ALCRENO 25 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Alcreno, 25 mg, film-coated tablets
3. Alcreno, 100 mg, film-coated tablets
4. Alcreno, 150 mg, film-coated tablets
5. Alcreno, 200 mg, film-coated tablets
6. Alcreno, 300 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
7. What is Alcreno and what is it used for
8. Important information before taking Alcreno
   1. Do not take Alcreno if:
   2. Suicidal thoughts or worsening depression.
   3. Severe skin reactions (SCAR)
   4. Weight gain
   5. Children and adolescents
   6. Alcreno and other medicines
   7. Alcreno with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Alcreno contains lactose
   11. Alcreno contains sodium
   12. Effect on urine tests for drug presence
9. How to take Alcreno
   1. Patients with liver function disorders
   2. Elderly patients
   3. Adults and children
   4. Taking a higher dose of Alcreno than recommended
   5. Missing a dose of Alcreno
   6. Stopping Alcreno treatment
10. Possible side effects
    1. Severe side effects
    2. Other side effects
    3. Very common side effects (may affect more than 1 in 10 people):
    4. Common side effects (may affect up to 1 in 10 people):
    5. Uncommon side effects (may affect up to 1 in 100 people):
    6. Rare side effects (may affect up to 1 in 1,000 people):
    7. Very rare side effects (may affect up to 1 in 10,000 people):
    8. Frequency not known (frequency cannot be estimated from the available data):
    9. Additional side effects in children and adolescents
    10. Side effects that occur more frequently in children and adolescents than in adults:
    11. Very common side effects (may affect more than 1 in 10 people):
    12. Common side effects (may affect up to 1 in 10 people):
    13. Reporting side effects
11. How to store Alcreno
12. Contents of the packaging and other information
    1. What Alcreno contains
    2. What Alcreno looks like and what the pack contains
    3. Marketing authorization holder:
    4. Manufacturer/Importer:
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Alcreno, 25 mg, film-coated tablets

Alcreno, 100 mg, film-coated tablets

Alcreno, 150 mg, film-coated tablets

Alcreno, 200 mg, film-coated tablets

Alcreno, 300 mg, film-coated tablets

Quetiapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Alcreno and what is it used for
• 2. Important information before taking Alcreno
• 3. How to take Alcreno
• 4. Possible side effects
• 5. How to store Alcreno
• 6. Contents of the packaging and other information

1. What is Alcreno and what is it used for

The active substance of Alcreno is quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. Alcreno can be used to treat many diseases, such as:

• Schizophrenia: the patient may hear or feel things that do not exist; believe in things that are not true or experience unusual suspicion, anxiety, disorientation, guilt, tension, and depression.
• Mania: the patient may be very excited, agitated, and restless, may have impaired judgment of reality, including exhibiting troublesome and aggressive behavior.
• Depression in bipolar disorder: mood disorders that cause the patient to feel sad. The patient has feelings of guilt, depression, is devoid of energy, experiences loss of appetite, and cannot sleep.

The doctor may prescribe continued use of Alcreno, even if the patient's condition improves.

2. Important information before taking Alcreno

Do not take Alcreno if:

• you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• you are taking any of the following medicines:
• certain medicines used to treat HIV infection),
• azoles (antifungal medicines),
• erythromycin, clarithromycin (certain antibiotics),
• nefazodone (an antidepressant). If you have any doubts, consult your doctor before taking Alcreno.

Before taking Alcreno, tell your doctor if:

• you or a family member have or have had heart disease, such as arrhythmias, weakness, or inflammation of the heart muscle, or if you are taking any medicines that may affect heart rhythm,
• you have low blood pressure,
• you have had a stroke, especially if you are elderly,
• you have liver function disorders,
• you have had seizures (convulsions),
• you have diabetes or an increased risk of developing diabetes. If you are at risk, your doctor may order a blood sugar test while taking Alcreno,
• you have ever had a low white blood cell count, which may or may not be related to taking other medicines,
• you are an elderly person with dementia (reduced brain function). Such a person should not take Alcreno, as medicines in this group may increase the risk of stroke and sometimes the risk of death in such patients,
• you are elderly and have Parkinson's disease/parkinsonism,
• you or a family member have had venous thrombosis, as the use of such medicines (antipsychotics) is associated with the formation of blood clots,
• you have or have had a condition characterized by short pauses in breathing during normal sleep at night (so-called sleep apnea) and are taking medicines that slow down brain function (so-called depressants),
• you have or have had a condition characterized by inability to completely empty the bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased eye pressure. Such symptoms may sometimes be caused by medicines (so-called anticholinergic medicines) used to treat certain diseases and affecting the function of nerve cells,
• you have or have had problems with alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following symptoms after taking Alcreno:

