ABILIUM 10 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Abilium, 10 mg, Hard Capsules
3. Abilium, 15 mg, Hard Capsules
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
4. What is Abilium and What is it Used For
5. Important Information Before Taking Abilium
   1. When Not to Take Abilium
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Abilium and Other Medications
   5. Taking Abilium with Food, Drink, and Alcohol
   6. Pregnancy, Breastfeeding, and Fertility
   7. Driving and Operating Machinery
   8. Abilium Contains Sodium
6. How to Take Abilium
   1. Administration in Children and Adolescents
   2. Method of Administration
   3. Taking a Higher Dose of Abilium Than Recommended
   4. Missing a Dose of Abilium
   5. If you miss a dose, take the missed dose as soon as you remember. Do not take two doses on the same day.
   6. Stopping Treatment with Abilium
   7. Do not stop treatment if you feel better.
7. Possible Side Effects
   1. Additional Side Effects in Children and Adolescents
   2. Reporting Side Effects
8. How to Store Abilium
9. Contents of the Package and Other Information
   1. What Abilium Contains
   2. What Abilium Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:
   6. Date of Last Revision of the Package Leaflet:

Package Leaflet: Information for the Patient

Abilium, 10 mg, Hard Capsules

Abilium, 15 mg, Hard Capsules

Aripiprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm others, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Abilium and What is it Used For
• 2. Important Information Before Taking Abilium
• 3. How to Take Abilium
• 4. Possible Side Effects
• 5. How to Store Abilium
• 6. Contents of the Package and Other Information

1. What is Abilium and What is it Used For

Abilium contains the active substance aripiprazole and belongs to a group of medications called antipsychotics.
It is used to treat adults and adolescents aged 15 years and older with schizophrenia, a disease characterized by symptoms such as hearing, seeing, and feeling things that are not real, suspiciousness, delusions, disorganized speech and behavior, and emotional flattening. Patients with these symptoms may also feel sad, anxious, or tense, and may have feelings of guilt.
Abilium is used to treat adults and adolescents aged 13 years and older with mania, a disease characterized by symptoms such as excessive excitement, increased energy, reduced need for sleep, very fast speech, racing thoughts, and sometimes extreme irritability. In adults, this medication also prevents the recurrence of these symptoms in patients who have responded to Abilium treatment.

2. Important Information Before Taking Abilium

When Not to Take Abilium

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

Warnings and Precautions

Before starting treatment with Abilium, discuss it with your doctor.
During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.
Immediately inform your doctor if you experience any thoughts or feelings related to self-harm.
Before starting treatment with Abilium, inform your doctor if you have:

• high blood sugar levels(characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes;
• seizures (epilepsy), as this may indicate that your doctor will want to monitor you closely;
• involuntary, irregular muscle movements, especially of the face;
• cardiovascular diseases(heart and blood vessel diseases) , a family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure;
• blood clotsor a family history of blood clots, as the use of antipsychotic medications is associated with the formation of blood clots;
• gambling addictionin the past.

If you experience weight gain, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, you should inform your doctor.
If an elderly patient with dementia experiences a stroke or "mini" stroke, they (their caregiver or relative) should inform their doctor if this has ever occurred.
Immediately inform your doctor if you experience any thoughts or feelings related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.
Immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental status changes, or very fast or irregular heartbeat.
If you or your family member or caregiver notice that you are developing an unusual behavior and cannot resist the impulse, drive, or temptation to perform activities that may harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, overeating, or uncontrollable spending, excessive sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
Your doctor may consider changing the dose or discontinuing the medication.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which may lead to falls.
Caution should be exercised, especially in elderly or weakened patients.

Children and Adolescents

Abilium should not be used in children and adolescents under the age of 13. It is not known whether the use of aripiprazole is safe and effective in these patients.

Abilium and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take, including those available without a prescription.
Blood pressure-lowering medications:
Abilium may enhance the effects of blood pressure-lowering medications. If you are taking blood pressure-lowering medications, inform your doctor.
Taking Abilium with other medications may require a dose adjustment of Abilium or other medications you are taking. It is especially important to inform your doctor about the use of the following medications:

• medications used to treat heart rhythm disorders(such as quinidine, amiodarone, flecainide);
• antidepressant medications or herbal remedies used to treat depression and anxiety(such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medications(such as ketoconazole, itraconazole);
• certain medications used to treat HIV infection(such as efavirenz, nevirapine, protease inhibitors, e.g., indinavir, ritonavir);
• antiepileptic medicationsused to treat epilepsy(such as carbamazepine, phenytoin, phenobarbital);
• certain antibioticsused to treat tuberculosis (rifabutin, rifampicin).

Taking these medications may increase the risk of side effects or reduce the effectiveness of Abilium. If you experience any unusual symptoms while taking these medications with Abilium, inform your doctor.
Medications that increase serotonin levels are usually used to treat 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), and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs, such as paroxetine and fluoxetine) used to treat depression, OCD, panic disorder, and anxiety;
• other antidepressant medications (such as venlafaxine and tryptophan) used to treat 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;
• pain relievers (such as tramadol and pethidine) used to alleviate pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

Taking these medications may increase the risk of side effects. If you experience any unusual symptoms while taking these medications with Abilium, inform your doctor.

Taking Abilium with Food, Drink, and Alcohol

This medication can be taken with or without food.
Alcohol should be avoided.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medication.
In newborns whose mothers took aripiprazole during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice any of these symptoms in your child, contact your doctor.
If you are taking Abilium, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take the medication and breastfeed. You should discuss with your doctor the best way to feed your child if you are taking this medication.

Driving and Operating Machinery

During treatment with this medication, dizziness and vision disturbances (see section 4) may occur.
This should be taken into account when performing tasks that require full attention, such as driving or operating machinery.

Abilium Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per capsule, which means the medication is considered "sodium-free".

3. How to Take Abilium

This medication should always be taken as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
The recommended dose of Abilium for adults is 15 mg per day.However, your doctor may prescribe a lower or higher dose, which should not exceed 30 mg per day.

Administration in Children and Adolescents

Treatment can be initiated with a low dose of the oral solution (liquid).
The dose may 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 per day.

Method of Administration

Abilium should be taken orally, with or without food.
If you feel that the effect of Abilium is too strong or too weak, consult your doctor or pharmacist.
Abilium should be taken daily at the same time.It does not matter whether the tablet is taken with food or without food. The tablet should be swallowed whole and washed down with water.
Even if you feel better, do not change the dose or stop taking Abilium without consulting your doctor.

Taking a Higher Dose of Abilium Than Recommended

In case of taking a higher dose of Abilium than prescribed by your doctor (or if someone else has taken some of the medication not intended for them), immediately contact your doctor. If you have difficulty contacting your doctor, go to the nearest hospital, taking the medication packaging with you.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

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

Other symptoms may include:

• severe confusion, seizures (epilepsy), coma, simultaneous fever, rapid breathing, excessive sweating;
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, abnormal heart rhythm.

If you experience any of these symptoms, immediately contact your doctor or hospital.

Missing a Dose of Abilium

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

Stopping Treatment with Abilium

Do not stop treatment if you feel better.

It is very important to take Abilium as directed by your doctor and for the period prescribed by your doctor.
In case of any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Abilium can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes,
• sleep disturbances,
• feeling anxious,
• feeling restless and unable to sit or stand still,
• akathisia (feeling of inner restlessness and a compulsion to perform continuous movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• blurred vision,
• reduced bowel movements or difficulty with bowel movements,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling tired.

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

• decreased or increased prolactin levels in the blood,
• high blood sugar levels,
• depression,
• changes in sexuality or increased interest in sex,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorders causing twisting 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, 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:

• decreased white blood cell count,
• decreased platelet count,
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, rash),
• onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the 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, attempted suicide, and completed suicide,
• feeling aggressive,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness, and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (symptoms: inappropriate feeling of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling of intoxication, fever, sweating, or muscle stiffness),
• speech disorders,
• fixation of the eyeballs in one position,
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs, chest pain, and difficulty breathing - if you experience any of these symptoms, you must immediately see a doctor),
• high blood pressure,
• fainting,
• accidental choking on food - risk of pneumonia,
• muscle spasm around the vocal cords,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• jaundice - yellowing of the skin and whites of the eyes,
• abnormal liver test results,
• increased creatine phosphokinase activity,
• 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 cell (eosinophilia),
• abnormal breakdown of muscle leading to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination,
• difficulty urinating,
• withdrawal syndrome in newborns in case of exposure to the medication during pregnancy,
• prolonged and (or) painful erection,
• difficulty regulating body temperature or overheating,
• breast pain,
• swelling of the hands, ankles, or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin levels,
• inability to resist the impulse, drive, or temptation to perform activities and behaviors, such as:
• excessive gambling despite significant personal or family consequences,
• altered or increased interest in sex and behaviors that significantly disturb the patient or others, such as increased sexual drive,
• 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.

If you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.
In elderly patients with dementia taking aripiprazole, more cases of death have been reported. Additionally, cases of stroke or "mini" stroke have been noted.

Additional Side Effects in Children and Adolescents

In adolescents aged 13 years and older, side effects occurred with a similar frequency and type as in adults, except for drowsiness, uncontrolled trembling or movements, restlessness, and fatigue, which occurred very frequently (more than 1 in 10 patients) and upper abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle tremors, uncontrolled limb movements, and dizziness, especially when standing up from a lying or sitting position, which occurred frequently (more than 1 in 100 patients).

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C, 02-222 Warsaw,
phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Abilium

Store in a temperature below 30°C.
Store in the original packaging to protect from moisture.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after: "EXP". The expiration date refers to the last day of the month.
Medications should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Abilium Contains

Abilium, 10 mg:

• The active substance of the medication is aripiprazole. Each hard capsule contains 10 mg of aripiprazole.
• Other ingredients are: Microcrystalline cellulose Sodium carboxymethyl cellulose type A Povidone Colloidal anhydrous silica Magnesium stearate Carmine (E 120) Titanium dioxide (E 171) Gelatin

Abilium, 15 mg:

• The active substance of the medication is aripiprazole. Each hard capsule contains 15 mg of aripiprazole.
• Other ingredients are: Microcrystalline cellulose Sodium carboxymethyl cellulose type A Povidone Colloidal anhydrous silica Magnesium stearate Yellow iron oxide (E 172) Titanium dioxide (E 171) Gelatin

What Abilium Looks Like and Contents of the Package

Abilium, 10 mg
Hard, gelatin, opaque capsules No. 3, pink in color.
Capsule contents: White to creamy white powder.
Abilium, 15 mg
Hard, gelatin, opaque capsules No. 2, creamy in color.
Capsule contents: White to creamy white powder.
One blister pack contains 7 capsules.
The single pack contains 2 or 4 or 8 blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
pharma2pharma Sp. z o.o.
Klaudyny 38/117
01-684 Warsaw
Manufacturer
Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
A. Fleminga 2
03-176 Warsaw
To obtain more detailed information about this medication, contact the local representative of the marketing authorization holder:
VITAMED PHARMACEUTICALS Sp. z o.o.
Posła Józefa Ostrowskiego 24
97-213 Smardzewice
e-mail: [email protected]

This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Poland:
Abilium
Spain:
Abilium 10 mg hard capsules EFG
Abilium 15 mg hard capsules EFG

Date of Last Revision of the Package Leaflet: