Quetiapine Kern Pharma 50 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Quetiapine Kern Pharma 50 mg prolonged-release tablets EFG

Read the entire leaflet carefully before starting to take 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; do 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Quetiapine Kern Pharma is and what it is used for

Quetiapine Kern Pharma contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapine Kern Pharma 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, have loss of appetite, or are unable to sleep.
• Mania: where you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or violent.
• 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 Quetiapine Kern Pharma extended-release tablets are being used to treat major depressive episodes in major depressive disorder, they will be taken in addition to another medicine you are already using for this condition.

Your doctor may continue prescribing Quetiapine Kern Pharma even after you start feeling better.

2. What you need to know before taking Quetiapina Kern Pharm

Do not take Quetiapina Kern Pharm:

• if you are allergic (hypersensitive) to quetiapine or to any of the other ingredients of Quetiapina Kern Pharm (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 Quetiapina Kern Pharm if any of the above apply to you. If you have any doubts, consult your doctor or pharmacist before taking Quetiapina Kern Pharm.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Quetiapina Kern Pharm 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 an elderly patient.
• 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 Quetiapina Kern Pharm belongs may increase the risk of stroke, or in some cases, the risk of death, in these individuals.
• You or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
• You suffer from depression or other conditions treated with antidepressants. The use of these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Quetiapina Kern Pharm with other medicines").

Inform your doctor immediately if, after taking Quetiapina Kern Pharm, 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 (epileptic fits).
• 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 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 have thoughts of harming yourself or of 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. Such thoughts may be more likely 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 of 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.

Weight gain

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

Children and adolescents

Quetiapina Kern Pharm must not be used in children and adolescents under 18 years of age.

Use of Quetiapina Kern Pharm with other medicines

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

Do not take Quetiapina Kern Pharm 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).

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 heartbeat, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics ("water pills") or certain antibiotics (medicines for treating 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 Quetiapina Kern Pharm prolonged-release tablets with food, drinks, and alcohol

• Quetiapina Kern Pharm 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. This is because the combined effect of Quetiapina Kern Pharm and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapina Kern Pharm. 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 become pregnant, consult your doctor before using this medicine.

You should not take Quetiapina Kern Pharm during pregnancy unless advised by your doctor. You must not use Quetiapina Kern Pharm if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns 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.

Quetiapina Kern Pharm prolonged-release tablets contain lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her 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 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 Kern Pharma

Follow exactly the instructions for use of this medicine as given 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 your tablets once daily.
• 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 tell you when).
• Do not drink grapefruit juice while taking Quetiapine Kern Pharma. 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.

Use in elderly patients

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

Use in children and adolescents

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

If you take more Quetiapine Kern Pharma than you should

If you take more Quetiapine Kern Pharma than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Bring the Quetiapine Kern Pharma tablets with you.

You may also call the Toxicology Information Service at telephone number: 915620420, stating the name of the medicine and the amount taken.

If you forget to take Quetiapine Kern Pharma

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 a missed tablet.

If you stop taking Quetiapine Kern Pharma

If you stop taking Quetiapine Kern Pharma abruptly, you may have difficulty sleeping (insomnia), or may 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 decrease 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. 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 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 patients).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzyme levels measured in blood.
• Increases in prolactin hormone levels in blood. Elevated prolactin levels may, 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.
• 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.
• 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, 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 (galactorrhea).
• 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 difficulty breathing. If you notice any of these symptoms, seek immediate medical help.
• 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, 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.
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Adverse effects with unknown frequency (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.
• 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 Kern Pharma 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, 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 prolactin levels. Elevated prolactin levels may, 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.

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 the blood. Elevated prolactin levels may, 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 (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of adverse effects

If you experience any type of 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quetiapine Kern Pharma

Keep this medicine out of 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.

Quetiapine Kern Pharma does not require any special storage conditions.

Medicines must not be disposed of via wastewater or in household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of any unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Kern Pharma

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

The other components are:

Tablet core: lactose monohydrate, hypromellose, sodium chloride, povidone K-30, silicified microcrystalline cellulose (silicon dioxide and microcrystalline cellulose), talc, and magnesium stearate (E572).

Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (E553b), talc, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of Quetiapine Kern Pharma and contents of the pack

The tablets are peach-coloured, round, biconvex, film-coated tablets, marked with the inscription “Q50” on one side and smooth on the other. They are available in PVC/PVDC/Aluminum blisters or Alu/Alu blisters, in pack sizes of 10 or 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent 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/