Tractiva

Patient Information Leaflet

Tractiva, 2.5 mg, tablets
Tractiva, 5 mg, tablets
Tractiva, 10 mg, tablets
Tractiva, 15 mg, tablets
Tractiva, 20 mg, tablets
Tractiva, 30 mg, tablets
Aripiprazole
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Tractiva is and what it is used for

Tractiva contains aripiprazole as the active substance and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who have an illness characterised by symptoms such as hearing, seeing, or sensing things that are not real, suspiciousness, beliefs that are not based in reality, disorganised speech and behaviour, and emotional detachment. Patients with these symptoms may also experience depression, feelings of guilt, anxiety, or tension.

Tractiva is also used to treat adults and adolescents aged 13 years and older who have an illness characterised by symptoms such as extreme excitement, increased energy, reduced need for sleep, very rapid speech with racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the recurrence of these symptoms in patients who have responded to treatment with Tractiva.

2. Important information before using Tractiva

When not to use 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 treatment with Tractiva, discuss this with your doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Immediately inform your doctor if you experience any thoughts or feelings related to harming yourself.
Before starting treatment with Tractiva, inform your doctor if the patient has:

• high blood sugar levels (characteristic symptoms include excessive thirst, passing large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
• seizures (epilepsy), as this may mean that the doctor will want to monitor the patient closely;
• involuntary, irregular muscle movements, especially of the facial muscles;
• cardiovascular diseases (heart and circulatory diseases), family history of cardiovascular disease, stroke or "mini" stroke (transient ischaemic attack), or abnormal blood pressure;
• blood clots or a family history of blood clots, as the use of antipsychotic medicines has been associated with blood clot formation;
• a history of gambling addiction.

If the patient experiences weight gain, unusual movements, drowsiness that interferes with daily activities, any difficulty swallowing, or symptoms of an allergic reaction, they should inform their doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, caregiver, or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
Immediately inform the doctor about any thoughts or feelings related to harming oneself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform the doctor if the patient experiences muscle stiffness or stiffness accompanied by high fever, sweating, changes in mental state, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient begins to feel an urge or desire to behave in an unusual way and cannot resist an impulse, urge, or temptation to engage in activities that could harm themselves or others, they should inform the doctor. These phenomena are known as impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating, or excessive spending, increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider adjusting the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls. Caution is advised, 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 whether the use of this medicine is safe and effective in these patients.

Tractiva with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
Medicines that lower blood pressure: Tractiva may enhance the effect of blood pressure-lowering medicines. If the patient is taking medicines to lower blood pressure, they should inform their doctor.
Taking Tractiva with other medicines may require dose adjustments of Tractiva or the other medicines. It is especially important to inform the doctor about the use of:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide);
• antidepressants 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 reduce the effectiveness of Tractiva; if any unusual symptoms occur while taking these medicines together with Tractiva, inform your doctor.
Medicines that increase serotonin levels are usually used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social anxiety disorder, migraine, and pain:

• triptans, tramadol, and tryptophan used to treat conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social anxiety disorder, 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 major depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depression;
• St. John's wort (Hypericum perforatum) used as a herbal product 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 any unusual symptoms occur while taking these medicines together with Tractiva, inform your doctor.

Tractiva with food, drink, and alcohol
This medicine can be taken regardless of meals.
Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Newborns whose mothers took Tractiva during the last trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms are observed in the newborn, contact a doctor immediately.
If the patient is taking Tractiva, the doctor will discuss with her whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding. Tractiva should not be taken while breastfeeding. Discuss with your doctor the best feeding methods for the baby if you are taking this medicine.

Driving and operating machinery
During treatment with this medicine, dizziness and visual disturbances may occur (see section 4). This should be taken into account when performing tasks requiring full attention, such as driving or operating machinery.

Tractiva contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Tractiva
This medicine should always be used exactly as prescribed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
The recommended dose in adults is 15 mg once daily. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.

Use in children and adolescents
Treatment with aripiprazole may be initiated at 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 daily. However, the treating doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.

If the effect of Tractiva seems too strong or too weak, consult the doctor or pharmacist.
Tractiva tablets should be taken daily at the same time. It does not matter whether the tablet is taken with or without food. The tablet should be swallowed whole and taken with water.
Even if you feel better, do not change the dose or stop taking Tractiva without first discussing it with your doctor.

Taking more Tractiva than prescribed
If more Tractiva is taken than prescribed (or if someone else takes some of the medicine not intended for them), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken an excessive dose of aripiprazole, the following symptoms have occurred:

• rapid 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:

• acute confusion, seizures (epilepsy), coma, fever combined with rapid breathing and excessive sweating;
• muscle stiffness and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heartbeat.

If any of the above symptoms occur, contact a doctor or hospital immediately.

Missing a dose of Tractiva
If a dose is missed, the patient should take the missed dose as soon as they remember, but should not take two doses on the same day.

Stopping Tractiva treatment
Do not stop treatment even if the patient feels better. It is very important to take Tractiva exactly as prescribed by the doctor and for the duration recommended by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

Common adverse reactions (may occur in no more than 1 in 10 people):

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

Uncommon adverse reactions (may occur in no more than 1 in 100 people):

• increased or decreased blood levels of a hormone called prolactin,
• high blood sugar levels,
• depression,
• altered 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,
• light sensitivity,
• rapid heartbeat,
• low blood pressure upon standing, causing dizziness, feeling of emptiness in the head, or fainting,
• hiccups.

The following adverse reactions have been reported after the introduction of oral aripiprazole to the market, but their frequency is unknown:

• decreased number of white blood cells,
• decreased number of platelets,
• allergic reactions (e.g. swelling of the mouth, tongue, face, and throat, skin itching, hives),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine), or coma,
• high blood sugar levels,
• low blood sodium levels,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts, and suicide,
• feeling of aggression,
• agitation,
• nervousness,
• occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that may cause feelings of extreme well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating, or muscle stiffness),
• speech disorders,
• fixed eye position (oculogyric crisis),
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack,
• slow heart rate,
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if any of these symptoms occur, the patient must contact a doctor immediately),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of developing pneumonia,
• muscle spasms around the larynx,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes (jaundice),
• abnormal liver function test results,
• skin rash,
• photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially resembles flu-like symptoms with a rash on the face, followed by a rash on other parts of the body, high fever, swollen lymph nodes, increased liver enzyme activity (seen in blood tests), and increased numbers of a specific type of white blood cell (eosinophilia),
• abnormal muscle breakdown, which may lead to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination (urinary incontinence),
• difficulty urinating,
• withdrawal syndrome in newborns following exposure to the drug during pregnancy,
• prolonged and/or painful erection (priapism),
• difficulty regulating core body temperature or overheating,
• chest pain,
• swelling of hands, ankles, or feet,
• in blood tests: increased or fluctuating blood glucose levels, increased levels of glycated hemoglobin,
• inability to resist an impulse, drive, or urge to engage in an activity that may harm the patient or others, including behaviors such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • altered or increased interest in sex and behaviors significantly distressing to the patient or others, e.g. increased sexual drive,
  • uncontrolled excessive shopping or spending,
  • compulsive overeating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger),
  • impulse to wander (pica-like behavior). If such behaviors occur, the patient should inform their doctor, who will discuss treatment options or ways to reduce these symptoms.

In elderly patients with dementia treated with aripiprazole, there have been reports of a higher number of fatal outcomes. In addition, cases of stroke or "mini-strokes" (transient ischemic attacks) have been observed.

Additional adverse reactions in children and adolescents

In adolescents aged 13 years and older, adverse reactions occurred at a similar frequency and type as in adults, except for drowsiness, uncontrolled twitching or sudden movements, motor restlessness, and fatigue, which were very common (may occur in more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled limb movements, and dizziness—especially when rising from a lying or sitting position—which were common (may occur in more than 1 in 100 patients).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tractiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following "EXP".
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Tractiva contains

• The active substance is aripiprazole.
  Tractiva 2.5 mg tablets: Each tablet contains 2.5 mg of 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: monohydrate lactose, maize starch, microcrystalline cellulose (type 101), hydroxypropylcellulose, magnesium stearate, iron oxide red (E 172) (only for 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets).

What Tractiva looks like and contents of the pack
Tractiva 2.5 mg tablets: White, round, flat tablet with a score line on one side. The score line is not intended to divide the tablet into equal doses.
Tractiva 5 mg tablets: Round, flat, light pink tablet.
Tractiva 10 mg tablets: Round, biconvex, light pink tablet.
Tractiva 15 mg tablets: Round, biconvex, light pink tablet with a score line on one side. The score line is not intended to divide the tablet into equal doses.
Tractiva 20 mg tablets: Round, biconvex, light pink tablet with the number "20" on one side and a score line on the other side. The score line is not intended to divide the tablet into equal doses.
Tractiva 30 mg tablets: Round, biconvex, light pink tablet.

The medicine is available in aluminium/aluminium foil blisters packed in cardboard boxes containing 10, 14, 28, 30, 50, 56 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warszawa
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area under the following names:
Iceland: Tractiva 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablet
Belgium: Tractiva 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablets
Luxembourg: Tractiva 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablet
Czech Republic: 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
Italy: Tractiva 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablets
Poland: Tractiva 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg tablets
Spain: Aripiprazol Laboratorios Liconsa 2.5 mg, 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