QUETIAPINE VIATRIS 300 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Quetiapine Viatris 300 mg film-coated tablets EFG

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Quetiapine Viatris is and what it is used for
2. What you need to know before you take Quetiapine Viatris
3. How to take Quetiapine Viatris
4. Possible side effects
5. Storage of Quetiapine Viatris
6. Contents of the pack and further information

1. What Quetiapine Viatris is and what it is used for

Quetiapine Viatris contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat several diseases, such as:

• Bipolar depression: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or have trouble sleeping.
• Mania: where you may feel very excited, elated, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: where 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 to prescribe quetiapine for you even when you are feeling better.

2. What you need to know before you take Quetiapine Viatris

Do not take Quetiapine Viatris:

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

• Some medicines for HIV.
• Medicines of the azole type (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Do not take quetiapine if any of the above applies to you. If you are in doubt, 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, such as problems with your heart rhythm, weakening of the 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 (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 that you have had low white blood cell counts in the past (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine, as the group of medicines to which this medicine 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, have a history of blood clots, as medicines like these have been associated with the formation of blood clots.
• If you have or have had a condition where your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and are taking medicines that reduce normal brain activity ("depressants").
• If you have or have had a condition where you cannot empty your bladder completely (urinary retention), have an enlarged prostate, a blockage in your intestine, or increased pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect how nerve cells work, used to treat certain medical conditions.
• If you have a history of alcohol or drug abuse.
• If you suffer from depression or other conditions that are treated with antidepressants. The use of these medicines together with quetiapine may cause a condition called serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapine Viatris").

Tell your doctor immediatelyif, after taking quetiapine, you experience any of the following:

• Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.
• A combination of fever, severe muscle stiffness, sweating, or a decrease in consciousness level (a disorder called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injury (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).

These disorders can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

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

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think of harming or killing yourself. This may increase when you first start treatment, as all these medicines take time to work, usually around two weeks, but sometimes more. 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. Clinical trial data have shown an increased risk of suicidal behavior and/or thoughts in young adults under 25 years with depression.

If you have had thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital immediately. It may be helpful to tell a relative or close friendthat you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Severe skin reactions (SCARs)

With the use of this medicine, very rare but serious skin reactions (SCARs) have been reported, which can be life-threatening or fatal. These are commonly manifested as:

• Stevens-Johnson syndrome (SSJ), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes widespread peeling of the skin.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including an increased number of white blood cells (eosinophilia) and elevated liver enzymes).
• Acute generalized 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 monitor your weight regularly.

Children and adolescents

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

Other medicines and Quetiapine Viatris

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

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

• Some medicines for HIV.
• Medicines of the azole type (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Consult 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, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Antidepressants. These medicines can interact with quetiapine, and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, 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 Viatris with food, drinks, and alcohol

Be careful with the amount of alcohol you drink. This is because the combined effect of quetiapine and alcohol can 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take quetiapine during pregnancy, unless your doctor has advised you to do so. You should not use quetiapine if you are breastfeeding.

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

Driving and using machines

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

Quetiapine Viatris contains lactose and sodium

Quetiapine Viatris contains , a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this 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 antidepressant medicines called tricyclic antidepressants (TCAs) when some analysis methods are used, even if you are not taking methadone or TCAs. If this happens, a more specific test can be performed.

3. How to take Quetiapine Viatris

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and needs, but it 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 disease.
• Swallow your tablets whole with water. You can 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 change your dose.

Elderly people

If you are an elderly patient, your doctor may change your dose.

Use in children and adolescents

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

If you take more Quetiapine Viatris than you should

If you take more quetiapine than your doctor has 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. Take the pack and any remaining tablets with you.

You can also call the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken.

If you forget to take a dose of Quetiapine 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 forgotten tablet.

If you stop taking Quetiapine Viatris

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

If you have any other 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 all people suffer from them.

