Package leaflet: Information for the user

Apiprax, 15 mg, tablets
Aripiprazole
Please read the entire leaflet carefully before using this 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 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 others, 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

What Apiprax is and what it is used for
Important information before taking Apiprax
How to take Apiprax
Possible side effects
How to store Apiprax
Contents of the pack and other information

1. What Apiprax is and what it is used for

Apiprax contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
This medicine is used to treat adults and adolescents aged 15 years and older who have an illness characterised by symptoms such as seeing, hearing, or feeling things that are not real, suspiciousness, beliefs that are not based in reality, disorganised speech and behaviour, and emotional blunting. Patients with these symptoms may also experience sadness, anxiety or tension, and feelings of guilt.
Apiprax is also used to treat adults and adolescents aged 13 years and older whose illness is characterised by symptoms such as excitement, increased energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the return of these symptoms in patients who have responded to treatment with Apiprax.

2. Important information before using Apiprax

When not to use Apiprax

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 Apiprax, 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 Apiprax, 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 your doctor will want to monitor you 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 ischaemic attack), or abnormal blood pressure
blood clots or a family history of blood clots, as use of antipsychotic medicines is associated with formation of blood clots
a history of gambling addiction.

If the patient notices weight gain, development of unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or symptoms of allergy, 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 your doctor if you experience thoughts or feelings related to harming yourself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient develops muscle stiffness or stiffness with high fever, sweating, changes in mental state, 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 perform actions that could harm themselves or others, they should tell their doctor. These phenomena are known as impulse control disorders and may manifest as compulsive gambling, binge eating or excessive spending, abnormally high sex drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may decide it is appropriate to change the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which may lead to falls. Exercise caution, especially in elderly or weakened patients.

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

Apiprax and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.
Medicines that lower blood pressure: Apiprax 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 Apiprax with certain medicines may require adjustment of the dose of Apiprax or other medicines the patient is taking. It is especially important to inform the doctor if the patient is taking any 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 side effects or reduce the effectiveness of Apiprax. If the patient experiences any unusual symptoms while taking these medicines with Apiprax, 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 in treating 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 major 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 Apiprax, they should inform their doctor.

Apiprax with food, drink, and alcohol
Apiprax can be taken with or without food.
Avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Newborns whose mothers have used Apiprax 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 a doctor immediately.
If the patient is taking Apiprax, the doctor will discuss with her whether she should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. Do not take Apiprax and breastfeed at the same time. Discuss the best feeding methods for the baby with your doctor if you are taking this medicine.

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

Apiprax contains monohydrate 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 take Apiprax

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should 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.
Other arypiprazole-containing medicines with lower or higher strengths are available, for example
as an oral solution. You should consult your doctor for further information.
Use in children and adolescents
Treatment may be initiated with a low dose of the medicine in the form of an oral solution (liquid).
The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily.
However, your treating doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
If you feel that the effect of Apiprax is too strong or too weak, you should consult your doctor or
pharmacist.
Apiprax 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 Apiprax
without first discussing it with your treating doctor.
Taking more Apiprax than recommended
If you take more Apiprax than prescribed by your doctor (or if someone else takes a dose of
Apiprax 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 been
reported:

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

Other 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 in a patient, contact a doctor or hospital immediately.
Missing a dose of Apiprax
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 Apiprax treatment
Do not stop treatment even if you feel better.
It is very important to take Apiprax 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 effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Common adverse effects (may affect 1 in 10 patients):

Diabetes,
Sleep disturbances,
Feeling of anxiety,
Feeling of restlessness and inability to sit or stand still,
Akathisia (unpleasant sensation of inner restlessness and compulsion to perform constant movements),
Uncontrollable trembling, jerking movements or writhing movements,
Tremor,
Headache,
Fatigue,
Drowsiness,
Feeling of emptiness in the head,
Blurred vision and double vision,
Decreased number of bowel movements or difficulty defecating,
Indigestion,
Nausea,
Excessive salivation,
Vomiting,
Feeling of tiredness.

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

Increased prolactin levels in blood,
Excessively high blood sugar levels,
Depression,
Changes in sexuality or excessive interest in sex,
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,
Decreased blood pressure upon standing, causing dizziness, feeling of emptiness in the head or fainting,
Hiccups.

The following adverse effects have been reported after the marketing of oral aripiprazole, but their frequency is unknown:

Decreased white blood cell count,
Decreased platelet count,
Allergic reactions (e.g. swelling of the mouth, tongue, face and throat, itching, rash),
Development or worsening of diabetes, ketoacidosis (presence of ketone compounds in blood and urine) or coma,
High blood sugar levels,
Low sodium levels in blood,
Loss of appetite (anorexia),
Decreased body weight,
Increased body weight,
Suicidal thoughts, suicide attempts and completed suicides,
Feeling of aggression,
Agitation,
Nervousness,
Concurrent occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced 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 happiness, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness),
Speech disorders,
Fixed eye position (oculogyria),
Sudden unexplained death,
Life-threatening irregular heartbeat,
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 seek medical advice immediately),
High blood pressure,
Fainting,
Accidental aspiration of food with risk of developing pneumonia,
Muscle spasms 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,
Skin sensitivity 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, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (visible 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,
Difficulty urinating,
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 hemoglobin, increased creatine kinase activity,
Inability to resist an impulse, drive or temptation to engage in behavior that may harm the patient or others, including behaviors such as: strong impulse towards excessive gambling despite serious personal or family consequences, changed or increased interest in sexual activity and behaviors significantly distressing to the patient or others, for example increased sexual drive, uncontrolled excessive shopping or spending, compulsive binge eating (eating large amounts of food in a short time) or compulsive overeating (eating more food than usual and more than needed to satisfy hunger), impulse to wander.

If such behaviors occur in a patient, they should inform their doctor, who will discuss with the patient ways of managing or reducing 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 have been observed.
Additional adverse effects in children and adolescents
In adolescents aged 13 years and older, adverse effects occurred at similar frequency and type 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 abdominal pain in the upper part of the abdomen, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle twitching, uncontrollable limb movements, and dizziness, particularly when standing up from a lying or sitting position, which occurred commonly (more than 1 in 100 patients).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Apiprax

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine Apiprax contains

The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
The other ingredients are: monohydrate lactose, corn starch, microcrystalline cellulose (type 101), yellow iron oxide (E 172), hydroxypropylcellulose, magnesium stearate.

What Apiprax looks like and contents of the pack
Apiprax 15 mg, tablets: light yellow to yellow, round (diameter 7.2 mm and thickness 3.3 mm), bevelled-edge, biconvex tablets, embossed with "I" on one side and "97" on the other side.
Apiprax is available in blisters made of OPA/Aluminium/PVC/Aluminium, packed in cardboard boxes containing 28 tablets.
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta