Quetiapine Sandoz Farmaceutica 300 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Quetiapine Sandoz Farmacéutica 300 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Sandoz Farmacéutica is and what it is used for
2. What you need to know before taking Quetiapine Sandoz Farmacéutica
3. How to take Quetiapine Sandoz Farmacéutica
4. Possible side effects
5. How to store Quetiapine Sandoz Farmacéutica
6. Contents of the pack and other information

1. What Quetiapina Sandoz Farmacéutica is and what it is used for

Quetiapina Sandoz Farmacéutica 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 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: where you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: where 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.

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 are feeling better.

2. What you need to know before taking Quetiapine Sandoz Farmacéutica

Do not take Quetiapine Sandoz Farmacéutica

• 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:

• certain HIV medicines,

• 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 quetiapine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine Sandoz Farmacéutica 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 (convulsion),
• 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 functions). 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 these people,
• you are an elderly person with Parkinson's disease/parkinsonism,
• you or a family member has a history of blood clots, as medicines like this have been associated with the formation of blood clots,
• you have or have had a condition in which your breathing stops for short periods during normal 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 a history of alcohol or drug abuse, or suffer from depression or other conditions treated with antidepressants. Using these medicines together with Quetiapine Sandoz Farmacéutica may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapine Sandoz Farmacéutica”).

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 called “neuroleptic malignant syndrome”). Immediate medical treatment may be necessary,
• uncontrollable movements, mainly of your face or tongue,
• dizziness or feel very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients,
• seizures (convulsions),
• a prolonged and painful erection (priapism),
• rapid 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 discontinuation of 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 your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This 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 taking 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 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 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) have been reported with the use of this medicine, which may be life-threatening or fatal. These commonly manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters 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), consisting of 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 pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with itchy, irregular red spots.

If you develop any of these symptoms, stop using Quetiapine Sandoz Farmacéutica 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 Sandoz Farmacéutica

Inform your doctor 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 HIV medicines.
• 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 Sandoz Farmacéutica with food, drinks and alcohol

• Quetiapine may be affected by food, so you should take your tablets at least one hour before a meal or before bedtime.
• Be cautious with 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 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 quetiapine during the third trimester (last three months of pregnancy): tremor, muscle rigidity 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.

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 (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.

Quetiapine Sandoz Farmacéutica 300 mg contains sodium

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

3. How to take Quetiapine Sandoz Farmacéutica

Follow exactly the instructions for use of this medicine 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 range between 150 mg and 800 mg.

• You will take your tablets once daily.
• 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 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 children and adolescents under 18 years of age.

If you take more Quetiapine Sandoz Farmacéutica than you should

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

If you have taken more quetiapine than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Quetiapine Sandoz Farmacéutica

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 a missed dose.

If you stop taking Quetiapine Sandoz Farmacéutica

If you stop taking quetiapine abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.

If you have any further questions about using 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.
• Feeling drowsy (which may go away 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 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 stiffness.
• 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 (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of your depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Decreased 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:
  • Breast enlargement and unexpected milk production in both men and women.
  • 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.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (prolongation of 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 (may lead to falls).
• Stuffy nose.
• Decreased number of red blood cells in the blood.
• Decreased sodium levels 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, and extreme drowsiness or dizziness (a disorder called "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 the 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 attention.
• Walking, talking, eating, or 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: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased levels of a type of blood fat called triglycerides, increased blood pressure, and increased blood sugar.
• 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 levels of 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.
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Frequency not known: cannot be estimated from available data

• Skin rashes with irregular red patches (erythema multiforme).
• Rapid appearance of red skin areas spotted 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).
• 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 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 can cause heart rhythm problems that may 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 thyroid hormone levels in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased number of red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in the blood, 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.

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

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

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

• 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 stiffness.

• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (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 Sandoz Farmacéutica

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP/CAD. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Sandoz Farmacéutica

• The active substance is quetiapine. Each tablet contains 300 mg of quetiapine (as quetiapine fumarate).
• The other components are:

Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate and magnesium stearate.

Tablet coating: titanium dioxide (E-171), hypromellose, macrogol 400, polysorbate 80, yellow iron oxide (E-172), red iron oxide (E-172) and black iron oxide (E-172).

Appearance of the product and contents of the pack

The tablets are light yellow, oblong, biconvex, and marked with “Q 300” on one side and smooth on the other.

They are presented in: aluminum/PVC-PVDC blisters, in packs of 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

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

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