltose, talc and magnesium stearate.
  • Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1), type A and triethyl citrate.

Appearance of the product and contents of the pack

Quetiapine 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, printed with “200” on one side.

For blister pack presentation only

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

For bottle presentation only

Packs of 10, 30, 50 and 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid)

Spain

Manufacturer

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

Date of the most recent revision of this leaflet: December 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/