Aribit Odt

Leaflet attached to the packaging: information for the user

Aribit ODT, 10 mg, orally disintegrating tablets

Aribit ODT, 15 mg, orally disintegrating tablets

Aribit ODT, 30 mg, orally disintegrating 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 specifically. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aribit ODT and what is it used for

Aribit ODT contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
It is used to treat adults and adolescents aged 15 years and older with a disease characterized by symptoms such as: seeing, hearing, and feeling things that do not exist in reality, suspiciousness, beliefs that are contrary to reality, chaotic speech and behavior, and emotional numbness. Patients with such symptoms may also feel sad, anxious, or tense, and may have a sense of guilt.
Aribit ODT is used in adults and adolescents aged 13 years and older to treat a disease with symptoms such as: severe excitement, overflowing energy, reduced need for sleep, very fast speech, racing thoughts, and sometimes very severe irritability. In adults, this medicine also prevents the recurrence of the above symptoms in patients who have responded to treatment with Aribit ODT.

2. Important information before taking Aribit ODT

When not to take Aribit ODT

• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Aribit ODT, you should discuss it with your doctor.
During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. You should immediately inform your doctor if you experience thoughts or feelings related to self-harm.
Before starting treatment with Aribit ODT, you should tell your doctor if you have:

• high blood sugar levels (typical symptoms include: excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes;
• seizures (epilepsy), as this may mean that your doctor will want to monitor you closely;
• involuntary, irregular muscle movements, especially of the face;
• cardiovascular diseases (heart and blood vessel diseases), a family history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots in you or your family, as the use of antipsychotic medicines is associated with the formation of blood clots;
• a history of gambling addiction.

If you notice an increase in weight, appearance of unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or symptoms of an allergic reaction, you should inform your doctor.
If you are an elderly patient with dementia, you or your caregiver should inform your doctor if you have ever had a stroke or "mini" stroke.
You should immediately inform your doctor if you experience thoughts or feelings related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.
You should immediately inform your doctor if you experience muscle stiffness or muscle stiffness with high fever, sweating, mental disorders, or very fast or irregular heartbeat.
If you or your family member notice that you are starting to feel the urge or desire to behave in an unusual way, and you cannot resist the impulse, drive, or temptation to engage in activities that may harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased interest in sex and behaviors that are significantly disturbing to you or others, such as increased sexual drive;
• uncontrolled excessive shopping or spending;
• uncontrolled eating (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 you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.

Your 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. You should be careful, especially if you are an elderly or weakened patient.

Children and adolescents

Aribit ODT should not be used in children and adolescents under the age of 13. You should consult your doctor or pharmacist before taking Aribit ODT.

Aribit ODT and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Blood pressure-lowering medicines: Aribit ODT may enhance the effect of blood pressure-lowering medicines.
If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Aribit ODT with certain medicines may require a change in the dose of Aribit ODT or other medicines you are taking. It is especially important to inform your doctor about taking:

• 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);
• 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 (such as rifabutin, rifampicin).

Taking these medicines may increase the risk of side effects or reduce the effect of Aribit ODT. If you experience any unusual symptoms while taking these medicines with Aribit ODT, you should tell your doctor.
Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat 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 medicines (such as clomipramine and amitriptyline) used to treat depression;
• St. John's wort (Hypericum perforatum) used as a herbal preparation 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 you experience any unusual symptoms while taking these medicines with Aribit ODT, you should tell your doctor.

Taking Aribit ODT with food, drink, and alcohol

Aribit ODT can be taken with or without food.
You should not drink alcohol during treatment with Aribit ODT.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If you notice such symptoms in your child, you should contact your doctor.
If you are taking Aribit ODT, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take the medicine and breastfeed. You should discuss with your doctor the best methods for feeding your child if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur (see section 4).
You should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Aribit ODT contains aspartame (E 951), lactose, benzyl alcohol, and sodium

Aribit ODT 10 mg contains 1.00 mg of aspartame in each tablet. Aribit ODT 15 mg contains 1.50 mg of aspartame in each tablet. Aribit ODT 30 mg contains 3.00 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 its improper excretion.
The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
Aribit ODT 10 mg contains 0.036 mg of benzyl alcohol in each tablet. Aribit ODT 15 mg contains 0.0054 mg of benzyl alcohol in each tablet. Aribit ODT 30 mg contains 0.0180 mg of benzyl alcohol in each tablet.
Benzyl alcohol may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Aribit ODT

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The recommended dose of Aribit ODT for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

Use in children and adolescents

Treatment can be started with a low dose of aripiprazole in the form of an oral solution (liquid) available on the market. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.
If you feel that the effect of Aribit ODT is too strong or too weak, you should consult your doctor or pharmacist.

Aribit ODT orally disintegrating tablets should be taken every day at the same time

at the same time.It does not matter whether the tablet is taken with or without food.
You should not open the blister until you are ready to take the medicine. You should peel off the foil from the blister to remove a single tablet. You should not push the tablet through the foil, as this may damage it. After opening the blister with dry hands, you should remove the tablet and place it whole on the tongue. The tablet will dissolve quickly in saliva. The orally disintegrating tablet can be taken with or without liquid.
You can also dissolve the tablet in water and drink the resulting suspension.
Even if you feel better,you should not change the dose or stop taking Aribit ODT without first discussing it with your doctor.

Taking a higher dose of Aribit ODT than recommended

If you take a higher dose of Aribit ODT than your doctor prescribed (or if someone else takes tablets of Aribit ODT that were not prescribed for them), you should immediately contact your doctor. If you have difficulty contacting your doctor, you should go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

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

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating, changes in blood pressure and heart rate, loss of consciousness;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, abnormal heart rhythm.

If you experience any of these symptoms, you should immediately contact your doctor or hospital.

Missing a dose of Aribit ODT

If you miss a dose, you should take the missed dose as soon as you remember. You should not take two doses in one day.

Stopping treatment with Aribit ODT

You should not stop treatment if you feel better.
It is very important to take Aribit ODT as prescribed by your doctor and for the period prescribed by your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aribit ODT can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes,
• sleep disturbances,
• feeling anxious,
• feeling restless and unable to sit or stand still,
• uncontrolled trembling, jerking movements or twitching, restless legs syndrome,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• decreased number of bowel movements or difficulty with bowel movements,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling tired.

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

• increased prolactin levels in the blood,
• high blood sugar levels,
• depression,
• changes in sexuality or increased interest in sex,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• 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 marketing of aripiprazole, but their frequency is not known (the frequency cannot be determined from the available data):

• decreased white blood cell count,
• decreased platelet count,
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, skin itching, rash),
• onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the blood and urine) or diabetic 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 aggressive,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, changes in mental status, and sudden changes in blood pressure and heart rate, loss of consciousness (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling 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 difficulty breathing (if you experience any of these symptoms, you must immediately see a doctor),
• high blood pressure,
• fainting,
• accidental choking on food with a risk of pneumonia,
• muscle spasm around the vocal cords,
• pancreatitis,
• difficulty swallowing;
• diarrhea,
• discomfort in the abdominal cavity,
• discomfort in the stomach,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes,
• abnormal liver test results,
• skin rash,
• sensitivity to light,
• hair loss,
• excessive sweating,
• abnormal breakdown of muscle leading to kidney dysfunction,
• muscle pain,
• muscle 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 hands, ankles, or feet,
• in blood tests: fluctuations in blood sugar levels, increased glycated hemoglobin levels,
• inability to resist impulse, drive, or temptation to engage in activities that may harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased interest in sex and behaviors that are significantly disturbing to you or others, such as increased sexual drive;
• uncontrolled excessive shopping or spending;
• uncontrolled eating (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 you experience such behaviors, you should tell your doctor, who will discuss with you 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 occurred with a similar frequency and type as in adults, except for drowsiness, uncontrolled trembling or movements, restlessness, and fatigue, which occurred very frequently (more than 1 in 10 patients), as well as abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle tremors, uncontrolled limb movements, and dizziness, especially when standing up from a lying or sitting position, which occurred frequently (more than 1 in 100 patients).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aribit ODT

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Aribit ODT contains

• The active substance of the medicine is aripiprazole. Aribit ODT, 10 mg: each orally disintegrating tablet contains 10 mg of aripiprazole. Aribit ODT, 15 mg: each orally disintegrating tablet contains 15 mg of aripiprazole. Aribit ODT, 30 mg: each orally disintegrating tablet contains 30 mg of aripiprazole.
• Other ingredients are: Aribit ODT, 10 mg and 30 mg: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, aspartame (E 951), magnesium stearate, red iron oxide (E 172), vanilla flavor (containing maltodextrin, arabic gum, propylene glycol, benzyl alcohol, vanilla flavors). Aribit ODT, 15 mg: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, aspartame (E 951), magnesium stearate, yellow iron oxide (E 172), vanilla flavor (containing maltodextrin, arabic gum, propylene glycol, benzyl alcohol, vanilla flavors).

What Aribit ODT looks like and contents of the pack

Aribit ODT, 10 mg: Round, flat tablets of pink color, with the number "10" embossed on one side and smooth on the other, with a diameter of 8.0 mm ± 0.1 mm.
Aribit ODT, 15 mg: Round, flat tablets of yellow color, with the number "15" embossed on one side and smooth on the other, with a diameter of 9.0 mm ± 0.1 mm.
Aribit ODT, 30 mg: Round, flat tablets of pink color, with the number "30" embossed on one side and smooth on the other, with a diameter of 10.0 mm ± 0.1 mm.
Aribit ODT orally disintegrating tablets are packaged in:
Peelable blister packs of paper/PET/Aluminum//PVC/Aluminum/OPA in cardboard boxes containing 14, 28, 49 orally disintegrating tablets.
Peelable blister packs of paper/PET/Aluminum//PVC/Aluminum/OPA divided into single doses in cardboard boxes containing 14x1, 28x1, 49x1 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larissa Industrial Area
41500 Larissa
Greece
Genepharm S.A.
18 km Marathonos Ave, Pallini Attiki
15351 Greece
Date of last revision of the leaflet:May 2024