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

• 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• 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 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 disorder characterised by symptoms such as seeing, hearing or experiencing things that are not real, suspiciousness, beliefs that are not based in reality, disorganised speech and behaviour, and emotional blunting. Patients with these symptoms may also feel sadness, anxiety, tension, or guilt.
Aribit ODT is used in adults and adolescents aged 13 years and older to treat a condition with symptoms such as extreme excitement, high energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the return of these symptoms in patients who have responded to treatment with Aribit ODT.

2. Important information before using Aribit ODT

When not to use Aribit ODT

• 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 Aribit ODT, please discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. You should inform your doctor immediately if you experience any thoughts or feelings related to harming yourself.
Before starting treatment with Aribit ODT, 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 diabetes in the family;
• seizures (epilepsy), as this may mean your doctor will want to monitor you closely;
• involuntary, irregular muscle movements, especially of the facial muscles;
• cardiovascular diseases (heart and circulatory disorders), family history of cardiovascular disease, stroke or "mini" stroke (transient ischaemic attack), or abnormal blood pressure;
• blood clots in the patient or in family members, as the use of antipsychotic medicines is 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 symptoms of an allergic reaction, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient or their caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
Inform your doctor immediately if you experience thoughts or feelings about harming yourself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if the patient develops muscle stiffness or muscle stiffness accompanied by 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 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, excessive spending, increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
Your doctor may decide to adjust the dose or discontinue 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
Aribit ODT should not be used in children and adolescents under 13 years of age. Consult your doctor or pharmacist before taking Aribit ODT.

Aribit ODT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Blood pressure-lowering medicines: Aribit ODT may enhance the effect of blood pressure-lowering medicines. If the patient is taking medicines to lower blood pressure, they should inform their doctor.
Taking Aribit ODT with certain medicines may require a dose adjustment of Aribit ODT or other medicines. 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);
• certain 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 (such as rifabutin, rifampicin).

Taking these medicines may increase the risk of adverse effects or reduce the effectiveness of Aribit ODT. If the patient experiences any unusual symptoms while taking these medicines with Aribit ODT, they should inform their doctor.

Medicines that increase serotonin levels, typically used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, and tryptophan used for conditions involving 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 major 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 may increase the risk of adverse effects. If the patient experiences any unusual symptoms while taking these medicines with Aribit ODT, they should inform their doctor.

Taking Aribit ODT with food, drink, and alcohol
Aribit ODT can be taken regardless of meals.
Alcohol should not be consumed during treatment with Aribit ODT.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Newborns whose mothers have taken 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 you observe any of these symptoms in your newborn, contact your doctor.
If the patient is taking Aribit ODT, the doctor will discuss whether she should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. Do not take this medicine and breastfeed at the same time. Discuss the best feeding methods for your baby with your doctor 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 tasks requiring 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 per tablet. Aribit ODT 15 mg contains 1.50 mg of aspartame per tablet. Aribit ODT 30 mg contains 3.00 mg of aspartame per 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.
The medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Aribit ODT 10 mg contains 0.036 mg of benzyl alcohol per tablet. Aribit ODT 15 mg contains 0.0054 mg of benzyl alcohol per tablet. Aribit ODT 30 mg contains 0.0180 mg of benzyl alcohol per tablet.
Benzyl alcohol may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

3. How to use Aribit ODT

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe a
lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
Treatment may be initiated with a low dose of aripiprazole in the form of an oral liquid solution
available on the market. The dose may be gradually increased to the recommended dose for
adolescents of 10 mg once daily. However, your doctor may prescribe a lower or higher dose,
up to a maximum of 30 mg once daily.
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 every day at the same time. It does not matter
whether the tablet is taken with or without food.
Do not open the blister pack until you are ready to take the medicine. Peel back the foil to expose the
single tablet. Do not push the tablet through the foil, as this may damage it. After opening the blister,
remove the tablet with dry hands and place it whole on the tongue. The tablet disintegrates rapidly in
saliva. The orodispersible tablet may be taken with or without liquid.
The tablet may also be dissolved in water and the resulting suspension drunk.
Even if the patient feels better, the dose should not be changed or treatment with Aribit ODT
discontinued without first consulting the doctor.
Taking more Aribit ODT than recommended
If you take more Aribit ODT than prescribed (or if someone else takes tablets of Aribit ODT 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), coma, combination 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.
Missing a dose of Aribit ODT
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 Aribit ODT treatment
Do not stop treatment even if you feel better.
It is very important to take Aribit ODT exactly as directed by your doctor and for the duration
recommended by your doctor.
If you have any further questions about 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 will experience them.

