Quetiapine Viatris 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quetiapine Viatris 25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

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 Quetiapine Viatris is and what it is used for

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

• Bipolar depression: when you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: when you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or violent.
• Schizophrenia: when you may hear or sense 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 even after you start feeling better.

2. What you need to know before taking Quetiapine Viatris

Do not take Quetiapine Viatris:

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

• If you are taking any of the following medicines:

• Certain medicines for HIV.

• Azole-type medicines (for fungal infections).

• Erythromycin or clarithromycin (for infections).

• Nefazodone (for depression).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting quetiapine if:

• You, or a family member, have or have had any heart problems, for example, irregular heartbeat, 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 (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, as the group of medicines to which this medicine belongs may increase the risk of stroke or, in some cases, risk of death in elderly patients 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 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 fully 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 a history of alcohol or drug abuse.
• You suffer from 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 Quetiapine Viatris”).

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

• Fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, 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 required.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injury (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 count of white blood cells and may require stopping treatment with quetiapine and/or additional treatment.
• Constipation along with persistent abdominal pain or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. This risk 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 suddenly. You may be more likely to have such thoughts if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour and/or thoughts in young adults under 25 years of age with depression.

If you have ever had thoughts of harming yourself or committing 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 also ask them to let you know if they think your depression is getting worse or if they are concerned about changes in your behaviour.

Serious skin adverse reactions (SCARs)

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

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering and peeling of the skin, 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 pustules filled with pus.
• Erythema multiforme (EM), skin rashes with itchy, irregular red spots.

If you develop any of these symptoms, stop taking quetiapine 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 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 need to take any other medicine.

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

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

Talk to 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, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (“water pills”) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Antidepressants. These medicines may interact with quetiapine and you may experience symptoms such as involuntary, rhythmic muscle contractions, including those 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.

Do not stop taking any of your medicines without first consulting your doctor.

Taking Quetiapine Viatris with food, drinks, and alcohol

Be cautious about the amount of alcohol you consume. This is because 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 advised by your doctor. You should not use quetiapine if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns of mothers who have taken 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 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 operate tools or machinery until you know how these tablets affect you.

Quetiapine Viatris contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; 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 antidepressants called tricyclic antidepressants (TCAs) 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.

3. How to take Quetiapine Viatris

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine your initial dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

• You will take your tablets once daily at bedtime or twice daily, depending on your condition.
• Swallow your tablets whole with water. You may take the tablets with or without food. Do not drink grapefruit juice while taking quetiapine, as it may affect how the medicine works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to do so.

Liver problems

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

Elderly patients

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

Use in children and adolescents

Quetiapine must 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 prescribed by your doctor, you may feel drowsy, dizzy, and experience abnormal heartbeats, dry mouth, constipation, dilated pupils, or blurred vision. Contact your doctor or nearest hospital immediately. Take the packaging and any remaining tablets with you.

You may also call the Toxicology Information Service at telephone number 915620420, stating the name of 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 missed tablet.

If you stop taking Quetiapine Viatris

If you stop taking quetiapine abruptly, you may have difficulty sleeping (insomnia), feel nauseous, or experience headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce 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 will experience 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 initiating muscle movements, tremors, restlessness, or painless muscle rigidity.

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

• Thoughts of self-harm or suicide, or worsening of your 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 available insulin. This causes hyperglycaemia (excess sugar in the blood). Symptoms may include excessive thirst, increased appetite with weight loss, fatigue, drowsiness, weakness, depression, irritability, general malaise, and increased urination.
• Seizures or convulsions.
• Allergic reactions that may include lumps (papules), skin swelling, or swelling around the mouth.
• Uncontrollable movements, mainly of the face or tongue.
• Changes detected on ECG in the heart's electrical activity (prolongation of the QT interval) that may cause a very rapid heartbeat and fainting, and may lead to serious heart problems.
• Difficulty urinating.
• Worsening of pre-existing diabetes.

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

• A combination of high temperature (fever), sweating, muscle rigidity, extreme drowsiness or fainting, marked increase in blood pressure or heart rate (a disorder known as “neuroleptic malignant syndrome”).
• Inflammation of the pancreas causing severe abdominal and back pain.
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• A prolonged and painful erection (priapism).
• Blood clots in the veins, especially in the legs (symptoms may 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 known as agranulocytosis.
• Intestinal obstruction causing severe constipation and absence of gas (flatulence), with stomach swelling or pain.

