Aribit

Package leaflet: Information for the patient

Aribit 5 mg tablets
Aribit 10 mg tablets
Aribit 15 mg tablets
Aribit 30 mg tablets
Aripiprazole
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Aribit is and what it is used for

Aribit 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 who have schizophrenia – a condition characterized by symptoms such as seeing, hearing, or sensing things that are not real, excessive suspiciousness, beliefs that are not based in reality, disorganized speech and behavior, and emotional blunting.
Patients may also feel sadness, anxiety, or tension, and may experience feelings of guilt.
Aribit is used in adults and adolescents aged 13 years and older to treat manic episodes, which may include symptoms such as intense excitement, overwhelming energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes extreme irritability. In adults, this medicine also helps prevent the recurrence of these symptoms in patients who have responded to treatment with Aribit.

2. Important information before using Aribit

When not to use Aribit

• 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, discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if you experience thoughts or feelings related to harming yourself.
Before starting treatment with Aribit, 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;
• has seizures (epilepsy), as this may mean your doctor will want to monitor the patient closely;
• has involuntary, irregular muscle movements, especially of the facial muscles;
• has heart or circulatory system disorders, a family history of circulatory disorders, stroke or "mini" stroke, or abnormal blood pressure;
• has a history of blood clots (thrombosis) in themselves or in family members, as use of antipsychotic medicines has been associated with blood clot formation;
• has 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 whether the patient has ever had a stroke or "mini" stroke.
Immediately inform your doctor if suicidal thoughts or feelings occur. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient develops muscle stiffness or muscle 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 an urge or desire to behave in an unusual way and cannot resist the impulse, urge, or temptation to carry out 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, abnormally strong sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may decide to change the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls. Exercise caution, especially in elderly or weakened patients.

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

Aribit with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines they plan to take.
Medicines that lower blood pressure: Aribit may enhance the effect of medicines that lower blood pressure. If the patient is taking medicines to lower blood pressure, they should inform their doctor.
Taking Aribit with certain medicines may require adjustment of the dose of Aribit or of other medicines the patient is taking. It is especially important to inform the doctor if the patient is taking:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressants or herbal remedies 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);
• anticonvulsants 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 effectiveness of Aribit. If the patient experiences any unusual symptoms while taking these medicines with Aribit, they should inform their doctor.
Medicines that increase serotonin levels are usually used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, and tryptophan used to treat 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 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 may increase the risk of side effects. If the patient experiences any unusual symptoms while taking these medicines with Aribit, they should inform their doctor.

Taking Aribit with food, drink and alcohol
This medicine can be taken with or without food.
Avoid drinking alcohol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Newborns whose mothers have taken Aribit 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 your newborn, contact your doctor immediately.
If the patient is taking Aribit, the doctor will discuss with her 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. Talk to your doctor about the best feeding methods for your baby if you are taking this medicine.

Driving and using machines
During treatment with this medicine, dizziness and visual disturbances may occur (see section 4). This should be taken into account when performing tasks requiring full concentration, such as driving or operating machinery.

Aribit contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Aribit

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, the treating physician may prescribe
a lower or higher dose, up to a maximum of 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)
available on the market. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily. However, the treating physician may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
If the effect of the medicine seems too strong or too weak, consult the doctor or pharmacist.
Aribit should be taken every day 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 you feel an improvement in your condition, do not change the dose or stop taking Aribit
without first discussing it with your doctor.
Taking more than the recommended dose of Aribit
If you take more Aribit than prescribed (or if someone else takes Aribit tablets 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.
The following symptoms have been reported in patients who have taken an excessive dose of aripiprazole:

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

Other possible symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, and excessive sweating;
• muscle stiffness and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, heart rhythm disturbances.

If any of the above symptoms occur, contact a doctor or hospital immediately.
Missing a dose of Aribit
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 treatment
Do not stop treatment even if you feel better.
It is very important to take Aribit 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 disorders,
• feeling of anxiety,
• restlessness and inability to sit or stand still,
• uncontrollable tremors, jerking movements or writhing movements, restless legs syndrome,
• tremor,
• headache,
• fatigue,
• somnolence (drowsiness),
• feeling of emptiness in the head,
• blurred vision and visual flickering,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

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

• increased blood prolactin levels,
• high blood sugar levels,
• depression,
• changes in sexual desire or excessive interest in sex,
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• double vision,
• light sensitivity (photophobia),
• rapid heartbeat,
• reduced blood pressure when standing, causing dizziness, feeling of emptiness in the head or fainting,
• hiccups.

The following adverse reactions have been reported since aripiprazole has been marketed, but their frequency is unknown (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, skin itching, rash),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine) or coma,
• high blood sugar levels,
• low blood sodium levels,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts and completed suicides,
• feelings of aggression,
• agitation,
• nervousness,
• concomitant occurrence of fever, muscle stiffness, rapid breathing, sweating, altered 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 position (oculogyric crisis),
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include leg swelling, pain and redness), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if any of these symptoms occur, the patient must contact a doctor immediately),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of pneumonia,
• spasm of muscles around the larynx,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes (jaundice),
• 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 (priapism),
• 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 temptation to perform an activity that may harm the patient or others, including behaviors such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • altered or increased interest in sexual activity and behaviors significantly distressing to the patient or others, e.g. increased sexual drive,
  • uncontrolled excessive shopping or spending,
  • compulsive overeating (consuming 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 or compulsive wandering). If such behaviors occur, the patient should inform the doctor, who will discuss ways to treat or reduce these symptoms.

In elderly patients with dementia treated with aripiprazole, a higher number of cases ending in death have been reported. In addition, cases of stroke or "mini-strokes" (transient ischemic attacks) have been observed.

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 somnolence, uncontrollable 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, uncontrollable limb movements, and dizziness—especially upon standing from a lying or sitting position—which occurred commonly (more than 1 in 100 patients).

Reporting of adverse reactions

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 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 responsible entity.

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

5. How to store Aribit

Store below 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Aribit contains

• The active substance is aripiprazole.

Aribit 5 mg tablets: each tablet contains 5 mg of aripiprazole.
Aribit 10 mg tablets: each tablet contains 10 mg of aripiprazole.
Aribit 15 mg tablets: each tablet contains 15 mg of aripiprazole.
Aribit 30 mg tablets: each tablet contains 30 mg of aripiprazole.

• Other ingredients are: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, pregelatinized starch (corn), corn starch, magnesium stearate, and yellow iron oxide (E 172) – Aribit 5 mg and 15 mg, red iron oxide (E 172) – Aribit 10 mg and 30 mg.

What Aribit looks like and contents of the pack
Aribit 5 mg: elongated, biconvex tablets, light yellow in colour, slight speckling may occur.
Aribit 10 mg: elongated, biconvex tablets, light pink in colour, slight speckling may occur.
Aribit 15 mg: round, flat tablets on both sides, light yellow in colour, slight speckling may occur.
Aribit 30 mg: round, biconvex tablets, light pink in colour, slight speckling may occur.
The medicine is available in aluminium/OPA/aluminium/PVC blisters containing 14, 28, 49, 56 or 98 tablets, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Branch in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba