Abilium 15 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Abilium 10 mg hard capsules EFG

Abilium 15 mg hard capsules EFG

aripiprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet 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 adverse 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 who have a disorder characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, disorganized speech, and emotional and behavioral blunting. People in this condition may also feel depressed, guilty, restless, or tense.

Abilium is used to treat adults and adolescents aged 13 years and older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to take Abilium.

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

Before starting treatment with Abilium, tell your doctor if you have:

• High blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or 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 clots or family history of blood clots, as antipsychotics have been associated with blood clot formation;
• History of gambling addiction.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

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

Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior during treatment with aripiprazole have been reported.

Speak to your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental state, or very rapid 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 that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping your dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in ability to move and maintain balance, which could lead to falls. Caution should be taken, especially if you are an elderly patient or have some degree of weakness.

Children and adolescents

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

Other medicines and Abilium

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines without a prescription.

Medicines that lower blood pressure:

Abilium may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control blood pressure.

If you are taking Abilium together with any other medicine, this may mean that your doctor needs to adjust the dose of Abilium or the other medicines. It is especially important to tell your doctor if you are taking:

• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• Antidepressants or herbal medicines used for treatment of depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's wort);
• Medicines for treating fungal infections (antifungals) (such as ketoconazole, itraconazole);
• Certain medicines for treating HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as indinavir, ritonavir);
• Anticonvulsants 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 effect of Abilium; if you notice any unusual symptoms while taking any of these medicines together with Abilium, you must inform your doctor.

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

• Triptans, tramadol, and tryptophan used for conditions 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 amitriptiline) used in depressive disorders;
• St. John's wort (Hypericum perforatum) used in herbal medicines for mild depression;
• Analgesics (such as tramadol and pethidine) used to relieve pain;
• Triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects. If you notice any unusual symptoms while taking any of these medicines together with Abilium, you must inform your doctor.

Taking Abilium with food, drinks, and alcohol

This medicine can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

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

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

If you are taking Abilium, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. 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 medicine.

Driving and using machines

During treatment with this medicine, 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 medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Abilium

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents

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

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

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, inform your doctor or pharmacist.

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

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

If you take more Abilium than you should

If you realize that 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 reach your doctor, go to the nearest hospital and take the packaging with you.

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

• rapid heartbeat, agitation/aggression, speech 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 rigidity and drowsiness, slowed breathing, suffocation, high or low blood pressure, abnormal heart rhythms.

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

If you forget to take Abilium

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

If you stop taking Abilium

Do not stop your treatment just because you feel better.

It is important that you continue taking Abilium for as long as your doctor has instructed.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent adverse effects (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep disturbances;
• anxiety;
• feeling restless and unable to stay still, difficulty remaining seated;
• akathisia (an uncomfortable inner restlessness and an urgent need to keep moving);
• uncontrollable twisting, writhing, or spasmodic movements;
• tremor;
• headache;
• fatigue;
• somnolence;
• dizziness;
• shakiness and blurred vision;
• difficulty passing stools or reduced frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of tiredness.

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

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

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

• low white blood cell count;

• low platelet count;

• allergic reaction (e.g., swelling of 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;

• low sodium levels in the blood;

• loss of appetite (anorexia);

• weight loss;

• weight gain;

• suicidal thoughts, suicide attempt, 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 may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);

• speech disorder;

• fixed eye position;

• unexplained sudden death;

• potentially life-threatening irregular heartbeat;

• heart attack;

• slower heartbeat;

• blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing (if you experience any of these symptoms, contact your doctor immediately);

• high blood pressure;

• fainting;

• accidental inhalation of food with risk of pneumonia (lung infection);

• muscle spasms around the glottis (a part of the larynx);

• inflammation of the pancreas;

• difficulty swallowing;

• diarrhea;

• abdominal discomfort;

• stomach upset;

• liver failure;

• inflammation of the liver;

• yellowing of the skin and whites of the eyes;

• abnormal liver function test results;

• increased creatine phosphokinase activity;

• rash;

• skin photosensitivity;

• hair loss;

• excessive sweating;

• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with facial rash, followed by generalized rash, high fever, swollen lymph nodes, elevated liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);

• abnormal breakdown of muscle tissue, which may lead to kidney problems;

• muscle pain;

• stiffness;

• involuntary loss of urine (incontinence);

• difficulty urinating;

• withdrawal symptoms in newborns due to exposure to medications during pregnancy;

• prolonged and/or painful erection;

• difficulty controlling core body temperature or overheating;

• chest pain;

• swollen hands, ankles, or feet;

• in blood tests: fluctuations in blood sugar levels, increased glycated hemoglobin;

• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:

• strong urge to gamble excessively despite serious personal or family consequences;

• altered or increased sexual interest and behavior concerning to yourself or others, for example, increased sex drive;

• uncontrollable excessive shopping;

• binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger);

• tendency to wander.

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

In elderly patients with dementia, an increased number of deaths has been reported while taking aripiprazole. Additionally, cases of stroke or "mini" strokes have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years or older experience adverse effects similar in frequency and type to adults, except for somnolence, muscle spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (may affect more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary limb movements, and dizziness, especially when standing up from lying or sitting positions, which were common (may affect up to 1 in 100 patients).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abilium

Store below 30°C.

Keep in the original packaging to protect from moisture.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abilium

Abilium 10 mg hard capsules EFG:

The active substance is aripiprazole.

Each hard capsule contains 10 mg of aripiprazole.

The other components 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 hard capsules EFG:

The active substance is aripiprazole.

Each hard capsule contains 15 mg of aripiprazole.

The other components are:

Microcrystalline cellulose

Sodium carboxymethyl starch type A

Povidone

Colloidal anhydrous silica

Magnesium stearate

Yellow iron oxide (E 172)

Titanium dioxide (E 171)

Gelatin

Appearance of the product and contents of the pack

Abilium 10 mg hard capsules EFG:

Hard, gelatinous, opaque pink capsules, size 3.

Contents of the capsule: white to cream-colored powder.

Abilium 15 mg hard capsules EFG:

Hard, gelatinous, opaque cream-colored capsules, size 2.

Contents of the capsule: white to cream-colored powder.

One blister contains 7 capsules.

The unit pack contains 2, 4 or 8 blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharma2pharma Sp. z o.o.

Klaudyny 38/117

Warsaw 01-684

Poland

Local representative

Desitin Arzneimittel GmbH

Weg beim Jäger 214

Hamburg 22335

Germany

Manufacturer

Tarchominskie Zaklady Farmaceutyczne Polfa S.A.

Fleminga 2

Warsaw 03-173

Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

Poland: Abilium

Spain: Abilium 10 mg hard capsules EFG

Abilium 15 mg hard capsules EFG

Date of the most recent review of this leaflet: October 2023