Aryzalera

Package leaflet: Information for the patient

Aryzalera, 5 mg, tablets
Aryzalera, 10 mg, tablets
Aryzalera, 15 mg, tablets
Aryzalera, 30 mg, tablets
aripiprazole
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Aryzalera is and what it is 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 pack and other information

1. What Aryzalera is and what it is 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 years and older who have a disorder
characterized by symptoms such as seeing, hearing, and sensing things that are not real, suspiciousness,
false beliefs, disorganized speech and behavior, and emotional blunting. Patients with these symptoms
may also experience sadness, feelings of guilt, anxiety, or tension.
Aryzalera is used to treat adults and adolescents aged 13 years and older whose condition is
characterized by symptoms such as excitement, excessive energy, reduced need for sleep, very rapid
speech with racing thoughts, and sometimes marked irritability. In adults, this medicine also helps
prevent recurrence of these symptoms in patients who have responded to treatment with Aryzalera.

2. Important information before using Aryzalera

When not to use 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, discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if you experience thoughts or feelings related to harming yourself.
Before starting treatment with Aryzalera, inform your doctor if the patient has:

• high blood sugar levels (characteristic symptoms include excessive thirst, passing large amounts of urine, 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 facial muscles;
• cardiovascular diseases (heart and circulatory system disorders), family history of cardiovascular disease, stroke or "mini" stroke (transient ischaemic attack), or abnormal blood pressure;
• blood clots or a family history of blood clots, as the use of antipsychotic medicines has been associated with their formation;
• a history of gambling addiction.

If the patient notices weight gain, development of unusual movements, drowsiness interfering with daily activities, any difficulties with swallowing, or allergic reactions, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, caregiver or relative should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
Immediately inform your doctor if you experience thoughts or feelings related to harming yourself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient develops muscle stiffness or stiffness with high fever, excessive sweating, changes in mental state, or very rapid or irregular heartbeat.
If the patient, or their family or caregiver, notices that the patient begins to feel an urge or desire to behave in an unusual way and cannot resist the impulse, drive or temptation to carry out activities that could harm themselves or others, they should tell the doctor. These phenomena are known as impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating or excessive spending, increased sex drive or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider it appropriate to change the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in movement and balance, which may lead to falls. Caution is advised, especially in elderly or weakened patients.

Children and adolescents
Aryzalera must not be used in children and adolescents under 13 years of age. It is not known whether the medicine is safe and effective in these patients.

Aryzalera and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
Medicines that lower blood pressure: Aryzalera may enhance the effect of medicines that lower blood pressure. If the patient is taking medicines to lower blood pressure, they should inform their doctor.
Taking Aryzalera with certain medicines may require adjustment of 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);
• 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);
• specific antibiotics used to treat tuberculosis (rifabutin, rifampicin).

Taking these medicines may increase the risk of adverse effects or reduce the effectiveness of Aryzalera. If the patient experiences any unusual symptoms while taking these medicines with Aryzalera, they should inform their doctor.
Medicines that increase serotonin levels are usually used in conditions involving depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine and pain:

• triptans, tramadol and tryptophan used in conditions involving depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, 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 major depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depression;
• St John's wort (Hypericum perforatum) used as a herbal remedy 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 adverse effects. If the patient experiences any unusual symptoms while taking these medicines with Aryzalera, they should inform their doctor.

Aryzalera with food, drink and alcohol
This medicine can be taken regardless of meals.
Do not drink alcohol while being treated with Aryzalera.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Newborn babies whose mothers have taken Aryzalera during the third trimester of pregnancy (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If such symptoms are observed in the baby, contact a doctor.
If the patient is taking Aryzalera, the doctor will discuss with her whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. Do not take this medicine and breastfeed at the same time. Talk to your doctor about the best feeding methods for your baby if you are taking this medicine.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account when performing tasks requiring full attention, such as driving or operating machinery.

Aryzalera contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to take Aryzalera

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, the doctor may prescribe a lower or
higher dose, which must not exceed 30 mg once daily.
Use in children and adolescents
Treatment with aripiprazole may be initiated with a low dose of aripiprazole in the form of an oral solution
(liquid). The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily.
However, the treating physician may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
Aryzalera is intended for oral administration.
Aryzalera should be taken at the same time each day. It does not matter whether the tablet is taken with or
without food. The tablet should be swallowed whole and taken with water.
Even if you feel an improvement in your condition, do not change the dose or stop taking Aryzalera
without first discussing it with your treating physician.
Taking more Aryzalera than recommended
If you take more than the prescribed dose (or if someone else takes medicine not intended for them),
contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital, taking the
medicine packaging with you.
In patients who have taken an excessive dose of aripiprazole, the following symptoms have occurred:

• rapid heartbeat, agitation/aggression, speech difficulties;
• unusual body movements (especially of the face or tongue), and reduced level of consciousness.

Other symptoms include:

• acute confusion, seizures (epilepsy), coma, accompanied by fever, rapid breathing, and excessive sweating;
• muscle rigidity and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm.

If any of the above symptoms occur in a patient, contact a doctor or hospital immediately.
Missing a dose of Aryzalera
If a dose is missed, the patient should take the missed dose as soon as they remember. Do not take two
doses on the same day.
Stopping Aryzalera treatment
Do not stop treatment just because you feel better. It is very important to take Aryzalera exactly as
prescribed by the doctor and for the duration recommended by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common adverse effects (may occur in up to 1 in 10 patients):

• Diabetes,
• Sleep disturbances,
• Anxiety,
• Restlessness and inability to sit or stand still,
• Akathisia (a feeling of inner restlessness and a compulsion to keep moving),
• Uncontrollable tremors, jerking movements, or writhing movements,
• Tremor,
• Headache,
• Fatigue,
• Drowsiness,
• Feeling of "emptiness in the head",
• Blurred or unstable vision,
• Decreased number of bowel movements or difficulty with defecation,
• Indigestion,
• Nausea,
• Excessive salivation,
• Vomiting,
• Feeling of tiredness.

Uncommon adverse effects (may occur in up to 1 in 100 patients):

• Decreased or increased blood prolactin levels,
• High blood sugar levels,
• Depression,
• Sexual changes or excessive interest in sex,
• Uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• Muscle disorders causing twisting movements (dystonia),
• Restless legs syndrome,
• Double vision,
• Light sensitivity of the eyes,
• Rapid heartbeat,
• Low blood pressure upon standing, causing dizziness, a feeling of "emptiness in the head", or fainting,
• Hiccups.

The following adverse effects have been reported after arypiprazole was introduced into clinical use, but their frequency is unknown:

• Decreased white blood cell count,
• Decreased platelet count,
• Allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, itching, rash),
• Development or worsening of diabetes, ketoacidosis (presence of ketones in blood and urine), or coma,
• High blood sugar levels,
• Low sodium levels in blood,
• Loss of appetite (anorexia),
• Weight loss,
• Weight gain,
• Suicidal thoughts, suicide attempts, and completed suicides,
• Feelings of aggression,
• Agitation,
• Nervousness,
• Concurrent occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• Seizures,
• Serotonin syndrome (a reaction that may cause feelings of extreme well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness),
• Speech disorders,
• Fixed eye position (oculogyria),
• Sudden unexplained death,
• Life-threatening irregular heart rhythm,
• Heart attack (myocardial infarction),
• Slow heartbeat,
• Blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (if any of these symptoms occur, the patient must seek medical attention immediately),
• High blood pressure,
• Fainting,
• Accidental aspiration of food with risk of pneumonia,
• Muscle spasms around the larynx,
• Pancreatitis,
• Difficulty swallowing,
• Diarrhea,
• Abdominal discomfort,
• Stomach discomfort,
• Liver failure,
• Hepatitis,
• Yellowing of the skin and whites of the eyes (jaundice),
• Abnormal liver function tests,
• Skin rash,
• Skin photosensitivity,
• 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 facial rash, followed by a rash on other body parts, high fever, swollen lymph nodes, elevated liver enzyme activity (visible in blood tests), and increased levels of a specific type of white blood cells (eosinophilia),
• Abnormal muscle breakdown leading to kidney dysfunction,
• Muscle pain,
• Stiffness,
• Involuntary urination (urinary incontinence),
• Difficulty urinating,
• Withdrawal syndrome in newborns following exposure to the drug during pregnancy,
• Prolonged and/or painful erection (priapism),
• Difficulty regulating core body temperature or overheating,
• Breast pain,
• Swelling of hands, ankles, or feet,
• In blood tests: fluctuations in blood glucose levels, increased levels of glycated hemoglobin,
• Inability to resist an impulse, drive, or urge to engage in behavior that may harm the patient or others, including behaviors such as:
  • Strong impulse to gamble excessively despite serious personal or family consequences,
  • Altered or increased interest in sexual activity and behaviors that significantly disturb the patient or others, e.g. increased sexual drive,
  • Uncontrolled excessive shopping or spending,
  • Compulsive overeating (consuming large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger),
  • Impulse to wander (pica or aimless wandering).

If such behaviors occur, the patient should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with arypiprazole, there have been reports of a higher number of deaths. Additionally, cases of stroke or "mini" stroke (transient ischemic attack) have been observed.

Additional adverse effects in children and adolescents:

In adolescents aged 13 years and older, adverse effects occurred with similar frequency and type as in adults, except for drowsiness, uncontrollable tremors or movements, motor restlessness, and fatigue, which occurred very commonly (in more than 1 in 10 patients), and abdominal pain in the upper part of the abdomen, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle twitching, uncontrollable limb movements, and dizziness—especially when standing up from a lying or sitting position—which occurred commonly (in more than 1 in 100 patients).

Reporting of adverse effects:

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aryzalera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
No special storage conditions are required for this medicine.
Medicines must 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 Aryzalera contains

• The active substance is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other ingredients are: monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, 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 (E 132) – only in 5 mg tablets, and magnesium stearate. See section 2 "Aryzalera contains lactose".

What Aryzalera looks like and contents of the pack
5 mg tablets: blue, round tablets with bevelled edges, possibly with darker and lighter spots (diameter: 5 mm, thickness: 1.4 - 2.4 mm)
10 mg tablets: light pink, rectangular tablets with bevelled edges, possibly with darker and lighter spots, marked with the symbol "A10" 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 biconvex tablets with bevelled edges, possibly with darker and lighter spots, marked with the symbol "A15" on one side (diameter: 7.5 mm, thickness: 2.5 - 3.7 mm)
30 mg tablets: light pink, round, biconvex tablets with bevelled edges, possibly with darker and lighter spots, marked with the symbol "A30" 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 carton.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For more detailed information on the names of this medicinal product in the other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500