Apra

Package leaflet: Information for the patient

Apra, 5 mg, tablets
Apra, 10 mg, tablets
Apra, 15 mg, tablets
Apra, 30 mg, tablets
Aripiprazole
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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 of the leaflet

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

1. What Apra is and what it is used for

Apra 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 an illness 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 detachment. Patients with these symptoms may also feel sadness, anxiety, tension, or guilt.
Apra is also used to treat adults and adolescents aged 13 years and older who have an illness characterized by symptoms such as: excitement, increased energy, reduced need for sleep, rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the recurrence of these symptoms in patients who have responded to treatment with Apra.

2. Important information before using Apra

When not to use Apra

• 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 Apra, 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 Apra, inform your doctor if the patient has:

• high blood sugar levels (characteristic 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 circulatory diseases, stroke or "mini" stroke, or abnormal blood pressure;
• blood clots or a family history of blood clots, as use of antipsychotic medicines is associated with blood clot formation;
• 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 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 experiences 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 engage in activities that could harm themselves or others, they should inform the doctor. These phenomena are called impulse control disorders and may manifest as behaviours 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
Do not use Apra in children and adolescents under 13 years of age. It is not known whether use of the medicine is safe and effective in these patients.

Apra and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, and any medicines the patient plans to take.
Medicines that lower blood pressure: Apra may enhance the effects of blood pressure-lowering medicines. If the patient is taking blood pressure-lowering medicines, they should inform their doctor.
Taking Apra with certain medicines may require a dose adjustment of Apra. 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 Apra. If the patient experiences any unusual symptoms while taking these medicines with Apra, 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 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 severe depression;
• tricyclic antidepressants (such as clomipramine, 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 with Apra, inform the doctor.

Taking Apra with food, drink and alcohol
Apra can be taken with or without food.
Do not drink alcohol during treatment with Apra.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Newborns whose mothers took aripiprazole during the third trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems (such as difficulty sucking). If these symptoms are observed in your baby, contact your doctor.
If the patient is taking Apra, the doctor will discuss whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. Do not take the medicine 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 using machines
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.

Apra contains aspartame, lactose, sodium and benzyl alcohol

Aspartame
Apra 5 mg contains 0.5 mg aspartame per tablet.
Apra 10 mg contains 1 mg aspartame per tablet.
Apra 15 mg contains 1.5 mg aspartame per tablet.
Apra 30 mg contains 3 mg aspartame per tablet.
Aspartame is a source of phenylalanine. May be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Benzyl alcohol
Apra 5 mg contains 0.0018 mg benzyl alcohol per tablet.
Apra 10 mg contains 0.0036 mg benzyl alcohol per tablet.
Apra 15 mg contains 0.0054 mg benzyl alcohol per tablet.
Apra 30 mg contains 0.0108 mg benzyl alcohol per tablet.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to use Apra

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Apra in adults is 15 mg once daily. However, the doctor may prescribe a lower or
higher dose, which must not exceed 30 mg per day.
Use in children and adolescents
Treatment with Apra may be initiated with a low dose of aripiprazole 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, the treating doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
If the effect of the medicine seems too strong or too weak, consult a doctor or pharmacist.
Apra tablets 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 Apra
without first consulting your treating doctor.
Taking more than the recommended dose of Apra
If you take more Apra tablets than prescribed by your doctor (or if someone else takes 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 symptoms may include:
• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, and excessive sweating;
• muscle rigidity and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm. If any of these symptoms occur, contact a doctor or hospital immediately.

Missed dose of Apra
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 treatment with Apra
Do not stop treatment even if you feel better.
It is very important to take Apra exactly as directed by the doctor and for the duration prescribed by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, 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,
• restlessness and inability to sit or stand still,
• akathisia (a sensation of inner restlessness and a compulsion to keep moving),
• uncontrollable tremors, jerky movements or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred or double vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling tired.

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

• increased blood prolactin levels,
• high blood sugar levels,
• depression,
• changes in sexual interest or excessive sexual interest,
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• light sensitivity,
• rapid heartbeat,
• drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting,
• hiccups.

The following adverse effects have been reported since aripiprazole has been marketed, but their frequency is unknown (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 ketones in blood and urine) or diabetic coma,
• high blood sugar levels,
• low blood sodium levels,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts and completed suicides,
• feelings of aggression,
• agitation,
• nervousness,
• occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness, 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, alcohol intoxication-like feeling, fever, sweating or muscle stiffness),
• speech disorders,
• fixed eye position (oculogyric crisis),
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the bloodstream to the lungs causing chest pain and difficulty breathing (if any of these symptoms occur, the patient must seek immediate medical attention),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of developing pneumonia,
• muscle spasms 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,
• skin 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,
• difficulty urinating,
• withdrawal syndrome in newborns following exposure to the medicine during pregnancy,
• prolonged and/or painful erection (priapism),
• difficulty regulating core body temperature or overheating,
• breast pain,
• swelling of the 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 perform an activity that could harm the patient or others, including behaviours such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • changed or increased interest in sexual activity and behaviours significantly distressing to the patient or others, for example increased sexual drive,
  • uncontrolled excessive shopping or spending,
  • compulsive overeating (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 compulsive wandering).

If patients experience any of these types of behaviours, they should inform their doctor, who will discuss ways to manage or reduce these symptoms.

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

Additional adverse effects in children and adolescents

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

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 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 Apra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton.
There are no special requirements for storage of this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apra 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, sodium croscarmellose, anhydrous colloidal silicon dioxide, aspartame (E 951), magnesium stearate, and vanilla flavour (maltodextrin, gum arabic E 414, propylene glycol E 1520, benzyl alcohol E 1519).

• Indigo carmine, lac (E 132) – for 5 mg tablets
• Red iron oxide (E172) – for 10 mg and 30 mg tablets
• Yellow iron oxide (E172) – for 15 mg tablets

What Apra looks like and contents of the pack
Apra 5 mg tablets: rectangular, biconvex, blue tablets, 7.6 mm x 4.3 mm, smooth on both sides.
Apra 10 mg tablets: rectangular, biconvex, pink tablets, 9.3 mm x 5.2 mm, smooth on both sides.
Apra 15 mg tablets: round, flat, yellow tablets, 9.0 mm in diameter, smooth on both sides.
Apra 30 mg tablets: round, flat, pink tablets, 10.00 mm in diameter, smooth on both sides.
Apra 5 mg tablets are available in aluminium blisters, packed in cardboard boxes containing 7, 14, or 28 tablets.
Apra 10 mg, Apra 15 mg, and Apra 30 mg tablets are available in aluminium blisters, packed in cardboard boxes containing 7, 14, 28, 56, or 84 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. Box 3012, Larissa
41500 Greece
GENEPHARM S.A.
18th km Marathonos Avenue, Pallini Attiki
15351 Greece
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

December 2025