Aricogan

Leaflet included in the packaging: patient information

Aricogan, 5 mg, tablets
Aricogan, 10 mg, tablets
Aricogan, 15 mg, tablets
Aricogan, 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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Aricogan and what is it used for
• 2. Important information before taking Aricogan
• 3. How to take Aricogan
• 4. Possible side effects
• 5. How to store Aricogan
• 6. Contents of the pack and other information

1. What is Aricogan and what is it used for

Aricogan 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 a disease characterized by symptoms such as hearing, seeing, and feeling phenomena that do not exist in reality, suspiciousness, beliefs contrary to reality, incoherent speech and behavior, and emotional numbness. Patients with these symptoms may also feel sadness, fear, or tension, as well as guilt.
Aricogan is used to treat adults and adolescents aged 13 years and older with symptoms such as severe excitement, overwhelming energy, much reduced need for sleep, very rapid speech, racing thoughts, and sometimes very severe irritability. In adults, the medicine prevents the recurrence of these symptoms in patients who have responded to treatment with Aricogan.

2. Important information before taking Aricogan

When not to take Aricogan:

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

Warnings and precautions

Before starting to take Aricogan, you should discuss it with your doctor.
During treatment with aripiprazole, cases of suicidal thoughts and behaviors have been reported. You should immediately inform your doctor if you experience thoughts or feelings of self-harm.
Before taking Aricogan, you should consult your doctor if you have any of the following symptoms:

• high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a history of diabetes;
• seizures (convulsions), as your doctor may want to monitor you more closely;
• involuntary, irregular movements of the muscles, especially in the face;
• circulatory system diseases (heart and circulatory system diseases) that have occurred in you or your family, stroke or "mini" stroke, abnormal blood pressure;
• blood clots that have occurred in you or your family, as the use of antipsychotic medicines is associated with the formation of blood clots;
• a history of gambling addiction.

If you notice weight gain, involuntary movements, drowsiness that disrupts your daily activities, difficulty swallowing, or allergic symptoms, you should consult your doctor.
If an elderly patient has dementia (loss of memory and other mental abilities), the patient, their caregiver, or relative should inform the doctor if the patient has had a stroke or "mini" stroke in the past.
You should immediately inform your doctor if you experience thoughts or feelings of self-harm. Suicidal thoughts and behaviors have been reported during treatment with aripiprazole.
You should immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, changes in mental status, or rapid or irregular heartbeat.
You should inform your doctor if you or your loved ones notice behaviors that are the result of irresistible impulse, temptation, or compulsion to perform certain unusual actions that may be harmful to you or others. These phenomena are called impulse control disorders and may manifest as behaviors such as:

• compulsive gambling despite serious personal or family consequences;
• changed or increased sexual interests and behaviors of significant importance to you or others, e.g., increased sexual desire;
• uncontrolled excessive shopping;
• uncontrolled excessive 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);
• impulse to wander and travel. If you experience any of these behaviors, you should inform your doctor to discuss possible ways to alleviate symptoms or cope with them.

Aripiprazole may cause drowsiness, a sudden drop in blood pressure when changing position to standing, dizziness, and movement and balance disorders that can cause falls. You should be particularly careful in the case of 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 it is safe and effective in this patient group.

Aricogan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as medicines you plan to take, including those available without a prescription.
Blood pressure-lowering medicines: Aricogan may increase the effect of medicines used to lower blood pressure. You should inform your doctor that you are taking blood pressure-lowering medicines.
Taking Aricogan with certain medicines may require a change in the dose of Aricogan or other medicines. You should necessarily inform your doctor, especially when taking 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 infections (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 effect of Aricogan. If you experience any unusual symptoms while taking these medicines with Aricogan, you should consult your doctor.
Medicines that increase serotonin levels are usually used to treat disorders such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, and 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 major depressive episodes
• tricyclic antidepressant medicines (such as clomipramine and amitriptyline) used to treat depression
• St. John's wort (Hypericum perforatum) used as a herbal preparation for mild depression
• painkillers (such as tramadol and pethidine) used to treat 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 Aricogan, you should consult your doctor.

Aricogan with food, drink, and alcohol

Aricogan 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 or pharmacist before taking this medicine.
The following symptoms may occur in newborns of mothers who took Aricogan during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, feeding difficulties. If any of these symptoms are observed in the child, you should contact a doctor.
In the case of taking Aricogan, your doctor will discuss with you whether you should breastfeed, taking into account the benefits of treatment for you and the benefits of breastfeeding for your child. You should not breastfeed while taking this medicine.
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, dizziness and vision disturbances may occur (see section 4). You should take this into account in situations where full alertness is required, e.g., when driving a vehicle or operating machinery.

Aricogan contains lactose

If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Aricogan

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 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

Treatment with Aricogan can be started with a low dose, using an oral solution. The dose can 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 Aricogan is too weak or too strong, you should consult your doctor or pharmacist.
You should try to take Aricogan at the same time every day.
The medicine can be taken with or without food. You should always swallow the tablets whole with water.
Even if you feel better, you should not change the dose or stop taking the medicine without consulting your doctor.

Taking a higher dose of Aricogan than recommended

In case of taking a higher dose of Aricogan than recommended (or if someone else has taken the medicine not intended for them), you should immediately contact a doctor. If it is not possible to contact a doctor, you should go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

• rapid heartbeat, agitation, or aggressive behavior, speech disturbances
• involuntary movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, rapid breathing, excessive sweating
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat

In case of any of these symptoms, you should immediately contact a doctor or go to the nearest hospital.

