Aripiprazol aurovitas 10 mg comprimidos efg

Package Leaflet: Information for the User

Aripiprazol Aurovitas 10 mg Tablets EFG

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

• Keep this package 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, and you must 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, pharmacist or nurse, even if they are not listed in this package leaflet. See section 4.

Aripiprazol Aurovitascontains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years or more 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.

Aripiprazolis used to treat adults and adolescents aged 13 years or more 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 with aripiprazol.

Do not takeAripiprazole Aurovitas

• If you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Aripiprazole Aurovitas.

Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole have been reported. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazole Aurovitas, inform your doctor if you have:

• High blood sugar levels (characterized by excessive thirst, increased urine production, increased appetite, and feeling weak) or a family history of diabetes.
• Seizures, as your doctor may want to monitor you more closely.
• Irregular and involuntary muscle movements, especially in the face.
• Cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure.
• Blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots.
• A history of addiction to gambling.

Inform your doctor 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.

If you are an elderly patient with dementia (loss of memory and other mental abilities), you or the person or family member caring for you 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 behaviors during treatment with aripiprazole 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.

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 spending, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may need to adjust or discontinue your dose.

Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in your ability to move and balance, which may cause falls. You should be cautious, especially if you are an elderly patient or have any weakness.

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.

Other medicines and Aripiprazole Aurovitas

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:Aripiprazole may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are using any medicine to control blood pressure.

If you are using Aripiprazole Aurovitas with any other medicine, your doctor may need to change your dose of aripiprazole or the other medicines. It is especially important to mention to your doctor the following:

• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide).
• Antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort).
• Antifungals (such as ketoconazole, itraconazole).
• Certain medicines to treat HIV infection (such as efavirenz, nevirapine, protease inhibitors, for example, 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 adverse effects or reduce the effect of aripiprazole; if you observe any unusual symptoms when taking any of these medicines with aripiprazole, you should inform your doctor.

Medicines that increase serotonin levels are generally used to treat diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• Triptans, tramadol, and tryptophan, used to treat diseases such as depression, generalized anxiety disorder, OCD, and social phobia, as well as migraine and pain.
• Selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine), used to treat depression, OCD, panic, and anxiety.
• Other antidepressants (such as venlafaxine and tryptophan) used in severe depression.
• Tricyclic antidepressants (such as clomipramine, amitriptyline), used to treat depressive diseases.
• St. John's Wort (Hypericum perforatum) used in herbal remedies 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 adverse effects; if you observe any unusual symptoms when using any of these medicines with Aripiprazole Aurovitas, you should inform your doctor.

Taking Aripiprazole Aurovitas with food, drinks, and alcohol

Aripiprazole Aurovitas can be taken regardless of meals.

Alcohol consumption should be avoided while taking aripiprazole.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborns of mothers who have used Aripiprazole Aurovitas in the last trimester (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

If you are taking Aripiprazole Aurovitas, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of your treatment and the benefit of breastfeeding for your baby. You should not do both. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

During treatment with this medicine, dizziness and vision problems (see section 4) may occur. This should be taken into account when requiring maximum attention, for example, when driving or operating machinery.

Aripiprazole Aurovitas contains lactose

This medicine 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 as indicated by your doctor. 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 medicationshould 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 your Aripiprazol Aurovitas 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 aripiprazole without consulting your doctor first.

If you take moreAripiprazol Aurovitasthan 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 taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Patients who have taken too much aripiprazole have experienced the following symptoms:

Other symptoms may include:

Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.

If you forgot to useAripiprazol Aurovitas

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 the treatment with Aripiprazol Aurovitas

Do not stop your treatment just because you feel better. It is essential that you continue taking Aripiprazol Aurovitas tablets for 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 people):

• diabetes mellitus,
• sleep problems,
• anxiety,
• feeling restless and unable to stay still, difficulty staying seated,
• uncontrolled twisting, contorting, or spasmodic movements, restless legs,
• shakiness,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• shaking and blurred vision,
• difficulty passing stools or decreased frequency of bowel movements (constipation),
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling tired.

Less frequent side effects(may affect up to 1 in 100 people):

• increased or decreased levels of prolactin hormone in the blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sex drive,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• double vision, light sensitivity,
• rapid heartbeat,
• drop in blood pressure when standing, causing dizziness, fainting, or loss of consciousness,
• hypotension.

The following side effects have been reported during the post-marketing phase of aripiprazole oral,but the frequency of occurrence is unknown:

Unknown frequency: cannot be estimated from available data

• low white blood cell count,
• low platelet count,
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, hives, and redness),
• appearance or worsening of diabetes, ketoacidosis (ketones in the blood and urine), or coma,
• high blood sugar levels,
• insufficient sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, attempts, and suicide,
• aggression,
• agitation,
• nervousness,
• combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate; fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity),
• speech disorder,
• fixation of the eyeballs in a position,
• sudden unexplained death,
• potentially fatal irregular heartbeat,
• heart attack,
• slow heart rate,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food, which can lead to pneumonia (lung infection),
• spasms of the muscles around the glottis (a part of the larynx),
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and the white part of the eyes,
• abnormal liver function test results,
• skin rash,
• light sensitivity,
• hair loss,
• excessive sweating,
• abnormal muscle degradation that can cause kidney problems,
• muscle pain,
• rigidity,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• symptoms of withdrawal in newborns due to exposure to the medication during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling central body temperature or overheating,
• chest pain,
• swollen hands, ankles, or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased hemoglobin A1c,
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sex drive and concerning behavior for yourself or others, such as increased sex drive;
• uncontrollable excessive buying;
• binge eating (ingesting large amounts of food in a short period) 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, there have been reported 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, uncontrolled spasms or contractions, restlessness, and fatigue, which were very frequent (affecting 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 (affecting more than 1 in 100 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 Medicines for Human Use: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.

No special storage conditions are required.

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 point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofAripiprazol Aurovitas

• The active ingredient is aripiprazol. Each tablet contains 10 mg of aripiprazol.
• The other components are: lactose monohydrate, microcrystalline cellulose, cornstarch, hydroxypropyl cellulose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the packaging

White, uncoated tablet, rectangular, with the mark “63” on one face and “H” on the other. The size is 8 mm × 4.5 mm.

Aripiprazol Aurovitas is available in polyamide/aluminum/PVC/aluminum blister packaging.

Packaging sizes: 14 and 28 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Last review date of this leaflet:December 2022

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