QUETIAPINE VIATRIS 400 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Quetiapine Viatris 400 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Quetiapine Viatris and what is it used for
2. What you need to know before taking Quetiapine Viatris
3. How to take Quetiapine Viatris
4. Possible side effects
5. Storage of Quetiapine Viatris
6. Package Contents and Additional Information

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

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

• Bipolar depression and major depressive episodes in major depressive disorder: for which you feel sad. You may find that you feel depressed, guilty, lack energy, lose appetite, or cannot sleep.
• Mania: you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or violent.
• Schizophrenia: 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.

When quetiapine is used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medication used to treat this disease.

Your doctor may continue to prescribe quetiapine to you even when you are feeling better.

2. What you need to know before taking Quetiapine Viatris

Do not take Quetiapine Viatris:

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

- Some medications against HIV.

- Azole medications (for fungal infections).

- Erythromycin or clarithromycin (for infections).

- Nefazodone (for depression).

Do not take quetiapine if the above applies to you. If in doubt, consult your doctor or pharmacist before taking quetiapine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication if:

• You, or a family member, have or have had any heart problems, such as heart rhythm problems, weakening of the heart muscle, or heart inflammation, or are taking any medication that may affect your heart rate.
• You have low blood pressure.
• You have had a stroke, especially if you are an elderly person.
• You have liver problems.
• You have ever had a seizure (convulsions).
• 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 medications).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine because the group of medications to which quetiapine belongs may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
• If you are an elderly person with Parkinson's disease/parkinsonism.
• You, or a family member, have a history of blood clots, as medications like these have been associated with the formation of blood clots.
• You have or have had a condition in which your breathing stops for short periods 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 empty your bladder completely (urinary retention), have an enlarged prostate, a bowel obstruction, or increased pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• You have problems with alcohol or drug use.
• If you suffer from depression or other conditions treated with antidepressants. The use of these medications along with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapine Viatris").

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

• Rapid and irregular heartbeats, even when at rest, palpitations, breathing 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, severe muscle stiffness, sweating, or a decrease in consciousness level (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Uncontrolled movements, mainly of the face or tongue.
• Dizziness or a feeling of excessive drowsiness. 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.

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 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 bowel obstruction.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. These thoughts may increase when you start treatment, as all these medications take time to work, 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. Information from clinical trials has 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 think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may be helpful to tell a family member or close friend that you are depressed and ask them to read this package leaflet. You can 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, very rare but severe 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 (NET), a more severe form that causes extensive 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 this medication 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 under 18 years of age.

Other medications and Quetiapine Viatris

Tell your doctor if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription and herbal remedies.

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

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

Tell your doctor if you are taking any of the following medications:

• Medications for epilepsy (such as phenytoin or carbamazepine).
• Medications for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medications).
• Medications that affect heart rate, such as those that can cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics (medications to urinate) or certain antibiotics (medications to treat infections).
• Medications that can cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• Antidepressants. These medications may 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 when you experience these symptoms.

Before stopping any of your medications, consult your doctor first.

Taking Quetiapine Viatris with food, drinks, and alcohol

• Quetiapine may be affected by food, and you should take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you drink, as the combined effect of quetiapine and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not take quetiapine during pregnancy, unless you have discussed it with your doctor. You should not take quetiapine if you are breastfeeding.

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

Driving and using machines

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

Effect on urine drug tests

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

Quetiapine Viatris contains sodium

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

3. How to take Quetiapine Viatris

Follow the administration instructions indicated by your doctor for this medication exactly. Consult your doctor or pharmacist if you have any doubts. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and needs, but it is usually between 150 mg and 800 mg.

• You will take your tablets once a day.
• Do not split, chew, or crush the tablets.
• Swallow your tablets whole with a glass of water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will indicate when).
• Do not drink grapefruit juice while taking quetiapine. 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.

Elderly people

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

Use in children and adolescents

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

If you take more Quetiapine Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you take more quetiapine than your doctor has prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats.

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 forgotten doses.

If you stop taking Quetiapine Viatris

If you stop taking quetiapine abruptly, you may be unable to sleep (insomnia), feel nauseous (vomit), or experience headaches, 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 medication, 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. If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this leaflet.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time as you continue taking this medicine) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking this medicine), which include inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain lipids (triglycerides and total cholesterol).

