Quetiapine Teva-Ratio 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quetiapina Teva-ratio 300 mg film-coated 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See Section 4.

Leaflet contents:

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 side 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: 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, which may include aggressive or violent behavior.
• Schizophrenia: when 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.

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 (hypersensitive) to quetiapine or to any of the other components of Quetiapine Teva-ratio film-coated tablets (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 Quetiapine Teva-ratio.

Warnings and precautions

Talk to 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, 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 (convulsion).
• 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").
• 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 quetiapine.
• if you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain function). 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.
• 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 for short periods during normal nighttime 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), 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.
• if 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 discontinuation of treatment with Quetiapine Teva-ratio and/or additional treatment.

• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal 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 stop your medication abruptly. You may be more likely to have such thoughts if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you 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 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 reactions (SCARs) have been reported with this medicine, which may be life-threatening or fatal. These commonly manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with 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 eruptions with itchy, irregular red 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 Teva-ratio. 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.

Taking 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:

• 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).
• Antidepressants. These medicines may interact with Quetiapine Teva-ratio, 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.
• Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (medicines to increase urine production) 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.

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

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

• Quetiapine Teva-ratio can be taken with or without food.
• 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 might 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 withdrawal syndrome, may occur in newborns whose mothers 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.

Quetiapine Teva-ratio contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Quetiapine Teva-ratio contains sodium

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

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking Quetiapine Teva-ratio may produce positive results for methadone or certain antidepressant medicines known as tricyclic antidepressants (TCAs), when certain analytical methods are used, even though you may not be taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Quetiapine Teva-ratio

Follow exactly the instructions for using this medicine given by your doctor. If you are unsure, 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 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 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.

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 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 your Quetiapine Teva-ratio 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 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 forgotten 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, 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.

Very common: may affect more than 1 in 10 people

• Decrease in haemoglobin levels (a protein in red blood cells that carries oxygen)
• Dizziness (which may lead to falls), headache, dry mouth
• Drowsiness (which may diminish over time as you continue taking Quetiapina Teva-ratio) (which may lead to falls)
• Withdrawal symptoms (symptoms that occur when you stop taking Quetiapina Teva-ratio), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness, 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
• Increased hunger
• Feeling irritable
• Speech and language disorders
• Suicidal thoughts and worsening of depression
• Shortness of breath
• Vomiting (mainly in elderly people)
• Fever
• Changes in levels of thyroid hormones in blood
• Changes in the number of certain types of blood cells
• Increases in liver enzyme levels measured in blood
• Increases in the level of prolactin hormone in blood. 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
• Uncontrolled 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 (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 disorder
• 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 medical help immediately
• Walking, talking, eating, or other activities while asleep
• Decrease in body temperature (hypothermia)
• Inflammation of the pancreas
• A condition (called "metabolic syndrome") in which you may have 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 blood called triglycerides, increased blood pressure, and increased blood sugar
• Combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count, a condition called neutropenia
• 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). See section 2
• Inappropriate secretion of a hormone that controls urine volume
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis)

Not known: frequency cannot be estimated from available data

• Skin rashes with irregular red patches (erythema multiforme). See section 2
• Rapid appearance of red skin areas with small pustules (small blisters filled with yellow/white 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), consisting of 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 Quetiapina Teva-ratio 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
• Stroke

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

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 blood, increased liver enzymes, decreases in the number of certain types of blood cells, decrease in red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in blood, and increased levels of the hormone prolactin in blood. 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 have not been observed in adults:

Very common: may affect more than 1 in 10 people

• Increase in the level of a hormone called prolactin in 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, restlessness, 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, 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 after 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 a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Teva-ratio

The active substance is quetiapine. The tablets contain 300 mg of quetiapine (as quetiapine fumarate).

The other components are:

Tablet core: calcium hydrogen phosphate dihydrate, lactose monohydrate, povidone K-25, microcrystalline cellulose, sodium starch glycolate Type A from potato, colloidal anhydrous silica, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), triacetin, lactose monohydrate and yellow iron oxide (E172).

Appearance of Quetiapine Teva-ratio film-coated tablets and contents of the pack

The tablets are pale yellow, capsule-shaped, biconvex, and marked with "300" on one side and plain on the other.

They are presented in opaque white PVC/PE/Aclar-aluminum blisters or opaque white PVC/PVdC-aluminum blisters, in pack sizes of 1, 10, 20, 30, 50, 60, 90 and 100 (10 x 10) film-coated tablets, and clinical packs of 50, 120, 180 and 240 film-coated tablets.

HDPE bottle with white child-resistant propylene cap containing a desiccant, in pack sizes of 100 and 250 film-coated 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,

Alcobendas, 28108 - Madrid, Spain

Manufacturer

TEVA UK Ltd.

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

The Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

747 70 Opava, Komarov

Czech Republic

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31-546 Kraków,

Poland

Merckle GmbH,

Ludwig-Merckle-Str 3,

89143 Blaubeuren

Germany

Balkanpharma

Dupnitsa AD, 3

Samokovsko Shosse Str.,

Dupnitsa, 2600,

Bulgaria

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71132/P_71132.html

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