Patient Information Leaflet: Quetiapina Viatris 400 mg Extended-Release Tablets EFG

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 have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same 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.

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

2.What you need to know before you start taking Quetiapina Viatris

3.How to take Quetiapina Viatris

4.Possible side effects

5.Storage of Quetiapina Viatris

6.Contents of the pack and additional information

Quetiapina Viatris contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine may be used to treat several conditions, 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, lacking in energy, lose your appetite or cannot sleep.
• Mania: you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or present poor judgment which includes 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 using quetiapine to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine that is being used to treat this condition.

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 components of this medication (listed in section 6).

-If you are taking any of the following medications:

‑Some HIV medications.

‑Azole antifungals (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 this medication 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 are taking any medication that may affect your heart rhythm.
• You have low blood pressure.
• You have had a stroke, especially if you are an older person.
• 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 taking quetiapine.
• You have had low white blood cell counts (which may or may not have been caused by other medications).
• You are an older person with dementia (loss of brain function). If so, do not take quetiapine because the class of medications to which quetiapine belongs may increase the risk of stroke or, in some cases, death in older people with dementia.
• You are an older person with Parkinson's disease or parkinsonism.
• You, or a family member, have 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 problems with alcohol or drug use.
• You have depression or other conditions treated with antidepressants. The use of these medications with quetiapine may cause serotonin syndrome, a potentially fatal condition (see "Other medications and Quetiapina Viatris").

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

• 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 the face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in older adults.
• Seizures (convulsions).
• 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, 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 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 serious intestinal obstruction.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. These thoughts may increase when starting 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. Information from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 with depression.

If you ever think about harming yourself or committing suicide,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 can ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behavior.

Severe skin reactions (SCARs)

With the use of this medication, very rare 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 (eosinophilia) and elevated 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 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 old.

Other medications and Quetiapina Viatris

Inform your doctor if you are taking, have taken recently, 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 HIV medications.
• Azole antifungals (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

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

• Antiepileptic medications (such as phenytoin or carbamazepine).
• Antihypertensive medications.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or lithium (other antipsychotic medications).
• Medications that affect heart rhythm, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium), such as diuretics (medications for urination) or certain antibiotics (medications for treating infections).
• Medications that may cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• 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

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

Pregnancy and breastfeeding

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

Do not take quetiapine during pregnancy, unless you have consulted your doctor. Do not take quetiapine if you are breastfeeding.

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

Driving and operating machinery

These tablets may cause drowsiness. Do not drive or operate tools or machinery until you know how the tablets affect you.

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 (TCA) when using certain analysis methods, although you are not taking methadone or TCA. If this occurs, a more specific test may be performed.

Quetiapina Viatris contains sodium

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

Follow exactly the administration instructions provided by your doctor for this medication. 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 condition and needs, but will usually be between 150 mg and 800 mg.

• You will take your tablets once a day.
• Do not break, 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 before bedtime, your doctor will tell you when).
• 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 by individuals under 18 years of age.

If you take more Quetiapina 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 quetiapina than prescribed by your doctor, you may feel drowsy, feel dizzy, and experience abnormal heartbeats.

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 to take the next dose, wait until then. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Quetiapina Viatris

If you stop taking quetiapina abruptly, you may be unable to sleep (insomnia), feel nausea (urge to vomit), 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 the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience side effects, consult your doctor or pharmacist, even if they are side 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.
• Sensation of drowsiness (which may disappear over time as you continue to take this medicine) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking this medicine), which include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to taper off over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, 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):

• Fast heart rate.
• Feeling that your heart is beating strongly, very quickly, or irregularly.
• Constipation, indigestion.
• Feeling weak.
• Swelling of arms or legs.
• Drop in blood pressure when standing, which may make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorders.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in older people).
• 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 prolactin hormone in the blood. Elevated levels of prolactin hormone may, in rare cases, lead to the following:

• In men and women, breast swelling and unexpected milk production.
• Absence or irregularity of menstrual periods in women.

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

• Seizures or convulsions.
• Allergic reactions that may include hives, skin swelling, and swelling around the mouth.
• A combination of fever, symptoms similar to the flu, sore throat, or any other infection with a very low white blood cell count, a condition known as neutropenia.
• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in heart activity observed on an ECG (prolongation of the QT interval).
• Slow heart rate, which may occur at the start of treatment and be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which 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 condition known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• A prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Clots in the veins, especially in the legs (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. If you notice any of these symptoms, seek medical help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (known as "metabolic syndrome") where you may experience a combination of 3 or more of the following effects: increased fat around the abdomen, decreased "good" cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar levels.
• Intestinal obstruction.
• Increased levels of 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 (known as anaphylaxis) that may cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

Frequency not known (cannot be estimated from available data)

• Rashes on the skin with irregular red spots (erythema multiforme).
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Some withdrawal symptoms may occur in newborn babies of mothers who have taken quetiapine during pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS, for its acronym in English). Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug rash with eosinophilia and systemic symptoms, also known as DRESS). See section 2.
• Generalized pustular psoriasis (AGEP), a rash of superficial pustules.If you develop these symptoms, stop taking quetiapine and contact your doctor or seek medical attention immediately.
• Stroke, with symptoms including collapse, numbness or weakness of arms or legs, headache, confusion, visual disturbances, difficulty swallowing, or speech problems, such as slurring or loss of speech.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with a skin rash of small red or purple spots.

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

Some side 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 levels of liver enzymes, decreases in the number of certain types of blood cells, decreases in the amount of red blood cells, increases in the amount of creatine phosphokinase (a substance found in muscles) in the blood, decreases in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood.

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 levels of prolactin hormone may, in rare cases, lead to the following:
• • In children and adolescents, breast swelling and unexpected milk production.
  • Irregularity or absence of menstrual periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

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

• Feeling weak, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report any side effects directly through the Spanish System for 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 medicine.

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

Do not use this medication 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.

Do not dispose of medications through drains or trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Quetiapina Viatris

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

Tablet core: 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).

Tablet coating: titanium dioxide (E-171), hypromellose 2910 (E-464), macrogol/PEG 400, polisorbate 80.

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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

Further information on this medicine can be obtained 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:

SpainQuetiapina Viatris 400mg prolonged-release tablets EFG

FranceQUETIAPINE VIATRIS LP 400 mg prolonged-release tablet

GreeceQuetiapine/Mylan Prolonged Release Tablets 400 mg/TAB

ItalyQuetiapina Mylan

PortugalQuetiapina Mylan

United KingdomAlaquet XL 400 mg prolonged-release tablets

Czech RepublicQuetiapin Mylan 400 mg, tablets with prolonged release

Last review date of this leaflet:July 2024

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