Aribit Odt

Package Leaflet: Information for the User

Aribit ODT, 10 mg, orodispersible tablets

Aribit ODT, 15 mg, orodispersible tablets

Aribit ODT, 30 mg, orodispersible tablets

Aripiprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, 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 only. 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 package leaflet

• 1. What Aribit ODT is and what it is 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 pack and other information

1. What Aribit ODT is and what it is 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 are not real, suspiciousness, delusions, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also feel sad, anxious, or tense, and may have feelings of guilt.
Aribit ODT is used in adults and adolescents aged 13 years and older to treat a disease with symptoms such as: excessive excitement, overwhelming energy, less need for sleep than usual, very fast speech, racing thoughts, and sometimes 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 taking Aribit ODT, discuss this with your doctor.
During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience thoughts or feelings of self-harm.
Before starting treatment with Aribit ODT, tell your doctor if you have:

• high blood sugar levels (typical symptoms include: excessive thirst, passing large amounts of urine, increased appetite, and feeling weak) or diabetes in your family;
• seizures (epilepsy), as this may mean that your doctor will want to monitor you closely;
• involuntary, irregular movements of the muscles, especially facial muscles;
• heart or blood vessel disease, a history of heart or blood vessel disease in your family, stroke, or "mini-stroke", abnormal blood pressure;
• blood clots in you or your family, as the use of antipsychotic medicines has been 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 your daily activities, any difficulty swallowing, or symptoms of an allergic reaction, you should inform your doctor.
If an elderly patient with dementia experiences a stroke or "mini-stroke", they or their caregiver should inform the doctor if they have ever had a stroke or "mini-stroke".
You should immediately inform your doctor if you experience thoughts or feelings of self-harm. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported.
You should immediately inform your doctor if you experience muscle stiffness or muscle stiffness with high fever, sweating, confusion, 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, urge, 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 significantly disturb 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.

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 13 years of age. You should consult a doctor or pharmacist before taking Aribit ODT.

Aribit ODT and other medicines

Tell your doctor or pharmacist about all medicines you are taking now 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);
• 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 (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 in diseases including 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 including 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 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 preparation in mild depression;
• analgesics (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, ask your doctor for advice 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 way to feed 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 orodispersible tablet. Aribit ODT 15 mg contains 1.50 mg of aspartame in each orodispersible tablet. Aribit ODT 30 mg contains 3.00 mg of aspartame in each orodispersible 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 an 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 orodispersible tablet. Aribit ODT 15 mg contains 0.0054 mg of benzyl alcohol in each orodispersible tablet. Aribit ODT 30 mg contains 0.0180 mg of benzyl alcohol in each orodispersible tablet.
Benzyl alcohol may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is essentially "sodium-free".

3. How to take Aribit ODT

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, 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 orodispersible tablets should be taken at the same time every day

It does not matter whether the tablet is taken with or without food.Do not open the blister until you are ready to take the medicine. You should tear off the foil to take out a single tablet. Do not push the tablet through the foil, as this may damage it. After opening the blister with dry hands, take out the tablet and place it on your tongue. The tablet will dissolve quickly in your saliva. The orodispersible 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, do not change the dose or stop taking Aribit ODT without first discussing it with your doctor.

Taking more Aribit ODT than prescribed

If you take more Aribit ODT than your doctor prescribed (or if someone else takes your tablets), you should contact your doctor immediately. 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:

• fast heartbeat, agitation/aggression, speech problems;
• unusual body movements (especially 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, fainting (malignant neuroleptic syndrome),
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat.

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

Forgetting to take a dose of Aribit ODT

If you miss a dose, you should take the missed dose as soon as you remember. Do not take two doses on the same day.

Stopping treatment with Aribit ODT

You should not stop treatment if you feel better.
It is very important to take Aribit ODT as your doctor has prescribed and for the duration 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 writhing movements, restless legs syndrome,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• image trembling and blurred 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,
• fast 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 estimated from the available data):

• decreased white blood cell count,
• decreased platelet count,
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, skin 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 very fast or irregular heartbeat, fainting (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, or muscle stiffness),
• 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 veins of 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,
• spasm of the muscles 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, urge, 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 significantly disturb 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 deaths have been reported. Additionally, cases of stroke or "mini-stroke" have been recorded.

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 any 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Aribit ODT contains

• The active substance of Aribit ODT is aripiprazole. Aribit ODT, 10 mg: each orodispersible tablet contains 10 mg of aripiprazole. Aribit ODT, 15 mg: each orodispersible tablet contains 15 mg of aripiprazole. Aribit ODT, 30 mg: each orodispersible tablet contains 30 mg of aripiprazole.
• The 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 orodispersible tablets are packaged in:
Peelable paper/PET/Aluminum//PVC/Aluminum/OPA blisters in cardboard boxes containing 14, 28, 49 orodispersible tablets.
Peelable paper/PET/Aluminum//PVC/Aluminum/OPA blisters divided into single doses in cardboard boxes containing 14x1, 28x1, 49x1 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +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