Aripiprazole Orion

Leaflet accompanying the packaging: information for the user

Aripiprazole Orion, 5 mg, tablets

Aripiprazole Orion, 10 mg, tablets

Aripiprazole Orion, 15 mg, tablets

Aripiprazole Orion, 30 mg, tablets

Aripiprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Aripiprazole Orion and what is it used for
• 2. Important information before taking Aripiprazole Orion
• 3. How to take Aripiprazole Orion
• 4. Possible side effects
• 5. How to store Aripiprazole Orion
• 6. Contents of the packaging and other information

1. What is Aripiprazole Orion and what is it used for

Aripiprazole Orion 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, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may feel sad, anxious, or tense, and may also have feelings of guilt.
Aripiprazole Orion is used to treat adults and adolescents aged 13 years and older whose disease is characterized by symptoms such as: strong 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 Aripiprazole Orion.

2. Important information before taking Aripiprazole Orion

When not to take Aripiprazole Orion:

Warnings and precautions

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

• strong impulse to gamble excessively despite serious personal or family consequences;
• changed or increased interest in sex and behaviors that significantly disturb the patient or others, such as increased sexual drive;

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 can lead to falls.
Care should be taken, especially in elderly or weakened patients.

Children and adolescents

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

Aripiprazole Orion 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: Aripiprazole Orion may enhance the effect of blood pressure-lowering medicines. If the patient is taking blood pressure-lowering medicines, they should inform their doctor.
The use of Aripiprazole Orion with other medicines may require a change in the dose of Aripiprazole Orion or other medicines taken by the patient. 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 Aripiprazole Orion. If the patient experiences any unusual symptoms while taking these medicines with Aripiprazole Orion, they should tell their doctor.
Medicines that increase serotonin levels are usually used to treat diseases including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat diseases including 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 preparation for mild depression;
• painkillers (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; if the patient experiences any unusual symptoms while taking any of these medicines with Aripiprazole Orion, they should contact their doctor.

Aripiprazole Orion with food, drink, and alcohol

This medicine can be taken with or without food.
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
In newborns whose mothers took Aripiprazole Orion during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient notices such symptoms in their child, they should contact their doctor.
If the patient is taking Aripiprazole Orion, their doctor will discuss with them whether they should breastfeed, considering 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 method 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). This should be taken into account when performing tasks that require full attention, such as driving or operating machinery.

Aripiprazole Orion contains lactose

Aripiprazole Orion contains lactose (in the form of monohydrate): 5 mg tablets contain 72.2 mg, 10 mg tablets contain 63.2 mg, 15 mg tablets contain 94.8 mg, and 30 mg tablets contain 189.5 mg of lactose.
Patients with intolerance to some sugars should contact their doctor before taking the medicine.

3. How to take Aripiprazole Orion

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 Aripiprazole Orion for adults is 15 mg once a day.However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

Use in children and adolescents

Treatment with aripiprazole may be started with a low dose in the form of an oral solution (liquid).
The dose may be gradually increased to the 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 Aripiprazole Orion is too strong or too weak, they should consult their doctor or pharmacist.
Aripiprazole Orion 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 Aripiprazole Orion without first discussing it with their doctor.

Taking a higher dose of Aripiprazole Orion than recommended

If the patient takes more Aripiprazole Orion tablets than prescribed by their doctor (or if someone else takes some of the patient's Aripiprazole Orion 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;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heart rhythm.

If the patient experiences any of these symptoms, they should immediately contact their doctor or hospital.

Missing a dose of Aripiprazole Orion

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 Aripiprazole Orion

The patient should not stop treatment, even if they feel better. It is very important to take Aripiprazole Orion exactly as prescribed by the doctor and for the duration 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, Aripiprazole Orion can cause side effects, although not everybody gets them.
Common (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 perform continuous movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headaches,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision,
• decreased bowel movements or difficulty with bowel movements,
• nausea,
• vomiting,
• excessive salivation,
• feeling tired.

Uncommon (may affect up to 1 in 100 people):

• increased or decreased 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 in oral form, but the frequency of their occurrence is Unknown (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, hives),
• 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 consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant 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 heart rhythm,
• 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 breathing difficulties (if the patient experiences any of these symptoms, they 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 (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,
• chest pain,
• swelling of the hands, ankles, or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin levels,
• 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 serious 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 money;
• uncontrolled overeating or compulsive eating (eating more food than usual and more than needed to satisfy hunger);
• impulse to wander.

If the patient experiences such behaviors, they should tell their doctor, who will discuss ways to treat or reduce these symptoms with them.
In elderly patients with dementia taking aripiprazole, more deaths have been reported. Additionally, cases of strokes or "mini" strokes 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 sudden movements, restlessness, and fatigue, which occurred very frequently (may affect more than 1 in 10 patients), as well as upper 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 (may affect up to 1 in 10 patients).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient 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, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Aripiprazole Orion

The medicine should be stored out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister or carton. The expiry date refers to the last day of the month.
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 packaging and other information

What Aripiprazole Orion contains

• The active substance of the medicine is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, cornstarch, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate. Additionally, 5 mg tablets contain indigo carmine (E 132), lacquer.

What Aripiprazole Orion looks like and contents of the pack

Aripiprazole Orion 5 mg tablets are blue, modified rectangular in shape, uncoated, and marked with the number "62" on one side and the letter "H" on the other side.
Aripiprazole Orion 10 mg tablets are white, modified rectangular in shape, uncoated, and marked with the number "63" on one side and the letter "H" on the other side.
Aripiprazole Orion 15 mg tablets are white, round in shape, uncoated, and marked with the number "64" on one side and the letter "H" on the other side.
Aripiprazole Orion 30 mg tablets are white, round in shape, uncoated, and marked with the number "66" on one side and the letter "H" on the other side.
Aripiprazole Orion tablets are available in blisters (PA/Aluminum/PVC/Aluminum), packaged in cardboard boxes containing 14, 28, 56, or 98 tablets, or in HDPE bottles with a PP cap, packaged in cardboard boxes containing 100 or 200 tablets.
The bottle contains a desiccant.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl
Date of last revision of the leaflet:14.10.2022