• a syndrome of symptoms: fever, muscle stiffness, sweating, or decreased level of consciousness (a disease called malignant neuroleptic syndrome). Immediate medical attention may be required,
• involuntary movements, especially of the face or tongue,
• dizziness or severe drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• seizures, convulsions,
• prolonged and painful erection (priapism).
• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, immediately refer the patient to a cardiologist.

The occurrence of these symptoms is related to the use of such medicines.
Consult your doctor as soon as possible if you experience:

• fever, flu-like symptoms, sore throat, or other infections, as they may be caused by a very low white blood cell count, which may require discontinuation of Alcreno and/or appropriate treatment;
• constipation with persistent abdominal pain or constipation that does not improve with treatment, as it may lead to severe intestinal obstruction.

Suicidal thoughts or worsening depression.

Patients with depression may sometimes think about self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later. Suicidal thoughts may worsen in patients who have suddenly stopped taking their medicines.
The likelihood of such thoughts increases in young patients. Clinical trials have shown an increased risk of suicidal thoughts and/or behaviors in young patients under 25 years of age with depression.
If you experience thoughts of self-harm or suicidal thoughts, consult your doctor or go to the hospital immediately.
It may be helpful to inform your friends and family about your illness and its symptoms and ask them to read this leaflet and inform you if they notice that your depression or anxiety has worsened or if there are worrying changes in your behavior.

Severe skin reactions (SCAR)

During treatment with this medicine, very rare severe skin reactions (SCAR) have been reported, which can be life-threatening or fatal. The symptoms of these reactions include:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals;
• Toxic epidermal necrolysis (TEN), a more severe form of rash causing widespread skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS), symptoms similar to flu with a rash, fever, swelling of the lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity).

Weight gain

Patients taking Alcreno have experienced weight gain. You should regularly check your weight yourself or with your doctor.

Children and adolescents

Alcreno is not intended for use in children and adolescents under 18 years of age.

Alcreno and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Alcreno if you are taking any of the following medicines:

• certain medicines used to treat HIV,
• azoles (antifungal medicines),
• erythromycin or clarithromycin (antibiotics used to treat infections),
• nefazodone (an antidepressant). Tell your doctor if you are taking any of the following medicines:
• medicines used to treat epilepsy (such as phenytoin or carbamazepine),
• medicines used to treat high blood pressure,
• medicines used to treat insomnia (barbiturates),
• a medicine used to treat psychotic disorders (thioridazine or lithium),
• medicines that affect the heart, such as those that disrupt electrolyte balance (reducing potassium or magnesium levels), such as diuretics or certain antibiotics.
• medicines that can cause constipation,
• medicines used to treat certain diseases, affecting the function of nerve cells (so-called anticholinergic medicines).

Before stopping any of the medicines you are taking, consult your doctor.

Alcreno with food, drink, and alcohol

Alcreno can be taken with or without food.
Be careful with the amount of alcohol you drink. The combined effect of Alcreno and alcohol may cause drowsiness.
Avoid drinking grapefruit juice if you are taking Alcreno.
Grapefruit juice may affect the action of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Alcreno during pregnancy, unless agreed with your doctor.
Do not breastfeed while taking Alcreno.
In newborns whose mothers took Alcreno during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, consult your doctor.

Driving and using machines

Alcreno may cause drowsiness. You should not drive or operate machinery until you know how you react to the medicine.

Alcreno contains lactose

Alcreno contains lactose, a type of sugar. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Alcreno contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Effect on urine tests for drug presence

In patients taking Alcreno, urine tests for drug presence performed by some methods may show the presence of methadone or other antidepressant medicines (tricyclic antidepressants), even if the patient has not taken them. It is recommended to perform these tests by other methods to confirm the results.

3. How to take Alcreno

Always take this medicine exactly as your doctor has told you.
If you are not sure, consult your doctor or pharmacist.
Your doctor will determine the initial dose for you.
The maintenance dose (daily dose) depends on your symptoms and needs, usually within the range of 150 mg to 800 mg per day.

