Alcreno

Patient Information Leaflet: Alcreno

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 this leaflet carefully before taking Alcreno, as it contains important information for you.

• You should 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 symptoms are the same as yours.
• If you experience 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 Alcreno is and what it is used for
• 2. Before taking Alcreno
• 3. How to take Alcreno
• 4. Possible side effects
• 5. How to store Alcreno
• 6. Contents of the pack and other information

1. What Alcreno is and what it is used for

The active substance of Alcreno is quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. Alcreno can be used to treat several 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 overactive, may have impaired judgment of reality, including 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.

Your doctor may prescribe Alcreno for a longer period, even if you feel better.

2. 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.
• azole (antifungal medicines).
• erythromycin or clarithromycin (antibiotics used to treat infections).
• nefazodone (an antidepressant). If you have any doubts, consult your doctor before taking Alcreno.

Before taking Alcreno, tell your doctor if:

• you or someone in your family has or has had heart disease, such as irregular heart rhythm, weakness, or inflammation of the heart muscle, or if you are taking any medicines that may affect your heart rhythm.
• you have low blood pressure.
• you have had a stroke, especially if you are elderly.
• you have liver problems.
• you have had seizures (fits) in the past.
• you have diabetes or an increased risk of developing diabetes. If you are at risk, your doctor may recommend a blood sugar test while taking Alcreno.
• you have had a low white blood cell count in the past, which may have been related to or unrelated to previous medication use.
• you are an elderly patient with dementia (reduced mental ability). Such patients should not take Alcreno, as medicines in this group may increase the risk of stroke and, in some cases, the risk of death in these patients.
• you are elderly and have Parkinson's disease/parkinsonism.
• you or someone in your family has had blood clots, as the use of such medicines (antipsychotics) is associated with the formation of blood clots.
• you have or have had a condition that causes 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 that makes it difficult to empty your bladder completely (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure in the eye. These symptoms may be caused by certain medicines (so-called anticholinergic medicines) used to treat certain diseases and affect 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 condition 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, fits.
• prolonged and painful erections (priapism).
• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you to a cardiologist immediately.

These symptoms are associated with taking medicines like this. You should see your doctor as soon as possible if you experience:

• fever, flu-like symptoms, sore throat, or other infections, as these 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 respond to treatment, as this 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, contact your doctor or go to the hospital immediately. It may be helpful to inform your friends and family about your condition 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 any worrying changes in your behavior.

Severe skin reactions (SCAR)

During treatment with this medicine, very rare severe skin reactions have been reported, which can be life-threatening or fatal. 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 rash, fever, swelling of 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 with other medicines

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

• certain medicines used to treat HIV.
• azole (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 your medicines, 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. You should avoid drinking grapefruit juice if you are taking Alcreno, as 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 baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Alcreno during pregnancy unless agreed with your doctor. You should 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 any of these symptoms in your baby, contact your doctor.

Driving and using machines

Alcreno may cause drowsiness. You should not drive or operate machinery until you know how Alcreno affects you.

Alcreno contains lactose

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

Alcreno contains sodium

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

Effect on urine tests for drugs

In patients taking Alcreno, urine tests for drugs 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 Alcreno exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine your starting dose. 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 problems

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

Elderly patients

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

Adults and children

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

Overdose

If you take more Alcreno than you should, you may experience symptoms such as drowsiness, dizziness, and heart rhythm disturbances. Contact your doctor or go to the nearest hospital immediately, taking the medicine packaging with you.

Missed dose

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

Stopping 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 questions about taking Alcreno, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects

See 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.
• jaundice (yellowing of the skin and eyes).
• hepatitis.
• severe rash, blisters, or red patches 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).
• Stevens-Johnson syndrome (a severe skin condition with blisters and peeling skin).
• a severe, sudden allergic reaction with symptoms such as fever, blisters on the skin, and peeling skin (toxic epidermal necrolysis).
• stroke.
• rash with eosinophilia and systemic symptoms (DRESS), a widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node swelling, and involvement of other organs.

If you experience these symptoms, stop taking Alcreno and contact your doctor immediately.

Other side effects

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

• dizziness (which may lead to falls), headache, and dry mouth.
• drowsiness (this symptom usually goes away 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 anxious or stiff muscles 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 weak.
• swelling of hands and feet.
• low blood pressure, especially when standing up. This may cause dizziness and fainting, which may lead to falls.
• high blood sugar levels.
• blurred vision.
• unusual dreams and nightmares.
• increased appetite.
• feeling irritable.
• speech disorders.
• shallow breathing.
• vomiting (mainly in elderly patients).
• fever.
• changes in thyroid hormone levels in the blood.
• decreased white blood cell count.
• increased liver enzyme activity in the blood.
• increased prolactin levels in the blood, which may rarely lead to:
• breast swelling and unexpected milk production (in both men and women).
• missed periods or irregular periods (in women).

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

• seizures or fits.
• fainting (may lead to falls).
• unpleasant sensations in the legs (so-called 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.
• low 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 decreased level of consciousness (a condition called malignant neuroleptic syndrome).
• prolonged and painful erections (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, seek medical attention immediately.
• walking, talking, eating, and performing other activities while asleep.
• low body temperature (hypothermia).
• breast swelling and unexpected milk production (in both men and women).
• 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.
• increased creatine kinase activity in the blood (an enzyme found in muscles).

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

• inappropriate secretion of antidiuretic hormone.
• muscle breakdown and muscle pain (rhabdomyolysis).

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

• a rash with irregular red patches (erythema multiforme).
• a severe, sudden allergic reaction with symptoms such as fever and blisters on the skin, and peeling skin (toxic epidermal necrolysis). See section 2.
• drug reaction with eosinophilia and systemic symptoms (DRESS), including symptoms such as flu-like symptoms with rash, fever, swelling of 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).
• blood vessel inflammation (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 seen in blood tests. These include: increased levels of some 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 found in muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels in the blood may rarely lead to:

• breast swelling and unexpected milk production (in both men and women).
• missed periods or irregular periods (in women).

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):

• increased prolactin levels in the blood, which may rarely lead to:
• breast swelling and unexpected milk production in both boys and girls.
• girls may experience missed periods or irregular periods.
• increased appetite.
• vomiting.
• abnormal movements of the muscles. These include: difficulty starting movement, tremors, feeling anxious or stiff muscles without pain.
• increased blood pressure.

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

• feeling weak, fainting (may lead to falls).
• stuffy nose.
• feeling irritable.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alcreno

• Keep out of the sight and reach of children.
• There are no special storage instructions for this medicine.
• Do not use 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Alcreno contains

• The active substance is quetiapine. Each film-coated tablet contains 25, 100, 150, 200, or 300 mg of quetiapine (as quetiapine hemifumarate).
• The other ingredients are: 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 contents of the pack

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 a capsule shape with the number "300" embossed on one side and a smooth surface on the other.
The tablets are packaged in PVC/Aluminum blisters.
The pack may contain: 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets in a cardboard box.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +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