Package Leaflet: Information for the User

Tractiva 15 mg tablets 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Tractiva is and what it is used for

2.What you need to know before you start taking Tractiva

3.How to take Tractiva

4.Possible side effects

5.Storage of Tractiva

6.Contents of the pack and additional information

Tractiva 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.

Aripiprazol 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 less sleep 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 aripiprazol.

Do not take Tractiva

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

Warnings and precautions

Consult your doctor before starting to take Tractiva.

Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported. Inform your doctor immediately if you have thoughts or feelings of self-harm.

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

-high blood sugar levels (characterized by excessive thirst, increased urine production, increased appetite, and feeling weak) orfamily 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 addiction to gambling.

If you notice 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 your caregiver should inform your doctor if you have ever had a stroke or "mini" stroke.

Tell your doctor immediately if you have thoughts or feelings of self-harm. Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported.

Tell your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or 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 that you cannot resist, known as impulse control disorder, which may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about increased sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause drowsiness, low blood pressure when standing, dizziness, and changes in ability to move and maintain balance, which could lead to falls. Be cautious, 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 Tractiva

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: Tractiva 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 Tractiva with any other medication,it may mean that your doctor needs to change your dose of Tractiva or 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);

- medicationsto 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 Tractiva; if you observe any unusual symptoms while taking any of these medications with Tractiva, inform your doctor.

Medications that increase serotonin levels are generally used to treat conditions that include 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 in severe depression;
• other tricyclic antidepressants (such as clomipramine and amitriptyline)used to treat depressive disorders;
• St. John's Wort (Hypericum perforatum) used in plant-based 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 adverse effects; if you observe any unusual symptoms while taking any of these medications with Tractiva, inform your doctor.

Taking Tractiva with food, drinks, and alcohol

This medicationcan 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 Tractiva 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 Tractiva, 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 Tractiva, do not breastfeed. Talk toyour 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.

Tractiva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication 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

This medication should be started with the oral solution (liquid) at a low dose.

The dose can be gradually increased tothe 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 aripiprazole is too strong or too weak, inform your doctor or pharmacist.

Try to take Tractiva at the same time every day. It does not matter if you take it with or without food.

Take the tablets with water and swallow them whole.

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

If you take more Tractiva 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested.

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

• rapid heartbeats, 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 rigidity and somnolence, 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.

If you forgot to take Tractiva

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 Tractiva

Do not stop treatment just because you feel better. It is essential that you continue taking aripiprazole 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 restless and unable to stay still, difficulty staying seated;
• akathisia (an uncomfortable feeling of internal restlessness and an urgent need to move constantly);
• involuntary movements of twisting, contorting, or spasmodic movements;
• tremors;
• headaches;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty passing stools or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling tired.

Less frequent side effects (may affect up to 1 in 100 patients):

• increased levels of prolactin hormone in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sex drive;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• restless legs;

• double vision;
• eye sensitivity;
• 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 (ketones in the blood and urine), or coma;
• high blood sugar;
• insufficient sodium levels in the blood;
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• aggression;
• agitation;
• nervousness;
• combination of fever, muscle rigidity, 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 intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden and unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slower heart rate;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek immediate medical attention);
• high blood pressure;
• fainting;
• accidental inhalation of food with a risk of pneumonia (lung infection);
• spasms of the muscles around the glottis (a part of the larynx);
• pancreatitis;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• inflammation of the liver;
• yellowing of the skin and the white part of the eyes;
• abnormal liver enzyme analysis;
• hives;
• skin photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug-induced eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudogripal symptoms with facial rash, and later with generalized rash, high temperature, enlarged lymph nodes, elevated liver enzyme levels observed in blood tests, and increased eosinophil count;
• abnormal muscle degradation that can cause kidney problems;
• muscle pain;
• rigidity;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• symptoms of withdrawal in newborns due to exposure to medications during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling central body temperature or overheating;
• chest pain;
• swollen 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, such as increased sex drive;
• uncontrollable buying;
• binge eating (eating large amounts of food in a short period) 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; he will explain how to manage or reduce the symptoms.

In elderly patients with dementia, there have been reported a higher number of fatal cases 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 experienced side effects similar in frequency and type to those of adults, except for drowsiness, involuntary spasms or contractions, restlessness, and fatigue, which were very frequent (affects 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 (affects up to 1 in 10 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 medication.

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

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tractiva

The active ingredient is aripiprazol. Each tablet contains 15 mg of aripiprazol.

The other components are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, and yellow iron oxide (E172).

Appearance of Tractiva and content of the packaging

Tractiva 15 mg tablets are yellow, round, almost flat, with little volume, and convex.

Each standard package contains 28 tablets, packaged in blisters.

Holder of the marketing authorization

EXELTIS HEALTHCARE, S.L.

Avda de Miralcampo 7

Polígono Industrial Miralcampo.

19200. Azuqueca de Henares. (Guadalajara)

Spain

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet:November 2022

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/