Missing a dose of Aricogan

In case of missing a dose of Aricogan, you should take it as soon as possible. You should not take a double dose to make up for the missed dose.

Stopping treatment with Aricogan

You should not stop treatment just because you feel better. It is important to take Aricogan for as long as your doctor has prescribed it.
If you have any further questions about taking 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
• sleep disturbances
• feeling of sadness
• restlessness, or inability to stay still, difficulty sitting still
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements)
• involuntary trembling, jerking, or writhing movements
• tremors
• headache
• fatigue
• drowsiness
• dizziness
• tremors and blurred vision
• reduced number of bowel movements or difficulty in bowel movements
• nausea
• vomiting
• increased saliva production
• feeling of fatigue

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

• reduced or increased prolactin levels in the blood
• high blood sugar levels
• depression
• changed or increased sexual interests
• involuntary movements of the mouth, tongue, and lips (tardive dyskinesia)
• muscle disorders causing twisting movements (dystonia)
• restless legs syndrome
• double vision, increased sensitivity of the eyes to light
• rapid heartbeat
• drop in blood pressure when standing up, which may cause dizziness or fainting
• hiccups

The following side effects have been reported after the marketing of aripiprazole in oral form, but the frequency of their occurrence is not known (cannot be determined from the available data):

• low white blood cell count
• low platelet count
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, hives)
• onset or worsening of diabetes, diabetic ketoacidosis (presence of ketone bodies in the blood and urine), coma
• high blood sugar levels
• low sodium levels in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• suicidal thoughts, suicide attempts, or suicide
• feeling of aggression
• agitation
• nervousness
• fever, stiffness, rapid breathing, sweating, changes in mental status, 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, intoxication, fever, sweating)
• speech disorders
• fixation of the eyeballs in one position
• sudden unexplained 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 blood vessels to the lungs, causing chest pain and breathing difficulties (if you notice any of these symptoms, you should immediately seek medical attention)
• high blood pressure
• fainting
• accidental choking on food with a risk of developing pneumonia
• muscle spasm around the vocal cords
• pancreatitis
• difficulty swallowing
• diarrhea
• discomfort in the abdomen
• discomfort in the liver
• liver failure
• liver inflammation
• yellowing of the skin and whites of the eyes
• abnormal liver function 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, enlarged lymph nodes, elevated liver enzyme activity (visible in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia)
• muscle breakdown, which can lead to kidney disorders
• muscle pain
• stiffness
• involuntary urination (incontinence)
• difficulty urinating
• withdrawal symptoms 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 impulse, temptation, or compulsion to perform activities that may harm you or others, including behaviors such as:
• strong impulse to gamble despite serious personal or family consequences
• changed or increased sexual interests and behaviors of significant importance to you or others, e.g., increased sexual desire
• uncontrolled excessive shopping
• uncontrolled excessive 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)
• impulse to wander and travel. If you experience any of these behaviors, you should inform your doctor to discuss possible ways to alleviate symptoms or cope with them.

In elderly patients with dementia taking aripiprazole, more cases of fatal outcomes have been reported. Additionally, there are reports of stroke or "mini" stroke.

Additional side effects in children and adolescents

In adolescents aged 13 years and older, side effects have occurred with a similar frequency and type as in adults, with the exception of drowsiness, involuntary trembling, or sudden movements, restlessness, and fatigue, which occur very frequently (more frequently than in 1 in 10 patients), as well as abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, tremors, involuntary movements of the limbs, and dizziness, especially when standing up from a lying or sitting position, which occur frequently (more frequently than in 1 in 100 patients).

Reporting side effects

If you experience any side effects, including any side effects not mentioned in the leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.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 Aricogan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
This medicine does not require special temperature storage conditions.
Store in the original packaging to protect from moisture.
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 Aricogan contains

• The active substance is aripiprazole. Each tablet contains 5/10/15/30 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate, and:

Aricogan 5 mg, tablets
Indigo carmine (E 132)
Aricogan 10 mg, tablets
Red iron oxide (E 172)
Aricogan 15 mg, tablets
Yellow iron oxide (E 172)
Aricogan 30 mg, tablets
Red iron oxide (E 172)

What Aricogan looks like and contents of the pack

Aricogan 5 mg, tablets
Tablets are blue, speckled, rectangular, and have the inscription "250" on one side, and are smooth on the other side. Dimensions: 8.1 mm x 4.6 mm.
Aricogan 10 mg, tablets
Tablets are pink, speckled, rectangular, and have the inscription "252" on one side, and are smooth on the other side. Dimensions: 8.1 mm x 4.6 mm.
Aricogan 15 mg, tablets
Tablets are yellow, speckled, round with beveled edges, and have the inscription "253" on one side, and are smooth on the other side. Diameter: 7.3 mm.
Aricogan 30 mg, tablets
Tablets are pink, speckled, round with beveled edges, and have the inscription "L255" on one side, and are smooth on the other side. Diameter: 9.1 mm.
Aricogan is packaged in OPA/Aluminum/PVC/Aluminum blisters in cardboard boxes containing 28, 30, 56, 60 tablets.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer/Importer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
GE Pharmaceuticals Ltd.
Industrial Zone “Chekanitza-South” area,
2140 Botevgrad
Bulgaria
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: 25.11.2024