Atrolak Prolong 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Atrolak Prolong 400 mg prolonged-release tablets EFG

quetiapine

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

• Keep this leaflet as you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Atrolak Prolong is and what it is used for
2. What you need to know before taking Atrolak Prolong
3. How to take Atrolak Prolong
4. Possible adverse effects
5. How to store 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 known as antipsychotics. Atrolak Prolong prolonged-release tablets can be used to treat several conditions, such as:

• Schizophrenia: in 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: in which you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment including aggressive or violent behaviour.
• Bipolar depression and major depressive episodes in major depressive disorder: in which you feel sad. You may find that you feel depressed, guilty, lack energy, have loss of appetite, or are unable to sleep.

When Atrolak Prolong is being used to treat major depressive episodes in major depressive disorder, it is taken in addition to another medicine you are already taking for this condition.

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

2. What you need to know before starting Atrolak Prolong

Do not take Atrolak Prolong:

• If you are allergic (hypersensitive) to quetiapine or to any of the other components 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 apply to you. If you have any doubts, 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 suffer from depression or other conditions treated with antidepressants. The use of these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see “Use of quetiapine with other medicines”).
• If you, or a family member, have or have had any heart problems, for example, heart rhythm problems, or if you are taking any medicine that may affect your heart rate.
• 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 know you have previously had low levels of white blood cells (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 has a history of blood clots, as medicines like this have been associated with blood clot formation.
• If you are an elderly person with Parkinson's disease/parkinsonism.
• If you are an elderly person with dementia (loss of brain function). If so, you should not take Atrolak Prolong, as the group of medicines to which Atrolak Prolong belongs may increase the risk of stroke, or in some cases the risk of death, in these individuals.
• If you have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).
• If you have or have had a condition in which you cannot fully empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
• If you have a history of alcohol or drug abuse.

Contact 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 decreased level of consciousness (a disorder known as “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
• Uncontrollable 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.

Contact your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low count of white blood cells and may require discontinuation of treatment with Atrolak Prolong prolonged-release tablets and/or additional treatment.
• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medicines take time to work, usually about two weeks but sometimes longer. These thoughts may also increase if you stop your medication abruptly. You may be more likely to have such thoughts if you are a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they think your depression is worsening or if they are concerned about changes in your behavior.

Serious skin adverse reactions (SCARs)

Very rarely, serious skin adverse reactions (SCARs), which may be life-threatening or fatal, have been reported with the use of this medicine. These commonly manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), consisting 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).
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with irregular red spots that itch.

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

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 must not be used in children and adolescents under 18 years of age.

Other medicines and Atrolak Prolong prolonged-release tablets

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

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).
• Nefazodone (for depression).

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

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine (another antipsychotic medicine).
• Medicines that affect your heart rate, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (medicines to increase urination) or certain antibiotics (medicines to treat infections).
• Antidepressants. These medicines may interact with quetiapine prolonged-release tablets and you may experience symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). Contact your doctor if 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 cautious about 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 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 must not take Atrolak Prolong prolonged-release tablets during pregnancy unless you have discussed it with your doctor. You must 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 during the third trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. 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 machinery until you know how these tablets affect you.

Atrolak Prolong prolonged-release tablets contain lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 undergoing a urine drug screening test, taking Atrolak Prolong prolonged-release tablets may produce positive results for methadone or certain antidepressant medicines known as tricyclic antidepressants (TCAs) when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Atrolak Prolong

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

The recommended dose (daily dose) will depend on your condition and individual needs, but will usually range between 150 mg and 800 mg.

• You will take your tablets once daily.
• Swallow your tablets whole with water.
• Do not split, chew, or crush the tablets.
• Take the tablets on an empty stomach (at least one hour before a meal or at bedtime; your doctor will advise you 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 adjust your dose.

Elderly patients

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

Use in children and adolescents

Atrolak Prolong prolonged-release tablets must 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 prescribed by your doctor, you may experience drowsiness, dizziness, or abnormal heartbeats. Contact your doctor or the nearest hospital immediately, or call the Toxicology Information Service at 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, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a missed tablet.

If you stop taking Atrolak Prolong prolonged-release tablets

If you stop taking Atrolak Prolong prolonged-release tablets abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

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

If you experience 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 require urgent medical attention:

Very common adverse effects: may affect more than 1 in 10 people

• Dizziness (which could lead to falls), headache, dry mouth.
• Drowsiness (which may diminish over time as you continue taking Atrolak Prolong prolonged-release tablets) (could lead to falls).
• Discontinuation symptoms (symptoms occurring when you stop taking Atrolak Prolong), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness, or painless muscle rigidity.
• Changes in levels of certain fats (triglycerides and total cholesterol).

Common adverse effects: may affect up to 1 in 10 people

• Fast heartbeat.
• Sensation that your heart is beating strongly, very fast, or skipping beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs (oedema).
• Low blood pressure when standing. This may make you feel dizzy or faint (could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in levels of thyroid hormones in blood.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzymes measured in blood.
• Increases in the amount of prolactin hormone in blood. Elevated prolactin levels may, in rare cases, lead to:
  • Breast swelling and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

Uncommon adverse effects (may affect more than 1 in 100 people):

• Epileptic seizures or convulsions.
• Allergic reactions which may include raised, itchy rashes (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the heart's electrical activity seen on ECG (QT prolongation).
• A slower than normal heart rate, which may occur at the beginning of treatment and may be associated with bradycardia and fainting.
• Difficulty urinating.
• Fainting (could lead to falls).
• Nasal congestion.
• Decrease in the number of red blood cells in blood.
• Decrease in the amount of sodium in blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• A combination of high temperature (fever), prolonged sweating, muscle rigidity, and extreme drowsiness or dizziness (a disorder called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhoea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
• Sleepwalking, talking during sleep, and sleep-related eating disorder.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas (pancreatitis).
• A condition (called "metabolic syndrome") where you may have a combination of 3 or more of the following: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased blood 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 known as agranulocytosis.
• Intestinal obstruction.
• Increased blood creatine phosphokinase (a muscle substance).

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

• Severe rash, blisters, or red spots on the skin.
• A severe allergic reaction (called anaphylaxis) which may cause breathing difficulties or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious blistering condition affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Unknown frequency: frequency cannot be estimated from available data

• Skin rash with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.
• Sudden, severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who used Atrolak Prolong prolonged-release tablets during 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, may be fatal.

Some adverse effects are only detected through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in blood, increases in liver enzymes, decreases in certain types of blood cells, decreased red blood cell count, increased blood creatine phosphokinase (a muscle substance), decreased blood sodium levels, and increased blood prolactin levels. Elevated prolactin levels may, in rare cases, lead to:

• Breast swelling and unexpected milk production in both men and women.
• In women, absence of menstrual periods or irregular periods.

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

Additional adverse effects in children and adolescents:

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

The following adverse effects have been observed more frequently in children and adolescents:

Very common: may affect more than 1 in 10 people

• Increased levels of a hormone called prolactin in blood. Elevated prolactin levels may, in rare cases, lead to:
  • Breast swelling and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness, or painless muscle rigidity.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (could lead to falls).
• Nasal congestion.
• Feeling irritable.

Reporting of adverse effects

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

5. Storage of Atrolak Prolong

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label, carton, and blister after EXP. The expiry date refers to the last day of the month indicated.
• Do not use this medicine if you notice any visible signs of deterioration.
• Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

This medicine does not require any special storage conditions.

6. Package contents and other information

Composition of Atrolak Prolong prolonged-release tablets

• The active substance is quetiapine. Each Atrolak Prolong prolonged-release tablet contains 400 mg of quetiapine (as quetiapine fumarate).
• The other components are:

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

Tablet coating: titanium dioxide (E171), macrogol (E1521) and hypromellose 6cP (E464).

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

Atrolak Prolong prolonged-release 400 mg tablets are white, round, biconvex, film-coated tablets, marked with the inscription “I4” on one side and smooth on the other side. The tablets have a diameter of approximately 12.8 mm.

PVC/PVDC-Aluminum blister packs. Pack sizes of 10, 30, 50, 60 and 100 tablets are registered.

Only some pack 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

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

The Netherlands

Or

Accord Healthcare Single Member S.A.

64th Km National Road Athens

Lamia, 32009

Greece

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

Date of last review of this leaflet: July 2024

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