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
Aripiprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Aripiprazole Orion is and what it is used for
2. What you need to know before taking 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 who have a disorder characterised by symptoms such as seeing, hearing or feeling things that are not real, suspicion, beliefs not based in reality, disorganised speech and behaviour, and emotional blunting. Patients with these symptoms may also feel sadness, anxiety, tension or guilt.
Aripiprazole Orion is also used to treat adults and adolescents aged 13 years and older who have a disorder characterised by symptoms such as extreme excitement, overwhelming energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the return of these symptoms in patients who have responded to treatment with Aripiprazole Orion.

2. Important information before using Aripiprazole Orion

When must Aripiprazole Orion not be used:

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

Warnings and precautions
Before starting treatment with Aripiprazole Orion, discuss this with your doctor.
During treatment with aripiprazole, suicidal thoughts and behaviours have been reported. You should
immediately inform your doctor if you experience any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazole Orion, you should inform your doctor if the patient has:

• high blood sugar levels (characteristic symptoms include: excessive thirst, passing large amounts of urine, increased appetite and feeling weak) or a family history of diabetes;
• seizures (epilepsy), as this may mean your doctor will want to monitor you closely;
• involuntary, irregular muscle movements, particularly of the facial muscles;
• cardiovascular diseases (heart and circulation disorders), family history of cardiovascular disease, stroke or "mini" stroke, or abnormal blood pressure;
• blood clots or a family history of blood clots, as use of antipsychotic medicines has been associated with blood clot formation;
• a history of gambling addiction.

If the patient notices weight gain, development of unusual movements, drowsiness that interferes with
daily activities, any swallowing difficulties or allergic symptoms, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, 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 the patient experiences muscle stiffness or stiffness with
high fever, sweating, changes in mental state, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient starts to feel an urge or desire to behave in an unusual way and cannot resist an impulse, drive or temptation to engage in activities that could harm themselves or others, they should inform their doctor.
These phenomena are known as impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating, or excessive spending, increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider adjusting the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in movement and balance, which may 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 13 years of age. It is not known whether use of the medicine is safe and effective in these patients.
Aripiprazole Orion with other medicines
You should tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Medicines that lower blood pressure: Aripiprazole Orion may enhance the effect of medicines that lower blood pressure. If the patient is taking medicines that lower blood pressure, they should inform their doctor.
The use of Aripiprazole Orion with other medicines may require adjustment of the dose of Aripiprazole Orion or of other medicines being taken. It is particularly important to inform your doctor if the patient is taking the following medicines:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressants 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);
• anticonvulsant medicines used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• specific antibiotics used to treat tuberculosis (rifabutin, rifampicin).

Taking these medicines may increase the risk of side effects or reduce the effectiveness of Aripiprazole Orion. If the patient experiences any unusual symptoms while taking these medicines together with Aripiprazole Orion, they should inform their doctor.
Medicines that increase serotonin levels are usually used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine and pain:

• triptans, tramadol and tryptophan used to treat conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used to treat major 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;
• 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 adverse effects; if any unusual symptoms occur while taking any of the above medicines together with Aripiprazole Orion, 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Newborns whose mothers have taken Aripiprazole Orion during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If such symptoms are observed in the newborn, contact a doctor.
If the patient is taking Aripiprazole Orion, the doctor will discuss whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. The medicine should not be taken while breastfeeding. Do not take the medicine and breastfeed at the same time. Discuss the best feeding options for the baby with your doctor if you are taking this medicine.
Driving and using machines
Dizziness and visual disturbances (see section 4) may occur during treatment with this medicine. This should be taken into account when performing tasks requiring full attention, such as driving or operating machinery.
Aripiprazole Orion contains lactose
Aripiprazole Orion contains lactose (as 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 consult their doctor before taking this medicine.

3. How to use Aripiprazole Orion
This medicine should always be used exactly as prescribed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
The recommended dose in adults is 15 mg once daily. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
Use in children and adolescents
Treatment with aripiprazole may be initiated at 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 daily. However, the treating doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.
If you feel that the effect of Aripiprazole Orion is too strong or too weak, consult your doctor or pharmacist.
Aripiprazole Orion tablets should be taken every 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 taken with water.
Even if you feel better, do not change the dose or stop taking Aripiprazole Orion without first discussing it with your doctor.
Taking more Aripiprazole Orion than prescribed
If more Aripiprazole Orion tablets have been taken than prescribed by the doctor (or if someone else has taken some of the medicine not intended for them), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital, taking the medicine packaging with you.
Patients who have taken an excessive dose of aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech problems;
• unusual body movements (especially of the face or tongue) and reduced consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, excessive sweating;
• muscle stiffness and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm.

