Aripilek

Package Leaflet: Information for the Patient

Aripilek, 5 mg, tablets

Aripilek, 10 mg, tablets

Aripilek, 15 mg, tablets

Aripilek, 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 tell your 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. Contents of the pack 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 medicines called antipsychotics.
It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterized by symptoms such as: seeing, hearing, and feeling things that do not exist in reality, suspiciousness, beliefs that are not true, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also feel sad, anxious, or tense, and may have a sense of guilt.
Aripilek is used to treat adults and adolescents aged 13 years 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 you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Aripilek, you should 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 of self-harm.
Before starting treatment with Aripilek, you should tell your doctor if you 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 your doctor will want to monitor you closely;
• involuntary, irregular movements of the muscles, 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 you notice an increase in weight, appearance of unusual movements, drowsiness that interferes with daily activities, any difficulties in swallowing, or symptoms of an allergy, you should inform your doctor.
If an elderly patient with dementia is taking Aripilek, they or their caregiver or relative should inform the doctor if the patient has 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 stiffness with high fever, sweating, mental disorders, or very fast 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:

• 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 money,
• 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);

• wandering impulse. 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.
Caution should be exercised, especially in elderly or weakened patients.

Children and adolescents

Aripilek 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.

Aripilek 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, including those that are available without a prescription.
Blood pressure-lowering medicines: Aripilek may enhance the effect of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should tell your doctor.
Taking Aripilek with other medicines may require a change in the dose of Aripilek or other medicines you are taking. It is especially important to inform your 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 effect of Aripilek. If you experience any unusual symptoms while taking these medicines with Aripilek, you should tell 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 Aripilek, you should tell your doctor.

Aripilek with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
In newborns whose mothers took Aripilek 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 Aripilek, your doctor will discuss with you whether you should breastfeed, taking into account 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. This should be taken into account when performing activities that require full attention, such as driving or operating machinery.

Aripilek contains lactose monohydrate

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

3. How to take Aripilek

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 Aripilek for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a 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, 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 the medicine is too strong or too weak, you should consult your doctor or pharmacist.
Aripilek 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 Aripilek without first discussing it with your doctor.

Taking a higher dose of Aripilek than recommended

If you have taken more Aripilek than your doctor recommended (or if someone else has taken some of the medicine not intended for them), 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:

• fast 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;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heart rhythm.

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

Missing a dose of Aripilek

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

Stopping treatment with Aripilek

You should not stop treatment if you feel better.
It is very important to take Aripilek exactly as your doctor has told you and for the duration recommended by your doctor.
If you have any further questions about the use of this medicine, you should ask your 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 anxious,
• feeling restless and unable to sit or stand still,
• akathisia (feeling of inner restlessness and compulsion to make constant movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headaches,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double 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):

• decreased or 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),
• 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 aggressive,
• 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 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,
• 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,
• increased 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 dysfunction,
• 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 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,
• altered or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending money,
• 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);

• wandering impulse. 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, 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 you experience any side effects, including those not listed in this leaflet, you should tell 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 Tel.: (22) 49 21 301 Fax: (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 Aripilek

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 blister and carton after EXP. The expiry date refers to the last day of that month.
Store in a temperature below 30°C.
Medicines should 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 pack 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 contents of the pack

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, packaged 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.

Marketing authorization holder 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 last revision of the leaflet: