TRACTIVA 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Tractiva, 5 mg, tablets
3. Tractiva, 10 mg, tablets
4. Tractiva, 15 mg, tablets
5. Tractiva, 20 mg, tablets
6. Tractiva, 30 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
7. What is Tractiva and what is it used for
8. Important information before taking Tractiva
   1. When not to take Tractiva:
   2. Warnings and precautions
   3. Children and adolescents
   4. Tractiva and other medicines
   5. Tractiva with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Tractiva contains lactose
9. How to take Tractiva
   1. Use in children and adolescents
   2. Taking a higher dose of Tractiva than recommended
   3. Missing a dose of Tractiva
   4. Stopping Tractiva treatment
10. Possible side effects
    1. Additional side effects in children and adolescents
    2. Reporting side effects
11. How to store Tractiva
12. Contents of the packaging and other information
    1. What Tractiva contains
    2. What Tractiva looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: information for the user

Tractiva, 5 mg, tablets

Tractiva, 10 mg, tablets

Tractiva, 15 mg, tablets

Tractiva, 20 mg, tablets

Tractiva, 30 mg, tablets

Aripiprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tractiva and what is it used for
• 2. Important information before taking Tractiva
• 3. How to take Tractiva
• 4. Possible side effects
• 5. How to store Tractiva
• 6. Contents of the packaging and other information

1. What is Tractiva and what is it used for

Tractiva 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 with a disease characterized by symptoms such as hearing, seeing, or feeling things that are not real, suspiciousness, delusions, disorganized speech and behavior, and emotional numbness. Patients with these symptoms may also experience depression, guilt, anxiety, or tension. Tractiva is used to treat adults and adolescents aged 13 years and older with a disease characterized by symptoms such as excessive excitement, bursting energy, reduced need for sleep, very fast speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to Tractiva treatment.

2. Important information before taking Tractiva

When not to take Tractiva:

• if the patient is allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Tractiva, discuss it with your doctor. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience thoughts or feelings of self-harm. Before starting Tractiva, tell your doctor if you have:

• high blood sugar (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes;
• seizures (epilepsy), as this may mean that your doctor will want to monitor you closely;
• involuntary, irregular muscle movements, especially of 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 history of blood clots, as the use of antipsychotic medicines is associated with the formation of blood clots;
• a history of gambling addiction.

If you notice weight gain, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, you should tell your doctor. If an elderly patient has dementia, they or their caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke. You should immediately inform your doctor if you experience thoughts or feelings of self-harm. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience stiffness of the muscles or stiffness with high fever, sweating, disturbances of consciousness, or very fast or irregular heartbeat. If you or your family or caregiver notice that you are starting to feel the urge or desire to behave in an unusual way, and you cannot resist the impulse, drive, or temptation to engage in activities that may harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, overeating, or excessive spending, increased sexual drive, or increased frequency and intensity of thoughts or feelings about sexual topics. Your doctor may consider changing the dose or discontinuing the medicine. Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be careful, especially in elderly or weakened patients.

Children and adolescents

This medicine should not be used in children and adolescents under 13 years of age. It is not known if the use of this medicine is safe and effective in these patients.

Tractiva and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription. Blood pressure-lowering medicines: Tractiva may enhance the effects of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should tell your doctor. The use of Tractiva with other medicines may require a change in the dose of Tractiva or other medicines you are taking. It is especially important to inform your doctor about the use of:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressant medicines or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medicines (such as ketoconazole, itraconazole);
• certain medicines used to treat HIV infection (such as efavirenz, nevirapine, protease inhibitors, e.g., indinavir, ritonavir);
• antiepileptic medicines used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

Taking these medicines may increase the risk of side effects or decrease the effect of Tractiva; if you experience any unusual symptoms while taking these medicines with Tractiva, you should tell your doctor. Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social anxiety disorder, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social anxiety disorder, 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 antidepressant medicines (such as venlafaxine and tryptophan) used to treat severe depression;
• tricyclic medicines (such as clomipramine and amitriptyline) used to treat depression;
• St. John's Wort (Hypericum perforatum) used as a herbal remedy for mild depression;
• painkillers (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 experience any unusual symptoms while taking these medicines with Tractiva, you should tell your doctor.

Tractiva with food, drink, and alcohol

This medicine can be taken with or without food. You should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. In newborns whose mothers took Tractiva during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice any of these symptoms in your child, you should contact your doctor. If you are taking Tractiva, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take this medicine and breastfeed at the same time. You should discuss with your doctor the best methods of feeding your child if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur (see section 4). You should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Tractiva contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Tractiva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. The recommended dose of Tractiva for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.

Use in children and adolescents

Aripiprazole treatment may be started with a low dose in the form of an oral solution (liquid). The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day. If you feel that the effect of Tractiva is too strong or too weak, you should consult your doctor or pharmacist. Tractiva tablets should be taken every day at the same time.It does not matter whether the tablet is taken with or without food. The tablet should be swallowed whole and washed down with water. Even if you feel better, do not change the dose or stop taking Tractiva without first discussing it with your doctor.

Taking a higher dose of Tractiva than recommended

If you have taken more Tractiva than your doctor prescribed (or if someone else has taken some of the medicine not intended for them), you should immediately contact your doctor. If you have trouble contacting your doctor, you should go to the nearest hospital, taking the medicine packaging with you. In patients who have taken too much aripiprazole, the following symptoms have occurred:

• fast heartbeat, agitation, and/or aggression, speech problems;
• unusual body movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

• severe confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, sweating, changes in blood pressure, and changes in heart rate, fainting (malignant neuroleptic syndrome),
• muscle stiffness and drowsiness or lethargy, slow breathing, choking, high or low blood pressure, irregular heartbeat.

If you experience any of these symptoms, you should immediately contact your doctor or hospital.

Missing a dose of Tractiva

If you miss a dose, you should take the missed dose as soon as you remember, but you should not take two doses in one day.

Stopping Tractiva treatment

You should not stop treatment just because you feel better. It is very important to take Tractiva exactly as prescribed by your doctor and for the period prescribed by your doctor. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tractiva can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people):

• diabetes,
• sleep disturbances,
• anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (feeling of inner restlessness and compulsion to perform continuous movements),
• uncontrolled trembling, jerking movements, or writhing movements,
• trembling,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• reduced bowel movements or difficulty with bowel movements,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of fatigue.

Uncommon side effects (may affect up to 1 in 100 people):

• increased or decreased levels of a hormone called prolactin in the blood,
• high blood sugar,
• depression,
• changed or increased interest in sex,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• increased sensitivity of the eyes to light,
• fast heartbeat,
• decreased blood pressure when standing up, causing dizziness, feeling of emptiness in the head, or fainting,
• hiccups.

The following side effects have been reported after the marketing of aripiprazole in oral form, but the frequency of their occurrence is unknown:

• decreased white blood cell count,
• decreased platelet count,
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, hives),
• onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the blood and urine) or coma,
• high blood sugar,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, attempted suicide, and suicide,
• feeling of aggression,
• agitation,
• nervousness,
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, changes in consciousness, and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling of intoxication, fever, sweating),
• speech disorders,
• fixation of the eyeballs in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slow heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties (if you experience any of these symptoms, you must immediately contact your doctor),
• high blood pressure,
• fainting,
• accidental choking on food with a risk of pneumonia,
• muscle spasm around the larynx,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• jaundice (yellowing of the skin and whites of the eyes),
• abnormal liver test results,
• skin rash,
• increased sensitivity of the skin to light,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles flu-like symptoms with a rash on the face, and then a rash appears on other parts of the body, high fever, swollen lymph nodes, increased liver enzyme activity (visible in blood tests), and increased levels of a specific type of white blood cell (eosinophilia),
• abnormal breakdown of muscle tissue, which can lead to kidney problems,
• muscle pain,
• stiffness,
• involuntary urination (incontinence),
• difficulty urinating,
• withdrawal syndrome in newborns in case of exposure to the medicine during pregnancy,
• prolonged and/or painful erection,
• difficulty regulating body temperature or overheating,
• chest pain,
• swelling of the hands, ankles, or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased glycosylated hemoglobin levels,
• inability to resist the impulse, drive, or temptation to engage in activities that may harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite significant personal or family consequences,
• changed or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive,
• uncontrolled excessive shopping or spending,
• uncontrolled overeating or compulsive eating (eating more food than usual and more than needed to satisfy hunger);
• urge to wander. If you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.

In elderly patients with dementia taking aripiprazole, more deaths have been reported. Additionally, cases of stroke or "mini" stroke have been recorded.

Additional side effects in children and adolescents

In adolescents aged 13 years and older, side effects have occurred with a similar frequency and type as in adults, except for drowsiness, uncontrolled trembling, or sudden movements, restlessness, and fatigue, which have occurred very frequently (may occur in more than 1 in 10 patients), as well as upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle tremors, uncontrolled limb movements, and dizziness, especially when standing up from a lying or sitting position, which have occurred frequently (may occur in more than 1 in 100 patients).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Tractiva

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tractiva contains

• The active substance of the medicine is aripiprazole. Tractiva, 5 mg, tablets: Each tablet contains 5 mg of aripiprazole. Tractiva, 10 mg, tablets: Each tablet contains 10 mg of aripiprazole. Tractiva, 15 mg, tablets: Each tablet contains 15 mg of aripiprazole. Tractiva, 20 mg, tablets: Each tablet contains 20 mg of aripiprazole. Tractiva, 30 mg, tablets: Each tablet contains 30 mg of aripiprazole.
• Other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose (type 101), hydroxypropylcellulose, magnesium stearate, iron oxide, red (E 172).

What Tractiva looks like and contents of the pack

Tractiva 5 mg, tablets: Round, flat tablet, pink. Tractiva 10 mg, tablets: Round, biconvex tablet, pink. Tractiva 15 mg, tablets: Round, biconvex tablet, pink with a score line on one side. The score line on the tablet is not intended for breaking the tablet. Tractiva 20 mg, tablets: Round, flat tablet, pink with "20" on one side and a score line on the other side. The score line on the tablet is not intended for breaking the tablet. Tractiva 30 mg, tablets: Round, biconvex tablet, pink. The medicine is available in aluminum/aluminum blisters, packaged in cardboard boxes containing 14 or 28 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o. ul. Szamocka 8 01-748 Warsaw e-mail: [email protected]

Manufacturer

Laboratorios Liconsa, S.A. Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo 19200 Azuqueca de Henares Guadalajara Spain

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

Belgium Tractiva 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablets / tablets / tablets Czech Republic Tractiva Spain Aripiprazol Laboratorios Liconsa 5 mg EFG; Aripiprazol Laboratorios Liconsa 10 mg EFG; Aripiprazol Laboratorios Liconsa 15 mg EFG; Aripiprazol Laboratorios Liconsa 20 mg; Aripiprazol Laboratorios Liconsa 30 mg EFG Iceland: Tractiva Luxembourg Tractiva 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablets Germany Aripiprazol AAA-Pharma 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablets Poland Tractiva Italy Tractiva Date of last revision of the leaflet:11.07.2024