QUETIAPINE INTAS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Quetiapina Intas 25 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Quetiapina Intas and what is it used for
2. What you need to know before you take Quetiapina Intas
3. How to take Quetiapina Intas
4. Possible side effects
5. Storage of Quetiapina Intas
6. Contents of the pack and other information

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

This medicine contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat several diseases, such as:

• Bipolar depression: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or cannot sleep.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment which includes being aggressive or violent.
• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

Your doctor may continue to prescribe this medicine to you even when you are feeling better.

2. What you need to know before you take Quetiapina Intas

Do not take Quetiapina Intas:

• 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:
• • Some medicines for HIV
  • Medicines of the azole type (for fungal infections)
  • Erythromycin or clarithromycin (for infections)
  • Nefazodone (for depression)

If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you, or someone in your family, have or have had any heart problems, such as problems with the heartbeat, 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 have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking this medicine.
• if you know you have had low white blood cell counts in the past (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, you should not take quetiapine because the group of medicines to which this medicine belongs may increase the risk of stroke, or in some cases the risk of death, in these people.
• if you are an elderly person with Parkinson's disease/parkinsonism.
• if you or someone in your family has a history of blood clots, as medicines like this one have been associated with the formation of blood clots.
• if you have or have had a condition where your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and are taking medicines that reduce normal brain activity ("depressants").
• if you have or have had a condition where you cannot empty your bladder completely (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased 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.

Tell your doctor immediately if, after taking this medicine, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or a decrease in consciousness level (a disorder called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and may require discontinuation of treatment with this medicine and/or additional treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more severe blockage of the intestine.

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If you are depressed, you may sometimes think about harming or killing yourself. This may increase when you first start treatment, as all these medicines take time to work, usually around two weeks but sometimes more. 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 suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression. If at any time you think about harming or killing yourself, contact your doctor or go to a hospital immediately. It may help to tell a relative or close friend that you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Severe skin reactions (SCARs)

With the use of this medicine, very rare severe skin reactions (SCARs) have been reported, which can be life-threatening or fatal. These are commonly manifested as:

• Stevens-Johnson syndrome (SSJ), 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 that causes extensive peeling of the skin,
• 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 an increased number of white blood cells (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

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

Weight gain

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

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapina Intas

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

Do not take this medicine if you are using any of the following medicines:

• Some medicines for HIV.
• Medicines of the azole type (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Tell 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, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can 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 Intas with food, drinks, and alcohol

• This medicine can be taken with or without food.
• Be careful with the amount of alcohol you drink. This is because the combined effect of quetiapine and alcohol can make you drowsy.
• Do not drink grapefruit juice while taking this medicine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take this medicine during pregnancy, unless you have discussed it with your doctor. You should not use this medicine if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may appear in newborns of mothers who have used this medicine in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. 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 use tools or machines until you know how the tablets affect you.

Quetiapina Intas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Quetiapina Intas contains sodium

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

Effect on urine drug screening tests

If you are having a urine drug screening test, taking this medicine may produce positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs) when some analysis methods are used, even if you are not taking methadone or TCAs. If this happens, a more specific test can be performed.

3. How to take Quetiapina Intas

Follow exactly the administration instructions of this medicine given 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 needs but will normally be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your disease.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not drink grapefruit juice while taking this medicine. It may affect how the medicine works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

If you have liver problems, your doctor may change your dose.

Elderly people

If you are elderly, your doctor may change your dose.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

If you take more Quetiapina Intas than you should

If you take more quetiapine than your doctor has prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring the tablets of this medicine with you. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Quetiapina Intas

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 Quetiapina Intas

If you stop taking this medicine abruptly, you may be unable to sleep (insomnia), or you may feel nauseous, or you may experience headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other 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 all people suffer from them.

Very Frequent: May Affect More Than 1 in 10 People

• Dizziness (which may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time as you continue taking this medicine), (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking this medicine), which include inability to sleep (insomnia), feeling nauseous, headache, diarrhea, 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 starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Frequent: May Affect Up to 1 in 10 People

• Fast heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disorder of speech and language.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in the amount of liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:
• • Both in men and women, having swollen breasts and unexpected milk production.
  • In women, not having menstrual periods or having irregular periods.

Infrequent: May Affect Up to 1 in 100 People

• Seizures or convulsions.
• Allergic reactions that can include swollen lumps (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on the ECG (prolongation of the QT interval).
• Slower heart rate than normal, which can occur at the start 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 the blood.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.

Rare: May Affect Up to 1 in 1,000 People

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a disorder called "neuroleptic malignant syndrome").
• Yellowish color of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swollen breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Walking, talking, eating, or other activities while you are asleep.
• Decreased body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") in which you may have a combination of three or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased 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 called agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in 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) that can cause difficulty breathing or shock.
• Rapid 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).
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

Unknown: Frequency Cannot Be Estimated from Available Data

• Red spots on the skin with irregular red patches (erythema multiforme).
• Rapid appearance of areas of red skin with small pus-filled bumps (small blisters filled with white/yellow liquid known as acute generalized exanthematous pustulosis (AGEP). See section 2.
• Sudden and severe 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), which consists 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). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used this medicine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs can cause heart rhythm problems that can be serious and, in severe cases, potentially fatal.

Some adverse effects are only observed when a blood test is performed. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• Both in men and women, having swollen breasts and unexpected milk production.
• In women, not having menstrual periods or having 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 can occur in adults can 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 Frequent: May Affect More Than 1 in 10 People

• Increased amount of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:
• • Both in boys and girls, having swollen breasts and unexpected milk production.
  • In girls, not having menstrual periods or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Frequent: May Affect Up to 1 in 10 People

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• Stuffy nose.
• Feeling irritated.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Quetiapine Intas

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapine Intas

• The active ingredient is quetiapine. Each tablet contains 25 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:

• Core of the tablet: lactose monohydrate, microcrystalline cellulose, povidone, magnesium stearate, sodium starch glycolate type A, and dicalcium phosphate dihydrate.

• Coating of the tablet: opadry pink (03B84929): hypromellose 6CP, titanium dioxide (E-171), macrogol 400, yellow iron oxide (E-172), and red iron oxide.

Appearance of Quetiapine Intas and Package Contents

Quetiapine Intas 25 mg film-coated tablets are pink, round, biconvex, and flat on both sides.

Quetiapine Intas 25 mg film-coated tablets are available in packages of 6, 60, 250, and 500 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Intas Third Party Sales 2005, S.L.

Moll de Barcelona, s/n Edificio Este, 6ª planta

08039 Barcelona,

Spain

Manufacturer:

Laboratorio Fundació DAU

P.Ind Consorci Zona Franca c/C, 12-14

08040 Barcelona,

Spain

Or

Accord Healthcare Polska s.p.z.o.o

Ul. Lutomierska, 50

95-200 Pabianice

Poland

Or

Accord Healthcare B.V.

Winthoontlaan 200,

3526 KV Utrecht,

Netherlands

Date of Last Revision of this Leaflet: January 2022

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