Aripiprazole aurovitas

Package leaflet: Information for the user

Aripiprazole Aurovitas, 15 mg, tablets
Aripiprazole Aurovitas, 30 mg, tablets
Aripiprazole

Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you specifically. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Aripiprazole Aurovitas contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used in the treatment of adults and adolescents aged 15 years and older who have schizophrenia—a disorder characterized by symptoms such as seeing, hearing, or sensing things that do not exist, excessive suspiciousness, beliefs that are contrary to reality, disorganized speech and behavior, and emotional blunting. Patients with these symptoms may also experience sadness, anxiety, tension, or feelings of guilt.

Aripiprazole is also used in the treatment of adults and adolescents aged 13 years and older who experience symptoms such as excitement, overwhelming energy, reduced need for sleep, rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the recurrence of the aforementioned symptoms in patients who have responded to treatment with aripiprazole.

2. Important information before using Aripiprazole Aurovitas

When Aripiprazole Aurovitas must not be used

• 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 Aripiprazole Aurovitas, discuss the following with your doctor:
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. You should
immediately inform your doctor if you experience thoughts or feelings related to harming yourself.
Before starting treatment with Aripiprazole Aurovitas, inform your doctor if the patient has:

• high blood sugar levels (typical symptoms include excessive thirst, passing large amounts of urine, increased appetite and feeling weak) or a family history of diabetes
• seizures (epilepsy), which may mean that your doctor will want to closely monitor your condition
• involuntary, irregular movements of muscles, especially of the face
• cardiovascular diseases (heart and circulatory 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, because antipsychotic medicines are associated with blood clot formation
• a history of gambling addiction.

If the patient notices weight gain, unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing 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 if the patient has ever had a stroke or "mini-stroke".
You should immediately inform your doctor if suicidal thoughts or feelings related to self-harm occur. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
You should immediately inform your doctor if the patient develops muscle stiffness or stiffness with high fever, sweating, altered 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 engage in activities that could harm themselves or others, they should tell their doctor.
These phenomena are known as impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating or excessive spending, abnormally increased sex drive or increased frequency and intensity of sexual thoughts or feelings.
Your doctor may consider adjusting the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness and changes in mobility and balance, which may lead to falls. Caution is advised, especially in elderly or weakened patients.

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

Aripiprazole Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to take, even those available without a prescription.
Medicines that lower blood pressure: Aripiprazole Aurovitas may enhance the effect of medicines that lower blood pressure. If the patient is taking medicines that lower blood pressure, they should inform their doctor.
Taking Aripiprazole Aurovitas with other medicines may require a dose adjustment of Aripiprazole Aurovitas. It is especially important to inform your doctor if the patient is taking:

• 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)
• medicines used to treat HIV infection (such as efavirenz, nevirapine, protease inhibitors, e.g. indinavir, ritonavir)
• anticonvulsant 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 reduce the effectiveness of Aripiprazole Aurovitas. If the patient experiences any unusual symptoms while taking these medicines together with Aripiprazole Aurovitas, they should tell their doctor.
Medicines that increase serotonin levels are usually used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine and pain:

• triptans, tramadol and tryptophan used in the treatment of conditions such as depression, generalized 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 severe depression
• tricyclic antidepressants (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
This medicine can be taken regardless of meals.
Alcohol consumption should be avoided.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a child, she should consult her doctor before using this medicine.
Newborn babies whose mothers have taken aripiprazole during the third trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If you observe such symptoms in your baby, contact your doctor.
If the patient is taking Aripiprazole Aurovitas, the doctor will discuss with her whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding.
This medicine must not be taken while breastfeeding. Talk to your doctor about the best feeding methods 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 activities requiring 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 an intolerance to certain sugars, they should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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. This is a rare genetic disorder in which phenylalanine accumulates in the body due to 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 women or women who are breastfeeding should contact their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to take Aripiprazole Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Aripiprazole Aurovitas is available as 15 mg and 30 mg tablets. To achieve doses that cannot be
obtained using this product, an appropriate, commercially available medicinal product containing
aripiprazole should be used. You should consult your treating physician.
The recommended dose of this medicine in adults is 15 mg once daily. However, your doctor may
prescribe a lower or higher dose, but not exceeding 30 mg per day.
Use in children and adolescents
Treatment 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, which is 10 mg
once daily. However, your treating physician may prescribe a lower or higher dose, up to a maximum
of 00 mg per day.
If you feel that the effect of aripiprazole is too strong or too weak, you should consult your doctor or
pharmacist.
Aripiprazole Aurovitas should be taken daily 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 the patient feels an improvement in their condition, the dose should not be changed or
treatment discontinued without prior agreement with the treating physician.
Taking more than the recommended dose of Aripiprazole Aurovitas
If you take more aripiprazole than prescribed by your doctor (or if someone else takes any amount
of Aripiprazole Aurovitas 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 been
reported:

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

Other symptoms may include:

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

If any of the above symptoms occur, contact your doctor or hospital immediately.
Missed dose of Aripiprazole Aurovitas
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 treatment with Aripiprazole Aurovitas
Do not stop treatment even if you feel better.
It is very important to take Aripiprazole Aurovitas exactly as directed by your doctor and for the
duration recommended by your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Common adverse reactions (may affect up to 1 in 10 patients):

• diabetes,
• sleep disorders,
• feeling anxious,
• restlessness and inability to sit or stand still,
• akathisia (inner sense of restlessness and compulsion to make constant movements),
• uncontrollable trembling, jerking movements or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and unclear vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling tired.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• increased prolactin levels in blood,
• abnormally high blood sugar levels,
• depression,
• changes in sexual interest 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,
• eye sensitivity to light,
• rapid heartbeat,
• low blood pressure upon standing, causing dizziness, feeling of emptiness in the head or fainting,
• hiccups.

The following adverse reactions have been reported after the introduction of aripiprazole in oral form to the market, but their frequency is unknown:

• decreased number of white blood cells,
• decreased 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 diabetic 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,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction which may cause feelings of extreme well-being, drowsiness, lack of coordination, anxiety, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness),
• speech disorders,
• fixed eye position,
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the bloodstream to the lungs causing chest pain and difficulty breathing (if any of these symptoms occur, the patient must immediately contact a doctor),
• high blood pressure,
• fainting,
• accidental choking on food with risk of developing pneumonia,
• muscle spasms around the larynx, spasm of the oral part of the pharynx,
• pancreatitis,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes (jaundice),
• abnormal liver function 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, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzymes (seen 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,
• difficulty urinating,
• 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 the hands, ankles or feet,
• in blood tests: fluctuations in blood sugar levels, increased levels of glycated haemoglobin, increased activity of creatine phosphokinase,
• inability to resist an impulse, drive or temptation to engage in an activity that may harm the patient or others, including behaviours such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • changed or increased interest in sex and behaviours significantly disturbing to the patient or others, for example increased sexual drive,
  • uncontrolled excessive shopping or spending money,
  • compulsive 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),
  • impulse to wander. If such behaviours occur, the patient should inform their doctor, who will discuss ways of treating or reducing these symptoms.

In elderly patients with dementia treated with aripiprazole, more cases ending in death have been reported. In addition, cases of stroke or "mini-strokes" have been recorded.

Additional adverse reactions in children and adolescents

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

Reporting of adverse reactions

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

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

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

5. How to store Aripiprazole Aurovitas

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the packaging and blister after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Aripiprazole Aurovitas contains
The active substance 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: monohydrate lactose, microcrystalline cellulose (E 460), sodium croscarmellose, anhydrous colloidal silicon dioxide, aspartame (E 951), magnesium stearate (E 470b), vanilla flavour (containing maltodextrin, gum arabic (E414), propylene glycol, benzyl alcohol, and vanilla flavour), 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 tablets, smooth on both sides.
Aripiprazole Aurovitas 30 mg: pink, round, flat tablets, smooth on both sides.
Aripiprazole Aurovitas is available in blisters made of OPA/Aluminium/PVC/Aluminium, packed in cardboard boxes containing 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw
Poland
Tel.: +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