Apra

Leaflet accompanying the packaging: Patient information

Apra, 5 mg, tablets

Apra, 10 mg, tablets

Apra, 15 mg, tablets

Apra, 30 mg, tablets

Aripiprazole

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Apra and what is it 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 is Apra and what is it 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 suffer from a disease
characterized by symptoms such as: seeing, hearing, and feeling things that do not exist in reality,
suspicion, beliefs that are contrary to reality, chaotic speech and behavior, and emotional numbness.
Patient with the above symptoms may also feel sadness, anxiety, or tension, and may have a sense of guilt.
Apra 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 the above symptoms in patients who have responded to treatment with Apra.

2. Important information before taking Apra

When not to take Apra

Warnings and precautions

Before starting treatment with Apra, the patient should discuss it with their doctor.
During treatment with aripiprazole, thoughts and behaviors of suicide have been reported.
The patient should immediately inform their doctor if they experience thoughts or feelings related to self-harm.
Before starting treatment with Apra, the patient should inform their doctor if they have:

• high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes;
• seizures (epilepsy), as this may mean that the doctor will want to monitor the patient closely;
• involuntary, irregular muscle movements, 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 the patient notices an increase in weight, appearance of unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or symptoms of an allergy, they should inform their doctor.
If an elderly patient has dementia (loss of memory and other mental abilities), they or their caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
The patient should immediately inform their doctor if they experience thoughts or feelings related to self-harm. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported.
The patient should immediately inform their doctor if they experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very fast or irregular heartbeat.
If the patient or their family or caregiver notices that the patient starts to feel the urge or desire to behave in an unusual way, and cannot resist the impulse, drive, or temptation to engage in activities that may harm them or others, they should tell their doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, overeating, or excessive spending, excessive sexual drive, or increased frequency and intensity of thoughts or feelings about sexual topics.
The doctor may consider it appropriate to change the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which may lead to falls. The patient should be careful, especially if they are elderly or weakened.

Children and adolescents

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

Apra and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.
Blood pressure-lowering medicines: 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 change in the dose 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);
• 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 Apra. If the patient experiences any unusual symptoms while taking these medicines with Apra, they should tell their doctor.
Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, and migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, and 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 the patient experiences any unusual symptoms while taking these medicines with Apra, they should tell their doctor.

Taking Apra with food, drink, and alcohol

Apra can be taken with or without food.
The patient should not drink alcohol during treatment with Apra.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor before taking this medicine.
In newborns whose mothers took aripiprazole 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 the patient notices such symptoms in their child, they should contact their doctor.
If the patient is taking Apra, their doctor will discuss with them whether they should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. The patient should not take the medicine and breastfeed. They should discuss with their doctor the best methods of feeding their child if they are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur (see section 4).
The patient should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Apra contains aspartame, lactose, sodium, and benzyl alcohol

Aspartame

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

Lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Sodium

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

Benzyl alcohol

Apra 5 mg contains 0.0018 mg of benzyl alcohol in each tablet.
Apra 10 mg contains 0.0036 mg of benzyl alcohol in each tablet.
Apra 15 mg contains 0.0054 mg of benzyl alcohol in each tablet.
Apra 30 mg contains 0.0108 mg of benzyl alcohol in each tablet.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patient with liver or kidney disease should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to take Apra

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Apra for adults is 15 mg once a day.However, the doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a day.

Taking Apra in children and adolescents

Treatment with Apra can be started with a low dose of aripiprazole in the form of an oral solution (liquid). The dose can be gradually increased to a recommended dose for adolescents of 10 mg once a day. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.
Apra tablets 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 the patient feels better,they should not change the dose or stop taking Apra without first discussing it with their doctor.

Taking a higher dose of Apra than recommended

If the patient has taken a higher dose of Apra than prescribed by their doctor (or if someone else has taken some of the patient's Apra tablets), they should immediately contact their doctor. If it is difficult to contact the doctor, the patient should go to the nearest hospital, taking the packaging of the medicine with them.
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, changes in blood pressure, and changes in heart rate, fainting (malignant neuroleptic syndrome)
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat. If the patient experiences any of these symptoms, they should immediately contact their doctor or hospital.

Missing a dose of Apra

If the patient misses a dose, they should take the missed dose as soon as they remember. They should not take two doses in one day.

Stopping treatment with Apra

The patient should not stop treatment if they feel better.
It is very important to take Apra as prescribed by the doctor and for the period prescribed by the doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Apra can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes,
• sleep disturbances,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (feeling of inner restlessness and compulsion to make constant movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• reduced number of bowel movements or difficulty with bowel movements,
• nausea,
• vomiting,
• feeling of tiredness.

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 after the marketing of aripiprazole, but their frequency is not known (the frequency cannot be determined 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 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 of aggression,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, changes in mental status, and very fast or irregular heartbeat, fainting (malignant neuroleptic syndrome)
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor restlessness, 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 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 the patient experiences any of these symptoms, they should immediately contact their 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,
• gastric discomfort,
• liver failure,
• hepatitis,
• jaundice 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, 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 tissue 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 levels of glycosylated hemoglobin,
• inability to resist the impulse, drive, or temptation to engage in activities that may harm the patient or others, including behaviors such as:
  strong impulse to gamble excessively despite significant personal or family consequences,
  changed or increased interest in sex and behaviors that significantly disturb the patient or others, such as increased sexual drive,
  uncontrolled excessive shopping or spending,
  uncontrolled overeating or compulsive eating (eating large amounts of food in a short time) or eating;
  impulse to wander.

If the patient experiences such behaviors, they should tell their doctor, who will discuss with them 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 have occurred with a similar frequency and type as in adults, with the exception of drowsiness, uncontrolled trembling or movements, restlessness, and fatigue, which have 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 have occurred frequently (more than 1 in 100 patients).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 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, more information can be collected on the safety of the medicine.

5. How to store Apra

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the blister and carton.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Apra contains

The active substance of Apra is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
The medicine also contains lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, aspartame (E 951), magnesium stearate, vanilla flavor (maltodextrin, arabic gum E 414, propylene glycol E 1520, benzyl alcohol E 1519)

• indigo carmine, lake (E 132) - for 5 mg tablets
• iron oxide red (E172) - for 10 mg and 30 mg tablets
• iron oxide yellow (E 172) - 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 in size, smooth on both sides.
Apra 10 mg tablets: rectangular, biconvex, pink tablets, 9.3 mm x 5.2 mm in size, 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 aluminum blisters, packaged in cardboard boxes containing 7, 14, and 28 tablets.
Apra 10 mg, Apra 15 mg, and Apra 30 mg tablets are available in aluminum blisters, packaged in cardboard boxes containing 7, 14, 28, 56, and 84 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Rontis Hellas S.A., Medical and Pharmaceutical Products
P.O. Box 3012 Larisa Industrial Area, Larisa
41004 Greece
GENEPHARM S.A.
18th km Marathonos Avenue, Pallini Attiki
15351 Greece
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: