Patient Information Leaflet: Quetiapine Viatris 100 mg Film-Coated Tablets

Read this 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 are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Quetiapina Viatriscontains a substance called quetiapine.It belongs to a group of medications called antipsychotics.Quetiapine can be used to treat various conditions, such as:

-Bipolar depression: by which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.

-Mania: by which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or present poor judgment, including being aggressive or violent.

-Schizophrenia: by which 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 quetiapine even when you are feeling better..

Do not take Quetiapina Viatris:

• If you are allergic to quetiapine or any of the other ingredients in this medication (listed in section 6).
• If you are taking any of the following medications::

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

Do not take quetiapine if the above applies to you. 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 quetiapine if:

• You, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness, or heart inflammation, or if you are taking any medication 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 had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking quetiapine.
• You have had low white blood cell counts (which may or may not have been caused by other medications).
• You are an elderly person with dementia (loss of brain functions). If so, do not take quetiapine because the group of medications to which this medication belongs may increase the risk of stroke or, in some cases, the risk of death in elderly people with dementia.
• You are an elderly person with Parkinson's disease/parkinsonism.
• You or a family member has a history of blood clots, as medications like these have been associated with blood clot formation.
• You have or have had a condition in which your breathing is interrupted by brief periods of time during normal nighttime sleep (called "sleep apnea") and are taking medications that decrease normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• You have a history of alcohol or drug abuse.
• You have depression or other conditions that are treated with antidepressants. The use of these medications with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapina Viatris").

Inform your doctor immediately if after taking quetiapine you experience any of the following:

• Irregular or rapid heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.
• A combination of fever, intense muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).

These disorders may be caused by this type of medication.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation along with persistent abdominal pain or constipation that has not responded to treatment, as it may lead to a more severe intestinal blockage.

Thoughts of suicide 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 medications take time to be effective, usually around two weeks, but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult.The information from clinical trials has shown an increased risk of suicidal behavior and/or thoughts in young adults under 25 with depression.

If you have had thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the 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 tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Severe skin reactions (SCARs):

With the use of this medication, severe skin reactions (SCARs) have been reported, which may put your life at risk or be fatal. These typically manifest as:

• Stevens-Johnson syndrome (SSJ), a generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (NET), a more severe form that causes extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including elevated white blood cell count and liver enzymes).
• Generalized Acute Exanthematous Pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.

Weight gain:

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

Children and adolescents:

Quetiapine should not be used in children and adolescents under 18 years old.

Other medications and Quetiapina Viatris:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

Consult your doctor if you are using any of the following medications:

• Medications for epilepsy (such as phenytoin or carbamazepine).
• Medications for high blood pressure.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or lithium (other antipsychotic medications).
• Medications that affect your heart rate, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium levels), such as diuretics (medications for urination) or certain antibiotics (medications for treating infections).
• Medications that may cause constipation.
• Antidepressants. These medications may interact with quetiapine and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.

Consult your doctor before stopping any of your medications.

Quetiapina Viatris with food, drinks, and alcohol:

Be careful about the amount of alcohol you consume. This is because the combined effect of quetiapine and alcohol may make you drowsy.

Do not take grapefruit juice while taking quetiapine. It may affect how the medication works.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. Do not take quetiapine during pregnancy, unless you have consulted your doctor. Do not use quetiapina if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborns of mothers who have used quetiapine in the last trimester (last three months of their pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and feeding difficulties. If your newborn develops any of these symptoms, you should contact your doctor.

Driving and operating machines:

Thesetablets may make you feel drowsy. Do not drive or operate tools or machines until you know how the tablets affect you.

Quetiapina Viatris contains lactose and sodium:

Quetiapina Viatris containslactose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Effect on urine drug detection tests:

If you are undergoing a urine drug detection test, taking quetiapine may produce positive results for methadone or certain antidepressant medications called tricyclic antidepressants (TCAs) when using certain analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions for this medication as indicated 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 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 the help of water. You can take the tablets with or without food. Do not take grapefruit juice while taking quetiapina. It may affect how the medication 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 change your dose.

Older adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

Quetiapina should not be used in children and adolescents under 18 years old.

If you take more Quetiapina Viatris than you should

If you take more quetiapina than your doctor prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats, dry mouth, constipation, dilated pupils, or blurred vision.Contact your doctor or the nearest hospital immediately. Bring the packaging and any remaining tablets with you.

You can also call the Toxicology Information Service, phone 915620420, indicating the medication and the amount taken.

If you forget to take a dose of Quetiapina Viatris

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 one.

If you interrupt treatment with Quetiapina Viatris

If you stop taking quetiapina abruptly, you may be unable to sleep (insomnia), feel nausea, or experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact a doctor IMMEDIATELY if you develop any of the following side effects:

Very common (may affect more than 1 in 10 people):

• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or muscle stiffness without pain.

Common (may affect up to 1 in 10 people):

• Thoughts of self-harm or suicide or worsening of depression.

Uncommon (may affect up to 1 in 100 people):

• Diabetes mellitus: a condition in which the body does not produce enough insulin or the body's tissues cannot use the insulin present. This causes hyperglycemia (excess sugar in the blood). Symptoms may include excessive thirst, increased appetite with weight loss, fatigue, drowsiness, weakness, depression, irritability, and general discomfort, and increased urination.
• Seizures or convulsions.
• Allergic reactions that may include papules, skin swelling, and swelling around the mouth.
• Uncontrollable movements, mainly of the face or tongue.
• Detected change in ECG in heart electrical activity (prolongation of the QT interval) that may cause a very fast heart rate and fainting and may cause serious heart problems.
• Difficulty urinating.
• Worsening of pre-existing diabetes.

Rare (may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very sleepy or fainting, elevated blood pressure or heart rate (a condition known as "neuroleptic malignant syndrome").
• Pancreatitis that produces intense abdominal and back pain.
• Yellowing of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• A prolonged and painful erection (priapism).
• Clots in the veins, especially in the legs (between symptoms include swelling, pain, and redness in the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing.
• 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 that causes severe constipation and absence of gas (flatulence), with inflammation or pain in the stomach.

Very rare (may affect up to 1 in 10,000 people):

• Severe allergic reaction (anaphylaxis) that may include difficulty breathing, fainting, and collapse.
• A severe skin eruption that may develop rapidly. Symptoms may include redness, blisters, or skin peeling, especially around the mouth, nose, eyes, and genitals (a condition known as Stevens-Johnson syndrome). See section 2.
• Rapid skin swelling, usually around the eyes, lips, and throat.
• Inappropriate secretion of ADH, a hormone that makes the body retain water and dilute the blood, reducing the normal levels of sodium in the blood, causing weakness and confusion with muscle pain.
• Muscle fiber rupture causing pain, sensitivity, and weakness in the muscles (rhabdomyolysis).

Frequency not known (the frequency cannot be estimated from the available data):

• Generalized skin redness with blisters and peeling of most of the body surface (toxic epidermal necrolysis). See section 2.
• Drug-induced rash with eosinophilia and systemic symptoms (DRESS, for its English acronym). Generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug-induced rash with eosinophilia and systemic symptoms, also known as DRESS). See section 2.If you develop these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.
• Stroke.

Other possible side effects::

Very common (may affect more than 1 in 10 people):

• Dizziness (may cause falls), headache, dry mouth.
• Feeling sleepy(may disappear over time as you continue to take quetiapine) (may cause falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including being unable to sleep (insomnia), feeling unwell (nausea), headache, diarrhea, feeling unwell (vomiting), dizziness, and irritability. A gradual withdrawal over a period of at least 1 or 2 weeks is recommended.
• Weight gain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common (may affect up to 1 in 10 people):

• Fast heart rate.
• Feeling that the heart is beating strongly, beating quickly, or missing some beats.
• Constipation, stomach pain (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause dizziness or weakness (may cause falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language alterations.
• Difficulty breathing.
• Vomiting (mainly in the elderly).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increased levels of liver enzymes measured in the blood.
• Increased levels of the prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following:

• In men and women, breast swelling and unexpected milk production.
• In women, not having a menstrual period or having irregular periods.

Uncommon (may affect up to 1 in 100 people):

• Unpleasant sensation in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• Slower than normal heart rate, which may occur at the beginning of treatment andmay be associated with low blood pressure and fainting.
• Fainting (may cause falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.
• Confusion

Rare (may affect up to 1 in 1,000 people):

• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• A condition (known as "metabolic syndrome") in which you may have a combination of 3 or more of the following effects: increased fat around your abdomen, decreased good cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, high blood pressure, and increased blood sugar levels.
• Increased levels of creatine phosphokinase in the blood (a substance found in muscles).

Frequency not known (the frequency cannot be estimated from the available data):

• Rash on the skin with irregular red patches (erythema multiforme).
• Symptoms of withdrawal in newborns of mothers who have used quetiapine during pregnancy.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with skin rash with small red or purple spots.

The class of medications to which quetiapine belongs can cause heart rhythm problems that may be serious, and in severe cases, may be fatal.

Some side effects are only observed when a blood test is performed. These include increases in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood,increased liver enzymes, decreases in the number of certain types of blood cells, decrease in the amount of red blood cells,increase in the amount of creatine phosphokinase in the blood (a substance found in muscles),decrease in the amount of sodium in the bloodand increase in the blood of the prolactin hormone.

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

Side effects in children and adolescents:

The same side effects that may occur in adults may also occur in children and adolescents.

The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very common (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 children and girls, breast swelling and unexpected milk production.
• In girls, not having a menstrual period or having irregular periods.

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

Common (may affect up to 1 in 10 people):

• Feeling weak, fainting (may cause falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP.The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Quetiapina Viatris

The active ingredient is quetiapine fumarate.

Each film-coated tablet contains 100 mg of quetiapine (as quetiapine fumarate).

The other components are: lactose monohydrate, microcrystalline cellulose (E-460), povidone 30, magnesium stearate (E-572), sodium carboxymethylcellulose (type A) derived from potato starch, dihydrogen phosphate of calcium dihydrate. Tablet coating:hypromellose (E-464), titanium dioxide (E-171), macrogol 6000, yellow iron oxide (E-172), talc.

Appearance of the product and contents of the package

Quetiapina Viatris is presented in the form of film-coated tablets.

The tablets are round, yellow, biconvex, with the inscription “Q” over “100” on one face.

The tablets are available in blisters of 1, 3, 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 60 x 1 tablets and in bottles of 60, 84, 90, 98, 100, 250, 500, and 1000 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Or

Generics [UK] Limited

Station Close, Potters Bar

Hertfordshire, EN6 1TL

United Kingdom

Or

Mylan Hungary Kft.

Mylan utca 1.

2900 Komárom

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

BelgiumQuetiapine Viatris 100 mg filmomhulde tabletten

CyprusQuetiapine/Viatris 100 mg film-coated tablets

DenmarkQuetiapin Viatrisfilmovertrukne tabletter 100mg

SlovakiaQuetiapin Viatris 100 mg

SpainQuetiapina Viatris 100 mg comprimidos recubiertos con película EFG

GreeceQuetiapine/Viatris

IcelandQuetiapin Viatris 100 mg filmuhúðaðar töflur

IrelandGeroquel 100 mg film-coated tablets

MaltaQuetiapine/VIATRIS 100 mg film-coated tablets

NetherlandsQuetiapine Viatris 100 mg filmomhulde tabletten

PolandEtiagen

PortugalQuetiapina Mylan 100 mg comprimido revestido por pelicula

United Kingdom

(Northern Ireland)Quetiapine 100 mg film-coated tablets

Czech RepublicQuetiapin Viatris

Last review date of this leaflet:June 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/