Tractiva 5 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tractiva 5 mg tablets EFG
aripiprazole
Read all of 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Tractiva is and what it is used for
- What you need to know before taking Tractiva
- How to take Tractiva
- Possible side effects
- How to store Tractiva
- Contents of the pack and other information
1. What Tractiva is and what it is 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 who have an illness characterized by symptoms such as hearing, seeing, or sensing things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.
Aripiprazole is used to treat adults and adolescents aged 13 years and older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with aripiprazole.
2. What you need to know before taking Tractiva
Do not take Tractiva
- if you are allergic to aripiprazole or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before starting to take Tractiva.
Cases of patients experiencing suicidal thoughts and behaviours during treatment with aripiprazole have been reported. Inform your doctor immediately if you have thoughts or feelings of harming yourself.
Before starting treatment with Tractiva, tell your doctor if you:
- have high blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes;
- have seizures, as your doctor may want to monitor you more closely;
- have irregular and involuntary muscle movements, especially of the face;
- have cardiovascular disease (heart and circulation problems), a family history of cardiovascular disease, stroke or "mini" strokes, or abnormal blood pressure;
- have a history of blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
- have a history of gambling addiction.
If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.
If you have dementia (loss of memory and other mental abilities), you or your caregiver or family member should inform your doctor if you have ever had a stroke or "mini" stroke.
Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behaviour during treatment with aripiprazole have been reported.
Speak to your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental state, or very rapid 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 and are unable to resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviours such as gambling addiction, excessive eating or spending, abnormally increased sex drive, or preoccupation with increased sexual thoughts and feelings.
Your doctor may consider adjusting or stopping your dose.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution is advised, especially if you are elderly or have any weakness.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.
Other medicines and Tractiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.
Medicines that lower blood pressure: Tractiva may increase the effect of medicines used to lower blood pressure. Be sure to tell your doctor if you are taking any medicine to control blood pressure.
If you are taking Tractiva with any other medicine, it may mean that your doctor needs to adjust the dose of Tractiva or the other medicines. It is especially important to tell 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 Tractiva; if you notice any unusual symptoms while taking any of these medicines together with Tractiva, you must inform your doctor.
Medicines that increase serotonin levels are generally used for conditions including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:
- triptans, tramadol, and tryptophan used for conditions 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;
- other tricyclic antidepressants (such as clomipramine and amitriptiline) used in depressive disorders;
- St. John’s wort (Hypericum perforatum) used in herbal medicines for mild depression;
- analgesics (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 while taking any of these medicines together with Tractiva, you must inform your doctor.
Taking Tractiva with food, drinks, and alcohol
This medicine can be taken regardless of meals.
Alcohol consumption should be avoided.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The following symptoms may occur in newborn babies whose mothers have been treated with Tractiva during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. If you are being treated with Tractiva, 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
This medicine may cause dizziness and vision problems (see section 4). This should be taken into account when maximum attention is required, for example, when driving or operating machinery.
Tractiva contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Tractiva
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.
Use in children and adolescents
This medicine should be initiated with the oral solution (liquid) at a low dose.
The dose may gradually be increased to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.
If you feel that the effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.
Try to take Tractiva at the same time each day. It does not matter whether you take it with or without food.
Always take the tablets with water and swallow them whole.
Even if you feel better, do not change or stop your daily dose of aripiprazole without first consulting your doctor.
If you take more Tractiva than you should
If you realize 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 reach your doctor, go to the nearest hospital and take the packaging with you.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91.562.04.20, indicating the medicine and the amount ingested.
Patients who have taken too much aripiprazole have experienced the following symptoms:
- rapid heartbeat, agitation/aggression, speech 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 drowsiness, slowed breathing, suffocation, high or low blood pressure, abnormal heart rhythms.
Contact your doctor or the nearest hospital immediately if you experience any of the above symptoms.
If you forget to take Tractiva
If you miss a dose, take the missed dose as soon as you remember, but do not take a double dose to make up for the missed dose.
If you stop taking Tractiva
Do not stop your treatment just because you feel better. It is important that you continue taking aripiprazole for as long as your doctor has instructed.
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 everyone will experience them.
Common adverse effects (may affect up to 1 in 10 patients):
- diabetes mellitus;
- sleep disturbances;
- anxiety;
- feeling restless and unable to remain still, difficulty staying seated;
- akathisia (an uncomfortable sensation of inner restlessness and an urgent need to keep moving constantly);
- uncontrollable twisting, writhing, or spasmodic movements;
- tremor;
- headache;
- fatigue;
- somnolence;
- dizziness;
- shakiness and blurred vision;
- difficulty defecating or reduced frequency of bowel movements (constipation);
- indigestion;
- nausea;
- increased saliva production;
- vomiting;
- feeling of tiredness.
Uncommon adverse effects (may affect up to 1 in 100 patients):
- increased blood levels of the hormone prolactin;
- excessively high blood sugar levels;
- depression;
- altered or increased sexual interest;
- uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
- a muscular disorder causing twisting movements (dystonia);
- restless legs;
- double vision;
- ocular photosensitivity;
- rapid heartbeat;
- drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting;
- hiccups.
The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but their frequency is unknown:
- low white blood cell count;
- low platelet count;
- allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, and redness);
- onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;
- high blood sugar;
- low sodium levels in blood;
- weight loss;
- weight gain;
- suicidal thoughts, suicide attempt, and suicide;
- aggressiveness;
- agitation;
- nervousness;
- a combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);
- seizures;
- serotonin syndrome (a reaction that may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);
- speech disorder;
- fixed eye position;
- unexplained sudden death;
- potentially life-threatening irregular heartbeat;
- heart attack;
- slower heartbeat;
- blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, contact your doctor immediately);
- elevated blood pressure;
- fainting;
- accidental inhalation of food with risk of pneumonia (lung infection);
- spasms of muscles around the glottis (a part of the larynx);
- pancreatitis;
- difficulty swallowing;
- diarrhea;
- abdominal discomfort;
- stomach upset;
- liver failure;
- liver inflammation;
- yellowing of the skin and whites of the eyes (jaundice);
- abnormal liver function test results;
- rash;
- skin photosensitivity;
- hair loss;
- excessive sweating;
- severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with facial rash, followed by generalized rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);
- abnormal muscle breakdown that may lead to kidney problems;
- muscle pain;
- stiffness;
- involuntary loss of urine (incontinence);
- difficulty urinating;
- withdrawal symptoms in newborns due to exposure to medication during pregnancy;
- prolonged and/or painful erection;
- difficulty controlling body temperature or overheating;
- chest pain;
- swollen hands, ankles, or feet;
- in blood tests: increase or fluctuation in blood sugar levels, increased glycated hemoglobin;
- inability to resist the impulse, urge, or temptation to perform an action that may be harmful to you or others, possibly including:
- a strong urge to gamble excessively despite serious personal or family consequences;
- altered or increased sexual interest and behavior concerning to you or others, for example, increased sexual appetite;
- uncontrollable excessive shopping;
- binge eating (consuming large amounts of food in a short period of time) 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; they will explain how to manage or reduce the symptoms.
In elderly patients with dementia, an increased number of fatal cases have been reported while taking aripiprazole.
In addition, cases of stroke or "mini" strokes have been reported.
Other adverse effects in children and adolescents
Adolescents aged 13 years and older experienced adverse effects similar in frequency and type to those in adults, except for somnolence, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (affects more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary limb movements, and dizziness—especially upon standing up from lying or sitting positions—which were common (affects up to 1 in 10 patients).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tractiva
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tractiva
The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
The other components are: monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate and indigo carmine (E132).
Appearance of Tractiva and contents of the pack
Tractiva 5 mg tablets are blue, elliptical, nearly flat, low-profile and slightly convex.
Each standard pack contains 28 tablets, packed in blisters.
Marketing Authorization Holder
EXELTIS HEALTHCARE, S.L.
Avda de Miralcampo 7
Polígono Industrial Miralcampo
- Azuqueca de Henares (Guadalajara)
Spain
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira
2710-089 Sintra
Portugal
Date of the most recent review of this leaflet: November 2022
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):
http://www.aemps.gob.es/