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

• Diabetes,
• Sleep disturbances,
• Feeling of anxiety,
• Restlessness and inability to sit or stand still,
• Uncontrolled trembling, jerking movements or writhing movements, restless legs syndrome,
• Tremor,
• Headache,
• Fatigue,
• Drowsiness,
• Feeling of emptiness in the head,
• Blurred vision and unstable vision,
• Reduced frequency of bowel movements or difficulty defecating,
• Indigestion,
• Nausea,
• Excessive salivation,
• Vomiting,
• Feeling of tiredness.

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

• Increased prolactin levels in blood,
• High blood sugar levels,
• Depression,
• Changes in sexuality or excessive interest in sex,
• Uncontrolled movements of the mouth, tongue or limbs (tardive dyskinesia),
• Muscle disorders causing twisting movements (dystonia),
• Double vision,
• Light sensitivity of the eyes,
• Rapid heartbeat,
• Decreased blood pressure upon standing, causing dizziness, feeling of emptiness in the head or fainting,
• Hiccups.

The following adverse reactions have been reported after arypiprazole was placed on the market, but their frequency is unknown (frequency cannot be estimated from 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),
• Development of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine) or 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,
• Aggression,
• Agitation,
• Nervousness,
• Concurrent occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• Seizures,
• Serotonin syndrome (a reaction which may cause feelings of extreme well-being, 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 heartbeat,
• 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 blood vessels to the lungs causing chest pain and breathing difficulties (if any of these symptoms occur, the patient must contact a doctor immediately),
• High blood pressure,
• Fainting,
• Accidental aspiration of food with risk of developing pneumonia,
• Muscle spasms around the larynx,
• Pancreatitis,
• Difficulty swallowing;
• Diarrhea,
• Abdominal discomfort,
• Stomach discomfort,
• Liver failure,
• Hepatitis,
• Yellowing of the skin and whites of the eyes,
• Abnormal liver function tests,
• Skin rash,
• Light sensitivity,
• Hair loss,
• Excessive sweating,
• Abnormal muscle breakdown leading to kidney dysfunction,
• Muscle pain,
• Muscle 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,
• Chest pain,
• Swelling of hands, ankles or feet,
• In blood tests: fluctuations in blood glucose levels, increased levels of glycated hemoglobin,
• Inability to resist an impulse, drive or urge to perform an activity that could harm the patient or others, including behaviors such as:
  • Strong impulse to gamble excessively despite serious personal or family consequences,
  • Changed or increased interest in sexual activity and behaviors significantly distressing to the patient or others, for example increased sexual 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),
  • Urge to wander.

If such behaviors occur in a patient, they should inform their doctor, who will discuss ways to manage or reduce these symptoms.

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

Additional adverse reactions in children and adolescents

In adolescents aged 13 years and older, adverse reactions occurred at similar frequencies and types as in adults, except for drowsiness, uncontrolled tremors or movements, motor restlessness and fatigue, which occurred very commonly (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled limb movements, and dizziness, especially when standing up from lying or sitting positions, which occurred commonly (more than 1 in 100 patients).

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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 the medicine.

5. How to store Aribit ODT

Keep the medicine out of the 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Aribit ODT contains

• The active substance 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.
• Other ingredients:
  Aribit ODT 10 mg and 30 mg: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silicon dioxide, aspartame (E 951), magnesium stearate, red iron oxide (E 172), vanilla flavour (containing maltodextrin, gum arabic, propylene glycol, benzyl alcohol, vanilla flavours).
  Aribit ODT 15 mg: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silicon dioxide, aspartame (E 951), magnesium stearate, yellow iron oxide (E 172), vanilla flavour (containing maltodextrin, gum arabic, propylene glycol, benzyl alcohol, vanilla flavours).

What Aribit ODT looks like and contents of the pack
Aribit ODT 10 mg: Round, flat, pink tablets, 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, yellow tablets, 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, pink tablets, with the number "30" embossed on one side and smooth on the other, with a diameter of 10.0 mm ± 0.1 mm.
Orodispersible tablets Aribit ODT are packed in:
Peelable blisters paper/PET/Aluminium//PVC/Aluminium/OPA in cardboard boxes containing 14, 28, 49 orodispersible tablets.
Peelable blisters paper/PET/Aluminium//PVC/Aluminium/OPA divided into single doses in cardboard boxes containing 14x1, 28x1, 49x1 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne 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