Arizalera

Leaflet attached to the packaging: patient information

Aryzalera, 5 mg, tablets

Aryzalera, 10 mg, tablets

Aryzalera, 15 mg, tablets

Aryzalera, 30 mg, tablets

Aripiprazole

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have 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 as yours.
• 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 are not real, suspiciousness, false beliefs, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also feel sad, guilty, anxious, or tense.
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, you should discuss it with your doctor.
During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. You should immediately inform your doctor if you experience thoughts or feelings related to self-harm.
Before starting treatment with Aryzalera, you should tell your doctor if you have:

• high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes;
• seizures (epilepsy), as this may mean that your doctor will want to monitor you very closely;
• involuntary, irregular muscle movements, especially of the face;
• heart and blood vessel diseases, a family history of heart and blood vessel diseases, 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 you notice weight gain, unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or symptoms of an allergic reaction, you should inform your 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.
You should immediately inform your doctor if you experience thoughts or feelings related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.
You should immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, excessive sweating, mental disorders, or very fast or irregular heartbeat.
If you or your family member or caregiver notice that you are starting to feel the urge or desire to behave in an unusual way, and you cannot resist the impulse, drive, or temptation to engage in activities that may harm you or others, you should tell your 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.
Your doctor may consider changing the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be careful, especially in elderly or weakened patients.

Children and adolescents

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

Aryzalera and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Blood pressure-lowering medicines: Aryzalera may enhance the effects of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Aryzalera with certain medicines may require a change in the dose of Aryzalera or other medicines you are taking. It is especially important to inform your doctor about the use of the following medicines:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressants 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 you experience any unusual symptoms while taking these medicines with Aryzalera, you should tell your doctor.
Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used to treat severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depression;
• St. John's wort (Hypericum perforatum) used as a herbal preparation for mild depression;
• painkillers (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 you experience any unusual symptoms while taking these medicines with Aryzalera, you should tell your doctor.

Aryzalera with food, drink, and alcohol

The medicine can be taken with or without food.
You should not drink alcohol during treatment with Aryzalera.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, you should contact your doctor.
If you are taking Aryzalera, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take the medicine and breastfeed. You should discuss with your doctor the best methods of feeding your child if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances (see section 4) may occur.
You should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Aryzalera contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Aryzalera

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once a day.However, your 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, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.
If you feel that the effect of the medicine is too strong or too weak, you should consult your 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 or without food. The tablet should be swallowed whole and washed down with water.
Even if you feel better,you should not change the dose or stop taking Aryzalera without first consulting your doctor.

Overdose of Aryzalera

In case of taking a higher dose than prescribed by your doctor (or if someone else has taken some of the medicine not intended for them), you should immediately contact your doctor. If you have difficulty contacting your doctor, you should go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

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

Other symptoms include:

• severe confusion, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, and excessive sweating;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat.

If you experience any of these symptoms, you should immediately contact your doctor or hospital.

Missed dose of Aryzalera

In case of a missed dose, you should take the missed dose as soon as you remember. You should not take two doses in one day.

Stopping treatment with Aryzalera

You should not stop treatment just because you feel better. It is very important to take Aryzalera as prescribed by your doctor and for the period prescribed by your doctor.
If you have any further doubts about taking this medicine, you should consult your 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,
• feeling anxious,
• feeling restless and unable to sit or stand still,
• akathisia (feeling of inner restlessness and a 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,
• nausea,
• vomiting,
• excessive salivation,
• feeling tired.

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 increased 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 after the marketing of aripiprazole, 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 aggressive,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling of intoxication, fever, sweating),
• 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 breathing difficulties (if you experience any of these symptoms, you must immediately contact your 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, enlarged 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, drive, or temptation to engage in activities that may harm you 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 you or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending,
• uncontrolled overeating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger),
• urge to wander. If you experience such behaviors, you should tell your doctor, who will discuss with you 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aryzalera

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after the abbreviation "Lot".
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should 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 Aryzalera contains

• The active substance of the medicine is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, iron oxide red (E 172) - only in 10 mg and 30 mg tablets, iron oxide yellow (E 172) - only in 15 mg tablets, indigo carmine lake (E 132) - only in 5 mg tablets, and magnesium stearate. See section 2, "Aryzalera contains lactose".

What Aryzalera looks like and contents of the packaging

5 mg, tablets: blue, round tablets with beveled edges, with possible darker and lighter spots (diameter: 5 mm, thickness: 1.4 - 2.4 mm)
10 mg, tablets: light pink, rectangular tablets with possible darker and lighter spots and the symbol "A10" printed on one side (length: 8 mm, width: 4.5 mm, thickness: 2.1 - 3.1 mm)
15 mg, tablets: light yellow to brownish, round, slightly convex tablets with beveled edges, with possible darker and lighter spots and the symbol "A15" printed on one side (diameter: 7.5 mm, thickness: 2.5 - 3.7 mm)
30 mg, tablets: light pink, round, biconvex tablets with beveled edges, with possible darker and lighter spots and the symbol "A30" printed on one side (diameter: 9 mm, thickness: 3.9 - 5.3 mm)
Packaging:14, 28, 30, 50, 56, 60, 84, 90, 98, and 100 tablets in blisters, in a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder

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
To obtain more detailed information on the names of this medicine in other European Economic Area member states, you should contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:21.04.2023