Leaflet: information for the user

Abipol 5 mg hard capsules EFG

Abipol 10 mg hard capsules EFG

Abipol 15 mg hard capsules EFG

aripiprazol

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1.What is Abipol and what it is used for

2.What you need to know before starting to take Abipol

3.How to take Abipol

4.Possible side effects

5.Storage of Abipol

6.Contents of the pack and additional information

Abipol contains the active ingredient aripiprazol and belongs to a group of medications known as antipsychotics. It is used to treat adults and adolescents 15 years of age or older who suffer from a condition characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and monotony of emotional and behavioral state. People in this state may also feel depressed, guilty, anxious, or tense.

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

Do not take Abipol

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

Warnings and precautions

Consult your doctor before starting to take this medication.

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 this medication, tell your doctor if you have:

• high blood sugar levels (characterized by excessive thirst, increased urine production, increased appetite, and feeling weak); 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), a family history of cardiovascular disease, stroke, or mini-stroke, abnormal blood pressure;
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• a history of addiction to gambling.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your daily activities, having difficulty swallowing, or experiencing 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. Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole have been reported.

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 in you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

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

Children and adolescents

Do not use this medication in children and adolescents under 13 years old. Its safety and effectiveness in these patients are unknown.

Other medications and Abipol

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

Medications that lower blood pressure:

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

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

• medications to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based medications used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• medications to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);
• certain medications to treat 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 medications may increase the risk of adverse effects or reduce the effect of aripiprazole; if you observe any unusual symptoms when taking any of these medications with aripiprazole, inform your doctor.

Medications that increase serotonin levels are usually used to treat conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat conditions such as depression, generalized anxiety 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, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used to treat severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depressive disorders;
• St. John's Wort (Hypericum perforatum) used in herbal medications to treat 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 adverse effects. If you observe any unusual symptoms when taking any of these medications with aripiprazole, inform your doctor.

Taking Abipol with food, drinks, and alcohol

This medication can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and operating machinery

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

Abipol contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 mg once a day.However, your doctor may prescribe lower and 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) more suitable than aripiprazole may be used.

The dose may be gradually 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.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Try to take this medication every day at the same time. It does not matter if you take it with or without food. Take the capsule once with a little water.

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

If you take more Abipol than you should

If you realize that you have taken more aripiprazole than your doctor recommended (or if someone else has taken part of your aripiprazole), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the packaging with you.

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

• rapid heartbeats, 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 drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Abipol

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Abipol

Do not stop treatment just because you feel better.

It is essential that you continue taking this medication for the time your doctor has indicated.

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

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

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

• diabetes mellitus;
• sleep problems
• anxiety
• feeling of restlessness and inability to stay still, difficulty staying seated;
• akathisia (an uncomfortable feeling of internal restlessness and an urgent need to move constantly);
• involuntary, uncontrollable spasmodic or twisting movements;
• tremors;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• tremors and blurred vision;
• decreased number of bowel movements or difficulty passing them;
• indigestion;
• feeling of discomfort;
• excessive saliva in the mouth;
• vomiting;
• feeling of fatigue.

Less frequent side 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 sex drive;
• involuntary, uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• restless legs;
• double vision;
• photosensitivity of the eyes.
• rapid heartbeat;
• low blood pressure when standing, causing dizziness, fainting, or fainting;
• hypotension.

The following side 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)
• appearance or worsening of diabetes, ketoacidosis (ketosis in the blood and urine) or coma;
• high blood sugar;
• insufficient sodium levels in the blood;
• loss of appetite (anorexia),
• weight loss,
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• aggression,
• agitation,
• anxiety
• neuroleptic malignant syndrome (a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting);
• seizures;
• serotonin syndrome (a reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
• speech disorder;
• sudden, unexplained death;
• life-threatening irregular heartbeat;
• heart attack;
• slow heart rate;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you experience any of these symptoms, seek medical attention immediately)
• high blood pressure;
• fainting;
• accidental inhalation of food, with a risk of pneumonia (lung infection);
• spasms of the muscles surrounding the larynx;
• pancreatitis;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver insufficiency;
• inflammation of the liver;
• yellowing of the skin and the white part of the eyes;
• reports of abnormal values in liver function tests;
• skin rash;
• sensitivity of the skin to light;
• hair loss;
• excessive sweating;
• severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with symptoms similar to the flu, with a rash on the face, followed by a widespread rash, high temperature, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cell (eosinophilia),
• abnormal muscle breakdown that can cause kidney problems;
• muscle pain;
• rigidity;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• symptoms of withdrawal in newborns in the case of exposure during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling central body temperature or overheating;
• chest pain;
• swelling of hands, ankles, or feet;
• in blood tests: increased or fluctuating blood sugar levels, increased hemoglobin A1c.
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sex drive and concerning behavior for you or others, for example, increased sex drive;
• binge eating (ingestion of large amounts of food in a short period) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger);
• tendency to wander;
• increased activity of creatine phosphokinase.

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, there have been reported cases of increased mortality while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other side effects in children and adolescents

Adolescents aged 13 years or older experience side effects similar in frequency and type to those of adults, except for drowsiness, involuntary, uncontrollable spasms or 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 getting up after lying down or sitting, which were frequent (may affect up to 1 in 100 patients).

Reporting of side effects

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

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

Do not use this medication 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 into the drains or trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medication packaging. By doing so, you will help protect the environment.

Composition of Abipol

The active ingredient is aripiprazol.

Each hard capsule contains 5 mg of aripiprazol.

Each hard capsule contains 10 mg of aripiprazol.

Each hard capsule contains 15 mg of aripiprazol.

The other components are:

Abipol 5 mg:

• Core of the capsule: microcrystalline cellulose, sodium carboxymethyl starch type A, povidone, anhydrous colloidal silica, magnesium stearate.
• Capsule coating: indigo carmine (E-132), titanium dioxide (E-171), gelatin, black ink.

Abipol 10 mg:

• Core of the capsule: microcrystalline cellulose, sodium carboxymethyl starch type A, povidone, anhydrous colloidal silica, magnesium stearate.
• Capsule coating: carmine (E-120), titanium dioxide (E-171), gelatin.

Abipol 15 mg:

• Core of the capsule: microcrystalline cellulose, sodium carboxymethyl starch type A, povidone, anhydrous colloidal silica, magnesium stearate.
• Capsule coating: yellow iron oxide (E-172), titanium dioxide (E-171), gelatin.

Appearance of the product and contents of the package

Abipol 5 mg contains hard gelatin opaque capsules, size "3", blue in color, and the inscription "5 mg" in black ink. The capsules contain a white to cream-colored powder.

The capsules are packaged in OPA/AL/PVC-Al blisters.

Available in packages of 28 and 56 capsules.

Abipol 10 mg contains hard gelatin opaque capsules, size "3", pink in color. The capsules contain a white to cream-colored powder.

The capsules are packaged in OPA/AL/PVC-Al blisters.

Available in packages of 14, 28, and 56 capsules.

Abipol 15 mg contains hard gelatin opaque capsules, size "2", cream in color. The capsules contain a white to cream-colored powder.

The capsules are packaged in OPA/AL/PVC-Al blisters.

Available in packages of 14, 28, and 56 capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Abartis Pharma S.L.

C/ Princesa 31, door 2

28008 Madrid

Spain

Responsible manufacturer

Tarchominsckie Zaklady Farmaceutyczne Polfa S.A

Fleminga 2, 03-176 Warszawa, Poland

This medicinal product is authorized in the Member States of the European Economic Area with the following denominations:

Hungary:

Aripiprazole Abartis 5 mg hard capsule

Aripiprazole Abartis 10 mg hard capsule

Aripiprazole Abartis 15 mg hard capsule

Last review date of this leaflet:

09/2022

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/