Aripilek

Package leaflet: Information for the patient

Aripilek, 5 mg, tablets
Aripilek, 10 mg, tablets
Aripilek, 15 mg, tablets
Aripilek, 30 mg, tablets
Aripiprazole

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, 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, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Aripilek is and what it is 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 Aripilek is and what it is 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 have a disorder characterized by symptoms such as: seeing, hearing, or sensing things that are not real, suspiciousness, beliefs that are not based on reality, disorganized speech and behavior, and emotional blunting. Patients with these symptoms may also feel sadness, anxiety, or tension, and may experience feelings of guilt.
Aripilek is also used to treat adults and adolescents aged 13 years and older whose condition is characterized by symptoms such as: excitement, increased energy, reduced need for sleep, rapid speech, racing thoughts, and sometimes extreme irritability. In adults, this medicine also helps prevent recurrence of the above symptoms in patients who have responded to treatment with Aripilek.

2. Important information before using Aripilek

When not to use 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 treatment with Aripilek, discuss this with your doctor.
Suicidal thoughts and behaviors 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 Aripilek, 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;
• seizures (epilepsy), as this may mean the doctor will want to monitor the patient closely;
• involuntary, irregular muscle movements, especially of the facial muscles;
• cardiovascular diseases (heart and circulatory diseases), family history of cardiovascular disease, stroke or "mini" stroke (transient ischemic attack), or abnormal blood pressure;
• blood clots or a family history of blood clots, as use of antipsychotic medicines has been associated with formation of blood clots;
• a history of gambling addiction.

If the patient notices weight gain, unusual movements, drowsiness that interferes with daily activities, any swallowing difficulties, or allergic symptoms, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, caregiver, or relative should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
Immediately inform the doctor if suicidal thoughts or feelings occur. Suicidal thoughts and behaviors have been reported during treatment with aripiprazole.
Immediately inform the doctor if the patient develops muscle stiffness or 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 an impulse, drive, or temptation to carry out activities that could harm themselves or others, they should tell the doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, binge eating, excessive spending, increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider it appropriate to adjust 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
Aripilek should 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.

Aripilek and 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 the patient plans to take.
Medicines that lower blood pressure: Aripilek may enhance the effect of blood pressure-lowering medicines. If the patient is taking medicines for lowering blood pressure, they should inform their doctor.
Taking Aripilek together with other medicines may require adjustment of the dose of Aripilek or of other medicines the patient is taking. 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);
• 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);
• antiepileptic medicines used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• specific antibiotics used to treat tuberculosis (rifabutin, rifampicin).

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

Aripilek with food, drink, and alcohol
Aripilek can be taken with or without food.
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult her doctor before using this medicine.
Newborns whose mothers have taken Aripilek 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 the newborn, contact the doctor immediately.
If the patient is taking Aripilek, the doctor will discuss with her whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. Do not take Aripilek and breastfeed at the same time. Discuss with the doctor the best feeding methods for the baby if the patient is taking this medicine.

Driving and operating machinery
Dizziness and visual disturbances (see section 4) may occur during treatment with this medicine. This should be taken into account when performing activities requiring full attention, such as driving vehicles or operating machinery.

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

3. How to take Aripilek

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt, consult your
doctor or pharmacist.
The recommended dose of the medicine in adults is 15 mg once daily. However, your doctor may prescribe a lower or higher
dose, which must not exceed 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 of Aripilek for
adolescents, which is 10 mg once daily. However, the treating doctor may prescribe a lower or higher
dose, up to a maximum of 30 mg per day.
If you feel the effect of the medicine is too strong or too weak, consult your 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 taken with water.
Even if you feel an improvement in your condition, do not change the dose or stop
taking Aripilek without first discussing it with your treating doctor.
Taking more Aripilek than recommended
If you take more Aripilek than prescribed by your doctor (or if someone else takes some of the medicine 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 occurred:

• 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, combination of fever, rapid breathing, excessive sweating;
• muscle rigidity 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 Aripilek
If a dose of Aripilek is missed, the patient should take the missed dose as soon as they remember.
Do not take two doses on the same day.
Stopping Aripilek treatment
Do not stop treatment even if you feel better.
It is very important to take Aripilek exactly as directed by your doctor and for the period recommended by
the doctor.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

Common side effects (may affect 1 in 10 people):

• diabetes,
• sleep disorders,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (a sense of inner restlessness and a compulsion to keep moving),
• uncontrollable tremors, jerking movements or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

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

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

The following side effects have been reported after the oral form of aripiprazole has been marketed, but their frequency cannot be estimated from the 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, 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 sodium levels in the blood,

• loss of appetite (anorexia),

• weight decrease,

• weight increase,

• suicidal thoughts, suicide attempts and completed suicides,

• feeling of aggression,

• nervousness,

• agitation,

• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness and 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, feeling of alcohol intoxication, fever, sweating or muscle stiffness),

• speech disorders,

• oculogyria (fixed eye deviation),

• sudden unexplained death,

• life-threatening irregular heart rhythm,

• 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,

• laryngospasm (spasm of muscles around the larynx),

• pancreatitis,

• difficulty swallowing;

• diarrhoea,

• abdominal discomfort,

• stomach discomfort,

• liver failure,

• hepatitis,

• yellowing of the skin and whites of the eyes (jaundice),

• abnormal liver function tests,

• skin rash,

• photosensitivity,

• hair loss,

• excessive sweating,

• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially resembles flu-like symptoms with a rash on the face, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzymes (seen in blood tests) and increased levels of a specific type of white blood cells (eosinophilia),

• abnormal muscle breakdown leading to kidney dysfunction,

• muscle pain,

• stiffness,

• involuntary urination (urinary incontinence),

• difficulty passing urine,

• withdrawal syndrome in newborns following exposure to the medicine during pregnancy,

• prolonged and (or) painful erection,

• difficulty regulating core body temperature or overheating,

• breast pain,

• swelling of hands, ankles or feet,

• in blood tests: fluctuations in blood sugar levels, increased levels of glycated haemoglobin,

• inability to resist an impulse, drive or temptation to engage in behaviour that may harm the patient or others, including behaviours such as:

• strong impulse to gamble excessively despite serious personal or family consequences,

• altered or increased interest in sexual matters and behaviours significantly distressing to the patient or others, for example increased sexual drive,

• uncontrolled excessive shopping or spending,

• binge eating (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 aimless wandering). If such behaviours occur, the patient should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

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

Additional side effects in children and adolescents

In adolescents aged 13 years and older, side effects occurred with similar frequency and type as in adults, except for somnolence, uncontrollable tremors or movements, motor restlessness and fatigue, which were very common (affecting more than 1 in 10 patients), and abdominal pain in the upper part of the abdomen, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrollable limb movements and dizziness, particularly when standing up from a lying or sitting position, which were common (affecting more than 1 in 100 patients).

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.

Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Aripilek

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer cardboard box following EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
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 pack and other information

What Aripilek contains

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

What Aripilek looks like and contents of the pack
Aripilek tablets are white or almost white, round, biconvex, with engraved markings
“5”, “10”, “15”, or “30” on one side of the tablet.
Aripilek is available in blister packs containing 7 or 10 tablets, placed in cardboard
boxes. The cardboard box contains either 14, 28, 56, 84, or 112 tablets or 20, 30, 60, 90, or 120
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14A
05-170 Zakroczym
Tel.: (22) 785 27 60
Fax: (22) 785 27 60 ext. 106