ABILIUM 5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Abilium 5 mg Hard Capsules EFG

aripiprazole

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Abilium and what is it used for
2. What you need to know before taking Abilium
3. How to take Abilium
4. Possible side effects
5. Storage of Abilium
6. Package Contents and Additional 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 or older who suffer from a disease characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and emotional and behavioral monotony. People in this state may also feel depressed, guilty, restless, or tense.

Abilium is used to treat adults and adolescents aged 13 years or older who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking very quickly with a flight of ideas, and sometimes severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with Abilium.

2. What you need to know before taking Abilium

Do not take Abilium

• If you are allergic to aripiprazole or any of the other componentsof this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to take Abilium.

There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Abilium, tell your doctor if you suffer from

• high blood sugar levels(characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling of weakness) or a family history of diabetes;
• seizures, as your doctor may want to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face;
• cardiovascular diseases(heart and circulation diseases), family history of cardiovascular disease, stroke or mini-stroke, abnormal blood pressure;
• blood clotsor family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• history of gambling addiction.

If you notice that you are gaining weight, developing unusual movements, experiencing somnolence that interferes with your daily activities, having difficulty swallowing, or presenting allergic symptoms, please inform your doctor.

If you have dementia (loss of memory and other mental abilities), you or the person caring for you or a family member should inform your doctor if you have ever had a stroke or mini-stroke.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast or irregular heartbeat.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way and cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause somnolence, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are an elderly patient or have some weakness.

Children and Adolescents

Do not use this medication in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other Medications and Abilium

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications.

Medications that lower blood pressure:

Abilium may increase the effect of medications used to lower blood pressure. Make sure to inform your doctor if you use any medication to control blood pressure.

If you are taking Abilium with another medication, it may mean that your doctor needs to change your dose of Abilium or the other medication. It is especially important that you mention to your doctor if you are taking:

• medications to correct heart rhythm(such as quinidine, amiodarone, flecainide);
• antidepressants or herbal medications used for depression and anxiety treatment(such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medications(such as ketoconazole, itraconazole);
• certain medications for HIV infection treatment(such as efavirenz, nevirapine, and protease inhibitors like indinavir, ritonavir);
• anticonvulsantsused for epilepsy treatment(such as carbamazepine, phenytoin, phenobarbital);
• certain antibioticsused for tuberculosis treatment (rifabutin, rifampicin).

These medications may increase the risk of side effects or reduce the effect of Abilium; if you notice any unusual symptoms when taking any of these medications at the same time as Abilium, you should inform your doctor.

Medications that increase serotonin levels are commonly used in diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for diseases such as 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 for depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive diseases;
• St. John's Wort (Hypericum perforatum) used in herbal medications for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medications may increase the risk of side effects. If you notice any unusual symptoms when taking any of these medications at the same time as Abilium, you should inform your doctor.

Taking Abilium with Food, Drinks, and Alcohol

This medication can be taken independently of meals.

Alcohol consumption should be avoided.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The following symptoms may occur in newborn babies of mothers who have been treated with Abilium in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, somnolence, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

If you are taking Abilium, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit to you of your treatment and the benefit to your baby of breastfeeding. If you are being treated with Abilium, you should not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medication.

Driving and Using Machines

During treatment with this medication, dizziness and vision problems (see section 4) may occur. This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Abilium Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

3. How to Take Abilium

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Use in Children and Adolescents

To initiate treatment with a low dose, an alternative formulation (oral liquid solution) may be more suitable than Abilium.

Gradually, the dose may be increased to the recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

Method of Administration

Abilium should be taken orally, independently of meals.

If you think the effect of Abilium is too strong or too weak, inform your doctor or pharmacist.

Try to take Abilium at the same time every day.It does not matter if you take it with or without food. Always take the capsules with water and swallow them whole.

Even if you feel better,do not change or interrupt the daily dose of Abilium without consulting your doctor first.

If you take more Abilium than you should

If you realize you have taken more Abilium than your doctor recommended (or if someone else has taken part of your Abilium), contact your doctor immediately. If you cannot contact your doctor, go to the nearest hospital and take the package with you.

Patient who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggressiveness, language problems;
• unusual movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle stiffness and somnolence, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or the nearest hospital immediately if you experience any of the above symptoms.

If you forget to take Abilium

If you forget a dose, take the forgotten dose as soon as you remember, but do not take a double dose to make up for the forgotten dose.

If you interrupt treatment with Abilium

Do not stop your treatment just because you feel better.

It is important that you continue taking Abilium for the time your doctor has indicated.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Frequent Adverse Effects (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
• akathisia (an uncomfortable feeling of inner restlessness and an urgent need to move constantly);
• twisting, contorting, or spasmodic uncontrollable movements;
• tremor;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• shivering and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of fatigue.

Uncommon Adverse Effects (may affect up to 1 in 100 patients):

• increase or decrease in prolactin hormone levels in blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• restless legs;
• double vision;
• ocular photosensitivity;
• rapid heartbeat;
• drop in blood pressure when standing up, causing dizziness, lightheadedness, or fainting;
• hypo.

The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency of occurrence is unknown:

• low white blood cell count;
• low platelet count;
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, and redness);
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;
• high blood sugar;
• insufficient sodium levels in blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• aggression;
• agitation;
• nervousness;
• combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);
• seizures;
• serotonin syndrome (a reaction that can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slower heartbeat;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately);
• high blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• spasms in the muscles around the glottis (a part of the larynx);
• pancreatitis;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• liver inflammation;
• yellowing of the skin and the white part of the eyes;
• abnormal liver values in blood tests;
• increased creatine phosphokinase activity;
• rash;
• cutaneous photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudo-flu-like symptoms with a rash on the face and later with a generalized rash, high temperature, swollen lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased eosinophilia;
• abnormal muscle breakdown that can cause kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to drugs during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: fluctuation of blood sugar levels, increased hemoglobin glycosylated;
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and worrying behavior for yourself or others, for example, increased sexual appetite;
• uncontrollable excessive shopping;
• binge eating (ingesting large amounts of food in a short period) or compulsive eating (ingesting more food than normal and more than necessary to satisfy hunger);
• tendency to wander.

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

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

Other Adverse Effects in Children and Adolescents

Adolescents 13 years or older experience adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrollable contractions, restlessness, and fatigue, which were very frequent (may affect more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary movements of the limbs, and dizziness, especially when standing up after being lying down or sitting, which were frequent (may affect up to 1 in 100 patients).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Abilium

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging of medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Abilium

The active ingredient is aripiprazole.

Each hard capsule contains 5 mg of aripiprazole.

The other components are:

Microcrystalline cellulose type 102

Sodium carboxymethylcellulose type A

Povidone K 30

Anhydrous colloidal silica

Magnesium stearate

Carmine indigo (E 132)

Titanium dioxide (E 171)

Gelatin

Black ink 10A2

composed of:

Gum (E 904)

Black iron oxide (E 172)

Propylene glycol (E 1520)

Concentrated ammonia hydroxide

Potassium hydroxide (E 525)

Appearance of the Product and Package Contents

Hard, gelatinous, opaque capsules of light blue color no. 3.

Engraved "5 mg" on the body of the capsule.

Capsule contents: white to cream-colored powder.

A blister pack contains 7 capsules.

Packaged in boxes containing 14 or 28 or 56 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharma2pharma Sp. z o.o.

Klaudyny 38/117

Warsaw 01-684

Poland

Manufacturer

Tarchominskie Zaklady Farmaceutyczne Polfa S.A

• Fleminga 2

Warsaw 03-173

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Abilium

Spain: Abilium 5 mg hard capsules EFG

Date of the Last Revision of this Prospectus:October 2023