Leaflet: information for the user

Aripiprazol Tarbis15 mg film-coated tablets

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, consult your doctor or pharmacist.

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

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

1. What isAripiprazol Tarbisand what is it used for

2. What you need to know before starting to takeAripiprazol Tarbis

3. How to takeAripiprazol Tarbis

4. Possible side effects

5. Storage ofAripiprazol Tarbis

6. Contents of the pack and additional information

Aripiprazol Tarbis contains the active ingredient aripiprazol and belongs to a group of medicines called 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, restless or tense.

Do not take Aripiprazol Tarbis

Warnings and precautions

Consult your doctor before starting to take this medication if you have:

?High blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling weak) or a family history of diabetes

?Seizures

?Irregular and involuntary muscle movements, especially in the face

?Cardiovascular 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 the formation of blood clots

?History of addiction to gambling

If you notice that you are gaining weight, developing unusual movements, experiencing sleepiness that interferes with your daily activities, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor.

If you are an elderly patient with dementia (loss of memory and other mental abilities), you or the person caring for you should inform your doctor if you have ever had a stroke or "mini" stroke.

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

Immediately speak with your doctor if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast or irregular heartbeat.

Aripiprazol may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could cause falls. Caution should be exercised, especially if you are an elderly patient or have weakness.

Children and adolescents

Aripiprazol is not used in children and adolescents under 13 years old. Consult your doctor or pharmacist before taking this medication.

Taking Aripiprazol Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Medications that lower blood pressure: aripiprazol may increase the effect of medications used to lower blood pressure. Ensure that you inform your doctor if you are using any medication to control blood pressure.

If you are using aripiprazol with any other medication, you may need to change your aripiprazol dose. It is especially important to mention the following to your doctor:

?Medications to correct heart rhythm

?Antidepressants or herbal remedies used to treat depression and anxiety

?Antifungals

?Certain medications to treat HIV infection

?Anticonvulsants used to treat epilepsy

Medications that increase serotonin levels: triptans, tramadol, tryptophan, ISRS (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), petidina, St. John's Wort, and venlafaxine. These medications increase the risk of adverse effects; if you observe any unusual symptoms when using any of these medications with aripiprazol, inform your doctor.

Taking Aripiprazol Tarbis with food, drinks, and alcohol

Aripiprazol Tarbis can be taken regardless of meals.

Alcohol consumption should be avoided while taking this medication.

Pregnancy, breastfeeding, and fertility

Do not take aripiprazol if you are pregnantunless you have discussed it with your doctor.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

The following symptoms may occur in newborn babies of mothers treated with aripiprazol in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, sleepiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Ensure that you inform your doctor immediately if you are breastfeeding.

If you are taking aripiprazol, do not breastfeed.

Driving and operating machinery

Do not drive or operate tools or machines until you know how Aripiprazol Tarbis affects you.

Aripiprazol Tarbis contains lactose

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

Follow exactly the administration instructions for this medication as 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

Aripiprazol should be started with the oral solution (liquid) at a low dose. The dose can gradually 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 this medication is too strong or too weak, inform your doctor or pharmacist.

Try to take the aripiprazol tabletat the same time every day.It does not matter if you take it with or without food. Always take the tablets with water and swallow them whole.

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

If you take moreAripiprazol Tarbisthan 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 forgot to takeAripiprazol Tarbis

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 have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent side effects (may affect up to 1 in 10 patients): muscle spasms or uncontrollable contractions, headaches, fatigue, nausea, vomiting, stomach discomfort, constipation, increased saliva production, dizziness, sleep disturbances, agitation, anxiety, drowsiness, tremors, and blurred vision.

Less frequent side effects (may affect up to 1 in 100 patients): some people may feel dizzy, especially when getting up from a lying or sitting position, or feel that their heart is racing.

Some people may feel depressed.

Increased blood levels of the hormone prolactin.

Hoarseness.

Ocular photosensitivity.

The following side effects have been reported during the marketing of aripiprazole, but the frequency of occurrence is unknown (the frequency cannot be estimated with the available data):

Changes in the levels of some blood cells; irregular heartbeat, sudden unexplained death, heart attack; allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, hives, and redness); high blood sugar, appearance or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodium levels in the blood; weight gain, weight loss, anorexia; nervousness, agitation, anxiety, gambling addiction; suicidal thoughts, attempted suicide, and completed suicide; speech disorder, convulsions, serotonin syndrome (a reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity); combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate; fainting, high blood pressure, blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can be transported through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek immediate medical attention); spasms of the muscles around the glottis, accidental inhalation of food with a risk of pneumonia, difficulty swallowing; pancreatitis; liver failure, inflammation of the liver, yellowing of the skin and the white part of the eyes, abnormal liver function test results, abdominal and stomach discomfort, diarrhea; skin redness and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty urinating; prolonged and/or painful erection; difficulty controlling central body temperature or overheating, chest pain, and swollen hands, ankles, or feet; aggression; fixation of the eyeballs in a position.

In elderly patients with dementia, there have been 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, muscle spasms or uncontrollable contractions, restlessness, and fatigue, which were very frequent (may affect 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 (may affect more than 1 in 100 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 leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat 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 of Aripiprazol Tarbis

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

-The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and iron oxide red (E-172).

Appearance of the product and content of the packaging

Aripiprazol Tarbis 15 mg tablets are round, biconvex, pale pink, and scored on one side.

Each package contains 14 and 28 tablets, packaged in aluminum-aluminum blisters.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

J. Uriach and Company, S.A.

Av. Camí Reial, 51-57

08184 - Palau-solità i Plegamans (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Malta:Aripiprazol Uriach 15 mg tablets

Spain:Aripiprazol Tarbis 15 mg tablets

Last review date of this leaflet: June 2020

More detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/