Product Information for the User
Aripiprazol Tarbis Farma 10 mg Tablets
Read this entire product information carefully before starting to take this medicine, as it contains important information for you.
1. What is Aripiprazol Tarbis Farma and how is it used
2. What you need to know before starting to take Aripiprazol Tarbis Farma
3. How to take Aripiprazol Tarbis Farma
4. Possible adverse effects
5. Storage of Aripiprazol Tarbis Farma
6. Contents of the pack and additional information
AripiprazolTarbis Farmacontains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics.
It is used to treat adults and adolescents of 15 years or more 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 monotony of emotional and behavioral behavior. People in this state may also feel depressed, guilty, restless or tense.
AripiprazolTarbis Farmais used to treat adults and adolescents of 13 years or more who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less 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
Warnings and precautions
Consult your doctor before starting to take Aripiprazol Rodio.
Cases of patients experiencing suicidal thoughts and behaviors have been reported during treatment with aripiprazol. Inform your doctor immediately if you have thoughts or feelings of harming yourself.
Before starting treatment with aripiprazol, tell your doctor if you have:
If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal 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 the person caring for you or a family member 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 harming yourself. Cases of patients experiencing suicidal thoughts and behaviors have been reported during treatment with aripiprazol.
Tell 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.
Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way in you and cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as addiction to gambling, excessive intake or expenditure, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings.
Your doctor may consider adjusting or interrupting the dose.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years old. Its safety and effectiveness in these patients are unknown.
Taking Aripiprazol Rodio with other medicines
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including over-the-counter medicines.
Medicines that lower blood pressure: aripiprazol may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you use any medicine to control blood pressure.
If you are using Aripiprazol Rodio with any other medicine, it may mean that your doctor needs to change your dose of aripiprazol or the dose of the other medicines. It is especially important to mention to your doctor if you are taking:
fenobarbital);
These medicines may increase the risk of adverse effects or reduce the effect of aripiprazol; if you observe any unusual symptoms when taking any of these medicines at the same time as aripiprazol, you should inform your doctor.
selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety;
These medicines may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medicines at the same time as aripiprazol, you should inform your doctor.
Taking Aripiprazol Rodio 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, or if you think you may be pregnant, or if you are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazol in the last three months 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.
Driving and operating machinery
Aripiprazol Rodio contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.
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. Gradually the dose may be 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 weak, inform your doctor or pharmacist.
Try to take the aripiprazole tablet at the same time every day. It does not matter if you take it with or without food.
Take the tablets always 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 Aripiprazol Tarbis Farma than you should
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.If you cannot contact your doctor, go to the nearest hospital and bring the packaging with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:
Other symptoms may include:
abnormal heart rhythms.
Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.
If you forgot to take Aripiprazol Tarbis Farma
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 Aripiprazol Tarbis Farma
Do not stop treatment just because you feel better. It is essential that you continue taking AripiprazolTarbis Farmafor 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):
Less frequent side effects (may affect up to 1 in 100 patients):
The following side effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency of occurrence is unknown:
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, there have been reported cases of fatal outcomes 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 from a lying or sitting position, which were frequent (affects up to 1 in 10 patients).
Reporting 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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.
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 the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
Composition ofAripiprazol Tarbis Farma
Appearance of the product and contents of the packaging
Aripiprazol Tarbis Farma 10 mg tablets are light pink to pink, rectangular with a beveled edge, biconvex, and engraved with "I" on one side and "96" on the other. They are presented in Alu-Alu blisters in packaging that contains 14, 28, 49, 56, 98, or 100 tablets.
Only some package sizes may be commercially available.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
TARBIS FARMA, S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Spain
Responsible manufacturer:
Amarox Pharma B.V.
Rouboslaan 32
Voorschoten, 2252TR
Netherlands
Pharmadox HeaIthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
This medicine is authorized in the member states of the European Economic Area with the following names:
PTAripiprazol Hetero
ESAripiprazol Tarbis Farma 10 mg Comprimidos EFG
NLAripiprazol Amarox 10 mg, tabletten
UKAripiprazole Rivopharm 10 mg, Tablets
Last review date of this leaflet:October 2021
The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.
The average price of Aripiprazol tarbis farma 10 mg comprimidos efg in July, 2025 is around 47.18 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.