Aricogan

Package leaflet: Information for the patient

Aricogan, 5 mg, tablets
Aricogan, 10 mg, tablets
Aricogan, 15 mg, tablets
Aricogan, 30 mg, tablets
(Aripiprazolum)
Please read carefully all the information in this leaflet before taking the medicine, as it contains important information for the patient.

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

Contents of the leaflet

1. What Aricogan is and what it is used for
2. What you need to know 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 Aricogan is and what it is 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 who have a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, suspiciousness, beliefs that are not based on reality, disorganized speech and behavior, and emotional blunting. Patients with these symptoms may also experience sadness, anxiety, tension, or feelings of guilt.
Aricogan is also used to treat adults and adolescents aged 13 years and older who have symptoms such as severe excitement, a sense of overflowing energy, greatly reduced need for sleep, very rapid speech, racing thoughts, and sometimes extreme irritability. In adults, Aricogan helps prevent 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 treatment with Aricogan, you should discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. You should immediately inform your doctor if you experience thoughts or feelings related to harming yourself.
Before using Aricogan, consult your doctor if the patient has any of the following symptoms:

• high blood sugar levels (characterized by excessive thirst, passing large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
• seizures (fits), as your doctor may wish to monitor you more closely;
• involuntary, irregular muscle movements, especially in the face;
• cardiovascular diseases (heart and circulation problems) in the patient or family history, stroke or "mini" stroke (transient ischaemic attack), abnormal blood pressure;
• blood clots in the patient or family history, as antipsychotic medicines are associated with an increased risk of blood clots;
• a history of gambling addiction.

If the patient notices weight gain, unusual movements, feels sleepy to the extent that it interferes with normal daily activities, has difficulty swallowing, or experiences allergic symptoms, they should consult a doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient or their caregiver or relative should inform the doctor whether the patient has previously had a stroke or "mini" stroke.
You should immediately inform your doctor if the patient develops thoughts or feelings about harming themselves. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if the patient experiences muscle stiffness or stiffness with high fever, sweating, altered mental status, or very fast or irregular heartbeat.
Inform your doctor if the patient or their close relatives notice behaviours resulting from an irresistible urge, impulse, or compulsion to perform unusual actions that may be harmful to the patient or others. These phenomena are known as impulse control disorders and may manifest as compulsive gambling, excessive appetite or spending behaviour, abnormally increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
Your doctor may decide to reduce the dose or discontinue treatment.
Aripiprazole may cause drowsiness, sudden drop in blood pressure when changing to an upright position, dizziness, and movement and balance disorders that may lead to falls. Particular caution is advised 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 it is safe and effective in this patient group.

Aricogan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines available without a prescription.
Medicines that lower blood pressure: Aricogan may enhance the effect of medicines used to lower blood pressure. Inform your doctor if the patient is taking blood pressure-lowering medicines.
Taking Aricogan together with certain medicines may require dose adjustments of Aricogan or other medicines. You must inform your doctor, especially if 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)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effectiveness of Aricogan. If the patient experiences any unusual symptoms while taking these medicines together with Aricogan, consult a doctor.
Medicines that increase serotonin levels are usually used to treat conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), 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, as well as 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 depressive episodes
• tricyclic antidepressants (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 the patient experiences any unusual symptoms while taking these medicines with Aricogan, contact your doctor.

Aricogan with food, drink and alcohol
Aricogan can be taken independently of meals.
Alcohol consumption should be avoided.

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 or pharmacist before using 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 problems. If any of these symptoms are observed in the baby, contact a doctor.
When Aricogan is used, the doctor will discuss with the patient whether she should breastfeed, taking into account the benefits of treatment for the mother and the benefits of breastfeeding for the child. Breastfeeding should not be performed during treatment with this medicine. Discuss with your doctor the best feeding method if the patient is taking this medicine.

Driving and operating machinery
Dizziness and visual disturbances (see section 4) may occur during treatment with this medicine. This should be taken into account in situations requiring full alertness, such as driving or operating machinery.

Aricogan contains lactose.
If the patient has an intolerance to certain sugars, consult a doctor before using this medicine.

3. How to take Aricogan
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose for adults is 15 mg once daily. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.

Use in children and adolescents
Treatment with Aricogan may be initiated at a low dose using the oral solution. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.

If the patient feels that the effect of Aricogan is too weak or too strong, consult your doctor or pharmacist.

Try to take Aricogan at the same time each day.
The medicine can be taken independently of meals. The medicine should always be taken with water, and tablets should be swallowed whole.

Even if the patient feels better, do not change the dose or stop taking the medicine without consulting the doctor.

Taking more Aricogan than prescribed
If more Aricogan has been taken than prescribed (or if someone else takes medicine not intended for them), contact a doctor immediately. If you cannot reach a doctor, go to the nearest hospital and bring the medicine packaging with you.
In patients who have taken an excessive dose of aripiprazole, the following symptoms have occurred:

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

If any of these symptoms occur, contact a doctor or go to the nearest hospital immediately.

Missing a dose of Aricogan
If a dose of Aricogan is missed, take it as soon as possible. Do not take a double dose to make up for a missed dose.

Stopping Aricogan treatment
Do not stop treatment just because the patient feels better. It is important to continue taking Aricogan for as long as your doctor has instructed.
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 experiences them.

Common adverse effects (may affect 1 in 10 patients):

• diabetes,
• sleep problems,
• feeling anxious,
• restlessness or inability to remain calm, difficulty sitting still,
• akathisia (a sensation of inner restlessness and a compulsion to make continual movements),
• uncontrolled tremors, jerking or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• tremor and blurred vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• nausea,
• increased salivation,
• vomiting,
• feeling tired.

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

• decreased or increased blood levels of prolactin,
• high blood sugar levels,
• depression,
• altered or increased sexual interest,
• uncontrolled movements of the mouth, tongue or limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision, light sensitivity,
• rapid heartbeat,
• drop in blood pressure upon standing, which may cause dizziness or fainting,
• hiccups.

The following adverse effects have been reported after marketing of oral aripiprazole, but their frequency cannot be estimated from available data:

• low white blood cell count,
• low platelet count,
• allergic reactions (e.g. swelling of lips, tongue, face and throat, itching, urticaria),
• onset or worsening of diabetes, ketoacidosis (presence of ketones in blood and urine), coma,
• high blood sugar levels,
• hyponatraemia (low sodium levels in blood),
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts or suicide,
• feelings of aggression,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rhythm, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction which may cause feelings of extreme well-being, drowsiness, clumsiness, motor restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness),
• speech disorders,
• fixed eye position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slow heartbeat,
• venous thrombosis, particularly in legs (symptoms include swelling, pain and redness in legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (if patients notice any of these symptoms, they should seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental aspiration during feeding with risk of developing pneumonia,
• muscle spasms around the larynx,
• pancreatitis,
• difficulty swallowing,
• diarrhoea,
• feeling of discomfort in the abdomen,
• feeling of discomfort in the stomach,
• liver failure,
• hepatitis,
• jaundice (yellowing of the skin and whites of the eyes),
• abnormal liver function test results,
• skin rash,
• photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles influenza-like symptoms with a rash on the face, followed by a rash on other body parts, high fever, swollen lymph nodes, elevated liver enzymes (seen in blood tests), and increased levels of a specific type of white blood cells (eosinophilia),
• rhabdomyolysis (muscle breakdown), which may lead to kidney problems,
• muscle pain,
• stiffness,
• involuntary urination (urinary incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns following exposure to the medicine during pregnancy,
• prolonged and/or painful erection,
• difficulty regulating core body temperature or overheating,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increasing or fluctuating glucose levels, increased levels of glycated haemoglobin,
• inability to resist an impulse, drive or temptation to perform an activity that could harm the patient or others, including behaviours such as:
  • strong urge to gamble despite serious personal or family consequences,
  • altered or increased sexual interest and behaviour of significant concern to the patient or others, e.g. increased libido,
  • uncontrolled excessive shopping,
  • uncontrolled 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 or travel. If any of these behaviours occur, inform your doctor to discuss possible ways to alleviate or manage the symptoms.

In elderly patients with dementia treated with aripiprazole, a higher number of fatal cases have been reported. Additionally, there have been reports of stroke or "mini" stroke.

Additional adverse effects in children and adolescents

In adolescents aged 13 years and older, adverse effects occurred at similar types and frequencies as in adults, except for somnolence, uncontrolled jerking or sudden movements, motor restlessness, and fatigue, which occurred very commonly (more than 1 in 10 patients), and abdominal pain in the upper part of the stomach, dry mouth, increased heart rate, weight gain, increased appetite, muscle tremor, uncontrolled limb movements, and dizziness, particularly when rising from lying or sitting positions, which occurred commonly (more than 1 in 100 patients).

Reporting of adverse effects

If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]

Adverse effects can also be reported to the marketing authorisation holder.

By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Aricogan

Keep this medicine 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 stated month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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.
• Other ingredients are: monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate, and:

Aricogan 5 mg, tablets
Indigotine, lake (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
Uncoated, blue, speckled tablets, rectangular in shape, with the imprint "250" on one side and smooth on the other. Dimensions: 8.1 mm x 4.6 mm.
Aricogan 10 mg, tablets
Uncoated, pink, speckled tablets, rectangular in shape, with the imprint "252" on one side and smooth on the other. Dimensions: 8.1 mm x 4.6 mm.
Aricogan 15 mg, tablets
Uncoated, yellow, speckled, round tablets with bevelled edges, with the imprint "253" on one side and smooth on the other. Diameter: 7.3 mm.
Aricogan 30 mg, tablets
Uncoated, pink, speckled, round tablets with bevelled edges, with the imprint "L255" on one side and smooth on the other. Diameter: 9.1 mm.

Aricogan is packaged in OPA/Aluminum/PVC/Aluminum blisters in cardboard boxes containing 28, 30, 56, or 60 tablets.

Marketing Authorisation 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

For further information, please contact the representative of the Marketing Authorisation 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
[email protected]