Aryzalera

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Aryzalera, 10 mg, tablets
Aripiprazole
Please read this leaflet carefully before using the 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, 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. 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, which 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, or 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 also used to treat adults and adolescents aged 13 years and older whose illness 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
prevents the 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, particularly of the facial muscles;
• cardiovascular diseases (heart and circulatory system diseases), 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 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 that interferes with daily activities, any swallowing difficulties, or allergic symptoms, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, their caregiver, or relative should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
Immediately inform your doctor if suicidal thoughts or feelings occur. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient experiences muscle stiffness or stiffness with high fever, excessive sweating, changes in mental status, 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 an impulse, drive, or temptation to carry out activities that could harm themselves or others, they should tell the doctor. These phenomena are called impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating, or excessive spending, abnormally increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider it necessary to adjust the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls. Exercise caution, 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, has recently taken, or plans to take, including those obtained without a prescription.
Medicines that lower blood pressure: Aryzalera may enhance the effect 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 dose adjustments of Aryzalera or other medicines the patient is taking. It is especially important to inform the doctor about using 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);
• some 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 adverse effects or reduce the effectiveness of Aryzalera. If the patient experiences any unusual symptoms while taking these medicines together with Aryzalera, they should inform their doctor.
Medicines that increase serotonin levels are usually used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, and tryptophan used to treat conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain;
• 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.

Food, drink, and alcohol
This medicine can be taken with or without food.
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.
Newborns whose mothers have taken Aryzalera during the third trimester of pregnancy (last 3 months) 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 immediately.
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 using machines
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 monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Aryzalera

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Aryzalera is available in the following strengths: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg.
The recommended dose for adults is 15 mg once daily. However, your 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, your treating doctor 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, you should consult your doctor or pharmacist.
Aryzalera is intended for oral administration.
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 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 doctor.
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 heartbeat.

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 directed by your
doctor and for the duration recommended by your doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

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

• diabetes,
• sleep disorders,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• uncontrolled trembling, jerking movements or writhing movements, restless legs syndrome,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of "emptiness in the head",
• blurred vision and double vision,
• reduced number of bowel movements or difficulty with bowel movements,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

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

• decreased prolactin levels in the blood,
• excessively 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),
• double vision,
• rapid heartbeat,
• decreased blood pressure when standing, causing dizziness, feeling of "emptiness in the head" or fainting,
• hiccups.

The following side effects have been reported after the introduction of oral aripiprazole on the market, but their frequency is unknown:

• reduced number of white blood cells,
• reduced number of platelets,
• allergic reactions (e.g. swelling of the mouth, tongue, face and throat, itching, rash),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in 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, suicide attempts and completed suicides,
• feeling of aggression,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, decreased level of consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction which 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 (oculogyric crisis),
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if any of these symptoms occur, the patient must contact a doctor immediately),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of developing pneumonia,
• muscle spasms around the vocal cords,
• pancreatitis,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes,
• abnormal liver function tests,
• skin rash,
• photosensitivity,
• hair loss,
• excessive sweating,
• abnormal muscle breakdown leading to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination (urinary incontinence),
• difficulty passing urine,
• withdrawal syndrome in newborns following exposure to the medicine during pregnancy,
• prolonged and (or) painful erection,
• difficulty regulating core body temperature or overheating,
• breast pain,
• swelling of hands, ankles or feet,
• in blood tests: fluctuations in blood sugar levels, increased levels of glycated haemoglobin,
• inability to resist an impulse, drive or temptation to perform an activity that may harm the patient or others, including behaviours such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • altered or increased interest in sexual activity and behaviours significantly distressing to the patient or others, e.g. increased sexual drive,
  • uncontrolled excessive shopping or spending,
  • compulsive binge eating (consuming large amounts of food in a short time) or compulsive eating (eating larger amounts of food than usual and more than needed to satisfy hunger);
  • urge to wander (pica or aimless wandering). If such behaviours occur, the patient should inform the doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with aripiprazole, a higher number of cases ending in death have been reported. In addition, cases of stroke or "mini" stroke have been observed.

Additional side effects in children and adolescents

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

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also 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

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

5. How to store Aryzalera

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via the sewage system 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 10 mg of aripiprazole.
• The other ingredients are: monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, iron oxide red (E 172), and magnesium stearate. See section 2, "Aryzalera contains monohydrate lactose".

What Aryzalera looks like and contents of the pack
Light pink, rectangular tablets, possibly with darker and lighter specks,
imprinted with the symbol "A10" on one side (length: 8 mm, width: 4.5 mm, thickness: 2.1–3.1 mm).
Pack sizes: 30, 50, 60, 90, and 100 tablets in blister packs, packed in a cardboard carton.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Numbers in Romania, the country of export:
11818/2019/03
11818/2019/04
11818/2019/06
11818/2019/08
11818/2019/10

Parallel Import Licence Number: 64/23