Apra

Package Leaflet: Information for the Patient

Apra, 5 mg, tablets

Apra, 10 mg, tablets

Apra, 15 mg, tablets

Apra, 30 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 suffer from a disease characterized by symptoms such as: seeing, hearing, and feeling things that are not real, suspiciousness, delusions, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may also feel sad, anxious, or tense, and may have feelings 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 these symptoms in patients who have responded to treatment with Apra.

2. Important information before taking Apra

When not to take Apra

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

Warnings and precautions

Before starting treatment with Apra, you should 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 Apra, you should inform your doctor if you 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 indicate that your doctor wants to monitor you 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 you experience weight gain, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, you should inform your doctor.
If an elderly patient with dementia experiences a stroke or "mini" stroke, they or their caregiver or relative should inform the doctor.
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, mental disorders, or very fast or irregular heartbeat.
If you or your family or caregiver notice that you are starting to feel the urge or desire to behave in an unusual way, and you cannot resist the impulse, drive, or temptation to engage in activities that may harm you or others, you should tell your 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 sex.
Your doctor may consider changing the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be careful, especially in elderly or weakened patients.

Children and adolescents

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

Apra and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you 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 you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Apra with certain medicines may require a change in the dose of Apra. It is especially important to inform your 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 effectiveness of Apra. If you experience any unusual symptoms while taking these medicines with Apra, you should inform 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 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 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 you experience any unusual symptoms while taking these medicines with Apra, you should inform your doctor.

Taking Apra with food, drink, and alcohol

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

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 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 you notice such symptoms in your child, you should contact your doctor.
If you are taking Apra, your doctor will discuss with you whether you should breastfeed, considering 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 child if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur (see section 4).
You 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 you have been diagnosed with an intolerance to some sugars, you should contact your 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).
Patients 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 your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Apra for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a day.

Use 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 may be gradually increased to a 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 the medicine is too strong or too weak, you should consult your 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 you feel better, do not change the dose or stop taking Apra without consulting your doctor.

Overdose of Apra

In case of overdose, you should immediately contact your doctor. If you cannot contact your doctor, go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

• rapid 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 you experience any of these symptoms, you should immediately contact your doctor or hospital.

Missed dose of Apra

If you miss a dose, you should take the missed dose as soon as you remember. Do not take two doses in one day.

Stopping treatment with Apra

You should not stop treatment if you feel better.
It is very important to take Apra exactly as prescribed by your doctor and for the duration prescribed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 (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 bowel movements or difficulty with bowel movements,
• nausea,
• vomiting,
• excessive salivation,
• 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,
• rapid 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 estimated from the available data):

• decreased white blood cell count,
• decreased platelet count,
• 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,
• aggressive behavior,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, changes in mental status, 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 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 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 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 disorders,
• 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,
• inability to resist the impulse, drive, or temptation to engage in activities that may harm you 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 you or others, such as increased sexual drive,
  uncontrolled excessive shopping or spending,
  uncontrolled overeating or compulsive eating;
  urge to wander.

If you experience such 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 deaths have been reported. Additionally, cases of stroke or "mini" stroke have been recorded.

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), as well as abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle tremors, uncontrolled limb movements, 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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store Apra

The medicine should be stored 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 precautions for storage of the medicinal product.
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 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: