Label: Information for the User

Atrolak Prolong 300 mg Extended-Release Tablets EFG

quetiapine

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isAtrolak Prolongand for what it is used

2. What you need to know before starting to takeAtrolak Prolong

3. How to takeAtrolak Prolong

4. Possible adverse effects

5. Storage ofAtrolak Prolong

6. Contents of the package and additional information

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

• 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.
• Mania: for which you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or present poor judgment, which includes being aggressive or violent.
• 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, have a loss of appetite, or cannot sleep.

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

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

Do not take Atrolak Prolong:

• If you are allergic (hypersensitive) to quetiapine or to any of the other components of this medication (including those listed in section 6)
• If you are taking any of the following medications:

- some HIV medications

- azole-type medications (for fungal infections)

- erythromycin or clarithromycin (for infections)

- nefazodone (for depression).

Do not take Atrolak Prolong prolonged-release tablets if the above mentioned 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 treated with antidepressants. The use of these medications with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see “Use of Quetiapine with other medications”).
• If you, or a family member, have or have had any heart problems, for example, irregular heart rhythm or if you are taking any medication that may affect your heart rate.
• 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 that you have had low white blood cell counts (which may or may not have been caused by other medications).
• If you have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while taking Atrolak Prolong prolonged-release tablets.
• If you or a family member has a history of blood clots, as medications like this 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). Do not take Atrolak Prolong prolonged-release tablets because the group of medications to which Atrolak Prolong prolonged-release tablets belongs may increase the risk of stroke or, in some cases, death in these patients.
• If you have or have had a condition in which your breathing is interrupted by short periods of time during normal nighttime sleep (called “sleep apnea”) and are taking medications 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 medications (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 you experience any of the following after taking Atrolak Prolong prolonged-release tablets:

• 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.
• 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 (crises).
• Painful and prolonged erection (priapism).

These conditions may be caused by this type of medication.

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 Atrolak Prolong prolonged-release tablets 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 medications take time to take effect, 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 years old with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to the 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 medication, which may put your life at risk or be fatal. These typically manifest as:

• Stevens-Johnson syndrome (SSJ), a generalized 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).
• Generalized 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 this medication 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 regularly monitor your weight.

Children and adolescents

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

Other medications and Atrolak Prolong prolonged-release tablets

Inform your doctor if you are taking,have takenrecentlyor may need to take any other medication.

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

• Some HIV medications.
• Azole-type medications (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Inform your doctor if you are using any of the following medications:

• Medications for epilepsy (such as phenytoin or carbamazepine).
• Medications for high blood pressure.
• Barbiturates (for difficulty falling asleep).
• Thioridazine (another antipsychotic medication).
• Medications that affect your heart rate, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medications for urination) or certain antibiotics (medications for treating infections).
• Antidepressants. These medications may interact with quetiapine prolonged-release tablets and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, high body temperature (serotonin syndrome). Contact your doctor when you experience such symptoms.

Before stopping any of your medications, 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, so take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you consume. This is because the combined effect of Atrolak Prolong prolonged-release tablets and alcohol may make you drowsy.
• Do not take orange juice while taking Atrolak Prolong prolonged-release tablets. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.Do not take Atrolak Prolong prolonged-release tablets during pregnancy, unless you have consulted your doctor. Do 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): shivering, stiffness, or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby develops any of these symptoms, you may need to consult your doctor.

Driving and operating machinery

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

Atrolak Prolong prolonged-release tablets contain lactose

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

Atrolak Prolong prolonged-release tablets contain sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Effect on drug detection tests in urine

If you are undergoing a drug detection test in urine, taking Atrolak Prolong prolonged-release tablets may produce positive results for methadone or certain antidepressant medications called tricyclic antidepressants (TCAs) when using certain analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose (daily dose) will depend on your illness and your 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 break, chew, or crush the tablets.
• 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 Atrolak Prolong prolonged-release tablets. It may affect how 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

Atrolak Prolong prolonged-release tablets should not be used by 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 prescribed, you may feel drowsiness, dizziness, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

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 interrupt treatment with 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 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 doubts about the use of this medication, ask your doctor or pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

If you observe any of the following effects, you must 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:

Frequent side effects: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to takeAtrolak Prolongprolonged-release tablets) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop takingAtrolak Prolongprolonged-release tablets) include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to withdraw gradually over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating 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 heart rate.
• Sensation that your heart is beating strongly, very quickly, or skipping beats.
• Constipation, indigestion.
• Sensation of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This may make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorder.
• Thoughts of suicide 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. Prolactin hormone increases may, in rare cases, lead to the following:
• • Both men and women have breast swelling and unexpected milk production.
  • Women do not have a menstrual period or have irregular periods.

