Quetiapine Viatris 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Quetiapine Viatris 400 mg prolonged-release tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Quetiapina Viatris contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapine may be used to treat several conditions, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include 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 being used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine you are already using for this condition.

Your doctor may continue to prescribe quetiapine even after you start feeling better.

2. What you need to know before taking Quetiapina Viatris

Do not take Quetiapina 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.

‑ Azole antifungals (for fungal infections).

‑ Erythromycin or clarithromycin (for infections).

‑ Nefazodone (for depression).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine if:

• You, or a family member, have or have had any heart problems, for example, heart rhythm problems, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have ever had a seizure (epileptic fit).
• You have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking quetiapine.
• You know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine because the group of medicines to which quetiapine 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 this have been associated with blood clot formation.
• You have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and you are taking medicines that reduce normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called "anticholinergics") that affect how nerve cells function, used to treat certain medical conditions.
• You have problems with alcohol or drug use.
• You have depression or other conditions treated with antidepressants. Using these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapina Viatris").

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

• Fast or irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.
• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be needed.
• 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 (epileptic fits).
• A prolonged and painful erection (priapism).

These disorders may 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 this could be due to a very low white blood cell count and may require stopping treatment with quetiapine and/or additional treatment.
• Constipation, together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal obstruction.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also increase if you stop your medication abruptly.

You may be more likely to have such thoughts if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to alert you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Serious cutaneous adverse reactions (SCARs)

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

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

If you develop any of these symptoms, stop using this medicine and contact your doctor or seek immediate medical attention.

Weight gain

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

Children and adolescents

Quetiapine must not be used in individuals under 18 years of age.

Other medicines and Quetiapina Viatris

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

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

• Some medicines for HIV.
• Azole antifungals (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

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

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect heartbeat, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (medicines to increase urination) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells function, used to treat certain medical conditions.
• Antidepressants. These medicines may interact with quetiapine and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, 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 Quetiapina Viatris with food, drinks, and alcohol

• Quetiapine may be affected by food; therefore, you should take your tablets at least one hour before a meal or before bedtime.
• Be cautious about the amount of alcohol you consume, 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 medicine 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 medicine.

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

The following symptoms, which may indicate withdrawal, may occur in newborns of mothers who have used quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.

Driving and using machines

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

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 (TCA) when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

Quetiapina Viatris contains sodium

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

3. How to take Quetiapina Viatris

Follow exactly the administration instructions given by your doctor for this medicine. Consult your doctor or pharmacist if you have any doubts. Your doctor will determine your initial dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually range between 150 mg and 800 mg.

• You will take your tablets once 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 tell you when).
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medicine works.
• Do not stop taking your tablets, even if you feel better, unless your doctor tells you to.

Liver problems

If you have liver problems, your doctor may adjust your dose.

Elderly patients

If you are elderly, your doctor may adjust your dose.

Use in children and adolescents

Quetiapine must not be used in individuals under 18 years of age.

If you take more Quetiapina Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you take more quetiapine than prescribed by your doctor, you may feel drowsy, dizzy, or 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 for your next dose, wait until then. Do not take a double dose to make up for missed doses.

If you stop taking Quetiapina Viatris

If you stop taking quetiapine abruptly, you may have trouble sleeping (insomnia), feel nauseous (feel like vomiting), or experience headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

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

• Dizziness (could lead to falls), headache, dry mouth.
• Drowsiness (which may disappear over time as you continue taking this medicine) (could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking this medicine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless, or painless muscle stiffness.
• Changes in levels of certain lipids (triglycerides and total cholesterol).

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

• Fast heartbeat.

• Feeling that your heart is pounding, racing, or beating irregularly.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Drop in blood pressure upon standing, which may make you feel dizzy or faint (could lead to falls).

• Increased blood sugar levels.

• Blurred vision.

• Abnormal dreams and nightmares.

• Increased hunger.

• Feeling irritable.

• Speech and language disorders.

• Suicidal thoughts and worsening of depression.

• Shortness of breath.

• Vomiting (mainly in elderly people).

• Fever.

• Changes in levels of thyroid hormones in the blood.

• Decrease in the number of certain types of blood cells.

• Increase in liver enzyme levels measured in the blood.

• Increase in the amount of prolactin hormone in the blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• Breast swelling and unexpected milk production in both men and women.

• Absence or irregularity of menstrual periods in women.

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

• Seizures or convulsions.
• Allergic reactions which may include raised, itchy rashes (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 known as neutropenia.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the electrical activity of the heart seen on ECG (prolongation of the QT interval).
• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (could lead to falls).
• Nasal congestion.
• 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 extremely drowsy or fainting (a disorder called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• A prolonged, painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the bloodstream to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical help.
• Walking, talking, eating, or other activities while asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may experience a combination of 3 or more of the following: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar.
• Intestinal obstruction.
• Increase in 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) which may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious illness with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibres and muscle pain (rhabdomyolysis).

Frequency not known (cannot be estimated from available data)

• Skin rashes with irregular red spots (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Drug reaction with eosinophilia and systemic symptoms (DRESS). Generalised rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See section 2.
• Acute Generalized Exanthematous Pustulosis (AGEP), a rash with superficial pustules. If you develop these symptoms, stop taking quetiapine and contact your doctor or seek immediate medical attention.
• Stroke, whose symptoms include collapse, numbness or weakness in arms or legs, headache, confusion, visual disturbances, difficulty swallowing, or speech problems such as slurring or loss of speech.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple spots.

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

Some adverse effects are only detected through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in levels of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase (a substance found in muscles) in the blood, decreased sodium levels in the blood, and increased levels of the hormone prolactin 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 may occur in adults may also occur in children and adolescents.

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

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

• Increase in the amount of a hormone called prolactin in the blood. Increases in prolactin hormone could, in rare cases, lead to the following:
  • Breast swelling and unexpected milk production in both boys and girls.
  • Absence or irregularity of menstrual periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless, or painless muscle stiffness.
• Increased blood pressure.

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

• Feeling weak, fainting (could lead to falls).
• Nasal congestion.
• Feeling irritable.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. You can also report any adverse effect directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quetiapine Viatis

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

Do not use this medicine after the expiry date stated on the pack after "CAD" or "EXP". The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Viatris

• The active substance 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 “Quetiapine Viatris contains sodium”), magnesium stearate (E-572).

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

Appearance of the product and contents of the pack

Quetiapine Viatris is presented as 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 in blister strips within cardboard boxes, containing:

Continuous blisters – aluminium blisters in cardboard boxes with 10, 30, 60 and 100 prolonged-release tablets.

Perforated single-dose blisters – aluminium blisters in cardboard boxes with 10, 30, 60 and 100 prolonged-release tablets.

Only certain 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

Further information on this medicine is available upon request to 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 European Economic Area member states under the following names:

Spain Quetiapine 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, tablety s prodlouženým uvolňováním

Date of the most recent review of this leaflet: July 2024

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