Aripiprazole Mabo 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole MABO 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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 other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents

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

1. What Aripiprazol MABO is and what it is used for

Aripiprazole 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 feeling things that do not exist, distrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazol MABO 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 this condition in patients who have responded to treatment with Aripiprazol MABO.

2. What you need to know before taking Aripiprazole MABO

Do not take Aripiprazole MABO

• 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 this medicine 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.
• Seizures.
• Irregular and involuntary muscle movements, especially in the face.
• Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, or abnormal blood pressure.
• Blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation.
• A history of gambling addiction.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which could lead to falls. Caution is advised, especially if you are elderly or have any degree of physical weakness.

If you notice weight gain, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or show 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 suicidal thoughts and behavior have been reported in patients taking aripiprazole.

Speak to your doctor immediately if you experience muscle stiffness or numbness, high fever, sweating, altered mental state, or very rapid or irregular heartbeat.

Children and adolescents

Aripiprazole is not used in children and adolescents under 13 years of age. Consult your doctor or pharmacist before taking this medicine.

Other medicines and Aripiprazole MABO

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Medicines that lower blood pressure: aripiprazole may enhance the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medication to control blood pressure.

If you are taking this medicine together with other medicines, you may need to adjust your aripiprazole dose. It is especially important to inform your doctor about the following:

• Medicines used to correct heart rhythm.
• Antidepressants or herbal remedies used to treat depression and anxiety.
• Antifungals.
• Certain medicines used to treat HIV infection.
• Anticonvulsants used to treat epilepsy.

Medicines that increase serotonin levels: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), meperidine, St. John's Wort, and venlafaxine. These medicines increase the risk of adverse effects; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazole MABO with food, drinks, and alcohol

Aripiprazole can be taken regardless of meals.

Alcohol consumption should be avoided while taking this medicine.

The score line is only intended to divide the tablet if you have difficulty swallowing it whole.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 aripiprazole during the third 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.

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

If you are taking aripiprazole, you must not breastfeed.

Driving and using machines

Aripiprazole may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

Aripiprazole MABO 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 Aripiprazole MABO

Follow exactly the instructions for using this medicine as 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

Aripiprazole 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 the aripiprazole tablet 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 the daily dose of aripiprazole without first consulting your doctor.

If you take more Aripiprazole MABO than you should

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.

If you forget to take Aripiprazole MABO

If you forget a dose, take it as soon as you remember. However, do not take a double dose to make up for the forgotten dose.

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 experiences them.

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

Uncommon adverse effects (may affect up to 1 in 100 patients): some people may feel dizzy, especially when getting up after lying down or sitting, or may feel their heart racing. They may experience double vision, eye photosensitivity. Increased blood levels of the hormone prolactin.

Some people may feel depressed. Hiccups.

The following adverse effects have been reported during the post-marketing use of aripiprazole, but their frequency is unknown (frequency cannot be estimated from the available data): changes in levels of certain blood cells; unusual heartbeat, unexplained sudden death, heart attack; allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching and redness of the skin); elevated blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma, low sodium levels in blood; weight gain, weight loss, anorexia; restlessness, agitation, anxiety, aggression, gambling addiction; suicidal thoughts, suicide attempt; speech disorder, seizures, serotonin syndrome (a reaction that may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), a combination of fever, muscle stiffness, 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 leg swelling, pain, and redness), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if you experience any of these symptoms, contact your doctor immediately); spasms of the muscles around the glottis, accidental inhalation of food with risk of pneumonia, difficulty swallowing; pancreatitis; liver failure, liver inflammation, yellowing of the skin and whites of the eyes, abnormal liver function tests, abdominal and stomach discomfort, diarrhea; skin redness and light sensitivity, 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 core body temperature or overheating, chest pain, and swollen hands, ankles, or feet, fixation of the eyeballs in one position.

In elderly patients with dementia, a higher 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 or 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 (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 after lying down or sitting, which were common (may affect more than 1 in 100 patients).

Reporting of adverse effects

If you experience any type of 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole MABO

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazole MABO

• The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
• The other components are monohydrate lactose, microcrystalline cellulose (E-460), corn starch, hydroxypropylcellulose (E-463), magnesium stearate (E-470b) and purified water.

Description of the product and contents of the pack

Aripiprazole MABO 10 mg tablets are white, round, flat, bevelled tablets, scored on one side.

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

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802 Alcalá de Henares, Madrid

Spain

Date of the most recent revision of this leaflet: October 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http:// www.aemps.gob.es /