Quetiapine Kern Pharma 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Quetiapine Kern Pharma 50 mg film-coated tablets

Read the entire 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, consult 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, because it could harm them.
• If you experience any adverse effects, talk to 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 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: 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 highly 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 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 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).

If you have any doubts, consult your doctor or pharmacist before taking Quetiapine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Quetiapine if:

• You, or a family member, have or have had any heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heart rhythm.
• 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 belongs may increase the risk of stroke or, in some cases, death in these patients.
• if 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 condition in which your breathing stops for short periods during normal sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).
• You have or have had a condition in which you cannot fully empty your bladder (urinary retention), 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.
• You have a history of alcohol or drug abuse.
• You have 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”).

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 feel very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).
• Fast 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.

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 count of white blood cells 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 your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This risk 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. Data from clinical trials 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 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 behaviour.

• Serious skin adverse reactions (SCARs)

Very rarely, serious skin reactions (SCARs), which may be life-threatening or fatal, have been reported with the use of this medicine. These commonly manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin eruptions with irregular red, itchy spots.

If you develop any of these symptoms, stop using this medicine 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 Quetiapine

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

Do not take Quetiapine 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 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 may affect your heart rhythm, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (medicines to increase urine production) 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.
• 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.

Do not stop taking any of your medicines without first consulting your doctor.

Taking Quetiapine with food, drinks and alcohol

Quetiapine can be taken with or without food.

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 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 a withdrawal syndrome, may occur in newborns whose mothers 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 may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce your reaction time. These effects, as well as your underlying illness, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Quetiapine Kern Pharma contains lactose

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

Quetiapine Kern Pharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

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 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 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 range 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. 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 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 than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take your Quetiapine tablets with you.

You may also call the Toxicology Information Service, Telephone: 915620420, and inform them of the medicine and 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 it at the usual time. Do not take a double dose to make up for the missed tablet.

If you stop taking Quetiapine Kern Pharma

If you stop taking Quetiapine suddenly, you may have difficulty sleeping (insomnia), or feel nauseous, or experience headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce 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 disappear over time as you continue taking quetiapine) (which 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, feeling restless, 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 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 make you feel dizzy or faint (which 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.

• Decreased number of certain types of blood cells.

• Increased levels of liver enzymes in the blood.

• Increased levels of prolactin hormone in the blood. Increases in prolactin hormone 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):

• 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 start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Stuffy nose.
• Decreased number of red blood cells in the blood.
• Decreased sodium levels in the 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 condition called "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 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 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 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, 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).

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

• Skin rashes with irregular red spots (erythema multiforme) (see section 2).
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.
• Sudden, 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 with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms 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 with a skin rash showing small red or purple spots.

The class of medicines to which Quetiapine 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 the blood, increased liver enzymes, decreased numbers of certain 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. Increases in prolactin hormone 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):

• Increased levels of a hormone called prolactin in the blood. Increases in prolactin hormone 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 (which 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. 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 refers to 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 medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, 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

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

The other components are:

Tablet core: Lactose monohydrate, microcrystalline cellulose, calcium hydrogen phosphate, povidone, sodium carboxymethylstarch (Type A) from potato, and calcium stearate.

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

Appearance of Quetiapine Kern Pharma and contents of the pack

The tablets are white, biconvex, round, 8 mm in diameter, with a score line on one side.

The tablet can be divided into equal doses.

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

Manufacturer:

Laboratorios Alter S.A

Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

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