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

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 to you specifically. 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 who suffer from a disease characterized by symptoms such as: seeing, hearing, and feeling things that do not exist in reality, suspiciousness, beliefs that are inconsistent with reality, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may feel sad, anxious, or tense, and may also have a sense of guilt.
Aripiprazole Orion is used to treat adults and adolescents aged 13 years and older whose disease is characterized by symptoms such as: severe excitement, excessive energy, reduced need for sleep, very fast speech, racing thoughts, and sometimes extreme 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 to take Aripiprazole Orion, you should discuss it with your doctor.
During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. You should immediately inform your doctor if you experience thoughts or feelings related to self-harm.
Before starting to take Aripiprazole Orion, you should tell 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 mean that your doctor will want 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 notice an increase in weight, appearance of unusual movements, drowsiness that interferes with daily activities, any difficulties in swallowing, or symptoms of an allergy, you should inform your 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.
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 that 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:

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

Your 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.
Caution should be exercised, especially in elderly or weakened patients.

Children and adolescents

This medicine 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.

Aripiprazole Orion and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking 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: Aripiprazole Orion may enhance the effect of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Aripiprazole Orion with other medicines may require a change in the dose of Aripiprazole Orion or other medicines you are taking. 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 effect of Aripiprazole Orion. If you experience any unusual symptoms while taking these medicines with Aripiprazole Orion, you should tell your 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;
• pain relievers (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 you experience any unusual symptoms while taking any of these medicines with Aripiprazole Orion, you should contact your doctor.

Aripiprazole Orion with food, drink, and alcohol

This medicine can be taken with or without food.
You should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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 you notice such symptoms in your child, you should contact your doctor.
If you are taking Aripiprazole Orion, your doctor will discuss with you whether you should breastfeed, taking into account 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 methods of feeding 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.

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 certain sugars should contact their doctor before taking the medicine.

3. How to take Aripiprazole Orion

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose of Aripiprazole Orion for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

Use in children and adolescents

Aripiprazole treatment 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, 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 Aripiprazole Orion is too strong or too weak, you should consult your 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 you feel better, you should not change the dose or stop taking Aripiprazole Orion without first discussing it with your doctor.

Taking a higher dose of Aripiprazole Orion than recommended

If you take a higher dose of Aripiprazole Orion than your doctor prescribed (or if someone else takes some of the medicine that was not intended for them), you should immediately contact your doctor. If you have difficulty contacting your doctor, you should go to the nearest hospital, taking the packaging of the medicine 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 heart rate, fainting;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, abnormal heart rhythm.

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

Missing a dose of Aripiprazole Orion

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

Stopping treatment with Aripiprazole Orion

You should not stop treatment if you feel better. It is very important to take Aripiprazole Orion as directed by your doctor and for the period prescribed by your doctor.
If you have any further doubts about taking this medicine, you should consult your 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 compulsion to perform continuous movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headaches,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• decreased number of bowel movements or difficulties 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,
• 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 in oral form, but their frequency is Unknown (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 of the skin, 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 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 (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 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,
• 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 you 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 you or others, such as increased sexual drive;
• uncontrolled excessive shopping or spending money,
• uncontrolled excessive eating or compulsive eating (eating more food than usual and more than needed to satisfy hunger);
• 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 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 occurred with a similar frequency and type as in adults, except for drowsiness, uncontrolled trembling or sudden movements, restlessness, and fatigue, which occurred very commonly (may affect 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 commonly (may affect up to 1 in 10 patients).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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,
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this 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 on the label and carton. The expiry date refers to the last day of the month.
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 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, hydroxypropyl cellulose, 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 on this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
contact@orionpharma.info.pl
Date of last revision of the leaflet:14.10.2022