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 you.

• You should 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. 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 is Apra and what is it used for
• 2. Before you take 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 with a disease characterized by symptoms such as: seeing, hearing, and feeling things that are not real, suspiciousness, delusions, disorganized thinking and behavior, and emotional flattening. Patients with these symptoms may also feel depressed, anxious, or tense, and may have feelings of guilt.
Apra is used to treat adults and adolescents aged 13 years and older with a disease 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. Before you take 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 taking Apra, 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 taking Apra, tell your doctor if you have:

• high blood sugar (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a history of diabetes;
• 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 diseases, a history of heart or blood vessel diseases, 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 your daily activities, difficulty swallowing, or signs of allergy, you should inform your doctor.
If you are an elderly patient with dementia, you or your caregiver should inform your doctor if you have 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, changes in mental status, or very fast or irregular heartbeat.
If you or your family/caregiver notice that you are starting to feel the urge or impulse to behave in a way that is unusual for you 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 behaviors are called impulse control disorders and can be characterized by behaviors such as compulsive gambling, excessive eating or spending, excessive sexual desire, or an increased frequency and intensity of thoughts or feelings about sexual matters.
Your doctor may consider changing your dose or stopping your treatment.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in your ability to move and balance, which can lead to falls. You should be careful, especially if you are an elderly or weakened patient.

Children and adolescents

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

Apra and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take, including those that are available without a prescription.
Blood pressure-lowering medicines: Apra may increase the effect of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Apra with some 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 irregular heart rhythms (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 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;
• analgesic medicines (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, drinks, and alcohol

Apra can be taken with or without food.
During treatment with Apra, you should not drink 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 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 any of these symptoms in your baby, you should contact your doctor.
If you are taking Apra, your doctor will discuss with you whether you should breastfeed, considering the benefits of the treatment and the benefits of breastfeeding. You should not take the medicine and breastfeed at the same time. 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 may occur (see section 4).
You should take this into account when performing tasks that require full attention, such as driving a vehicle 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 (such as 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 (such as metabolic acidosis).

3. How to take Apra

Always take this medicine exactly as your doctor or pharmacist has told you.
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, not exceeding 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 can 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 food 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 first consulting your doctor.

What to do if you take more Apra than you should

If you have taken more Apra tablets than your doctor prescribed (or if someone else has taken some of your Apra tablets), 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:

• fast heartbeat, agitation/aggression, speech problems;
• unusual body movements (especially of the face or tongue) and decreased consciousness. Other symptoms may include:
• acute 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.

What to do if you forget to take 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.

What to do if you stop taking Apra

Do not stop treatment just because you feel better.
It is very important to take Apra 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 a compulsion to move),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• vision disturbances and blurred vision,
• decreased number of bowel movements or difficulty passing stools,
• 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 sexual desire or increased sexual desire,
• 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 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 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, 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 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 should immediately contact your 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,
• abdominal pain,
• liver failure,
• hepatitis,
• jaundice (yellowing 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 muscles 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, urge, or temptation to engage in an activity that could 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 are significantly disturbing to you or others, such as increased sexual desire,
  uncontrolled excessive shopping or spending,
  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);
  impulse 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) 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 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 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, you can help provide more information on the safety of this medicine.

5. How to store Apra

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton.
There are no special storage requirements for the medicinal product.
Medicines should not be disposed of via wastewater or household waste. 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, silicon dioxide, aspartame (E 951), magnesium stearate, vanilla flavor (maltodextrin, gum arabic 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: