Aripiprazole Orion

Package Leaflet: 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 all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Aripiprazole Orion is and what it is used for
• 2. What you need to know before you take Aripiprazole Orion
• 3. How to take Aripiprazole Orion
• 4. Possible side effects
• 5. How to store Aripiprazole Orion
• 6. Contents of the pack and other information

1. What Aripiprazole Orion is and what it is 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 schizophrenia, a mental illness with symptoms such as hearing, seeing, or feeling things that are not there, suspiciousness, mistaken beliefs, disorganized thinking and behavior, and emotional flatness. Patients with these symptoms may also feel depressed, anxious, or tense.
Aripiprazole Orion is also used to treat moderate to severe manic episodes in adults and in adolescents aged 13 years and older with bipolar I disorder, a mental illness with symptoms such as high mood, feeling full of energy, reduced need for sleep, and impaired attention.

2. What you need to know before you take Aripiprazole Orion

Do not take Aripiprazole Orion:

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

Warnings and precautions

Before taking Aripiprazole Orion, tell your doctor:
Suicidal thoughts and behaviors have been reported during aripiprazole treatment. Tell your doctor immediately if you have thoughts of harming or killing yourself at any time.
Before taking Aripiprazole Orion, tell your doctor if you have:

• high blood sugar (excessive thirst, excessive urination, increased appetite, and weakness) or a history of diabetes in your family;
• seizures (epilepsy), as your doctor may want to monitor you more closely;
• involuntary, irregular movements of the muscles, especially of the face;
• heart or blood vessel problems, a history of heart or blood vessel problems in your family, stroke, or "mini" stroke, abnormal blood pressure;
• blood clots or a history of blood clots, as antipsychotic medicines have been associated with the formation of blood clots;
• a history of gambling addiction.

If you notice any of the following side effects after taking Aripiprazole Orion, tell your doctor:
weight gain, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of allergy.
If you are an elderly patient with dementia, or if you are caring for someone with dementia, you should tell the doctor if the patient has ever had a stroke or a "mini" stroke.
Tell your doctor immediately if you have:
muscle stiffness or stiffness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
If you or your family/caregiver notice that you are developing impulses, urges, or behaviors that you cannot control, such as an overwhelming urge to gamble, increased sexual urges, or excessive spending, tell your doctor.
These impulses are known as impulse control disorders and can be intense and difficult to control. Your doctor may need to adjust your dose or stop your treatment.
Aripiprazole may cause drowsiness, dizziness, and changes in your ability to move and balance, which may increase the risk of falls. Be careful, especially if you are elderly or frail.

Children and adolescents

Do not take Aripiprazole Orion if you are under 13 years of age. It is not known if the medicine is safe and effective in children under 13 years of age.

Aripiprazole Orion with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.
Medicines that lower blood pressure: Aripiprazole Orion may increase the effect of medicines that lower blood pressure. If you are taking medicines that lower blood pressure, tell 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 tell your doctor if you are taking:

• medicines for irregular heartbeats (such as quinidine, amiodarone, flecainide);
• antidepressants or herbal medicines for depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medicines (such as ketoconazole, itraconazole);
• certain HIV medicines (such as efavirenz, nevirapine, protease inhibitors, e.g., indinavir, ritonavir);
• antiepileptic medicines for epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• certain antibiotics for tuberculosis (rifabutin, rifampicin).

Taking these medicines with Aripiprazole Orion may increase the risk of side effects or reduce the effectiveness of Aripiprazole Orion. If you experience any unusual symptoms while taking these medicines with Aripiprazole Orion, tell your doctor.
Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, and social anxiety disorder, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, and social anxiety disorder, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, obsessive-compulsive disorder, panic disorder, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used to treat severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depression;
• St. John's Wort (Hypericum perforatum) used as a herbal remedy 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 these medicines with Aripiprazole Orion, tell your doctor.

Aripiprazole Orion with food, drink, and alcohol

This medicine can be taken with or without food.
Do not drink alcohol while taking Aripiprazole Orion.

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 or pharmacist for advice before taking this medicine.
In newborns whose mothers took Aripiprazole Orion during the last trimester (last three months of pregnancy), the following symptoms have been reported: trembling, stiffness, and (or) weakness, sleepiness, agitation, difficulty breathing, and difficulty feeding. If you notice any of these symptoms in your baby, contact your doctor.
If you are taking Aripiprazole Orion and are pregnant or planning to become pregnant, your doctor will discuss with you whether you should continue to take Aripiprazole Orion. You should not take Aripiprazole Orion and breastfeed at the same time. You should talk to your doctor about the best way to feed your baby if you are taking Aripiprazole Orion.

Driving and using machines

Aripiprazole Orion may cause dizziness, drowsiness, and vision problems (see section 4). This should be taken into account when performing activities that require full attention, such as driving a car or operating machinery.

Aripiprazole Orion contains lactose

Aripiprazole Orion contains lactose (in the form of lactose 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 Aripiprazole Orion.

3. How to take Aripiprazole Orion

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 Aripiprazole Orion for adults is 15 mg once a day. Your 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 at a low dose, given as a liquid solution. 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, talk to your doctor or pharmacist.
Aripiprazole Orion tablets should be taken once a day at the same time. It does not matter whether you take it with or without food. Swallow the tablet whole with water.
Even if you feel better, do not change your dose or stop taking Aripiprazole Orion without talking to your doctor first.

If you take more Aripiprazole Orion than you should

If you have taken more Aripiprazole Orion than your doctor prescribed, contact your doctor or the nearest hospital immediately. If you cannot contact your doctor, go to the nearest hospital and take the packaging of the medicine with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech problems;
• abnormal 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, and changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome);
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat.

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

If you forget to take Aripiprazole Orion

If you miss a dose, take it as soon as you remember. Do not take a double dose on the same day.

Stopping treatment with Aripiprazole Orion

Do not stop taking Aripiprazole Orion unless your doctor tells you to. It is very important to continue taking Aripiprazole Orion for as long as your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

• diabetes,
• sleep disturbances,
• anxiety,
• restlessness and inability to sit or stand still,
• akathisia (feeling of inner restlessness and a compelling need to be in constant motion),
• uncontrolled movements of the body, or uncontrolled movements of the face or tongue,
• tremors,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision,
• constipation,
• nausea,
• excessive saliva production,
• vomiting,
• feeling of fatigue.

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

• increased or decreased prolactin levels in the blood,
• high blood sugar levels,
• depression,
• changes in sexual desire or increased sexual desire,
• uncontrolled movements of the mouth, tongue, or limbs (tardive dyskinesia),
• muscle disorders that cause twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• increased sensitivity of the eyes to light,
• rapid heartbeat,
• low blood pressure when standing up, causing dizziness, feeling of emptiness in the head, or fainting,
• hiccups.

The following side effects have been reported during post-marketing use of aripiprazole, but the frequency of these side effects is not known (cannot be estimated from the available data):

• low white blood cell count,
• low platelet count,
• allergic reactions (such as swelling of the mouth, tongue, face, and throat, itching, hives),
• onset of diabetes or worsening of diabetes, 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,
• aggression,
• agitation,
• nervousness,
• combination of fever, stiffness, rapid breathing, sweating, altered mental status, and rapid or irregular heartbeat, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially agitation, drunkenness, fever, sweating, and stiffness),
• 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 travel through the bloodstream to the lungs, causing chest pain and difficulty breathing (if you experience any of these symptoms, you must see a doctor immediately),
• high blood pressure,
• fainting,
• accidental inhalation of 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,
• 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 on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme levels (seen in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia),
• abnormal breakdown of muscle 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: increased or fluctuating blood sugar levels, increased levels of glycosylated hemoglobin,
• inability to resist impulses, urges, or behaviors that may harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences,
• altered or increased sexual interest and behaviors that cause significant distress or interfere with your daily activities, such as increased sexual drive,
• 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);
• urge to wander.

If you experience any of these behaviors, tell your doctor, who will discuss ways to manage or reduce these symptoms with you.
In elderly patients with dementia treated with aripiprazole, there have been more reports of death. Additionally, there have been reports of stroke or "mini" stroke.

Additional side effects in children and adolescents

In adolescents aged 13 years and older, side effects have been reported with a similar frequency and type as in adults, except for drowsiness, uncontrolled movements or sudden movements, restlessness, and fatigue, which have been reported very commonly (may affect more than 1 in 10 people), as well as upper abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, tremors, uncontrolled movements of the limbs, and dizziness, especially when standing up from a lying or sitting position, which have been reported commonly (may affect up to 1 in 10 people).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national reporting system listed below.
You can also report side effects directly via the national reporting system:
Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 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

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Aripiprazole Orion contains

• The active substance is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, 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, 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, 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, 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, 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 PP caps, 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, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
Date of last revision of the leaflet:14.10.2022