Quetiapine Teva-Ratio 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Quetiapina Teva-ratio 400 mg prolonged-release tablets EFG

quetiapine

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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See Section 4.

Contents of the leaflet

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

1. What Quetiapina Teva-ratio is and what it is used for

Quetiapina Teva-ratio contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapina Teva-ratio 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 aggressive or violent behaviour.
• 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 Quetiapina Teva-ratio prolonged-release tablets are used to treat major depressive episodes in major depressive disorder, they are taken in addition to another medicine you are already taking for this condition.

Your doctor may continue prescribing Quetiapina Teva-ratio even after you start feeling better.

2. What you need to know before taking Quetiapine Teva-ratio

Do not take Quetiapine Teva-ratio:

• 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 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 Quetiapine Teva-ratio.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine Teva-ratio 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 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 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 "Use of Quetiapine Teva-ratio with other medicines").
• 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). In this case, you should not take quetiapine, as the group of medicines to which Quetiapine Teva-ratio belongs may increase the risk of stroke, or in some cases the risk of death, in these individuals 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 night 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.

Inform your doctor immediately if, after taking Quetiapine Teva-ratio, 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.
• Fast or irregular heartbeats, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.
• 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 (convulsions).
• A prolonged and painful erection (priapism).

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 along with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more severe intestinal 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. This risk 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 behavior 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 inform 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 the use of this medicine, which may be life-threatening or fatal. 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 cell count (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with irregular red, itchy spots.

If you develop any of these symptoms, stop using Quetiapine Teva-ratio 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 Teva-ratio must not be used in children and adolescents under 18 years of age.

Use of Quetiapine Teva-ratio with other medicines

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

Do not take Quetiapine Teva-ratio 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).

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).
• 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 "Use of Quetiapine Teva-ratio with other medicines").
• Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics ("water pills") 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.

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

Taking Quetiapine Teva-ratio with food, drinks, and alcohol

• Quetiapine Teva-ratio 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. This is because the combined effect of Quetiapine Teva-ratio and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Teva-ratio. 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 Teva-ratio during pregnancy unless advised by your doctor. You should not use Quetiapine Teva-ratio while 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 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.

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 known as 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 Teva-ratio contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Quetiapine Teva-ratio

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 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 Teva-ratio. 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 Teva-ratio must not be used in children and adolescents under 18 years of age.

If you take more Quetiapine Teva-ratio than you should

If you take more Quetiapine Teva-ratio than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take the Quetiapine Teva-ratio tablets with you.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Quetiapine Teva-ratio

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 Teva-ratio

If you stop taking Quetiapine Teva-ratio 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 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.

If you experience any of the following serious adverse effects, stop taking Quetiapine Teva-ratio and go immediately to your doctor or nearest hospital:

Frequent adverse effects (may affect up to 1 in 10 people)

• Suicidal thoughts and worsening of your depression.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Sudden fever, especially with sore throat and flu-like symptoms. These may be signs of a very low white blood cell count.
• Signs of skin reactions such as rash, hives, welts, redness, itching, possibly with facial swelling, eyelids and lips. This could also cause difficulty breathing, dizziness or shock.
• Seizures or fits.
• Uncontrollable movements, mainly of the face or tongue (tardive dyskinesia).
• Feeling that your heart is pounding strongly or beating very fast, together with dizziness or fainting. This may be a sign of serious heart rhythm problems and, in severe cases, may be fatal.

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

• Severe pain and/or swelling and redness in one of your legs; sudden severe chest pain that may radiate to the left arm or sudden shortness of breath. These may be signs of blood clots in the veins.
• Severe upper abdominal pain, often radiating to the back, sometimes with nausea and vomiting. This may be a sign of inflammation of the pancreas.
• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as this may lead to a more serious intestinal blockage.
• Yellowing of the skin and eyes (jaundice), dark urine, especially together with unusual tiredness or fever (signs of hepatitis).
• A prolonged and painful erection.
• A combination of fever, sweating, stiff muscles, drowsiness or fainting (a disorder called "neuroleptic malignant syndrome").

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

• Severe rash, blisters, or red patches 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). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Adverse effects 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 dotted 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.
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Stroke

Drug reaction with eosinophilia and systemic symptoms (DRESS). Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.

Other possible adverse effects

Do not be alarmed if you see a tablet in your faeces after taking Quetiapine Teva-ratio. As the tablet passes through your gastrointestinal tract, quetiapine is slowly released. The tablet shell remains undissolved and is eliminated in the faeces. Therefore, although you may see a tablet in your faeces, your dose of quetiapine has been absorbed.

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

• Dizziness (may lead to falls), headache, dry mouth.
• Drowsiness (which may go away over time as you continue taking quetiapine), (may lead to falls).
• Withdrawal symptoms (symptoms occurring when you stop taking quetiapine), 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 movements, tremor, restlessness or painless muscle stiffness.
• Decreased haemoglobin levels (proteins in red blood cells that carry oxygen).
• Changes in levels of certain fats (triglycerides and total cholesterol).

Common adverse effects (may affect up to 1 in 10 people)

• Fast heartbeat.

• Feeling that your heart is pounding, racing or has irregular beats.

• 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.

• Feeling hungrier.

• Feeling irritable.

• Speech and language disorder.

• Shortness of breath.

• Vomiting (mainly in elderly people).

• Fever.

• Changes in levels of thyroid hormones in the blood.

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

• Increases in liver enzymes measured in blood.

• Increases in the amount of prolactin hormone in blood. Increases in prolactin hormone may, 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 adverse effects (may affect up to 1 in 100 people)

• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• Diabetes.
• 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.
• 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 adverse effects (may affect up to 1 in 1,000 people)

• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating or other activities while asleep.
• Decrease in body temperature (hypothermia).
• A condition (called "metabolic syndrome") where 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.
• Increased blood creatine phosphokinase (a substance from muscles).

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

• Inappropriate secretion of a hormone that controls urine volume.

Not known (frequency cannot be estimated from available data)

• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple spots.

Some adverse effects are only detected by 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 cell count, increased blood creatine phosphokinase (a substance found in muscles), decreased blood sodium levels, and increased blood prolactin hormone levels. Increases in prolactin hormone may, 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.

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 adverse effects (may affect more than 1 in 10 people)

• Increase in the amount of a hormone called prolactin in the blood. Increases in prolactin hormone may, 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 stiffness.
  • Increased blood pressure.

Common adverse effects (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, pharmacist or nurse, 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 Teva-ratio

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. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Quetiapine Teva-ratio 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 a pharmacy’s SIGRE collection point. If you are unsure, 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 Teva-ratio

The active substance is quetiapine. Quetiapine Teva-ratio tablets contain 400 mg of quetiapine (as quetiapine fumarate).

The other components are:

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

Tablet coating: titanium dioxide (E171), hypromellose, macrogol/PEG 400, and polysorbate 80.

Appearance of Quetiapine Teva-ratio and contents of the pack

The tablets are white, biconvex, oblong, film-coated, marked with “Q 400” on one side.

They are available in packs of 10, 20, 30, 50, 50x1 (perforated unit-dose blister) (hospital pack), 56 (calendar pack), 60, 90, 100 and 100x1 (perforated unit-dose blister) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi ùt 13, 4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

PLIVA Krakow Zaklady Farmaceutyczne S.A.

ul. Mogilska 80, 31-546, Krakow

Poland

Teva Pharma, S.L.U.

C/C, n. 4, Polígono Industrial Malpica, 50016 Zaragoza

Spain

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Adamed Pharma S.A

Pienków, ul. Mariana Adamkiewicza 6A

05-152 Czosnów

Poland

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

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/ ”

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the carton with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75282/P_75282.html