• Take the tablets once a day before bedtime or twice a day, depending on the disease.
• Swallow the tablets whole with water.
• You can take the tablets with or without food.
• Do not drink grapefruit juice while taking Alcreno, as it may affect the action of the medicine.
• Do not stop treatment without consulting your doctor, even if you feel better.

Patients with liver function disorders

Your doctor may recommend a dose change if you have liver function disorders.

Elderly patients

Your doctor may change the dose if you are an elderly patient.

Adults and children

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

Taking a higher dose of Alcreno than recommended

If you take a higher dose of Alcreno than recommended, you may experience symptoms of overdose, such as drowsiness, dizziness, and heart rhythm disturbances. Consult your doctor or go to the nearest hospital immediately, taking the medicine packaging with you.

Missing a dose of Alcreno

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed tablet.

Stopping Alcreno treatment

If you stop taking Alcreno suddenly, you may experience symptoms such as nausea, vomiting, sleep problems, headaches, dizziness, diarrhea, and irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alcreno can cause side effects, although not everybody gets them.

Severe side effects

Consult your doctor immediatelyif you experience:

• suicidal thoughts and worsening depression,
• allergic reactions, which can include blistering of the skin, skin swelling, and swelling around the mouth,
• yellowing of the skin and eyes (jaundice),
• hepatitis,
• severe skin rash, blisters, or red spots on the skin,
• severe allergic reaction (anaphylaxis), which can cause breathing difficulties or shock,
• sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• severe blistering skin disease, mouth, eyes, and genital areas (Stevens-Johnson syndrome),
• severe, sudden allergic reaction with symptoms such as fever, blisters on the skin, and peeling of the skin (toxic epidermal necrolysis),
• stroke,
• rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node swelling, and involvement of other organs (rash with eosinophilia and systemic symptoms is also known as DRESS or drug hypersensitivity syndrome).

If you experience these symptoms, stop taking Alcreno and consult your doctor or seek medical attention immediately

Other side effects

Very common side effects (may affect more than 1 in 10 people):

• dizziness (which can lead to falls), headache, and dry mouth,
• drowsiness (this symptom usually subsides after some time of taking the medicine) (may lead to falls),
• withdrawal symptoms (symptoms that occur after stopping Alcreno): insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability; it is recommended to gradually stop the medicine over 1-2 weeks,
• weight gain,
• abnormal movements of the muscles. These include: difficulty starting movement, tremors, feeling of restlessness or muscle stiffness without pain.
• changes in the levels of some fats (triglycerides and total cholesterol) in the blood.

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

• rapid heartbeat,
• feeling of palpitations or rapid and irregular heartbeat,
• constipation, upset stomach (indigestion),
• feeling of weakness,
• swelling of the hands and feet,
• drop in blood pressure, especially when standing up. This may cause dizziness and fainting, which can lead to falls,
• high blood sugar levels,
• blurred vision,
• unusual dreams and nightmares,
• increased appetite,
• feeling of irritability,
• speech disorders,
• shallow breathing,
• vomiting (mainly in elderly patients),
• fever,
• changes in thyroid hormone levels in the blood,
• decrease in the number of certain types of blood cells,
• increase in liver enzyme activity in the blood,
• increase in prolactin levels in the blood, which in rare cases may lead to:
• (in both men and women) breast swelling and unexpected milk production,
• (in women) menstrual cessation or irregular menstruation.

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

• seizures or convulsions,
• fainting (may lead to falls),
• unpleasant sensations in the legs (also known as restless legs syndrome),
• difficulty swallowing,
• involuntary movements, especially of the face or tongue,
• sexual disorders,
• stuffy nose,
• diabetes,
• changes in the electrical activity of the heart recorded on an ECG (prolongation of the QT interval),
• slow heart rate at the beginning of treatment, which may be caused by low blood pressure and fainting,
• difficulty urinating,
• decrease in red blood cell count,
• decrease in sodium levels in the blood,
• worsening of existing diabetes,
• confusion.

