Quetiapine Pensa 200 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Quetiapina Pensa 200 mg film-coated tablets EFG
quetiapine
Please read all of 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 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 side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What Quetiapina Pensa is and what it is used for
- What you need to know before taking Quetiapina Pensa
- How to take Quetiapina Pensa
- Possible side effects
- How to store Quetiapina Pensa
- Contents of the pack and other information
1. What Quetiapina Pensa is and what it is used for
Quetiapina Pensa contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapina Pensa can be used to treat several conditions, such as:
• Bipolar depression: when you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: when you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: when 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 Pensa to you even after you start feeling better.
2. What you need to know before taking Quetiapine Pensa
Do not take Quetiapine Pensa:
? if you are allergic (hypersensitive) to quetiapine or to any of the other ingredients of this medicine (listed in section 6).
? if you are taking any of the following medicines:
- certain medicines for HIV
- azole-type medicines (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression)
Do not take Quetiapine Pensa if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Quetiapine Pensa.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Quetiapine Pensa if:
? You, or a family member, have or have had any heart problems, for example, heart rhythm problems, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medicine 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 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 functions). In this case, you should not take quetiapine, as the group of medicines to which Quetiapine Pensa belongs may increase the risk of stroke or, in some cases, the risk of death in these individuals.
? You or a family member have a history of blood clots, as medicines like this have been associated with blood clot formation.
- If 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 Pensa").
Inform your doctor immediately if, after taking Quetiapine Pensa, 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).
- Rapid or irregular heartbeats, even at rest, palpitations, breathing difficulties, 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.
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 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 depression
If you are depressed, you may sometimes have thoughts about harming yourself or committing suicide. These thoughts 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 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 inform you 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 Pensa must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine Pensa
Tell your doctor if you are taking, have recently taken, or might need to take any other medicine.
Do not take Quetiapine Pensa if you are using any of the following medicines:
? Certain medicines for HIV.
? Azole-type medicines (for fungal infections).
? Erythromycin or clarithromycin (for infections).
? Nefazodone (for depression).
Inform 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 rhythm, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics ("water pills") or certain antibiotics (medicines to treat infections).
? Medicines that may cause constipation.
- Antidepressants. These medicines may interact with quetiapine 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.
Before stopping any of your medicines, consult your doctor first.
Taking Quetiapine Pensa with food, drinks, and alcohol
? Quetiapine Pensa can be taken with or without food.
? Be cautious about the amount of alcohol you consume. This is because the combined effect of Quetiapine Pensa and alcohol may make you drowsy.
? Do not drink grapefruit juice while taking Quetiapine Pensa. 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 should not take Quetiapine Pensa during pregnancy unless advised by your doctor. You should not use Quetiapine Pensa if you are breastfeeding.
The following symptoms, which may represent a withdrawal syndrome, may occur in newborns of mothers who have used 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.
Quetiapine Pensa contains lactose.
If your doctor has informed 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 antidepressant medicines known as tricyclic antidepressants (TCAs) when certain analytical 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 Pensa
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will decide 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 daily at bedtime or twice daily, depending on your condition.
? Swallow your tablets whole with water.
? You may take the tablets with or without food.
? Do not drink grapefruit juice while taking Quetiapine Pensa. It may affect how the medicine 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 adjust your dose.
Elderly patients
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents
Quetiapine Pensa must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine Pensa than you should
If you take more Quetiapine Pensa than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately.
Take the Quetiapine Pensa tablets with you.
You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Quetiapine Pensa
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 Pensa
If you stop taking Quetiapine Pensa abruptly, you may have difficulty sleeping (insomnia), feel nauseous, or experience headache, diarrhoea, 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), feeling nauseous, headache, diarrhoea, 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, restlessness, or painless muscle stiffness.
? Changes in levels of certain fats (triglycerides and total cholesterol).
Common adverse effects (may affect up to 1 in 10 people):
? Fast heartbeat
? Feeling that 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 make you feel dizzy or faint (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 levels of thyroid hormones in the blood
- Decrease in the number of certain types of blood cells
- Increases in liver enzymes measured in blood
- Increases in the amount of prolactin hormone in blood. 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
Uncommon adverse effects (may affect up to 1 in 100 people):
- 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
- Change 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 (may lead to falls)
- Stuffy nose
- Decrease in the number of red blood cells in blood
? Decrease in the amount of sodium 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, painful erection (priapism)
? Breast enlargement and unexpected milk production (galactorrhoea)
? Menstrual disorder
-
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 notice any of these symptoms, seek immediate medical help.
-
Walking, talking, eating, or other activities while 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 the abdomen, decreased “good cholesterol” (HDL-C), increased levels of a type of fat in the blood called 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 known as agranulocytosis
-
Intestinal obstruction
? Increased blood creatine phosphokinase (a substance from 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) 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
- Muscle fiber breakdown and muscle pain (rhabdomyolysis)
? Worsening of pre-existing diabetes
Not known (frequency cannot be estimated from available data):
- Skin rashes with irregular red spots (erythema multiforme)
- Sudden, severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis)
? Newborns of mothers who used quetiapine during pregnancy may experience withdrawal symptoms
- Drug reaction with eosinophilia and systemic symptoms (DRESS). Generalised rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction 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.
- Heart muscle disorder (cardiomyopathy)
- Inflammation of the heart muscle (myocarditis)
- Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple spots
The class of medicines to which Quetiapina Pensa 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 blood, increases in liver enzymes, decreases in the number of certain blood cells, decrease in 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. 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 have not been observed in adults:
Very common adverse effects (may affect more than 1 in 10 people):
- Increase in the level 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 stiffness
- 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 System of Pharmacovigilance for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Quetiapine Pensa
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.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Quetiapina Pensa
The active substance is quetiapine. The tablets contain 200 mg of quetiapine (as quetiapine fumarate).
? The other components are:
Tablet core: povidone K30 (E1201); microcrystalline cellulose (E460); calcium hydrogen phosphate dihydrate; sodium starch glycolate from maize type C (maize starch); colloidal anhydrous silica; magnesium stearate (E572).
Tablet coating: hypromellose (E464); lactose monohydrate (lactose); macrogol 3350; triacetin; titanium dioxide (E171).
Appearance of the product and contents of the container
The tablets are round, biconvex, and white in colour.
They are presented in PVC-Al blisters within packaging containing 60 or 90 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer
Zaklady Farmaceutyczne Polpharma S.A.,
(Pharmaceutical Works Polpharma SA)
ul. Pelplinska 19,
83-200 Starogard Gdanski,
Poland
This medicinal product is authorized in the European Economic Area member states under the following names:
Spain: Quetiapina Pensa 200 mg, film-coated tablets EFG
Date of the most recent review of this leaflet: May 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/