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

• Severe allergic reaction (called anaphylaxis) which may include difficulty breathing, fainting, and collapse.
• A severe skin rash, which may develop rapidly. Symptoms may include redness, blisters, or skin peeling, especially around the mouth, nose, eyes, and genitals (a condition known as Stevens-Johnson syndrome). See section 2.
• Rapid swelling of the skin, usually around the eyes, lips, and throat.
• Inappropriate secretion of ADH, a hormone that causes the body to retain water and dilute the blood, reducing sodium levels. This may lead to decreased normal sodium levels in the blood, causing weakness, confusion, and muscle pain.
• Breakdown of muscle fibres causing muscle pain, tenderness, and weakness (rhabdomyolysis).

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

• Widespread redness of the skin with blisters and peeling of most of the body surface (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS). Widespread 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. If you develop these symptoms, stop taking quetiapine and contact your doctor or seek immediate medical attention.
• Stroke.

Other possible adverse effects:

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

• Dizziness (may lead to falls), headache, dry mouth.
• Drowsiness (may disappear over time as you continue taking quetiapine) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling unwell (vomiting), dizziness, and irritability. Gradual withdrawal over a period of at least 1 or 2 weeks is recommended.
• Weight gain.
• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• Rapid heartbeat.

• Awareness of heartbeats (palpitations), fast heartbeat, or skipped beats.

• Constipation, stomach pain (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Low blood pressure when standing. This may make you feel dizzy or weak (may lead to falls).

• Increased blood sugar levels.

• Blurred vision.

• Abnormal dreams and nightmares.

• Increased appetite.

• Feeling irritable.

• Speech and language disturbances.

• Difficulty breathing.

• 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 enzymes measured in blood.

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

• In both men and women, breast enlargement and unexpected milk production.

• In women, absence of menstrual periods or irregular periods.

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

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

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

• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating, or other activities during sleep.
• Decrease in body temperature (hypothermia).
• A condition (called “metabolic syndrome”) in which you may have a combination of 3 or more of the following: increased abdominal fat, decreased good cholesterol (HDL-C), increased blood fats called triglycerides, high blood pressure, and increased blood sugar levels.
• Increased creatine phosphokinase in blood (a substance found in muscles).

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

• Skin rashes with irregular red spots (erythema multiforme).
• Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
• 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 quetiapine belongs can cause heart rhythm problems that may be serious and, in severe cases, may be fatal.

Some adverse effects are only detected through blood tests. These include increases in certain fats (triglycerides and total cholesterol) or blood sugar levels, changes in thyroid hormone levels in blood, increased liver enzymes, decreased numbers of certain blood cells, decreased red blood cell count, increased creatine phosphokinase in blood (a muscle substance), decreased sodium levels in blood, and increased blood levels of the hormone prolactin.

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):

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

• In both boys and girls, breast enlargement and unexpected milk production.

• In girls, absence of menstrual periods or irregular periods.

• Increased appetite.

• Vomiting.

• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness, or painless muscle rigidity.

• Increased blood pressure.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them 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 Viatris

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapina Viatris

The active substance is quetiapine fumarate.

Each film-coated tablet contains 25 mg of quetiapine (as quetiapine fumarate).

The other components 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 iron oxide red (E-172).

Appearance of the product and contents of the pack

Quetiapina Viatris is presented as film-coated tablets.

The tablets are round, peach-colored, biconvex, with the inscription “Q” on one side.

The tablets are available in blisters of 1, 3, 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 6 × 1, 60 x 1 tablets, and in bottles containing 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 responsible

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area (EEA) countries and in the United Kingdom (Northern Ireland) under the following names:

Belgium: Quetiapine Viatris 25 mg film-coated tablets
Cyprus: Quetiapine/Viatris 25 mg film-coated tablets
Denmark: Quetiapin Viatris filmovertrukne tabletter 25 mg
Spain: Quetiapina Viatris 25 mg comprimidos recubiertos con película EFG
Greece: Quetiapine/Viatris
Iceland: Quetiapin Viatris 25 mg filmuhúðaðar töflur
Ireland: Geroquel 25 mg film-coated tablets
Malta: Quetiapine/VIATRIS 25 mg film-coated tablets
Netherlands: Quetiapine Viatris 25 mg filmomhulde tabletten
Poland: Etiagen
Portugal: Quetiapina Mylan
United Kingdom (Northern Ireland): Quetiapine 25 mg film-coated tablets
Czech Republic: Quetiapin Viatris

Date of latest review of this leaflet: June 2024.

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