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

• a syndrome of symptoms: high fever, sweating, muscle stiffness, and feeling of severe drowsiness or fainting (a disorder called malignant neuroleptic syndrome),
• prolonged and painful erection (priapism),
• menstrual disorders,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, consult your doctor immediately,
• walking, talking, eating, and performing other activities while sleeping,
• low body temperature (hypothermia),
• breast swelling and unexpected milk production (galactorrhea),
• pancreatitis,
• a condition called metabolic syndrome, which may include: increased fat around the abdomen, decreased "good" HDL cholesterol, increased triglyceride levels in the blood, high blood pressure, and increased blood sugar levels,
• a combination of fever, flu-like symptoms, sore throat, or other infections with a very low white blood cell count (so-called agranulocytosis),
• intestinal obstruction,
• increase in creatine kinase activity in the blood (an enzyme produced in muscles).

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

• inappropriate secretion of the hormone that controls the amount of urine excreted,
• breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Frequency not known (frequency cannot be estimated from the available data):

• skin rash with irregular red spots (erythema multiforme),
• severe, sudden allergic reaction with symptoms such as fever and blisters on the skin, and peeling of the skin (toxic epidermal necrolysis). See section 2.
• drug reaction with eosinophilia and systemic symptoms (DRESS), including symptoms such as flu-like symptoms with a rash, fever, swelling of the lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity). See section 2.
• withdrawal symptoms in newborns whose mothers took Alcreno during pregnancy.
• stroke.
• heart muscle disorders (cardiomyopathy).
• heart muscle inflammation (myocarditis).
• inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots

Medicines in the same group as Alcreno may cause heart rhythm disturbances, which can be severe and, in some cases, fatal.
Some side effects are only visible in blood test results. These include: increased levels of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme activity, decreased white blood cell count, decreased red blood cell count, increased creatine kinase activity (an enzyme produced in muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood.
An increase in prolactin levels in the blood may, in rare cases, lead to:

• (in both men and women) breast swelling and unexpected milk production,
• (in women) menstrual cessation or irregular menstruation.

Your doctor may recommend regular blood tests.

Additional side effects in children and adolescents

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

Side effects that occur more frequently in children and adolescents than in adults:

Very common side effects (may affect more than 1 in 10 people):

• increase in prolactin levels in the blood, which in rare cases may lead to:
• breast swelling and unexpected milk production in both boys and girls,
• in girls, menstrual cessation or irregular menstruation.
• increased appetite,
• vomiting,
• abnormal movements of the muscles. These include: difficulty starting movement, tremors, feeling of restlessness or muscle stiffness without pain.
• increased blood pressure.

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

• feeling of weakness, fainting (may lead to falls),
• stuffy nose,
• feeling of irritability.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Alcreno

• Keep out of sight and reach of children.
• There are no special precautions for storing the medicine.
• Do not take this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Alcreno contains

• The active substance of Alcreno is quetiapine. Each film-coated tablet contains 25, 100, 150, 200, or 300 mg of quetiapine (in the form of quetiapine hemifumarate).
• The medicine also contains: Core:lactose monohydrate, microcrystalline cellulose, povidone K30, magnesium stearate, sodium carboxymethylcellulose (type A), calcium hydrogen phosphate dihydrate

Coating:
25 mg
Hypromellose
Titanium dioxide (E 171)
Macrogol 400
Yellow iron oxide (E 172)
Red iron oxide (E 172)
100 mg
Hypromellose
Titanium dioxide (E 171)
Macrogol 400
Yellow iron oxide (E 172)
150 mg
Hypromellose
Titanium dioxide (E 171)
Macrogol 400
Yellow iron oxide (E 172)
200 mg, 300 mg:
Hypromellose
Macrogol 400
Titanium dioxide (E 171)

What Alcreno looks like and what the pack contains

25 mg: pink, round, biconvex, film-coated tablets with a smooth surface on both sides.
100 mg: yellow, round, biconvex, film-coated tablets with a smooth surface on both sides.
150 mg: pale yellow, round, biconvex, film-coated tablets with a smooth surface on both sides.
200 mg: white or almost white, round, biconvex, film-coated tablets with a smooth surface on both sides.
300 mg: white or almost white, biconvex, film-coated tablets in the shape of a capsule with the number "300" embossed on one side and smooth on the other.
The tablets are packaged in PVC/Aluminum blisters.
The packaging may contain: 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets in a carton.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer:

Laboratori FUNDACIO DAU,
C/ De la letra C, 12-14,
Poligono Industrial de la Zona Franca,
08040 Barcelona,
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:September 2022