ATROLAK PROLONG 200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Atrolak Prolong 200 mg prolonged-release tablets EFG

quetiapine

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

1. What Atrolak Prolong is and what it is used for

Atrolak Prolong prolonged-release tablets contain a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Atrolak Prolong prolonged-release tablets can be used to treat several diseases, such as:

• 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.
• Mania: where you may feel very excited, elated, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or violent.
• 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 have trouble sleeping.

When Atrolak Prolong is used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine being used to treat this disease.

Your doctor may continue to prescribe Atrolak Prolong prolonged-release tablets even when you are feeling better.

2. What you need to know before you take Atrolak Prolong

Do not take Atrolak Prolong:

• If you are allergic (hypersensitive) 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
• azole-type medicines (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression)

Do not take Atrolak Prolong prolonged-release tablets if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Atrolak Prolong prolonged-release tablets.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Atrolak Prolong prolonged-release tablets

• If you have depression or other conditions that are treated with antidepressants. The use of these medicines with quetiapine may cause a condition called serotonin syndrome, a potentially life-threatening condition (see "Use of quetiapine with other medicines").
• If you, or a family member, have or have had any heart problems, such as problems with your heart rhythm, 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 an elderly patient.
• If you have liver problems.
• If you have ever had a seizure (convulsion).
• 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 have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking Atrolak Prolong prolonged-release tablets.
• If you or a family member have a history of blood clots, as medicines like this one have been associated with the formation of blood clots.
• If you are an elderly patient with Parkinson's disease/parkinsonism.
• If you are an elderly patient with dementia (loss of brain function). If so, you should not take Atrolak Prolong because the group of medicines that Atrolak Prolong belongs to may increase the risk of stroke, or in some cases the risk of death, in these patients.
• 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 intestine, 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 you experience any of the following after taking Atrolak Prolong prolonged-release tablets:

• 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 may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (fits).
• Painful and prolonged erection (priapism).

These disorders may 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 interruption of treatment with Atrolak Prolong prolonged-release tablets 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 serious blockage of the intestine.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think of 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 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 suicidal thoughts and/or suicidal behavior in young adults under 25 years with depression.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go to a hospital immediately. It may be helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might 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 but serious 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 increased white blood cell count (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled bumps.
• 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 Atrolak Prolong prolonged-release tablets. You and your doctor should monitor your weight regularly.

Children and adolescents

Atrolak Prolong should not be used in children and adolescents under 18 years of age.

Other medicines and Atrolak Prolong prolonged-release tablets

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

Do not take Atrolak Prolong prolonged-release tablets if you are using any of the following medicines:

• Some medicines for HIV.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Neafazodone (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 (another antipsychotic medicine).
• Medicines that affect your heart rhythm, 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).
• Antidepressants. These medicines may interact with quetiapine prolonged-release tablets, and you may experience symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience such symptoms.

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

Taking Atrolak Prolong prolonged-release tablets with food, drinks, and alcohol

• Atrolak Prolong prolonged-release tablets may be affected by food, and therefore, you should take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Atrolak Prolong prolonged-release tablets and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Atrolak Prolong prolonged-release tablets. 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 or pharmacist before using this medicine. You should not take Atrolak Prolong prolonged-release tablets during pregnancy, unless your doctor has advised you to do so. You should not use Atrolak Prolong prolonged-release tablets if you are breastfeeding.

The following symptoms may occur in newborns if mothers have taken Atrolak Prolong prolonged-release tablets in the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you may need to consult your doctor.

Driving and using machines

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

Atrolak Prolong prolonged-release tablets contain lactose

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

Atrolak Prolong prolonged-release tablets contain 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 Atrolak Prolong prolonged-release tablets may produce positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs) when some analysis methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

3. How to take Atrolak Prolong

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

The recommended 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.
• Swallow your tablets whole with the help of water.
• Do not split, chew, or crush the tablets.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will indicate when).
• Do not drink grapefruit juice while taking Atrolak Prolong prolonged-release tablets. 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 patients

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

Use in children and adolescents

Atrolak Prolong prolonged-release tablets should not be used in children and adolescents under 18 years of age.

If you take more Atrolak Prolong prolonged-release tablets than you should

If you take more Atrolak Prolong prolonged-release tablets than your doctor has prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atrolak Prolong prolonged-release tablets

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 Atrolak Prolong prolonged-release tablets

If you stop taking Atrolak Prolong prolonged-release tablets abruptly, you may be unable to sleep (insomnia), or you may feel nauseous, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest gradually reducing the dose before stopping treatment.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

If you observe any of the following effects, you should stop taking Atrolak Prolong prolonged-release tablets and contact your doctor immediately or go to the nearest hospital as you may need urgent medical attention:

Very frequent adverse effects: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 Atrolak Prolong prolonged-release contents) (which may lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking Atrolak Prolong) include being unable 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 advised.
• 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 that your heart is beating strongly, very fast, or skipping 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 in speech and language.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• 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. The increases in prolactin hormone could, 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.

Uncommon (may affect up to 1 in 100 people):

• Seizures or convulsions.
• Allergic reactions that can include 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 in ECG (QT prolongation).
• A slower than normal heart rate that can occur at the start of treatment and can be associated with a slow heart rate 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.
• Confusion.

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

• A combination of high temperature (fever), prolonged sweating, muscle stiffness, feeling very drowsy or dizzy (a disorder called "neuroleptic malignant syndrome").
• Yellowish color in 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.
• Sleepwalking, talking while asleep, and sleep-related eating disorder.
• Decreased body temperature (hypothermia).
• Pancreas inflammation (pancreatitis).
• A condition (called "metabolic syndrome") where there may be a combination of three or more of the following: increased fat around the abdomen, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and high 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 muscle substance).

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

• Severe rash, blisters, or red spots on the skin.
• A 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). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).

Unknown: frequency cannot be estimated from the available data

• Red rash with irregular red spots (erythema multiforme). See section 2.
• Rapid onset 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.
• Severe and sudden allergic reaction with symptoms such as fever, 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 Atrolak Prolong prolonged-release tablets during their pregnancy.
• Stroke.

The class of medicines to which Atrolak Prolong prolonged-release tablets belong may 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 the blood, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase (a muscle substance) in the blood, decreased sodium in the blood, and increased prolactin hormone in the blood. The increases in prolactin hormone could, 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:

Very frequent:may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. The increase in prolactin hormone could, 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.

Frequent: may affect up to 1 in 10 people

• Feeling of weakness, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritated.

Notification of adverse effects

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

5. Storage of Atrolak Prolong

• Keep out of sight and reach of children.
• Do not use this medicine after the expiration date that appears on the label, carton, and blister after CAD. The expiration date is the last day of the month indicated.
• Do not use this medicine if you notice visible signs of deterioration.
• Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

This medicine does not require special storage conditions.

6. Package contents and additional information

Composition of Atrolak Prolong prolonged-release tablets

• The active ingredient is quetiapine. Each Atrolak Prolong prolonged-release tablet contains 200 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:

Core of the tablet: lactose monohydrate, hydroxypropylmethylcellulose (hypromellose), sodium chloride, povidone K-30, talc, magnesium stearate.

Coating of the tablet: titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172), and hydroxypropylmethylcellulose (hypromellose 6cP) (E464).

Appearance of Atrolak Prolong prolonged-release tablets and package contents

Atrolak Prolong 200 mg prolonged-release tablets are yellow, round, biconvex, film-coated tablets, engraved with the inscription "I2" on one face and smooth on the other face. The tablets have a diameter of approximately 9.6 mm.

PVC/PVDC-Aluminum blister packs. Registered package sizes are 10, 30, 50, 60, and 100 tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Manufacturer

GA PHARMACEUTICALS GAP

46, Agisilaou St., Agios Dimitrios

17341 – Attica

Greece

Or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

Or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht

Netherlands

Or

Accord Healthcare Single Member S.A.

64th Km National Road Athens

Lamia, 32009

Greece

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of last revision of this prospectus: July 2024

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