Arizalera

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Aryzalera, 15 mg, tablets

Aripiprazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aryzalera and what is it used for

Aryzalera contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. Aryzalera is used to treat adults and adolescents aged 15 and older with a disease characterized by symptoms such as seeing, hearing, and feeling things that do not exist in reality, suspiciousness, false beliefs, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also experience sadness, guilt, anxiety, or tension.

Aryzalera is used to treat adults and adolescents aged 13 and older whose disease is characterized by symptoms such as excitement, having too much energy, needing much less sleep than usual, very fast speech with racing thoughts, and sometimes severe irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to treatment with Aryzalera.

2. Important information before taking Aryzalera

When not to take Aryzalera:

• if the patient is allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Aryzalera, the patient should discuss it with their doctor.

During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. The patient should immediately inform their doctor if they experience thoughts or feelings related to self-harm.

Before starting treatment with Aryzalera, the patient should inform their doctor if they have:

• high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feeling weak) or a family history of diabetes;
• seizures (epilepsy), as this may mean that the doctor will want to monitor the patient very closely;
• involuntary, irregular muscle movements, especially of the face;
• heart or blood vessel disease, family history of heart or blood vessel disease, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots or a history of blood clots, as the use of antipsychotic medicines is associated with their formation;
• a history of gambling addiction.

If the patient notices an increase in weight, appearance of unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or symptoms of an allergic reaction, they should inform their doctor.

If an elderly patient has dementia (loss of memory and other mental abilities), they, their caregiver, or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.

The patient should immediately inform their doctor if they experience thoughts or feelings related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.

The patient should immediately inform their doctor if they experience muscle stiffness or stiffness with high fever, excessive sweating, mental disorders, or very fast or irregular heartbeat.

If the patient or their family or caregiver notices that the patient is starting to feel the urge or desire to behave in an unusual way, and cannot resist the impulse, urge, or temptation to engage in activities that may harm them or others, they should tell their doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, overeating, or excessive spending, excessive sexual drive, or increased frequency and intensity of thoughts or feelings about sexual topics.

The doctor may consider it appropriate to change the dose or discontinue the medicine.

Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. The patient should be careful, especially if they are elderly or weakened.

Children and adolescents

Aryzalera should not be used in children and adolescents under the age of 13. It is not known if the use of this medicine is safe and effective in these patients.

Aryzalera and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.

Blood pressure-lowering medicines: Aryzalera may enhance the effects of blood pressure-lowering medicines. If the patient is taking blood pressure-lowering medicines, they should inform their doctor.

Taking Aryzalera with certain medicines may require a change in the dose of Aryzalera or other medicines the patient is taking. It is especially important to inform the doctor about the use of the following medicines:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressant medicines or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medicines (such as ketoconazole, itraconazole);
• certain medicines used to treat HIV infection (such as efavirenz, nevirapine, protease inhibitors, e.g., indinavir, ritonavir);
• antiepileptic medicines used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

Taking these medicines may increase the risk of side effects or decrease the effect of Aryzalera. If the patient experiences any unusual symptoms while taking these medicines with Aryzalera, they should tell their doctor.

Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, and migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, and migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety;
• other antidepressant medicines (such as venlafaxine and tryptophan) used to treat severe depression;
• tricyclic antidepressant medicines (such as clomipramine and amitriptyline) used to treat depression;
• St. John's Wort (Hypericum perforatum) used as a herbal preparation for mild depression;
• pain relievers (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

Taking these medicines may increase the risk of side effects. If the patient experiences any unusual symptoms while taking these medicines with Aryzalera, they should tell their doctor.

Aryzalera with food, drink, and alcohol

The medicine can be taken with or without food.

The patient should not drink alcohol during treatment with Aryzalera.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.

In newborns whose mothers took Aryzalera during the last trimester of pregnancy (the last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If the patient notices any of these symptoms in their child, they should contact their doctor.

If the patient is taking Aryzalera, their doctor will discuss with them whether they should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. The patient should not take the medicine and breastfeed. They should discuss with their doctor the best methods for feeding their child if they are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances (see section 4) may occur.

The patient should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Aryzalera contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Aryzalera

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Aryzalera is available in the following strengths: 5 mg, 10 mg, 15 mg, and 30 mg.

The recommended dose for adults is 15 mg once a day.However, the doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a day.

Use in children and adolescents

Aripiprazole treatment can be started with a low dose of aripiprazole oral solution (liquid). The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Aryzalera is intended for oral use.

Aryzalera should be taken every day at the same time. It does not matter whether the tablet is taken with food or without food. The tablet should be swallowed whole and washed down with water.

Even if the patient feels an improvement in their condition,they should not change the dose or stop taking Aryzalera without first discussing it with their doctor.

Taking a higher dose of Aryzalera than recommended

If the patient takes a higher dose than prescribed by their doctor (or if someone else takes some of the medicine not intended for them), they should immediately contact their doctor. If they have difficulty contacting their doctor, they should go to the nearest hospital, taking the medicine packaging with them.

In patients who have taken too much aripiprazole, the following symptoms have occurred:

• fast heartbeat, agitation/aggression, speech problems;
• uncontrolled body movements (especially of the face or tongue) and decreased consciousness.

Other symptoms include:

• acute confusion, seizures (epilepsy), coma, simultaneous occurrence of fever, muscle stiffness, accelerated breathing, sweating, and changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat.

If the patient experiences any of these symptoms, they should immediately contact their doctor or hospital.

Missing a dose of Aryzalera

If the patient misses a dose, they should take the missed dose as soon as they remember. They should not take two doses in one day.

Stopping treatment with Aryzalera

The patient should not stop treatment just because they feel better. It is very important to take Aryzalera as directed by the doctor and for the period prescribed by the doctor.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

• diabetes,
• sleep disturbances,
• anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of "emptiness in the head",
• blurred vision and double vision,
• decreased number of bowel movements or difficulty with bowel movements,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of fatigue.

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

• decreased or increased prolactin levels in the blood,
• high blood sugar levels,
• depression,
• changes in sexuality or excessive interest in sex,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• eye sensitivity to light,
• fast heartbeat,
• decreased blood pressure when standing up, causing dizziness, feeling of "emptiness in the head", or fainting,
• hiccups.

The following side effects have been reported since the introduction of aripiprazole in oral form, but their frequency is not known:

• decreased white blood cell count,
• decreased platelet count,
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, rash),
• onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, attempted suicide, and completed suicide,
• feeling of aggression,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, accelerated breathing, sweating, and changes in consciousness and blood pressure, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling of intoxication, fever, sweating, or muscle stiffness),
• speech disorders,
• fixation of the eyeballs in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing (if the patient experiences any of these symptoms, they should immediately contact their doctor),
• high blood pressure,
• fainting,
• accidental choking on food with a risk of pneumonia,
• muscle spasm around the vocal cords,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• jaundice,
• abnormal liver test results,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles flu-like symptoms with a rash on the face, and then a rash appears on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (visible in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia),
• abnormal breakdown of muscle leading to kidney disorders,
• muscle pain,
• stiffness,
• involuntary urination (incontinence),
• difficulty urinating,
• withdrawal syndrome in newborns in case of exposure to the medicine during pregnancy,
• prolonged and (or) painful erection,
• difficulty regulating body temperature or overheating,
• chest pain,
• swelling of the hands, ankles, or feet,
• in blood tests: fluctuations in blood sugar levels, increased glycated hemoglobin levels,
• inability to resist the impulse, urge, or temptation to engage in activities that may harm the patient or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences,
• changed or increased interest in sex and behaviors that significantly disturb the patient or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending,
• uncontrolled overeating or compulsive eating (eating larger amounts of food than usual and more than needed to satisfy hunger),
• urge to wander. If the patient experiences such behaviors, they should tell their doctor, who will discuss with them ways to treat or reduce these symptoms.

In elderly patients with dementia taking aripiprazole, more cases of death have been reported. Additionally, cases of stroke or "mini" stroke have been noted.

Additional side effects in children and adolescents

In adolescents aged 13 and older, side effects occurred with a similar frequency and type as in adults, except for drowsiness, uncontrolled trembling or movements, restlessness, and fatigue, which occurred very frequently (more than 1 in 10 patients), as well as upper abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle tremors, uncontrolled limb movements, and dizziness, especially when standing up from a lying or sitting position, which occurred frequently (more than 1 in 100 patients).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aryzalera

The medicine should be stored out of sight and reach of children.

The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Aryzalera contains

• The active substance of the medicine is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, yellow iron oxide (E 172), and magnesium stearate. See section 2, "Aryzalera contains lactose monohydrate".

What Aryzalera looks like and contents of the pack

Light yellow to brownish, round, slightly convex tablets with beveled edges, with possible darker and lighter spots, and engraved with the symbol ",A15" on one side (diameter: 7.5 mm, thickness: 2.5 - 3.7 mm).

Packaging:30, 50, 60, 90 tablets in blisters, in a cardboard box.

For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Krka, d.d., Novo mesto

Šmarješka cesta 6, 8501, Novo mesto, Slovenia

Manufacturer:

Krka, d.d., Novo mesto

Šmarješka cesta 6, 8501, Novo mesto, Slovenia

TAD PHARMA GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven

Germany

Parallel importer:

InPharm Sp. z o.o.

ul. Strumykowa 28/11

03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.

ul. Chełmżyńska 249

04-458 Warsaw

Marketing authorization number in Romania, the country of export:11819/2019/03

Parallel import authorization number:79/23

Date of approval of the leaflet: 04.07.2023

[Information about the trademark]