If the patient experiences any of the above symptoms, contact a doctor or hospital immediately.
Missing a dose of Aripiprazole Orion
If a dose is missed, the patient should take the missed dose as soon as they remember. Do not take a double dose on the same day.
Stopping Aripiprazole Orion treatment
Do not stop treatment even if the patient feels better. It is very important to take Aripiprazole Orion exactly as prescribed by the doctor and for the duration recommended by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common (may affect up to 1 in 10 patients):

• diabetes,
• sleep disturbances,
• feeling of anxiety,
• restlessness and inability to sit or stand still,
• akathisia (inner sense of restlessness and a compulsion to keep moving),
• uncontrolled trembling, jerking movements or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and unstable visual image,
• reduced number of bowel movements or difficulty in defecation,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

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

• increased or decreased prolactin levels in blood,
• too high blood sugar level,
• depression,
• changes in sexuality or excessive interest in sex,
• uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• light sensitivity of the eyes,
• rapid heartbeat,
• reduced blood pressure in standing position, causing dizziness, feeling of emptiness in the head or fainting,
• hiccups.

The following adverse reactions have been reported after marketing of aripiprazole in oral form, but their frequency is Unknown (frequency cannot be estimated from the available data):

• decreased number of white blood cells,
• decreased number of blood platelets,
• allergic reactions (e.g. swelling of the mouth, tongue, face and throat, skin itching, urticaria),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine) or coma,
• high blood sugar level,
• low sodium level in blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts and completed suicides,
• feeling of aggression,
• agitation,
• nervousness,
• occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction which may cause feelings of extreme well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, feeling of alcohol intoxication, fever, sweating or muscle stiffness),
• speech disorders,
• oculogyric crisis (fixed abnormal eye position),
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if any of these symptoms occur, the patient must contact a doctor immediately),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of developing pneumonia,
• spasm of muscles around the glottis,
• pancreatitis,
• difficulty in swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes (jaundice),
• abnormal liver function tests,
• skin rash,
• skin photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially resembles flu-like symptoms with a rash on the face, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (seen in blood tests) and increased levels of a specific type of white blood cells (eosinophilia),
• abnormal muscle breakdown leading to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination,
• difficulty in urinating,
• withdrawal syndrome in newborns following exposure to the drug during pregnancy,
• prolonged and (or) painful erection,
• difficulty in regulating core body temperature or overheating,
• breast pain,
• swelling of hands, ankles or feet,
• in blood tests: increased or fluctuating blood glucose levels, increased levels of glycated hemoglobin,
• inability to resist the impulse, drive or temptation to engage in an activity that may harm the patient or others, including behaviors such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • altered or increased interest in sexual activity and behaviors significantly distressing to the patient or others, for example, increased sexual drive,
• uncontrolled excessive shopping or spending,
• compulsive overeating (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 such behaviors occur in a patient, they should be reported to the doctor, who will discuss with the patient ways of treating or reducing these symptoms.
In elderly patients with dementia treated with aripiprazole, an increased number of cases ending in death has been reported. In addition, cases of stroke or "mini" strokes ("transient ischemic attacks") have been observed.

Additional adverse reactions in children and adolescents
In adolescents aged 13 years and older, adverse reactions occurred at a similar frequency and type as in adults, except for drowsiness, uncontrolled tremors or sudden movements, motor restlessness and fatigue, which occurred very commonly (may affect more than 1 in 10 patients), and abdominal pain in the upper part of the abdomen, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, 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 of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the blister or on the label and carton.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, respectively.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, corn starch, hydroxypropylcellulose, anhydrous colloidal silicon dioxide, magnesium stearate. Additionally, in the 5 mg tablets: indigo carmine (E 132), lac.

What Aripiprazole Orion looks like and contents of the pack
Aripiprazole Orion 5 mg tablets are blue, modified rectangular-shaped, uncoated tablets 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-shaped, uncoated tablets marked with the number “63” on one side and the letter “H” on the other side.
Aripiprazole Orion 15 mg tablets are white, round-shaped, uncoated tablets marked with the number “64” on one side and the letter “H” on the other side.
Aripiprazole Orion 30 mg tablets are white, round-shaped, uncoated tablets marked with the number “66” on one side and the letter “H” on the other side.
Aripiprazole Orion tablets are available in blisters (PA/Aluminium/PVC/Aluminium), packed in cardboard boxes containing 14, 28, 56, or 98 tablets, or in HDPE bottles with PP caps, packed in cardboard boxes containing 100 or 200 tablets.
The bottle contains a desiccant to absorb moisture.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]