Abilium

Package leaflet: Information for the patient

Abilium, 5 mg, hard capsules
Aripiprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of contents

1. What Abilium is and what it is used for
2. What you need to know 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 a group of medicines called antipsychotics.
It is used to treat adults and adolescents aged 15 years and older with schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, suspiciousness, beliefs that are not based in reality, disorganized speech and behavior, and emotional withdrawal. 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, a condition characterized by symptoms such as extreme excitement, overwhelming energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the 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 components 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 any thoughts or feelings of harming yourself occur.
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 family history of diabetes;

• seizures (epilepsy), as this may mean your doctor will want to monitor the patient closely;

• involuntary, irregular muscle movements, particularly of the facial muscles;

• cardiovascular diseases (heart and blood vessel conditions), family history of cardiovascular disease, stroke or "mini" stroke, or abnormal blood pressure;

• blood clots or family history of blood clots, because use of antipsychotic medicines has been associated with formation of blood clots;

• history of gambling addiction.

If the patient notices weight gain, development of unusual movements, drowsiness interfering with daily activities, any difficulty swallowing or signs 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 any thoughts or feelings of self-harm 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 state, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient begins to show signs of 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 the doctor. These phenomena are known as impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating or uncontrolled spending, excessive sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider it appropriate 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, especially 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 or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
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 dose adjustments of Abilium or other medicines. It is especially important to inform the doctor about the use 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 together with Abilium, they should inform their doctor.
Medicines that increase serotonin levels are usually used in conditions involving depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine and pain:

• triptans, tramadol and tryptophan used to treat conditions involving depression, generalised 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 remedy 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 together with Abilium, they should inform their doctor.

Taking Abilium with food, drink and alcohol
This medicine can be taken with or without food.
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Newborn babies 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 such symptoms are observed in the newborn, contact a doctor immediately.
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. Do not take this medicine and breastfeed at the same time. Talk to your doctor about the best feeding methods for your baby if you are taking this medicine.

Driving and using machines
Dizziness and visual disturbances (see section 4) may occur during treatment with this medicine.
This should be taken into account when performing tasks 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 take Abilium

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose of Abilium 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.
Use in children and adolescents
Treatment may be initiated with a low dose of the oral solution (liquid formulation).
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, regardless of meals.
If you feel that the effect of Abilium is too strong or too weak, consult your 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 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 you take more Abilium than prescribed (or if someone else takes any amount of Abilium not intended for them),
contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital, taking the medicine pack with you.
In patients who have taken an overdose of aripiprazole, the following symptoms have occurred:

• rapid heartbeat, agitation/aggression, speech difficulties;
• unusual body movements (especially of the face or tongue) and decreased 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, contact your 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 prescribed by the doctor and for the duration recommended by the doctor.
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 1 in 10 patients):

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

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

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

The following adverse effects have been reported after the introduction of oral arypiprazole to the market, but their frequency is unknown:

• decreased number of white blood cells,
• decreased 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 ketones in blood and urine), or diabetic coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts, and completed suicides,
• feelings of aggression,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (symptoms: inappropriate sense of extreme happiness, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness),
• speech disorders,
• fixed eye position,
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs, chest pain, and difficulty breathing – if the patient experiences any of these symptoms, they must contact a doctor immediately),
• high blood pressure,
• fainting,
• accidental aspiration of food – risk of pneumonia,
• muscle spasm around the larynx,
• pancreatitis,
• difficulty in swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• jaundice – yellowing of the skin and whites of the eyes,
• abnormal liver function tests,
• increased creatine phosphokinase activity,
• skin rash,
• skin sensitivity 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, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (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 in urinating,
• withdrawal syndrome in newborns following exposure to the medicine during pregnancy,
• prolonged and/or painful erection,
• difficulty in regulating core body temperature or overheating,
• breast pain,
• swelling of hands, ankles, or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased levels of glycated haemoglobin,
• inability to resist an impulse, drive, or urge to engage in activities and behaviours such as:
  • excessive gambling despite serious personal or family consequences,
  • altered or increased interest in sexuality and behaviours significantly distressing 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);
  • impulse to wander.

If such behaviours occur in a patient, they should inform their doctor, who will discuss ways of managing or reducing these symptoms.
In elderly patients with dementia taking arypiprazole, a higher number of deaths have been reported. In addition, 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 drowsiness, 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 twitching, uncontrollable movements of the limbs, and dizziness, particularly upon standing 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 adverse effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store ABILIUM

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

6. Contents of the package and other information

What Abilium contains

• The active substance is aripiprazole. Each hard capsule contains 5 mg of aripiprazole.
• The other ingredients are: microcrystalline cellulose type 102, sodium carboxymethyl starch type A, povidone K 30, colloidal anhydrous silica, magnesium stearate, indigo carmine (E 132), titanium dioxide (E 171), gelatin, ink 10A2 black with the composition: shellac (E 904), black iron oxide (E 172), propylene glycol (E 1520), concentrated ammonium hydroxide, potassium hydroxide (E 525).

What Abilium looks like and contents of the pack
Hard, gelatin, opaque, light blue capsules size number 3.
On the body of the capsule, a black imprint "5 mg".
Contents of the capsules: white to cream-colored powder.
7 capsules in one blister.
The unit pack contains 14, 28, or 56 hard capsules in a cardboard box.
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, Poland
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Abilium
Spain: Abilium 5 mg cápsulas duras EFG