ABIPOL 15 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Abipol 5 mg hard capsules EFG

Abipol 10 mg hard capsules EFG

Abipol 15 mg hard capsules EFG

aripiprazole

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet

1. What is Abipol and what is it used for
2. What you need to know before you take Abipol
3. How to take Abipol
4. Possible side effects
5. Storage of Abipol
6. Package contents and further information

1. What is Abipol and what is it used for

Abipol 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 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.

This medicine is used to treat adults and adolescents aged 13 years and older who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep more than usual, talking 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 medicine.

2. What you need to know before you take Abipol

Do not take Abipol

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

Warnings and precautions

Talk to your doctor before you start taking this medicine.

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

Before you start treatment with this medicine, 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 clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• a history of gambling addiction.

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 suffer from 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.

Tell 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 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 drowsiness, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. You should be cautious, especially if you are an elderly patient or suffer from weakness.

Children and adolescents

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

Other medicines and Abipol

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

Medicines that lower blood pressure:

This medicine may increase the effect of medicines used to lower blood pressure. Make sure to tell your doctor if you are using any medicine to control your blood pressure.

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

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• medicines to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);
• certain medicines 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 medicines may increase the risk of side effects or reduce the effect of aripiprazole; if you notice any unusual symptoms when taking any of these medicines at the same time as aripiprazole, you should tell your doctor.

Medicines that increase the level of serotonin are normally used in 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 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 illnesses;
• St. John's Wort (Hypericum perforatum) used in herbal medicines for mild depression;
• pain relievers (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 when taking any of these medicines at the same time as aripiprazole, you should tell your doctor.

Taking Abipol with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with this medicine 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, you should 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, 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 requiring maximum attention, for example, when driving or operating machinery.

Abipol contains sodium

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

3. How to take Abipol

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask 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 used, which is more suitable than aripiprazole.

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.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

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

Even if you feel better, do not change or interrupt the daily dose of this medicine 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 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/aggression, 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 the 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abipol

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 stop taking Abipol

Do not stop your treatment just because you feel better.

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

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 all people suffer from them.

Common 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);
• uncontrolled spasmodic or twisted movements,
• tremors,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• tremors and blurred vision,
• decrease in the number of bowel movements or difficulty making them,
• indigestion,
• feeling of discomfort,
• more saliva in the mouth than normal,
• vomiting,
• feeling of fatigue.

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

• increase or decrease in prolactin hormone levels in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder that causes 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 appearance 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 (ketosis in 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,
• nervousness
• malignant neuroleptic syndrome (a combination of fever, muscle stiffness, 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 of being drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• sudden unexplained death,
• life-threatening irregular heartbeats,
• heart attack,
• slower heartbeats,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in 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 advice immediately)
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasms of the muscles surrounding 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,
• reports of abnormal values in liver function tests,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially appears as symptoms similar to those of the flu, with a rash on the face and then with a widespread rash, elevated temperature, swollen lymph nodes, elevated liver enzyme levels observed in blood tests, and elevated levels of a type of white blood cell (eosinophilia),
• abnormal muscle breakdown that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns in 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, increased hemoglobin glycosylated.
• 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 sexual interest and worrisome behavior for you or others, for example, increased sexual appetite;
• binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than necessary 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, 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 of age or older experience adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrolled 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 sitting or lying down, 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 Abipol

Keep this medicine out of the 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 the sewers or in 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 Abipol

The active ingredient is aripiprazole.

Each hard capsule contains 5 mg of aripiprazole.

Each hard capsule contains 10 mg of aripiprazole.

Each hard capsule contains 15 mg of aripiprazole.

The other components are:

Abipol 5 mg:

• Capsule core: microcrystalline cellulose, sodium carboxymethyl starch type A, povidone, anhydrous colloidal silica, magnesium stearate.
• Capsule shell: carmine (E-132), titanium dioxide (E-171), gelatin, black ink.

Abipol 10 mg:

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

Abipol 15 mg:

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

Appearance of the Product and Package Contents

Abipol 5 mg contains hard, opaque gelatin 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, opaque gelatin 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, opaque gelatin 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Abartis Pharma S.L.

C/ Princesa 31, puerta 2

28008 Madrid

Spain

Manufacturer

Tarchominsckie Zaklady Farmaceutyczne Polfa S.A

Fleminga 2, 03-176 Warszawa, Poland

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

Hungary:

Aripiprazole Abartis 5 mg hard capsule

Aripiprazole Abartis 10 mg hard capsule

Aripiprazole Abartis 15 mg hard capsule

Date of the Last Revision of this Prospectus:

09/2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/