Quetiapine Kern Pharma 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Quetiapine Kern Pharma 300 mg prolonged-release film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side 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: 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 sense 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 Quetiapine Kern Pharma even after you start feeling better.

2. What you need to know before taking Quetiapine Kern Pharma

Do not take Quetiapine Kern Pharma:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Quetiapine Kern Pharma 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 (whether or not 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 Kern Pharma 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.
• 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 "Taking Quetiapine Kern Pharma with other medicines").

Contact your doctor immediately if, after taking Quetiapine Kern Pharma, 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 sleepy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).
• Fast 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.

Contact 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 together 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 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 behaviour 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 also ask them to let you know if they think your depression is getting worse or if they are concerned about changes in your behaviour.

Weight gain

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

Children and adolescents

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

Taking Quetiapine Kern Pharmawith other medicines

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

Do not take Quetiapine Kern Pharma 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 taking 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 (medicines to increase urination) 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 Kern Pharmawith food, drinks and alcohol

• Quetiapine Kern Pharma can be taken with or without food.
• Be cautious about the amount of alcohol you consume. This is because the combined effect of Quetiapine Kern Pharma and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Kern Pharma. 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 Kern Pharma during pregnancy unless you have discussed it with your doctor. You must not use Quetiapine Kern Pharma 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.

Quetiapine Kern Pharmac 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 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 Kern Pharma

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 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.

• You will take your tablets once a day, at bedtime, or twice a day, 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 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.

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 Pharama than you should

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

You may also call the Toxicology Information Service, Telephone: 915620420, stating 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 and take the next dose at the scheduled time. Do not take a double dose to make up for the forgotten 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 may 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 (could lead to falls), headache, dry mouth.
• Drowsiness (which may decrease over time as you continue taking quetiapine) (could 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 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 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 (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 tests.
• Increased levels of prolactin hormone in blood. Elevated prolactin levels may, in rare cases, lead to:
  • 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, or 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 (QT interval prolongation).
• Slower than normal heart rate, which may occur at the start 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 the blood.
• Decreased sodium levels 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 condition 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 notice any of these symptoms, seek immediate medical attention.
• Walking, talking, eating, or performing other activities while asleep.
• Decreased 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: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased blood 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).
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

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

• Skin rashes with irregular red patches (erythema multiforme).
• Sudden and 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 reaction 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 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 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, reduced numbers of certain blood cells, decreased red blood cell count, 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:

• 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):

• Increased levels of a hormone called prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to:
  • 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 (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 Kern Pharma

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 empty containers and unused medicines at a SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 300 mg of quetiapine (as quetiapine fumarate).

The other components are:

Tablet core: Lactose monohydrate (lactose), microcrystalline cellulose, calcium phosphate dibasic dihydrate, povidone K30, sodium carboxymethylstarch from potato (potato starch) (Type A) and calcium stearate.

Tablet coating: Hypromellose, titanium dioxide (E171) and glyceryl triacetate.

Appearance of Quetiapine Kern Pharma and contents of the pack

The tablets are white, round and oblong.

They are presented in PVC/aluminum blisters, in packs of 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Laboratorios Alter, S.A.

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Manufacturer

Laboratorios Alter S.A.

Mateo Inurria, 30

28036 Madrid

Date of the most recent revision of this product information: June 2024

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