ARIBIT 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Aribit 5 mg tablets
3. Aribit 10 mg tablets
4. Aribit 15 mg tablets
5. Aribit 30 mg tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
6. What is Aribit and what is it used for
7. Important information before taking Aribit
   1. When not to take Aribit
   2. Warnings and precautions
   3. Children and adolescents
   4. Aribit and other medicines
   5. Taking Aribit with food, drinks, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Aribit contains lactose
8. How to take Aribit
   1. Use in children and adolescents
   2. Taking a higher dose of Aribit than recommended
   3. Missing a dose of Aribit
   4. Stopping treatment with Aribit
9. Possible side effects
   1. Additional side effects in children and adolescents
   2. Reporting side effects
10. How to store Aribit
11. Contents of the pack and other information
    1. What Aribit contains
    2. What Aribit looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Aribit 5 mg tablets

Aribit 10 mg tablets

Aribit 15 mg tablets

Aribit 30 mg tablets

Aripiprazole

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

• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Aribit and what is it 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 is Aribit and what is it 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 with schizophrenia - a disease characterized by symptoms such as: seeing, hearing, and feeling things that do not exist in reality, excessive suspiciousness, beliefs that are inconsistent with reality, incoherent speech and behavior, and emotional numbness. Patients may also experience sadness, anxiety, or tension, as well as feelings of guilt.
Aribit is used in adults and adolescents aged 13 years and older to treat manic episodes, with symptoms such as: strong excitement, bursting energy, reduced need for sleep, very rapid 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 Aribit treatment.

2. Important information before taking Aribit

When not to take Aribit

Warnings and precautions

Before starting to take Aribit, discuss it 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 related to self-harm.
Before starting treatment with Aribit, tell your doctor if you have:

• high blood sugar levels (typical symptoms include: excessive thirst, urination, increased appetite, and feeling of weakness) or a history of diabetes in your family;
• 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 history of cardiovascular disease in your family, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots in you or your family members, 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, unusual movements, drowsiness that interferes with your daily activities, difficulty swallowing, or signs of an allergic reaction, you should inform your doctor.
If you are an elderly patient with dementia, or if you are a caregiver or relative, you should inform your doctor if the patient has 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, 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, mental disorders, or very rapid or irregular heartbeat.
If you or your family member or caregiver notice that you are starting to feel the urge or desire to behave in an unusual way, and that 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: compulsive gambling, overeating, or excessive spending, excessive sexual drive, or increased frequency and intensity of thoughts or feelings about sexual topics.
Your doctor may decide to change the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in movement and balance, which can lead to falls. You should be careful, especially if you are an elderly or weakened patient.

Children and adolescents

Aribit should not be used in children and adolescents under 13 years of age. It is not known if the use of this medicine is safe and effective in these patients.

Aribit and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those that are available without a prescription.
Blood pressure-lowering medicines: Aribit may enhance the effect of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Aribit with certain medicines may require a change in the dose of Aribit 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. If you experience any unusual symptoms while taking these medicines with Aribit, you should inform 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, you should inform your doctor.

Taking Aribit with food, drinks, and alcohol

The medicine can be taken with or without food.
You should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
In newborns whose mothers took Aribit 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, 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 of feeding your child if you are taking this medicine.

Driving and using machines

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

Aribit contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Aribit

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 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 with Aribit may 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 is too strong or too weak, you should consult your doctor or pharmacist.
Aribit should be taken once a 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 washed down with water.
Even if you feel better, do not change the dose or stop taking Aribit without first consulting your doctor.

Taking a higher dose of Aribit than recommended

If you have taken more Aribit than your doctor recommended (or if someone else has taken your Aribit tablets), 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:

• severe confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating, and 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 the above symptoms, you should immediately contact your doctor or hospital.

Missing a dose of Aribit

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

You should not stop treatment if you feel better.
It is very important to take Aribit exactly as your doctor has told you and for as long as your doctor has told you.
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 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,
• headaches,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• image tremor and blurred vision,
• reduced 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 excessive 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 the frequency of their occurrence is not known (the frequency cannot be determined based on available data):

• decreased number of white blood cells,
• decreased number of platelets,
• 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 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, and changes in consciousness and blood pressure, as well as changes in heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, uncoordinated movements, 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 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 contact your doctor),
• high blood pressure,
• fainting,
• accidental inhalation of food with the 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,
• jaundice 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 disorders,
• 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 levels of glycosylated hemoglobin,
• inability to resist the 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,
• changed or increased interest in sex and behaviors that significantly disturb you or others, e.g., increased sexual drive,
• uncontrolled excessive shopping or spending,
• uncontrolled 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 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, with the exception of 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 inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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

Store in a temperature below 30°C.
The medicine should be stored out of 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 month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
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 pack and other information

What Aribit contains

• The active substance of Aribit 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: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, corn starch, maize 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: tablets are oblong, flat on both sides, light yellow in color, with slight notches allowed.
Aribit 10 mg: tablets are oblong, flat on both sides, light pink in color, with slight notches allowed.
Aribit 15 mg: tablets are round, flat on both sides, light yellow in color, with slight notches allowed.
Aribit 30 mg: tablets are round, convex on both sides, light pink in color, with slight notches allowed.
The medicine is available in aluminum/OPA/aluminum/PVC blisters containing 14, 28, 49, 56, or 98 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
Aribit 10 mg, 15 mg, 30 mg
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: