Apiprax

Package Leaflet: Information for the User

Apiprax, 15 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Apiprax and what is it used for
• 2. Important information before taking Apiprax
• 3. How to take Apiprax
• 4. Possible side effects
• 5. How to store Apiprax
• 6. Contents of the pack and other information

1. What is Apiprax and what is it used for

Apiprax 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
an illness that is characterized by symptoms such as: seeing, hearing, and feeling things that are not there, suspiciousness, delusions, disorganized thinking and behavior, and emotional numbness. Patients with these symptoms may also experience sadness, anxiety, or tension, as well as feelings of guilt.
Apiprax is used to treat adults and adolescents aged 13 years and older who suffer from
an illness that 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 Apiprax.

2. Important information before taking Apiprax

When not to take Apiprax

• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Apiprax, discuss this 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 Apiprax, tell your doctor if you have:

• high blood sugar (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 movements of the muscles, especially of the face
• heart or blood vessel disease, a history of heart or blood vessel disease in your family, stroke, or "mini" stroke, abnormal blood pressure
• blood clots or a history of blood clots, as the use of antipsychotic medicines has been 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 your daily activities, any difficulty swallowing, or symptoms of an allergic reaction, you should inform your doctor.
If an elderly patient with dementia is taking Apiprax, 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, altered mental status, or very fast or irregular heartbeat.
If you or your family or caregiver notice that you are starting to feel the urge or impulse to behave in an unusual way, and you cannot resist the impulse, urge, or temptation to perform an activity that could harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and can manifest as behaviors such as: a strong impulse to gamble excessively despite serious personal or family consequences, a changed 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), or an impulse to wander. Your doctor 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 the ability to move and balance, which can lead to falls. You should be careful, especially in elderly or weakened patients.

Children and adolescents

Do not take this medicine if you are under 13 years old. It is not known if the medicine is safe and effective in these patients.

Apiprax with 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: Apiprax may increase the effect of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Apiprax with certain medicines may require a change in the dose of Apiprax 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 irregular heartbeat (such as quinidine, amiodarone, flecainide);
• antidepressant 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 Apiprax. If you experience any unusual symptoms while taking these medicines with Apiprax, 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 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;
• analgesics (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 Apiprax, you should tell your doctor.

Apiprax with food, drink, and alcohol

Apiprax 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 Apiprax during the last trimester (last 3 months of pregnancy), the following symptoms may occur: tremor, muscle stiffness, and (or) weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If you notice any of these symptoms in your baby, you should contact your doctor.
If you are taking Apiprax, 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 way to feed your baby 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 attention, such as driving or operating machinery.

Apiprax contains lactose monohydrate

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

3. How to take Apiprax

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Apiprax for adults is 15 mg once a day. However, your doctor may prescribe a lower or higher dose, not exceeding 30 mg once a day.
Other medicines containing aripiprazole are available in lower or higher strengths, e.g., in the form of an oral solution. You should ask your doctor for further information.

Use in children and adolescents

Treatment can be started with a low dose of the medicine in the form of an oral solution (liquid). The dose can 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 Apiprax is too strong or too weak, you should consult your doctor or pharmacist.
Apiprax 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, you should not change the dose or stop taking Apiprax without first discussing it with your doctor.

Take more Apiprax than prescribed

If you take more Apiprax than your doctor prescribed (or if someone else took some of the medicine not intended for them), you should immediately contact your doctor or go to the nearest hospital, taking the medicine package with you.
In patients who took too much aripiprazole, the following symptoms occurred:

• fast heartbeat, agitation, or 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, altered consciousness, and sudden 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 these symptoms, you should immediately contact your doctor or hospital.

Miss a dose of Apiprax

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.

Stop taking Apiprax

You should not stop treatment if you feel better.
It is very important to take Apiprax as directed by your doctor and for the duration prescribed 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, Apiprax 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 (unpleasant feeling of inner restlessness and a compelling need to be in constant motion),
• uncontrolled trembling, jerking movements, or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• image blur and blurred vision,
• decreased number of bowel movements or difficulty passing stools,
• 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 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 since the marketing of aripiprazole in oral form, but the frequency of their occurrence is not known:

• 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 its course, ketoacidosis (presence of ketone bodies in the blood and urine) or diabetic 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, altered 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),
• 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,
• spasm of the muscles around the vocal cords,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• jaundice,
• abnormal liver test results,
• 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, and then a rash appears on other parts of the body, high fever, swollen 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,
• 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,
• breast pain,
• swelling of the hands, ankles, or feet,
• in blood tests: fluctuations in blood sugar levels, increased glycated hemoglobin levels, increased creatine phosphokinase activity
• inability to resist the impulse, urge, or temptation to engage in an activity that may harm you or others, including behaviors such as: a strong impulse to gamble excessively despite serious personal or family consequences, a changed 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), or an impulse to wander.

If you experience any of these 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, rapid heartbeat, weight gain, increased appetite, tremor, uncontrolled movements of the limbs, 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 any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 Apiprax

Keep this medicine out of the 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.
There are no special precautions for storage.
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 Apiprax contains

• The active substance of Apiprax is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose (type 101), yellow iron oxide (E 172), hydroxypropyl cellulose, 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)
tablets, with beveled edges, convex on both sides with an engraving "I" on one side and "97" on the other side.
Apiprax is available in OPA/Aluminum/PVC/Aluminum blisters, packaged in cardboard boxes containing 28 tablets.
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Date of last revision of the leaflet:March 2022