Aripiprazole Aurovitas

Leaflet included in the packaging: Information for the user

Aripiprazole Aurovitas, 15 mg, tablets

Aripiprazole Aurovitas, 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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you personally. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aripiprazole Aurovitas and what is it used for

Aripiprazole Aurovitas contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. The medicine is used to treat adults and adolescents aged 15 years and older who suffer from schizophrenia - a disease characterized by symptoms such as seeing, hearing, and feeling things that do not exist in reality, excessive suspiciousness, beliefs that are inconsistent with reality, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also experience sadness, fear, or tension, as well as feelings of guilt.
Aripiprazole is used to treat adults and adolescents aged 13 years and older whose disease is characterized by symptoms such as excitement, excessive energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes very severe irritability. In adults, the medicine also prevents the recurrence of the above symptoms in patients who have responded to aripiprazole treatment.

2. Important information before taking Aripiprazole Aurovitas

When not to take Aripiprazole Aurovitas

Warnings and precautions

Before starting treatment with Aripiprazole Aurovitas, the patient should discuss the following with their doctor:
Suicidal thoughts and behaviors have been reported during treatment with aripiprazole. The patient should immediately inform their doctor if they experience suicidal thoughts or feelings of self-harm.
Before starting treatment with Aripiprazole Aurovitas, the patient should inform their doctor if they have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, urination, increased appetite, and feelings of weakness) or a family history of diabetes
• seizures (epilepsy), which may mean that the doctor will want to closely monitor the patient's condition
• involuntary, irregular muscle movements, especially in the face
• circulatory system diseases (heart and circulatory diseases), a family history of circulatory system 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 the formation of blood clots
• a history of gambling addiction.

If the patient experiences an increase in weight, unusual movements, drowsiness that interferes with daily activities, or any signs of allergy, they should inform their doctor.
If the patient is elderly and has dementia, 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 suicidal thoughts or feelings of self-harm. Suicidal thoughts and behaviors have been reported during treatment with aripiprazole.
The patient should immediately inform their doctor if they experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very rapid 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, drive, 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 desire, or an increase in sexual thoughts or feelings.
The 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. The patient should be cautious, especially if they are elderly or weakened.

Children and adolescents

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

Aripiprazole Aurovitas 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: Aripiprazole Aurovitas may enhance the effects of blood pressure-lowering medicines. If the patient is taking blood pressure-lowering medicines, they should inform their doctor.
Taking Aripiprazole Aurovitas with other medicines may require a change in the dose of Aripiprazole Aurovitas. It is especially important to inform the doctor about the use of:

• 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)
• 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 effectiveness of Aripiprazole Aurovitas. If the patient experiences any unusual symptoms while taking these medicines with Aripiprazole Aurovitas, they should tell their doctor.
Medicines that increase serotonin levels are usually used to treat diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat diseases such as 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 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 medicine 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 the patient experiences any unusual symptoms while taking these medicines with Aripiprazole Aurovitas, they should contact their doctor.

Taking Aripiprazole Aurovitas with food, drink, and alcohol

The medicine can be taken with or without food.
The patient should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or are planning to have a baby, they should consult their doctor before taking this medicine.
In newborns whose mothers took aripiprazole during the last trimester (last 3 months of pregnancy), the following symptoms may occur: tremors, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the patient notices such symptoms in their child, they should contact their doctor.
If the patient is taking Aripiprazole Aurovitas, their doctor will discuss with them whether they should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. The patient should not take this medicine and breastfeed. They should discuss the best methods of feeding their child with their doctor 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 activities that require full attention, such as driving or operating machinery.

Aripiprazole Aurovitas contains lactose monohydrate, sodium, aspartame, propylene glycol, and benzyl alcohol

This medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".
Aripiprazole Aurovitas, 15 mg contains 1.5 mg of aspartame in each tablet.
Aripiprazole Aurovitas, 30 mg contains 3 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Aripiprazole Aurovitas 15 mg contains 0.0054 mg of benzyl alcohol in each tablet.
Aripiprazole Aurovitas 30 mg contains 0.0108 mg of benzyl alcohol in each tablet.
Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease, pregnant or breastfeeding women should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to take Aripiprazole Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should ask their doctor or pharmacist.
Aripiprazole Aurovitas is available in 15 mg and 30 mg tablets. To take doses that cannot be obtained using this product, the patient should use an appropriate, available medicinal product containing aripiprazole. The patient should consult their doctor.
The recommended dose for adults is 15 mg once a day.However, the doctor may prescribe a lower or higher dose, but not more than 30 mg per day.

Use in children and adolescents

Treatment can be started with a low dose of aripiprazole in the form of an oral solution (liquid). The dose can be gradually increased to the recommended dose for adolescents, which is 10 mg once a day. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
If the patient feels that the effect of aripiprazole is too strong or too weak, they should consult their doctor or pharmacist.
Aripiprazole Aurovitas 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 the patient feels better, they should not change the dose or stop taking aripiprazole without first discussing it with their doctor.

Taking a higher dose of Aripiprazole Aurovitas than recommended

If the patient takes a higher dose of aripiprazole than prescribed by their doctor (or if someone else takes a certain amount of Aripiprazole Aurovitas that was not intended for them), they should immediately contact their doctor. If it is not possible to contact the doctor, the patient should go to the nearest hospital, taking the packaging of the medicine with them.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

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

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, excessive sweating.
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, abnormal heart rhythm.

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

Missing a dose of Aripiprazole Aurovitas

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 Aripiprazole Aurovitas

The patient should not stop treatment if they feel better.
It is very important to take Aripiprazole Aurovitas exactly as prescribed 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, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes,
• sleep disturbances,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements),
• uncontrolled body movements, especially in the face or tongue, and involuntary movements of the limbs,
• tremors,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• decreased urination or difficulty urinating,
• nausea,
• vomiting,
• feeling of tiredness.

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

• increased prolactin levels in the blood,
• high blood sugar levels,
• depression,
• changes in sexual function or increased sexual interest,
• uncontrolled movements of the mouth, tongue, and lips (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• increased sensitivity of the eyes to light,
• rapid 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 medicine was placed on the market, 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, rapid breathing, sweating, decreased consciousness, and 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, agitation, especially motor, feelings 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 the patient experiences any of these symptoms, they should immediately contact their doctor),
• high blood pressure,
• fainting,
• accidental inhalation of food with the risk of developing pneumonia,
• muscle spasm around the vocal cords, spasm of the upper part of the throat,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• liver discomfort,
• liver failure,
• liver inflammation,
• yellowing of the skin and whites of the eyes,
• abnormal liver function tests,
• skin rash,
• increased sensitivity of the skin 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 tissue leading to kidney function disorders,
• muscle pain,
• stiffness,
• involuntary urination,
• 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 arms, legs, or feet,
• in blood tests: fluctuations in blood sugar levels, increased glycated hemoglobin levels, increased creatine phosphokinase activity,
• inability to resist impulse, drive, 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 behavior with increased sexual interest and behavior that is disturbing to the patient or others, for example, increased sexual desire,
• 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 the patient experiences such behaviors, they should tell their doctor, who will discuss 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 years and older, side effects have occurred with a similar frequency and type as in adults, with the exception of drowsiness, uncontrolled body movements, or sudden movements, restlessness, and fatigue, which occur very frequently (more frequently than in 1 in 10 patients), as well as abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, tremors, uncontrolled movements of the limbs, and dizziness, especially when standing up, which occur frequently (more frequently than in 1 in 100 patients).

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Aripiprazole Aurovitas

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiry date stated on the packaging and blister pack after: "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
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 Aripiprazole Aurovitas contains

The active substance of the medicine is aripiprazole.
Aripiprazole Aurovitas, 15 mg: each tablet contains 15 mg of aripiprazole.
Aripiprazole Aurovitas, 30 mg: each tablet contains 30 mg of aripiprazole.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, colloidal anhydrous silica, aspartame (E 951), magnesium stearate (E 470b), vanilla flavor (including maltodextrin, arabic gum (E414), propylene glycol, benzyl alcohol, and vanilla flavor), yellow iron oxide (E 172) (Aripiprazole Aurovitas, 15 mg) or red iron oxide (E 172) (Aripiprazole Aurovitas, 30 mg).

What Aripiprazole Aurovitas looks like and contents of the pack

Aripiprazole Aurovitas, 15 mg: yellow, round, flat, and smooth tablets on both sides.
Aripiprazole Aurovitas, 30 mg: pink, round, flat, and smooth tablets on both sides.
Aripiprazole Aurovitas is available in blisters of OPA/Aluminum/PVC/Aluminum foil, packaged in cardboard boxes containing 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lokal 27
01-909 Warsaw
Poland
phone: +48 22 311 20 00

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
41004 Larisa
Greece
Genepharm S.A.
18th km Marathonos Avenue,
15351 Pallini Attiki
Greece

Date of last revision of the leaflet