Rare (may affect more than 1 in 100 people):

• Seizures or convulsions.
• Allergic reactions that may include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes
• Change in the heart's electrical activity seen on an ECG (prolongation of QT).
• A slower than normal heart rate that may occur at the start of treatment and may be associated with a slow heart rate and fainting.
• Difficulty urinating.
• Fainting (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 1000 people):

• Combination of high temperature (fever), prolonged sweating, muscle stiffness, feeling very drowsy or dizzy (a condition called "neuroleptic malignant syndrome").
• Yellowish discoloration of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis)
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• Somnambulism, talking in one's sleep, and disordered eating related to sleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas (pancreatitis)
• A condition (called "metabolic syndrome") where a combination of 3 or more of the following may occur: increased fat around the abdomen, decreased "good" cholesterol (HDL-C), increased triglycerides, increased blood pressure, and increased blood sugar levels.
• Combination of fever, symptoms similar to the flu, 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 skin rash, blisters, or red spots.
• Severe allergic reaction (anaphylaxis) that may cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe skin rash, blisters, or ulcers (Stevens-Johnson syndrome). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis, a condition where muscle fibers break down and cause muscle pain.

Unknown: the frequency cannot be estimated from available data

• Maculopapular rash with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of skin areas with red spots and small white/yellow-filled blisters (Pustulosis Exantemática Generalizada Aguda (AGEP). See section 2.
• Severe and sudden allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS), which includes symptoms similar to the flu, 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 newborn babies of mothers who have takenAtrolak Prolongprolonged-release tablets during pregnancy.
• Stroke.

The class of medicines to which Atrolak Prolong prolonged-release tablets belongs may cause heart rhythm problems that can be serious and, in severe cases, fatal.

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 number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase (a muscle substance) in the blood, decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood. Prolactin hormone increases may, in rare cases, lead to the following:

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

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

Additional side effects in children and adolescents:

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

The following side 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. Prolactin hormone increases may, in rare cases, lead to the following:
• Both boys and girls have breast swelling and unexpected milk production.
• Girls do not have a menstrual period or have irregular periods.
• Increased appetite.
• Vomiting
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.

Frequent: may affect up to 1 in 10 people

• Sensation of weakness, fainting (may lead to falls)
• Stuffy nose
• Feeling irritable

Reporting of side effects

If you experience any type of side effect, consult your doctor or 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 the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep out of sight and reach of children.
• Do not use this medication after the expiration date that appears on the label, box, and blister after CAD. The expiration date is the last day of the month indicated.
• Do not use this medication if you observe visible signs of deterioration.
• Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

This medication does not require special conditions for conservation.

Composition of Atrolak Prolong prolonged-release tablets

• The active ingredient is quetiapine. Each Atrolak Prolong prolonged-release tablet contains 300 mg of quetiapine (as quetiapine fumarate).
• The other components are:

Tablet core: lactose monohydrate, hydroxypropylmethylcellulose (hypromellose), sodium chloride, povidone K-30, talc, magnesium stearate.

Tablet coating: titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172) and hydroxypropylmethylcellulose (hypromellose 6cP) (E464).

Appearance of Atrolak Prolong prolonged-release tablets and contents of the package

Atrolak Prolong prolonged-release tablets 300 mg are pale yellow, round, biconvex, film-coated tablets, engraved with the inscription “Q300” on one face and smooth on the other face. The tablets have a diameter of approximately 11.2 mm.

PVC/PVDC-Aluminium blister packs. They are registered package sizes of 10, 30, 50, 60 and 100 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Responsible Person

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 medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: July 2024

The detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.