Abilium

Package leaflet: Information for the patient

Abilium, 10 mg, hard capsules
Abilium, 15 mg, hard capsules
Aripiprazole
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Abilium is and what it is 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 pack and other information

1. What Abilium is and what it is used for

Abilium contains the active substance aripiprazole and belongs to the group of antipsychotic medicines.
It is used to treat schizophrenia in adults and adolescents aged 15 years and older. Schizophrenia is a condition characterised by symptoms such as hearing, seeing, or sensing things that are not real, suspiciousness, beliefs that are not based on reality, disorganised speech and behaviour, and emotional blunting. Patients with these symptoms may also experience sadness, anxiety, tension, or feelings of guilt.
Abilium is also used to treat mania in adults and adolescents aged 13 years and older. Mania is characterised by symptoms such as intense excitement, overwhelming energy, reduced need for sleep compared to usual, very rapid speech, racing thoughts, and sometimes extreme irritability. In adults, this medicine also helps prevent recurrence of these symptoms in patients who have responded to treatment with Abilium.

2. Important information before using Abilium

When not to use Abilium

• if the patient has hypersensitivity to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Abilium, discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if you experience any thoughts or feelings related to harming yourself.
Before starting treatment with Abilium, inform your doctor if the patient has:

• high blood sugar levels (typical symptoms include excessive thirst, passing large amounts of urine, increased appetite and feeling weak) or a family history of diabetes;
• seizures (epilepsy), as this may mean your doctor will want to monitor you closely;
• involuntary, irregular muscle movements, especially of the facial muscles;
• cardiovascular diseases (heart and blood vessel diseases), a family history of cardiovascular disease, stroke or "mini" stroke, or abnormal blood pressure;
• blood clots or a family history of blood clots, as use of antipsychotic medicines has been associated with formation of blood clots;
• a history of gambling addiction.

If the patient notices weight gain, development of unusual movements, drowsiness interfering with daily activities, any difficulty swallowing or symptoms of allergy, they should inform their 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 if the patient has ever had a stroke or "mini" stroke.
Immediately inform your doctor if you experience any thoughts or feelings related to harming yourself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform your doctor if the patient develops muscle stiffness or stiffness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient starts to display a tendency towards unusual behaviour and is unable to resist an impulse, urge or temptation to carry out activities that could harm themselves or others, they should tell their doctor. These phenomena are called impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating or uncontrollable spending, excessive sexual drive or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider it necessary to adjust the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls.
Exercise caution, particularly in elderly or weakened patients.

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

Abilium 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:
Abilium may enhance the effect of medicines that reduce blood pressure. If the patient is taking medicines to lower blood pressure, they should inform their doctor.
Taking Abilium together with other medicines may require adjustment of the dose of Abilium or other medicines the patient is taking. 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).

Taking these medicines may increase the risk of adverse effects or reduce the effectiveness of Abilium. If the patient experiences any unusual symptoms while taking these medicines with Abilium, they should inform their doctor.

Medicines that increase serotonin levels are usually used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine and pain:

• triptans, tramadol and tryptophan used in treating conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, 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 severe depression;
• 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 relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

Taking these medicines may increase the risk of adverse effects. If the patient experiences any unusual symptoms while taking these medicines with Abilium, they should inform their doctor.

Taking Abilium with food, drink and alcohol
This medicine can be taken regardless of meals.
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Newborns whose mothers have taken aripiprazole 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 you observe any of these symptoms in your newborn, contact your doctor.
If the patient is taking Abilium, the doctor will discuss with her whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. You should not take this medicine and breastfeed at the same time. Discuss with your doctor the best feeding methods for your baby if you are taking this medicine.

Driving and operating machinery
During treatment with this medicine, dizziness and visual disturbances may occur (see section 4).
This should be taken into account when performing activities requiring full attention, such as driving or operating machinery.

Abilium contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Abilium

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of the medicine in adults is 15 mg once daily. However, the doctor may prescribe a lower or
higher dose, which must not exceed 30 mg per day.
Use in children and adolescents
Treatment may be initiated with a low dose of the oral solution (liquid) form.
The dose may be gradually increased to the recommended dose for adolescents of 10 mg once
daily. However, the treating physician may prescribe a lower or higher dose, up to a maximum of
30 mg per day.
Method of administration
Abilium should be taken orally, independent of meals.
If the effect of Abilium seems too strong or too weak, consult a doctor or pharmacist.
Abilium 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 the patient feels an improvement in their condition, the dose should not be changed or
treatment discontinued without first consulting the treating physician.
Taking more Abilium than prescribed
If a dose of Abilium greater than recommended is taken (or if someone else takes some of the
medicine not intended for them), contact the treating physician immediately. If unable to contact
the doctor promptly, go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken an excessive dose of aripiprazole, the following symptoms have occurred:

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

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, fever, rapid breathing, excessive sweating;
• muscle rigidity and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm.

If any of the above symptoms occur in a patient, contact a doctor or hospital immediately.
Missed dose of Abilium
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 treatment with Abilium
Do not stop treatment even if the patient feels better.
It is very important to take Abilium exactly as directed by the doctor and for the duration recommended
by the doctor.
If there are any further doubts regarding the use of this medicine, consult a 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 1 in 10 patients):

• diabetes,
• sleep disturbances,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (a sensation of inner restlessness and a compulsion to keep moving),
• uncontrollable tremors, jerking movements, or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• blurred or double vision,
• reduced number of bowel movements or difficulty defecating,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

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

• decreased or increased blood prolactin levels,
• high blood sugar levels,
• depression,
• changes in sexuality or excessive interest in sex,
• uncontrollable movements of the mouth, tongue, or limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• light sensitivity of the eyes,
• rapid heartbeat,
• reduced blood pressure when standing, causing dizziness, feeling faint, or fainting,
• hiccups.

The following adverse effects have been reported after the introduction of oral aripiprazole to the market, but their frequency is not known:

• reduced number of white blood cells,
• reduced number of platelets,
• allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, itching, rash),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine), or coma,
• high blood sugar levels,
• low sodium levels in blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts, and completed suicides,
• feeling of aggression,
• agitation,
• nervousness,
• occurrence of fever, muscle stiffness, rapid breathing, sweating, altered consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (symptoms: inappropriate feeling of extreme happiness, drowsiness, lack of coordination, restlessness, especially motor restlessness, feeling of alcohol intoxication, fever, sweating, or muscle stiffness),
• speech disorders,
• fixed eye deviation,
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, and redness, chest pain, and breathing difficulties – if any of these symptoms occur, the patient must immediately contact a doctor),
• high blood pressure,
• fainting,
• accidental aspiration of food – risk of pneumonia,
• muscle spasms 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 function tests,
• increased creatine kinase activity,
• skin rash,
• photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially 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 leading to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination,
• difficulty urinating,
• withdrawal syndrome in newborns following exposure to the drug during pregnancy,
• prolonged and/or painful erection,
• difficulty regulating core body temperature or overheating,
• breast pain,
• swelling of hands, ankles, or feet,
• in blood tests: increased or fluctuating blood glucose levels, increased glycated hemoglobin levels,
• inability to resist an impulse, drive, or temptation to engage in activities and behaviors such as:
  • excessive gambling despite serious personal or family consequences,
  • altered or increased interest in sexual activity and behaviors significantly disturbing to the patient or others, e.g. increased sexual drive,
  • uncontrollable excessive shopping,
  • compulsive 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 patients experience such behaviors, they should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

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

Additional adverse effects in children and adolescents

In adolescents aged 13 years and older, adverse effects occurred at a similar frequency and type as in adults, except for somnolence, uncontrollable tremors or movements, motor restlessness, and fatigue, which occurred very commonly (in more than 1 in 10 patients), and abdominal pain in the upper part of the abdomen, dry mouth, rapid heartbeat, weight gain, increased appetite, muscle tremors, uncontrollable limb movements, and dizziness, particularly when standing up from a lying or sitting position, which occurred commonly (in more than 1 in 100 patients).

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel: 22 49-21-301, Fax: 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 Abilium

Store below 30 °C.
Keep in the original packaging to protect from moisture.
Keep the 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Abilium contains
Abilium 10 mg:

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

Abilium 15 mg:

• The active substance is aripiprazole. Each hard capsule contains 15 mg of aripiprazole.
• Other ingredients are: Microcrystalline cellulose, Sodium carboxymethyl starch 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 pack
Abilium 10 mg
Hard, gelatin, opaque size 3 capsules, pink in colour.
Contents of the capsules: white to cream-coloured powder.
Abilium 15 mg
Hard, gelatin, opaque size 2 capsules, cream in colour.
Contents of the capsules: white to cream-coloured powder.
One blister contains 7 capsules.
The unit pack contains 2, 4 or 8 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
pharma2pharma Sp. z o.o.
ul. Klaudyny 38/117
01-684 Warsaw
Poland

Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
ul. A. Fleminga 2
03-176 Warsaw
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
VITAMED PHARMACEUTICALS Sp. z o.o.
ul. Posła Józefa Ostrowskiego 24
97-213 Smardzewice
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Poland: Abilium
Spain: Abilium 10 mg cápsulas duras EFG
Abilium 15 mg cápsulas duras EFG