Arpixor

Patient Information Leaflet

Arpixor 5 mg tablets
Arpixor 10 mg tablets
Arpixor 15 mg tablets
Arpixor 20 mg tablets
Arpixor 30 mg tablets
Aripiprazole
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Arpixor is and what it is used for
2. What you need to know 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 Arpixor is and what it is used for

Arpixor contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
It is used to treat adults with an illness characterised by symptoms such as:
seeing, hearing or sensing things that are not real, excessive suspiciousness,
false beliefs not based on reality, disorganised speech and behaviour, and emotional withdrawal.
Patients with these symptoms may also experience sadness, anxiety or tension, and feelings of guilt.

Arpixor is used to treat adults whose illness is characterised by symptoms such as:
marked excitement, overflowing energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes extreme irritability. In adults, this medicine also helps prevent the recurrence of these symptoms in patients who have responded to treatment with Arpixor.

2. Important information before using Arpixor

When not to use Arpixor

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

Warnings and precautions
Consult your doctor before starting treatment with Arpixor
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if you experience any thoughts or feelings of self-harm.
Before starting treatment with Arpixor, discuss the following with your doctor if the patient has:

• High blood sugar levels (characteristic symptoms include excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes.
• Seizures; your doctor may want to monitor the patient more frequently.
• Involuntary, irregular muscle movements, especially 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 the use of antipsychotic medicines has been associated with blood clot formation.
• A history of gambling addiction.

If the patient notices weight gain, unusual movements, drowsiness that interferes with daily activities, any swallowing difficulties, or symptoms of allergy, they should inform their doctor.
Arpixor may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls. Exercise caution, especially in elderly or weakened patients.
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.
Immediately inform your doctor if suicidal thoughts or feelings occur. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient experiences muscle stiffness or stiffness with high fever, sweating, changes in mental status, or very rapid or irregular heartbeat.
Inform your doctor if the patient or their family/caregiver notice increased appetite or thirst, unusual behaviour, impulsivity, or actions that could harm the patient or others. These are known as impulse control disorders and may include behaviours such as gambling, binge eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts or feelings.
The doctor may adjust the dose or discontinue treatment.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls. Exercise caution, especially in elderly or weakened patients.

Children and adolescents
This medicine should not be used in children and adolescents.

Arpixor and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.
Medicines that lower blood pressure: Arpixor may enhance the effect of blood pressure-lowering medicines. If the patient is taking medicines to control blood pressure, they should inform their doctor.
Taking Arpixor with other medicines may require dose adjustments of Arpixor.
It is especially important to inform your doctor if the patient is taking any of 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)
• 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 reduce the effectiveness of Arpixor. If any unusual symptoms occur while taking any of these medicines together with Arpixor, contact your doctor.
Medicines that increase serotonin levels are usually used in conditions including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• Triptans, tramadol, and tryptophan used for depression, generalized anxiety disorder, OCD, social phobia, migraine, and pain
• Selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety
• Other antidepressants (such as venlafaxine and tryptophan) used for 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 side effects; if any unusual symptoms occur while taking any of these medicines together with Arpixor, contact your doctor.

Taking Arpixor with food, drink, and alcohol
Arpixor can be taken with or without food.
Avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, 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 took Arpixor 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 problems. If these symptoms are observed in the newborn, contact your doctor.
If Arpixor is taken during breastfeeding, the doctor will discuss with the patient whether breastfeeding should be continued, considering the benefits of treatment and the benefits of breastfeeding for the infant. Both should not be combined. Discuss with your doctor the best way to feed the baby if the patient is taking this medicine.

Driving and using machines
While taking this medicine, seizures or vision problems may occur (see section 4).
Do not drive, use tools, or operate machinery until you know how Arpixor affects you.

Arpixor contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to use Arpixor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose of Arpixor in adults is 15 mg once daily. However, your doctor may prescribe a lower or
higher dose, which must not exceed 30 mg per day.
If you feel the effect of this medicine is too strong or too weak, 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 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 an improvement in your condition, do not change the dose or stop taking
Arpixor without first discussing it with your doctor.
Taking more Arpixor than recommended
If you take more Arpixor tablets than prescribed by your doctor (or if someone else
accidentally takes Arpixor tablets 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 aripiprazole may experience the following symptoms:

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

Other possible symptoms may include:

• confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating,
• muscle rigidity, drowsiness, slowed breathing, shortness of breath, high or low blood pressure, irregular heartbeat.

