Arpixor

Leaflet attached to the packaging: information for the user

Arpixor, 5 mg, tablets

Arpixor, 10 mg, tablets

Arpixor, 15 mg, tablets

Arpixor, 20 mg, tablets

Arpixor, 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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Arpixor and what is it used for
• 2. Important information before taking Arpixor
• 3. How to take Arpixor
• 4. Possible side effects
• 5. How to store Arpixor
• 6. Contents of the pack and other information

1. What is Arpixor and what is it used for

Arpixor contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
It is used to treat adults with a disease characterized by symptoms such as:
seeing, hearing, and feeling things that do not exist in reality, excessive suspicion,
beliefs that are inconsistent with reality, incoherent speech and behavior, and emotional numbness.
Patients with the above symptoms may also experience sadness, anxiety, or tension, as well as feelings of guilt.
Arpixor is used to treat adults whose disease is characterized by symptoms such as:
strong excitement, overflowing energy, reduced need for sleep, very fast speech, racing thoughts, and sometimes very severe irritability. In adults, this medicine also prevents the recurrence of the above symptoms in patients who have responded to Arpixor treatment.

2. Important information before taking Arpixor

When not to take Arpixor

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

Warnings and precautions

You should consult a doctor before starting to take Arpixor

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 Arpixor, you should discuss this with your doctor if you have:

• high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feelings of weakness) or a family history of diabetes.
• seizures, as your doctor may want to monitor you more closely.
• involuntary, irregular muscle movements, especially of the face.
• cardiovascular diseases (heart and circulatory 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, unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or signs of an allergic reaction, you should inform your doctor.
Arpixor may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be careful, especially if you are elderly or weakened.
If you are elderly and have dementia (loss of memory and other mental abilities), you or your caregiver or relative 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 related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.
You should immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very rapid or irregular heartbeat.
You should inform your doctor if you or your family/caregiver notice increased appetite or thirst, unusual behavior, impulse, actions that may harm you or others. These are so-called impulse control disorders and may include behaviors such as gambling, overeating, or excessive spending, abnormally high sexual desire, or being overly preoccupied with sexual thoughts or feelings.
Your doctor may adjust the dose or stop it.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be careful, especially if you are elderly or weakened.

Children and adolescents

This medicine should not be used in children and adolescents.

Arpixor and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those that are available without a prescription.
Blood pressure-lowering medicines: Arpixor may enhance the effects of blood pressure-lowering medicines. If you are taking medicines to control blood pressure, you should inform your doctor.
Taking Arpixor with other medicines may require a change in the dose of Arpixor. 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)

These medicines may increase the risk of side effects or decrease the effect of Arpixor. If you experience any unusual symptoms while taking any of these medicines with Arpixor, you should contact your doctor.
Medicines that increase serotonin levels are usually used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used in conditions such as 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 in depression, OCD, panic, and anxiety
• other antidepressant medicines (such as venlafaxine and tryptophan) used in 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
• analgesics (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 Arpixor, you should contact your doctor.

Taking Arpixor with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine.
In newborns whose mothers took Arpixor 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 child, you should contact your doctor.
When taking Arpixor, 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 do both. You should discuss with your doctor the best way to feed your child if you are taking this medicine.

Driving and using machines

While taking this medicine, seizures or vision problems may occur (see section 4).
You should not drive, use tools, or operate any machinery until you know how Arpixor affects you.

Arpixor contains lactose

If you have been diagnosed with an intolerance to some sugars, you should inform your doctor before taking this medicine.

3. How to take Arpixor

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose of Arpixor for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, which should not exceed 30 mg once a day.
If you feel that the effect of Arpixor is too strong or too weak, you should consult your doctor or pharmacist.
Arpixor 10 mg, 20 mg, and 30 mg: the tablet can be divided into equal doses.
Arpixor 15 mg: the score line is not intended for breaking the tablet.
Arpixor 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 Arpixor without first discussing it with your doctor.

Taking a higher dose of Arpixor than recommended

If you have taken more Arpixor tablets than your doctor recommended (or if someone else has taken some of the Arpixor tablets that were not intended for them), you should immediately contact your doctor or go to the nearest hospital, taking the packaging of the medicine with you.
Patient who have taken aripiprazole may experience the following symptoms:

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

Other symptoms may include:

• disorientation, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating, mental disorders, and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome)
• seizures

If you experience any of the above symptoms, you should immediately contact your doctor or pharmacist.

Missing a dose of Arpixor

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

Stopping treatment with Arpixor

You should not stop taking Arpixor even if you feel better. It is important to continue taking Arpixor for as long as your doctor has prescribed.
If you have any further questions about the use of this medicine, you should 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
• difficulty sleeping
• feeling anxious
• restlessness, especially motor, inability to stay still, difficulty sitting quietly
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements)
• uncontrolled muscle contractions or movements
• trembling
• headache
• fatigue
• drowsiness
• feeling of emptiness in the head
• trembling and blurred vision
• decreased or difficult bowel movements
• nausea
• malaise
• increased salivation
• vomiting
• feeling tired

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

• increased or decreased prolactin levels in the blood
• increased blood sugar levels
• depression
• changed or increased sexual interest
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• muscle disorders causing twisted 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, fainting
• hiccups

The following side effects have been reported since the introduction of Arpixor to the market, but their frequency is not known:

• low white blood cell count
• low platelet count
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, hives)
• development 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, suicide
• aggression
• agitation
• nervousness
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, mental disorders, 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, feelings of intoxication, fever, sweating, or muscle stiffness)
• speech disorders
• fixation of the eyeballs in one position
• sudden, unexpected death
• life-threatening irregular heartbeat
• heart attack
• 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 difficulty breathing (if you experience any of these symptoms, you should seek medical attention immediately)
• high blood pressure
• fainting
• accidental choking on food with a risk of developing pneumonia (lung infection)
• muscle spasm around the vocal cords
• pancreatitis
• difficulty swallowing
• diarrhea
• discomfort in the abdominal cavity
• discomfort in the stomach
• liver disorders
• hepatitis
• jaundice (yellowing of the skin and whites of the eyes)
• abnormal liver function tests
• 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 specific type of white blood cells (eosinophilia)
• abnormal muscle wasting, which can cause kidney problems
• muscle pain
• stiffness
• involuntary urination (incontinence)
• difficulty urinating
• exposure to neonatal withdrawal syndrome during pregnancy
• prolonged and/or painful erection
• difficulty regulating body temperature or overheating
• chest pain
• swelling of the hands, ankles, and feet
• in blood tests: increased or fluctuating blood sugar levels, increased hemoglobin A1c
• inability to resist impulses, urges, or temptations to perform acts that may be harmful to you or others, which are characterized by:
• strong tendencies to gamble despite serious consequences for you and your family
• variable or increased sexual interest and behavior, which are significantly related to you and others, e.g., increased sexual desire
• uncontrolled excessive shopping
• binge eating (consuming large amounts of food in a short period) or compulsive overeating (eating more food than usual and having a greater need to satisfy hunger)
• tendency to wander away. If you experience any of these behaviors, you should tell your doctor, who will suggest how to control or limit them.

In elderly patients with dementia, taking aripiprazole has been associated with a higher number of deaths. Additionally, cases of stroke or "mini-stroke" have been reported.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 Arpixor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month.
The batch number is stated after the abbreviation: Lot
There are no special precautions for storing the medicine.
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 pack and other information

What Arpixor contains

• The active substance of the medicine is aripiprazole. Arpixor 5 mg:Each tablet contains 5 mg of aripiprazole. Arpixor 10 mg:Each tablet contains 10 mg of aripiprazole. Arpixor 15 mg:Each tablet contains 15 mg of aripiprazole. Arpixor 20 mg:Each tablet contains 20 mg of aripiprazole. Arpixor 30 mg:Each tablet contains 30 mg of aripiprazole.
• Other ingredients are: lactose monohydrate, microcrystalline cellulose, cornstarch, hydroxypropylcellulose, crospovidone, colloidal anhydrous silica, magnesium stearate

What Arpixor looks like and contents of the pack

Arpixor, 5 mg: Oblong, biconvex tablets with the inscription "C1" on one side, with a main diameter of 8.5 ± 0.3 mm and a minor diameter of 5.0 ± 0.3 mm.
Arpixor 10 mg: Oblong, biconvex tablets with the inscription "C2" on one side, with a main diameter of 8.5 ± 0.3 mm and a minor diameter of 5.0 ± 0.3 mm.
Arpixor, 15 mg: Round, biconvex tablets with the inscription "C3" on one side and a diameter of 7.5 ± 0.3 mm.
Arpixor, 20 mg: Round, biconvex tablets with a score line, with a diameter of 8.5 ± 0.3 mm.
Arpixor, 30 mg: Round, biconvex tablets with the inscription "C7" on one side and a diameter of 10.0 ± 0.3 mm.
Arpixor is available in blisters /Aluminum/PVC/Aluminum/OPA, packed in cardboard boxes containing 14, 28, or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí (Barcelona), Spain
To obtain more detailed information, you should contact the representative of the marketing authorization holder
in Poland:
Neuraxpharm Polska sp. z o.o.
Domaniewska 37
02-672 Warsaw
info-poland@neuraxpharm.com

Date of last revision of the leaflet: 05/2024