Aripiprazole aurovitas

Package leaflet: Information for the patient

Aripiprazole Aurovitas, 15 mg, orodispersible tablets
Aripiprazole
Please read this leaflet carefully before using the medicine, because it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, 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 orodispersible tablets contain the active substance aripiprazole and belong to a group of medicines called antipsychotics. They are used to treat adults and adolescents aged 15 years and older who have a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, suspiciousness, beliefs that are not based on reality, disorganized speech and behavior, and emotional blunting. Patients with these symptoms may also feel sadness, anxiety, tension, or guilt.

Aripiprazole Aurovitas is used to treat adults and adolescents aged 13 years and older who have a condition characterized by symptoms such as extreme excitement, overwhelming energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the recurrence of these symptoms in patients who have responded to treatment with Aripiprazole Aurovitas.

2. Important information before using Aripiprazole Aurovitas

When not to use Aripiprazole Aurovitas

• 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 this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. You should immediately inform your doctor if you experience any thoughts or feelings related to harming yourself.
Before starting treatment with Aripiprazole Aurovitas, 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 the doctor will want to monitor the patient closely;
• involuntary, irregular movements of muscles, particularly facial muscles;
• cardiovascular diseases (heart and circulation diseases), a 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 a relative should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
You should immediately inform your doctor if you experience any thoughts or feelings related to harming yourself. 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 status, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient begins to feel urges or desires to behave in an unusual way and cannot resist an impulse, drive, or temptation to engage in activities that could harm themselves or others, they should inform the doctor. These phenomena are known as impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating, excessive spending, abnormally increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider adjusting the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which may lead to falls. Exercise caution, especially in elderly or weakened patients.

Children and adolescents
Aripiprazole Aurovitas should not be used in children and adolescents under 13 years of age. It is not known whether aripiprazole is safe and effective in these patients.

Aripiprazole Aurovitas orally disintegrating tablets and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.
Medicines that lower blood pressure: Aripiprazole Aurovitas may enhance the effect of medicines that lower blood pressure. If the patient is taking blood pressure-lowering medicines, they should inform their doctor.
Taking Aripiprazole Aurovitas with other medicines may require dose adjustments of Aripiprazole Aurovitas or other medicines. 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);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

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 to treat conditions such as 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 severe 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 together with Aripiprazole Aurovitas may increase the risk of adverse effects. If the patient experiences any unusual symptoms while taking these medicines with Aripiprazole Aurovitas orally disintegrating tablets, they should inform their doctor.

Aripiprazole Aurovitas with food, drink, and alcohol
This medicine can be taken regardless of meals.
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Newborns whose mothers used aripiprazole during the third trimester (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 newborn, contact a doctor immediately.
If the patient is taking Aripiprazole Aurovitas, the doctor will discuss 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. Discuss with your doctor the best feeding methods for your baby if you are taking this medicine.

Driving and operating machinery
Dizziness and vision 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 aspartame
This medicine contains 3.1 mg of aspartame in each orally disintegrating 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 impaired excretion.

Aripiprazole Aurovitas contains lactose and glucose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine. This medicine may also be harmful to teeth.
Each orally disintegrating tablet contains less than 1 mmol (23 mg) of sodium, meaning the medicine is considered "sodium-free".

3. How to use Aripiprazole Aurovitas
This medicine should always be used exactly as prescribed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Aripiprazole Aurovitas is available as orally disintegrating tablets with a strength of 15 mg. To achieve doses not available with this medicine, consult your doctor to use an appropriate alternative medicine containing aripiprazole.

The recommended dose for adults is 15 mg once daily. However, the doctor may prescribe a lower or higher dose, which should not exceed 30 mg per day.

Use in children and adolescents
Treatment may be initiated with a low dose of aripiprazole in oral solution (liquid) form. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily. However, the treating 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 Aurovitas 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 orally disintegrating tablet is taken with or without food.

[For standard blister pack]
Open the blister only when the patient is ready to take the medicine. Immediately after opening the blister, remove the orally disintegrating tablet with dry hands and place it whole on the tongue. The tablet will rapidly disintegrate in saliva. The orally disintegrating tablet may be taken with or without liquid.
The orally disintegrating tablet may also be dissolved in water and the resulting solution drunk.

[For peelable blister pack]
Open the blister only when the patient is ready to take the medicine. To take a single orally disintegrating tablet, open the package and detach one blister containing the tablet along the marked lines. Then peel back the foil to expose the tablet. Do not push the tablet through the foil, as this may damage it. Immediately after opening the blister, remove the tablet with dry hands and place it whole on the tongue. The tablet will rapidly disintegrate in saliva. The orally disintegrating tablet may be taken with or without liquid.
The orally disintegrating tablet may also be dissolved in water and the resulting solution drunk.

Even if the patient feels better, do not change the dose or stop taking Aripiprazole Aurovitas without first consulting the doctor.

Taking more Aripiprazole Aurovitas than prescribed
If the patient has taken more Aripiprazole Aurovitas than prescribed (or if someone else has taken some of the 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 overdose of aripiprazole, the following symptoms have occurred:

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

Other possible symptoms include:

• acute confusion, seizures (epilepsy), stupor, 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 these symptoms occur, contact a 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 Aripiprazole Aurovitas
Do not stop treatment even if the patient feels better.
It is very important to take Aripiprazole Aurovitas 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Common side effects (may affect more than 1 in 10 patients):

• diabetes
• sleep disturbances
• feeling of anxiety
• feeling of restlessness and inability to sit or stand still (akathisia),
• uncontrolled tremors, 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 in defecation,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

Uncommon side effects (may affect more than 1 in 100 patients):

• increased blood prolactin levels,
• high blood sugar levels,
• depression,
• changes in sexual function or excessive interest in sex,
• uncontrolled movements of the mouth, tongue and limbs (late dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• double vision,
• sensitivity of the eyes to light,
• rapid heartbeat,
• low 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 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,
• very 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, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction which may cause feelings of extreme happiness, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness),
• speech disorders,
• fixed eye deviation,
• 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 of the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if a patient experiences any of these symptoms, they must contact a doctor immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of developing pneumonia,
• muscle spasms around the voice box,
• pancreatitis,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• discomfort in the stomach area,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes (jaundice),
• abnormal liver function tests,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• abnormal muscle breakdown leading to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination,
• difficulty in urinating,
• withdrawal syndrome in newborns following exposure to the medicine during pregnancy,
• prolonged and/or painful erection (priapism),
• difficulty in regulating core body temperature or overheating,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increased or fluctuating blood glucose levels, increased levels of glycated haemoglobin,
• inability to resist an impulse, drive or temptation to perform an activity which 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 sex drive,
  • uncontrolled excessive shopping or spending,
  • 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 (pica).

If such behaviours occur in a patient, they should inform their doctor, who will discuss ways of treating or reducing these symptoms.

In elderly patients with dementia treated with aripiprazole, there have been more cases of death. In addition, cases of stroke or "mini" strokes (transient ischaemic attacks) have been reported.

Additional side effects in children and adolescents

In adolescents aged 13 years and older, side effects occurred at similar frequency and type as in adults, except for drowsiness, uncontrolled tremors or sudden 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 tremor, uncontrolled limb movements, and dizziness, especially when rising from a lying or sitting position, which occurred commonly (in more than 1 in 100 patients).

Reporting of side effects

If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the responsible entity.

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

5. How to store Aripiprazole Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton following "EXP".
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Aripiprazole Aurovitas contains

• The active substance is aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole.
• The other ingredients are: monohydrate lactose, magnesium stearate, anhydrous colloidal silicon dioxide, sodium croscarmellose, crospovidone, microcrystalline cellulose, yellow iron oxide (E172); vanilla flavouring powder (containing glucose), aspartame (E951), potassium acesulfame (E950), tartaric acid.

What Aripiprazole Aurovitas looks like and contents of the pack
Yellow, round orodispersible tablets with possible darker specks, marked with "AD15" on one side. They are contained in perforated blisters (OPA/Aluminium PVC/Aluminium) or in peelable perforated blisters (OPA/Aluminium PVC/Aluminium), packed in cardboard boxes containing 10, 14, 28, 30, 49, 50, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warszawa
Poland

Manufacturer
Synthon Hispania, S.L.
C/Castelló no1, Pol. Las Salinas,
Sant Boi de Llobregat
08830 Barcelona
Spain

Synthon s.r.o.
Brněnská 32/cp.597
678 01 Blansko
Czech Republic

Betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Aripiprazol Apotex
Netherlands: Aripiprazol Genthon 10 mg/ 15 mg orodispergeerbare tabletten
Germany: Aripiprazol beta 10 mg/ 15 mg Schmelztabletten
Poland: Aripiprazole Aurovitas