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

• Rapid heartbeat.
• Feeling that your heart is beating strongly, very fast, or irregularly.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Drop in blood pressure when standing up, which can make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disorder of speech and language.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increase in the amount of liver enzymes measured in the blood.
• Increased amount of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• Both in men and women, swelling of the breasts and unexpected production of milk.
• Absence or irregularity of menstrual period in women.

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

• Seizures or convulsions.
• Allergic reactions that can include swollen lumps (hives), skin swelling, and swelling around the mouth.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called neutropenia.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart observed in the ECG (prolongation of the QT interval).
• Slower than normal heart rate that can occur at the start of treatment and 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.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or fainting (a disorder called "neuroleptic malignant syndrome").
• Yellowish color of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• A long-lasting and painful erection (priapism).
• Swelling of the breasts and unexpected production of milk (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Decreased body temperature (hypothermia).
• Pancreas inflammation.
• A disease (called "metabolic syndrome") where you may suffer from a combination of 3 or more of the following effects: increased fat around the abdomen, decreased "good" cholesterol (HDL-C), increased triglycerides, increased blood pressure, and increased blood sugar.
• Intestinal obstruction.
• Increased creatine phosphokinase (a substance found in muscles) in the blood.

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

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe disease with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).

Frequency Not Known (cannot be estimated from the available data)

• Red, irregular skin rashes (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Symptoms of withdrawal may occur in newborns of mothers who have used quetiapine during pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug rash with eosinophilia and systemic symptoms, also known as DRESS). See section 2.
• Acute Generalized Exanthematous Pustulosis (AGEP), a rash of superficial pustules. If you develop these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.
• Stroke, whose symptoms include collapse, numbness or weakness of arms or legs, headache, confusion, visual disturbances, difficulty swallowing, or speech problems, such as stuttering or loss of speech.
• Heart 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 Quetiapina Viatris belongs may cause problems with the heart rhythm, which can be serious and in severe cases may be fatal.

Some adverse effects are only observed when a blood test is performed. These include changes 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, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase (a substance found in muscles) in the blood, decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood.

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 amount of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:
• • Both in boys and girls, swelling of the breasts and unexpected production of milk.
  • Absence or irregularity of menstrual period in girls.
• 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 patients):

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

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this leaflet. You can also report any adverse effect 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 Quetiapina 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 box after "CAD" or "EXP". The expiration date is the last day of the month indicated.

Store in the outer packaging to protect it from moisture.

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 way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapina Viatris

• The active ingredient is quetiapine. Each tablet contains 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:

Core of the tablet: hypromellose 2910 (E-464), hypromellose 2208 (E-464), microcrystalline cellulose (E-460i), anhydrous sodium citrate (see section 2 "Quetiapina Viatris contains sodium"), magnesium stearate (E-572).

Coating of the tablet: titanium dioxide (E-171), hypromellose 2910 (E-464), macrogol/PEG 400, polysorbate 80.

Appearance of the Product and Package Contents

Quetiapina Viatris is presented in the form of film-coated tablets, biconvex, oblong, white, marked with "Q 400" on one face.

This medicine is available in plastic bottles containing 60 prolonged-release tablets, or blister packs in cardboard boxes, which contain:

Continuous blisters – Aluminum blisters in a cardboard box with 10, 30, 60, and 100 prolonged-release tablets.

Perforated unit-dose blisters – Aluminum blisters in a cardboard box with 10, 30, 60, and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft,

H-2900 Komárom

Mylan utca 1,

Hungary

or

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

or

McDermott Laboratories t/a Gerard Laboratories t/a Mylan Dublin

Unit 35/36, Baldoyle Industrial Estate, Grange Road

Dublin 13

Ireland

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 with the following names:

Spain Quetiapina Viatris 400 mg prolonged-release tablets EFG

France QUETIAPINE VIATRIS LP 400 mg prolonged-release tablet

Greece Quetiapine/Mylan Prolonged Release Tablets 400 mg/TAB

Italy Quetiapina Mylan

Portugal Quetiapina Mylan

United Kingdom Alaquet XL 400 mg prolonged-release tablets

Czech Republic Quetiapin Mylan 400 mg, tablets with prolonged release

Date of the Last Revision of this Leaflet:July 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/