If any of the above symptoms occur, contact your doctor or
pharmacist immediately.
Missing a dose of Arpixor
If a dose is missed, the patient should take the missed dose as soon as they remember.
Do not take two doses on the same day.
Stopping Arpixor treatment
Do not stop taking Arpixor even if you feel better. It is important to continue taking
Arpixor for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

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

• diabetes
• difficulty sleeping
• feeling of anxiety
• restlessness, especially motor restlessness, inability to remain still, difficulty sitting quietly
• akathisia (a feeling of inner restlessness and a compulsion to keep moving)
• uncontrolled muscle contractions or movements
• tremor
• headache
• fatigue
• drowsiness
• feeling of emptiness in the head
• tremor and blurred vision
• reduced number or difficulty with bowel movements
• indigestion
• malaise
• increased salivation
• vomiting
• feeling of tiredness

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

• increased or decreased level of the hormone prolactin in the blood
• increased blood sugar level
• depression
• changed or increased interest in sexual activity
• 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
• drop in blood pressure upon standing causing dizziness, feeling of emptiness in the head, fainting
• hiccups

The following adverse effects have been reported after the marketing of orally administered Arpixor, but their frequency is unknown:

• low white blood cell count

• low platelet count

• allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, skin itching, urticaria)

• occurrence of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in blood and urine), or coma

• high blood sugar levels

• low sodium levels in the blood

• loss of appetite (anorexia)

• weight loss

• weight gain

• suicidal thoughts, suicide attempts, suicides

• aggression

• agitation

• nervousness

• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure, changes in heart rate, fainting (neuroleptic malignant syndrome)

• seizures

• serotonin syndrome (a reaction that may cause feelings of extreme well-being, drowsiness, lack of coordination, restlessness especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness)

• speech disorders

• fixed eye position (oculogyric crisis)

• sudden, unexpected death

• life-threatening irregular heartbeat

• heart attack

• slowed heart rate

• blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if any of these symptoms occur, the patient must seek immediate medical help)

• high blood pressure

• fainting

• accidental aspiration of food with risk of developing pneumonia (lung infection)

• muscle spasms around the larynx

• pancreatitis

• difficulty swallowing

• diarrhea

• discomfort in the abdominal area

• stomach discomfort

• liver disorders

• hepatitis

• yellowing of the skin and whites of the eyes (jaundice)

• abnormal liver function tests

• skin rash

• photosensitivity (skin sensitivity to light)

• hair loss (alopecia)

• 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, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzymes (visible in blood tests), and increased levels of a specific type of white blood cells (eosinophilia)

• abnormal muscle breakdown which may cause kidney problems

• muscle pain

• stiffness

• involuntary urination (urinary incontinence)

• difficulty urinating

• exposure during pregnancy leading to neonatal withdrawal syndrome

• prolonged and/or painful erection (priapism)

• difficulty regulating core body temperature or overheating

• chest pain

• swelling of hands, ankles, and feet

• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin

• inability to resist impulses, urges, or temptations to engage in behaviors that could be harmful to the patient or others, characterized by:

  • strong tendencies toward gambling despite serious consequences for the patient and family
  • changed or increased sexual interest and behaviors significantly affecting the patient and others, e.g. increased sexual drive
  • uncontrolled excessive shopping
  • binge eating (consuming large amounts of food in a short period of time) or compulsive overeating (eating more food than usual and a greater need to satisfy hunger)
  • tendency to wander away

If any of these behaviors occur, inform the treating physician, who will suggest ways to manage or reduce them.

In elderly patients with dementia treated with aripiprazole, there have been more cases ending in death. Additionally, cases of stroke or "mini-strokes" have been reported.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.

Adverse effects can be reported directly to:

Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Poland
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the responsible entity.

Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store the medicine Arpixor

Keep this medicine 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 stated month.
The batch number is indicated after the abbreviation: Lot
No special storage conditions are required for this medicine.
Medicines should 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 Arpixor contains

• The active substance 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: Monohydrate lactose, microcrystalline cellulose, maize starch, hydroxypropylcellulose, crospovidone, colloidal anhydrous silica, magnesium stearate.

What Arpixor looks like and contents of the pack
Arpixor 5 mg: Oval, biconvex tablets with the engraved mark "C1" on one side,
with a major diameter of 8.5 ± 0.3 mm and a minor diameter of 5.0 ± 0.3 mm.
Arpixor 10 mg: Oval, biconvex tablets with the engraved mark "C2" on one side,
with a major 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 engraved mark "C3" on one side,
with a diameter of 7.5 ± 0.3 mm.
Arpixor 20 mg: Round, biconvex tablets with score lines, with a diameter of 8.5 ± 0.3 mm.
Arpixor 30 mg: Round, biconvex tablets with the engraved mark "C7" on one side,
with 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 Authorisation 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

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]