Aripilek

Leaflet accompanying the packaging: patient information

Aripilek, 5 mg, tablets

Aripilek, 10 mg, tablets

Aripilek, 15 mg, tablets

Aripilek, 30 mg, tablets

Aripiprazole

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept to be able to read it again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Aripilek and what is it used for
• 2. Important information before taking Aripilek
• 3. How to take Aripilek
• 4. Possible side effects
• 5. How to store Aripilek
• 6. Package contents and other information

1. What is Aripilek and what is it used for

Aripilek contains the active substance aripiprazole and belongs to a group of antipsychotic medicines.
It is used to treat adults and adolescents aged 15 and older who have a disease characterized by symptoms such as: seeing, hearing, and feeling things that do not exist in reality, suspiciousness, beliefs that are inconsistent with reality, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also experience sadness, anxiety, or tension, as well as feelings of guilt.
Aripilek is used to treat adults and adolescents aged 13 and older whose disease is characterized by symptoms such as: excitement, excessive energy, reduced need for sleep, very fast speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to treatment with Aripilek.

2. Important information before taking Aripilek

When not to take Aripilek:

• 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 to take Aripilek, the patient should discuss it with their doctor.
During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. The patient should immediately inform their doctor if they experience thoughts or feelings related to self-harm.
Before starting to take Aripilek, the patient should inform their doctor if they 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 the doctor will want to monitor the patient closely;
• involuntary, irregular muscle movements, especially of the face;
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots or a history of blood clots, as the use of antipsychotic medicines is associated with the formation of blood clots;
• a history of gambling addiction.

If the patient notices an increase in weight, appearance of unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or symptoms of an allergy, they should inform their doctor.
If an elderly patient has dementia (loss of memory and other mental abilities), they or their caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
The patient should immediately inform their doctor if they experience thoughts or feelings related to self-harm. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported.
The patient should immediately inform their doctor if they experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very fast or irregular heartbeat.

Children and adolescents

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

Aripilek and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.
Blood pressure-lowering medicines: Aripilek may enhance the effects of blood pressure-lowering medicines. If the patient is taking blood pressure-lowering medicines, they should inform their doctor.
Taking Aripilek with other medicines may require a change in the dose of Aripilek or other medicines taken by the patient. It is especially important to inform the doctor about the use of the following medicines:

• 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 (rifabutin, rifampicin).

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

Aripilek with food, drink, and alcohol

Aripilek can be taken with or without food.
The patient should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
In newborns whose mothers took Aripilek in 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 sucking. If the patient notices such symptoms in their child, they should contact their doctor.
If the patient is taking Aripilek, their doctor will discuss with them whether they should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. The patient should not take the medicine and breastfeed. They should discuss with their doctor the best methods of feeding their child if they are taking this medicine.

Driving and using machines

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

Aripilek contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Aripilek

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Aripilek for adults is 15 mg per day.However, the doctor may prescribe a lower or higher dose, which should not exceed 30 mg per day.

Use in children and adolescents

Treatment with Aripilek 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 of Aripilek for adolescents, which is 10 mg once a day. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.
Aripilek 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 washed down with water.
Even if the patient feels an improvement in their condition,they should not change the dose or stop taking Aripilek without first discussing it with their doctor.

Taking a higher dose of Aripilek than recommended

In case of taking a higher dose of Aripilek than prescribed by the doctor (or if someone else has taken some of the medicine not intended for them), the patient should immediately contact their doctor.
If it is difficult to contact the doctor, the patient should go to the nearest hospital, taking the medicine packaging with them.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

• fast heartbeat, agitation/aggression, speech problems;
• uncontrolled 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;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, abnormal heart rhythm.

If the patient experiences any of these symptoms, they should immediately contact their doctor or hospital.

Missing a dose of Aripilek

In case of missing a dose of Aripilek, the patient should take the missed dose as soon as they remember. They should not take two doses in one day.

Stopping treatment with Aripilek

The patient should not stop treatment if they feel better.
It is very important to take Aripilek according to the doctor's instructions and for the period prescribed by the doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

• diabetes,
• sleep disturbances,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements),
• uncontrolled trembling, jerking movements, or twisting movements,
• trembling,
• headaches,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• reduced number of bowel movements or difficulty with bowel movements,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of fatigue.

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

• decreased or 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),
• restless legs syndrome,
• 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 in oral form, 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, 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 of aggression,
• nervousness,
• agitation,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating,

reduced consciousness and sudden changes in blood pressure and heart rate, 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 heart rhythm,
• 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 the patient experiences any of these symptoms, they 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,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes,
• abnormal liver test results,
• skin rash,
• sensitivity of the skin to light,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles flu-like symptoms with a rash on the face, and then a rash appears on other parts of the body, high fever, enlarged lymph nodes, elevated liver enzyme activity (visible in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia),
• abnormal breakdown of muscle leading to kidney problems,
• muscle pain,
• stiffness,
• involuntary urination (incontinence),
• 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 the impulse, drive, or temptation to engage in activities that may harm the patient or others, including behaviors such as:
• strong impulse to gamble excessively despite significant personal or family consequences,
• changed or increased interest in sex and behaviors that significantly disturb the patient or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending money,
• uncontrolled overeating or eating more food than usual and more than needed to satisfy hunger);

or compulsive eating (eating more food than usual and more than needed to satisfy hunger);

• impulse to wander. If the patient experiences such behaviors, they should tell their doctor, who will discuss with them ways to treat or reduce these symptoms.

In elderly patients with dementia taking aripiprazole, more cases of death have been reported. Additionally, cases of strokes or "mini" strokes have been noted.

Additional side effects in children and adolescents

In adolescents aged 13 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) and 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 side effects occur, including those not listed in this leaflet, the patient should inform their 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 Tel.: (22) 49 21 301 Fax: (22) 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the responsible entity. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aripilek

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Aripilek contains

• The active substance of Aripilek is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, cornstarch, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica.

What Aripilek looks like and what the package contains

Aripilek tablets are white or almost white, round, biconvex, with the inscription "5", "10", "15", or "30" on one side of the tablet.
Aripilek is available in blisters containing 7 or 10 tablets, which are placed in a carton. The carton contains 14, 28, 56, 84, or 112 tablets or 20, 30, 60, 90, or 120 tablets.
Not all pack sizes may be marketed.

Responsible entity and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Tel.: (22) 785 27 60
Fax: (22) 785 27 60 ext. 106

Date of the last update of the leaflet: