Package Leaflet: Information for the User

AripiprazoleMABO5 mg Tablets EFG

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, ask 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 isAripiprazoleMABOand what it is used for

2. What you need to know before you start takingAripiprazoleMABO

3. How to takeAripiprazoleMABO

4. Possible side effects

5. Storage ofAripiprazoleMABO

6. Contents of the pack and additional information

Aripiprazolbelongs to a group of medications known as 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, anxious, or tense.

AripiprazolMABO is used to treat adults and adolescents 13 years of age or older who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep 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 withAripiprazolMABO.

Do not takeAripiprazolMABO

•If you are allergic to aripiprazol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting 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 blood clot formation.

•History of addiction to gambling.

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

If you notice you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your daily normal activities, having difficulty swallowing, or presenting 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.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior during treatment with aripiprazol have been reported.

Talk to 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.

Children and adolescents

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

Other medications and Aripiprazol MABO

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. Make sure to inform your doctor if you are using any medication to control blood pressure.

If you are using this medication 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 producing adverse effects; if you observe any unusual symptoms when using any of these medications with aripiprazol, you should inform your doctor.

TakingAripiprazolMABOwith food, drinks, and alcohol

Aripiprazol can be taken regardless of meals.

It is recommended to avoid consuming alcohol while taking this medication.

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 medication.

The following symptoms may occur in newborn babies, from mothers who have been treated with aripiprazol in the last trimester 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.

Make sure to inform your doctor immediately if you are breastfeeding.

If you are taking aripiprazol, do not breastfeed.

Driving and operating machinery

Aripiprazol may produce symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Aripiprazol MABO contains lactose

If your doctor has indicated that you have a lactose intolerance, 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 aripiprazol is too strong or weak, inform your doctor or pharmacist.

Try to take the aripiprazol tablet at the same time every day. It does not matter if you take it with or without food.

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 consulting your doctor first.

If you take moreAripiprazolMABOthan 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 takeAripiprazolMABO

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 uncontrolled 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. They may experience double vision, eye sensitivity to light.Increased blood levels of the hormone prolactin.

Some people may feel depressed. Hiccups.

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, itching, 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, aggression, gambling addiction; suicidal thoughts, attempted 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 travel 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 white part of the eyes, abnormal liver function test results, abdominal and stomach discomfort, diarrhea; skin redness and sensitivity to light, unusual or decreased hair loss, 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, 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 uncontrolled 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 side effects

If you experienceany 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 Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special storage conditions.

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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aripiprazol MABO

-The active ingredient is aripiprazol. Each tablet contains 5 mg of aripiprazol.

-The other components are lactose monohydrate, microcrystalline cellulose (E-460), cornstarch, hydroxypropylcellulose (E-463), magnesium stearate (E-470b) and purified water.

Appearance of the product and contents of the packaging

Aripiprazol MABO 5 mg tablets are white, round, and biconvex.

They are presented in Al-PVC/PVC-Al-PA blisters containing 28 tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor

28821, Coslada, Madrid

Spain

Responsible for manufacturing

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802, Alcalá de Henares, Madrid

Spain

Last review date of this leaflet: October 2021

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