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

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

• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness 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 present insulin. 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 malaise, and increased urination.
• Seizures or convulsions.
• Allergic reactions that may include bumps (papules), skin swelling, and swelling around the mouth.
• Uncontrolled movements, mainly of the face or tongue.
• Detected change in the ECG in the electrical activity of the heart (prolongation of the QT interval) that can cause a very rapid heartbeat 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 elevated temperature (fever), sweating, muscle stiffness, feeling of great drowsiness or fainting, elevated increase in blood pressure or heart rate (a disorder called "neuroleptic malignant syndrome").
• Pancreatitis that produces severe abdominal and back pain.
• Yellowing of the skin and eyes (jaundice).
• Hepatitis (liver inflammation).
• A prolonged and painful erection (priapism).
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which could 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 called 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 (called anaphylaxis) that may include difficulty breathing, fainting, and collapse.
• A severe skin rash that can develop rapidly. Symptoms may include redness, blisters, or peeling of the skin, especially around the mouth, nose, eyes, and genitals (a condition known as Stevens-Johnson syndrome). See section 2.
• Rapid swelling of the skin, usually around the eyes, lips, and throat.
• Inappropriate secretion of ADH, a hormone that makes the body retain water and dilute blood, reducing the amount of sodium. This can lead to a decrease in normal sodium levels in the blood, causing weakness and confusion with muscle pain.
• Rupture of muscle fibers causing pain, sensitivity, and weakness in the muscles (rhabdomyolysis).

Frequency Not Known(frequency cannot be estimated from available data):

• A generalized redness of the skin with irregular red patches and peeling of most of the body surface (toxic epidermal necrolysis). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Cardiac muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of the blood vessels (vasculitis), often with a skin rash with small red or purple spots.

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

Some adverse 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 number of red blood cells, increase in creatine phosphokinase in the blood (a muscle substance), decrease in sodium levels in the blood, and increase in blood prolactin levels.

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

Adverse Effects in Children and Adolescents:

The same adverse effects that can occur in adults can 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(may affect more than 1 in 10 people):

• Increased blood levels of a hormone called prolactin. The increase in prolactin levels could, in rare cases, lead to the following:

• In both boys and girls, having swollen breasts and unexpected milk production.
• In girls, not having menstrual periods or having irregular periods.

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

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

• Feeling of weakness, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.

Reporting of Adverse Effects

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

5. Storage of Quetiapine Viatris

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

Do not use this medicine 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 medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapine Viatris

The active ingredient is quetiapine fumarate.

Each film-coated tablet contains 300 mg of quetiapine (as quetiapine fumarate).

The other ingredients are: lactose monohydrate, microcrystalline cellulose (E-460), povidone 30, magnesium stearate (E-572), sodium carboxymethyl starch (type A) derived from potato starch, and calcium hydrogen phosphate dihydrate. Tablet coating: hypromellose (E-464), titanium dioxide (E-171), macrogol 400, and polysorbate 80.

Appearance of the Product and Package Contents

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

The tablets are capsule-shaped, white, with the inscription "Q" notch "300" on one face. The tablet can be divided into equal doses.

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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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 Komáron

Hungary

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Belgium Quetiapine Viatris 300 mg film-coated tablets

Denmark Quetiapin Mylan film-coated tablets 300mg

Slovakia Quetiapin Viatris 300 mg

Spain Quetiapina Viatris 300 mg film-coated tablets EFG

Greece Quetiapine/Viatris

Iceland Quetiapin Viatris 300 mg film-coated tablets

Malta Quetiapine/VIATRIS 300 mg film-coated tablets

Netherlands Quetiapine Viatris 300 mg film-coated tablets

Portugal Quetiapina Mylan 300 mg film-coated tablets

United Kingdom (Northern Ireland) Quetiapine 300 mg film-coated tablets

Czech Republic Quetiapin Mylan

Date of the Last Revision of this Leaflet:June 2024.

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