Leaflet: information for the user

Quetiapina ratiopharm 400 mg prolonged-release tablets EFG

quetiapina

Read this 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, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See Section 4.

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

2. What you need to know before you start taking Quetiapina ratiopharm

3. How to take Quetiapina ratiopharm

4. Possible side effects

5. Storage of Quetiapina ratiopharm

6. Contents of the pack and additional information

Quetiapina ratiopharm contains a substance called quetiapina. It belongs to a group of medicines called antipsychotics. Quetiapina ratiopharm can be used to treat several diseases, such as:

• Bipolar depression and major depressive episodes in major depressive disorder:for which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.
• Mania: for which you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or present poor judgment which includes being aggressive or violent.
• Schizophrenia: for 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 using Quetiapina ratiopharm prolonged-release tabletsto treat major depressive episodes in major depressive disorder,it will be taken in addition to another medicine that is being used to treat this disease.

Your doctor may continue prescribing Quetiapina ratiopharm even when you are feeling better.

Do not takeQuetiapinaratiopharm:

• if you are allergic to quetiapina or any of the other ingredients in this medicine (see 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 are unsure, consult your doctor or pharmacist before taking Quetiapina ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina ratiopharm if:

• if you, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness or inflammation of the heart, or if you are taking any medicine that may affect your heart rhythm.
• 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 have depression or other conditions treated with antidepressants. The use of these medicines with quetiapina may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Quetiapina ratiopharm with other medicines").
• if you have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking quetiapina.
• if you know that you have had low white blood cell counts (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain function). If so, do not take quetiapina, because the group of medicines to which Quetiapina ratiopharm belongs may increase the risk of stroke or, in some cases, death in these people with dementia.
• 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 these have been associated with the formation of blood clots.
• if you have or have had a condition in which your breathing is interrupted by brief periods of time during normal sleep (called "sleep apnea") and are taking medicines that decrease 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, a bowel obstruction, or high pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.

Inform your doctor immediately if after taking Quetiapina ratiopharm you experience any of the following:

• A combination of fever, intense muscle stiffness, sweating, or a decrease in level of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).

These conditions may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it may be a consequence of very low white blood cell counts and require discontinuation of quetiapina treatment and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as it may lead to a more severe intestinal blockage.

Thoughts of suicide and worsening of 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 around two weeks but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 with depression.

If you ever 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 tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Severe skin reactions (SCARs)

Very rarely, severe skin reactions (SCARs) have been reported with the use of this medicine, which may put your life at risk or be fatal. These usually manifest as:

• Stevens-Johnson syndrome (SSJ), a generalised rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (NET), a more severe form that causes extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes).
• Generalised acute pustular psoriasis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using Quetiapina ratiopharm and contact your doctor or seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking quetiapina. You and your doctor should monitor your weight regularly.

Children and adolescents

Quetiapina ratiopharm should not be used in children and adolescents under 18 years of age.

Use of Quetiapina ratiopharm with other medicines

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

Do not take Quetiapina ratiopharm 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 falling asleep).
• Thioridazine or lithium (other antipsychotic medicines).
• Antidepressants. These medicines may interact with Quetiapina ratiopharm and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and a body temperature above 38 °C (serotonin syndrome). Contact your doctor when you experience these symptoms.
• Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.

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

Taking Quetiapina ratiopharm with food, drinks, and alcohol

• Quetiapina ratiopharm may be affected by food, so take your tablets at least one hour before a meal or before bedtime.
• Be careful about the amount of alcohol you drink. This is because the combined effect of Quetiapina ratiopharm and alcohol may make you drowsy.
• Do not take grapefruit juice while taking Quetiapina ratiopharm. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Do not take Quetiapina ratiopharm during pregnancy, unless you have consulted your doctor. Do not use Quetiapina ratiopharm if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapina in the last trimester (last three months of their pregnancy): tremor, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and feeding difficulties. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machines

These tablets may make you feel drowsy. Do not drive or operate tools or machines until you know how the tablets affect you.

Effect on drug detection tests in urine

If you are having a drug detection test in urine, taking quetiapina may produce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when using some analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Quetiapina ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg), that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and your needs, but it will normally be between 150 mg and 800 mg.

?You will take your tablets once a day.

?Do not break, chew, or crush the tablets.

?Swallow your tablets whole with the help of water.

?Take the tablets without food (at least one hour before a meal or before

going to bed, your doctor will tell you when).

?Do not take grapefruit juice while taking Quetiapina ratiopharm. It may affect the way the medication 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 change your dose.

Older patients

If you are an older patient, your doctor may change your dose.

Use in children and adolescents

Quetiapina ratiopharm should not be used in children and adolescents under 18 years of age.

If you take more Quetiapina ratiopharm than you should

If you take more Quetiapina ratiopharm than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring your Quetiapina ratiopharm tablets with you.

You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Quetiapina ratiopharm

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for the missed dose.

If you interrupt the treatment with Quetiapina ratiopharm

If you stop taking Quetiapina ratiopharm abruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability.

Your doctor may suggest reducing the dose gradually before interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you have any of the following serious side effects, stop taking Quetiapina ratiopharm and seek immediate medical attention:

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

• Thoughts of suicideand worsening of your depression.

Less frequent side effects(may affect up to 1 in 100 people)

• Sudden fever, especially withthroat painandsymptoms similar to the flu. They may be signs of a very low white blood cell count.
• Signs ofskin reactionssuch as skin rash, urticaria, hives, redness, itching, possibly withswelling of the face, eyelids, and lips. This could also cause difficulty breathing, dizziness, or shock.
• Seizuresorconvulsions.
• Uncontrollable movements, mainly of your face or tongue (tardive dyskinesia).
• Feeling like your heart isbeating very hard or beating very fastalong with dizziness or fainting.This can be a sign of serious heart rhythm problems and in severe cases can be fatal.

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

• Painintense and/orswellingand rednessin one of your legs;Severe chest painthat can reach your left arm ordifficulty breathingabruptly. These may be signs of blood clots in the veins.
• Severe pain in the upper stomach, often radiating to the back, sometimes withnausea and vomiting. This can be a sign of pancreatitis.
• Constipationalong withpersistent abdominal painor constipation that has not responded to treatment, as this can lead to a more severe intestinal blockage.
• Yellowing of the skin and eyes(jaundice), dark urine, especially along with unusual fatigue or fever (signs of hepatitis).
• Aprolonged and painful erection.
• A combination offever, sweating, rigid muscles, feeling drowsy or fainting (a condition called "neuroleptic malignant syndrome").

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

• Severe skin rash, blisters, or red spots.
• Severe allergic reaction (anaphylaxis) that can cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See Section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Rhabdomyolysis, a condition where muscle fibers break down and cause pain in the muscles.

Unknown side effects(frequency cannot be estimated from available data)

• Skin eruptions with irregular red spots (erythema multiforme). See Section 2.
• Rapid appearance of areas of red skin with small white/yellow-filled blisters (Pustulosis Exanthemática Generalizada Aguda (AGEP). See Section 2.
• Severe and sudden allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See Section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS, for its acronym in English) that consists of symptoms similar to the flu with skin rash, fever, lymph node inflammation, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See Section 2.
• Cardiomyopathy, a condition where the heart muscle becomes inflamed.
• Myocarditis, an inflammation of the heart muscle.
• Stroke

Other possible side effects

Do not worry if you see a tablet in your stoolafter taking Quetiapina ratiopharm. As the tablet travels through your gastrointestinal tract, quetiapine is released slowly. The tablet shape remains intact and is eliminated in the stool. Therefore, although you may see a tablet in your stool, your quetiapine dose has been absorbed.

Frequent side effects(may affect more than 1 in 10 people)

• Dizziness (could lead to falls), headache, dry mouth.
• Feeling drowsy (which may disappear over time as you continue to take quetiapine),(could lead to falls).
• Symptoms of withdrawal (symptoms that occur when you stop taking quetiapine), which include being unable to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability.It is recommended to taper off over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Decreased hemoglobin levels (proteins in red blood cells that carry oxygen).
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• Fast heart rate.
• Feeling like your heart is beating hard, beating fast, or having irregular heartbeats.
• Constipation, stomach upset (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This can make you feel dizzy or faint (could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorders.
• Lack of breath.
• Vomiting (mainly in older people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Changes in the number of certain types of blood cells.
• Increases in liver enzymes measured in the blood.
• Increases in prolactin hormone levels in the blood. Elevated prolactin levels may, in rare cases, lead to:

• Both men and women experiencing breast swelling and unexpected milk production.
• Women not having a menstrual period or having irregular periods.

Less frequent side effects(may affect up to 1 in 100 people)

• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Dysphagia (difficulty swallowing).
• Sexual dysfunction.
• Diabetes.
• Slower than normal heart rate, which may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (could lead to falls).
• Stuffy nose.
• Decreased red blood cell count.
• Decreased sodium levels in the blood.
• Worsening of pre-existing diabetes.
• Confusion

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

• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• A condition (called “metabolic syndrome”) where you may experience a combination of 3 or more of the following effects: increased abdominal fat, decreased “good” cholesterol (HDL-C), increased triglycerides in the blood, increased blood pressure, and increased blood sugar levels.
• Intestinal obstruction.
• Increased creatine phosphokinase levels in the blood (a substance found in muscles).

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

• Inappropriate secretion of a hormone that controls urine volume.

Unknown(frequency cannot be estimated from available data)

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

Some side effects are only observed when a blood test is performed. These include changes in the amount of certain fats (triglycerides and total cholesterol) or blood sugar levels, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, decreased sodium levels in the blood, and increased prolactin hormone levels in the blood. Elevated prolactin levels may, in rare cases, lead to:

• Both men and women experiencing breast swelling and unexpected milk production.
• Women not having a menstrual period or having irregular periods.

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

Side effects in children and adolescents

The same side effects that can occur in adults can also occur in children and adolescents.

The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

Frequent side effects(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:

–Both boys and girls experiencing breast swelling and unexpected milk production.

–Girls not having a menstrual period or having irregular periods.

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

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

• Feeling weak, fainting (could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture

Quetiapinaratiopharmdoes not requireany special storage temperature.

Only for bottles

After the first opening of the packaging, the product must be used within 60 days.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Quetiapina ratiopharm

The active ingredient is quetiapine. Quetiapina ratiopharm 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 Quetiapina ratiopharm and contents of the packaging

The tablets are white, biconvex, oblong, coated, and engraved with “Q 400” on one side.

They are presented in packaging of 10, 20, 30, 50, 50x1 (blister pack with individual perforation) (hospital packaging), 56 (calendar packaging), 60, 90, or 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid

Responsible manufacturer

PHARMACHEMIE B.V. Swensweg, 5. P.O. Box 552 (Haarlem) - NL-2003 RN - Netherlands

MERCKLE GMBH Ludwig-Merckle-Strasse, 3 (Blaubeuren) - D-89143 - Germany

TEVA UK LIMITED Brampton Road, Hampden Park (Eastbourne, East Sussex) - BN22 9AG - United Kingdom

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY Pallagi ut 13 (Debrecen) - H-4042 - Hungary

TEVA CZECH INDUSTRIES S.R.O. Ostravska 29, c.p. 305, Building No 80 Small OSD and building No 881 NOSD (Opava-Komarov) - 747 70 - Czech Republic

TEVA PHARMA, S.L.U. C/ C, n 4 Industrial Park Malpica (Zaragoza) - 50016 - Spain

TEVA OPERATIONS POLAND SP.Z.O.O. Ul. Mogilska 80 (Krakow) - 31-546 – Poland

Last review date of this leaflet: -July 2024

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