Quetiapine Alter 300 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Quetiapine Alter 150 mg prolonged-release tablets EFG

Quetiapine Alter 200 mg prolonged-release tablets EFG

Quetiapine Alter 300 mg prolonged-release tablets EFG

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

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

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

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

Your doctor may continue prescribing Quetiapina Alter even after you are feeling better.

2. What you need to know before taking Quetiapine Alter

Do not take Quetiapine Alter:

• 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:

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

If you have any doubts, consult your doctor or pharmacist before taking this medicine.

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, 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.

• if you have low blood pressure.

• if you have had a stroke, especially if you are elderly.

• if you have liver problems.

• if you have ever had a seizure (epileptic fit).

• if you have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking this medicine.

• if you know you have previously had low levels of white blood cells (whether or not caused by other medicines).

• if you are an elderly person with dementia (loss of brain functions). In this case, you should not take quetiapine, as the group of medicines to which quetiapine belongs may increase the risk of stroke or, in some cases, the risk of death in these individuals.

• if you are an elderly person with Parkinson's disease/parkinsonism.

• if you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.

• if you have or have had a condition in which your breathing stops briefly during normal sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).

• if you have or have had a condition in which you cannot completely empty your bladder (urinary retention), an enlarged prostate, a bowel 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.

• if you have a history of alcohol or drug abuse.

• if you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and quetiapine”).

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

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “neuroleptic malignant syndrome”). Immediate medical treatment may be necessary.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (fits).
• A prolonged and painful erection (priapism).
• Fast or irregular heartbeats, 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.

These disorders may be caused by this type of medicine.

Inform 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 together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious bowel blockage.
• Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes think about 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 suddenly stop taking your medication. 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 thoughts and/or suicidal behaviour 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 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 and potentially life-threatening or fatal skin reactions (SCARs) have been reported with this medicine. These commonly present 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), characterised by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red spots that itch.

If you develop any of these symptoms, stop using prolonged-release 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 Alter

Tell your doctor if you are taking, have recently taken, or might need to take any other medicine.

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

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

Inform 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 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 and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

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

Taking Quetiapine Alter with food, drinks, and alcohol

• Quetiapine may be affected by food, and 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. This is because the combined effect of quetiapine and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking this medicine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor 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 used this medicine 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 may need to 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 Alter contains lactose

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

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking Quetiapine Alter may produce positive results for methadone or certain antidepressant medicines 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 Alter

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

Your doctor will determine your starting 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 a day.
• Do not split, chew or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will advise you when).
• Do not drink grapefruit juice while taking this medicine. 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 elderly, 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 Alter 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 taken.

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

If you forget to take Quetiapine Alter

If you miss 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 Alter

If you stop taking quetiapine abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhoea, 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 will experience them.

Very common: may affect more than 1 in 10 people

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may diminish over time as you continue taking quetiapine), (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation 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 rigidity.
• Changes in levels of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Feeling as if your heart is pounding, racing, or beating irregularly.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This 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.
• 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 number of certain types of blood cells.
• Increases in liver enzymes measured in blood.
• Increases in blood levels of prolactin hormone. Elevated prolactin levels may, in rare cases, lead to the following:

o Breast enlargement and unexpected milk production in both men and women.

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

Uncommon: may affect up to 1 in 100 people

• Epileptic seizures or convulsions.
• Allergic reactions which may include raised, itchy rashes (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity 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 (which may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in blood.
• Decrease in the amount of sodium in 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, and feeling very drowsy or dizzy (a disorder known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorders.
• Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical help.
• Walking, talking, eating, or performing other activities while asleep.
• Decreased 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 effects: 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 levels.
• 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.
• Increased blood creatine phosphokinase (a substance from muscles).

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 condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from available data

• Skin rashes with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid), known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.
• Sudden and severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which includes flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
• Stroke.
• 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 may cause problems with heart rhythm that can be serious and, in severe cases, may 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 thyroid hormone levels in your blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased blood sodium levels, and increased blood levels of prolactin hormone. Elevated prolactin levels may, in rare cases, lead to the following:

• Breast enlargement and unexpected milk production in both men and women.
• In women, absence of menstrual periods or irregular periods.

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

Additional 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 were not observed in adults:

Very common: may affect more than 1 in 10 people

• Increase in blood levels of a hormone called prolactin. Elevated prolactin levels may, in rare cases, lead to the following:

o Breast enlargement and unexpected milk production in both boys and girls.

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

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless, or painless muscle rigidity.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

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

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 EXP. The expiry date is the last day of the month indicated.

Quetiapine Alter does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Quetiapine Alter

• The active substance is quetiapine. Quetiapine Alter tablets contain 150 mg, 200 mg, 300 mg, and 400 mg of quetiapine (as quetiapine fumarate).
• The other components are:

Tablet core: Methacrylic acid-ethyl acrylate copolymer (1:1), anhydrous lactose (lactose), crystalline maltose, talc, magnesium stearate

Tablet coating: Methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate

Appearance of Quetiapine Alter and contents of the pack

Quetiapine Alter 150 mg tablets are white, oblong biconvex tablets, engraved with "150" on one side.

Quetiapine Alter 200 mg tablets are white, oblong biconvex tablets, engraved with "200" on one side.

Quetiapine Alter 300 mg tablets are white, oblong biconvex tablets, engraved with "300" on one side.

Quetiapine Alter 400 mg tablets are white, oval biconvex tablets, engraved with "400" on one side.

The tablets are presented in blisters made of polychlorotrifluoroethylene and polyvinyl chloride with aluminum.

Pack sizes are:

Quetiapine Alter 150 mg: 60 tablets

Quetiapine Alter 200 mg: 60 tablets

Quetiapine Alter 300 mg: 60 tablets

Quetiapine Alter 400 mg: 60 tablets

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

or

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attiki,

Greece

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/