Aripiprazol aurovitas 1 mg/ml solucion oral efg

Package Insert: Information for the User

Aripiprazol Aurovitas 1 mg/ml Oral Solution EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Aripiprazol Aurovitas oral solution 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, anxious, or tense.

Aripiprazol 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 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.

Do not take Aripiprazol Aurovitas

• if you are allergic to aripiprazol or any of the other ingredients in this medicine

(see section 6).

Warnings and precautions

Consult your doctor before starting to take aripiprazol.

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 self-harm.

Tell 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), family history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure.

family history of blood clots, as antipsychotics have been associated with the formation of blood clots.

• history of addiction to gambling.
• aripiprazol may cause drowsiness, low blood pressure when standing up, dizziness, and changes in 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.

Tell your doctor immediately if you have thoughts or feelings of self-harm. 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 very fast or irregular heartbeat.

Inform your doctor if you, your family/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 called 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.

Other medicines and Aripiprazol Aurovitas with

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 taking aripiprazol 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:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
• antidepressants or plant-based medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort).
• medicines to treat fungal infections (antifungals) (such as ketoconazole, itraconazole).

itraconazole).

• some medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as, for example, indinavir, ritonavir).
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital).

phenobarbital).

• some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

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.

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.

anxiety.

• other antidepressants (such as venlafaxine and tryptophan), used in severe depression.
• tricyclic antidepressants (such as clomipramine and amitriptyline), used in depressive diseases.
• St. John's Wort (Hypericum perforatum),used in plant-based medicines 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 taking any of these medicines at the same time as aripiprazol, you should inform your doctor.

Taking Aripiprazol Aurovitas with food, drinks, and alcohol

This medicine can be taken regardless of meals. However, the oral solution should not be diluted with other liquids or mixed with any food before administration.

Alcohol consumption should be avoided.

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.

Cases of the following symptoms have been reported 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, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

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

Driving and operating machines

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

Aripiprazol Aurovitas contains fructose

Each ml of aripiprazol contains 200 mg of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, consult with them before taking you (or your child) this medicine.

Fructose and sucrose may harm teeth.

Aripiprazol oral solution contains sucrose

Each ml of Aripiprazol oral solution contains 400 mg of sucrose. In patients with diabetes mellitus, the administration of 12.5 ml or more of Aripiprazol oral solution per dose (which contains, at least, 5 g of sucrose) should be taken into account. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. It may be harmful to teeth.

Aripiprazol Aurovitas oral solution contains parahydroxybenzoates

The oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

They may cause allergic reactions (possibly delayed).

Aripiprazol Aurovitas contains propylene glycol

This medicine contains 53 mg of propylene glycol in each ml of oral solution.

Aripiprazol Aurovitas contains benzyl alcohol

This medicine contains 0.3 mg of benzyl alcohol in each ml of oral solution. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease. Consult your doctor or pharmacist if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Aripiprazol Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

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 ml of solution (which corresponds to 15 mg of aripiprazole) once a day.

However, your doctor may prescribe lower or higher doses up to a maximum of 30 ml (i.e., 30 mg) once a day.Your doctor may prescribe lower or higher doses up to a maximum of 30 ml (i.e., 30 mg) once a day.

Use in children and adolescents

The recommended dose for adolescents is 10 ml of solution (which corresponds to 10 mg of aripiprazole) once a day.Your doctor may prescribe lower or higher doses up to a maximum of 30 ml (i.e., 30 mg) once a day.

This dose of aripiprazole must be measured using the calibrated stopper or the 2 ml calibrated dropper that comes in the packaging.

If you believe the effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.

Try to takeAripiprazole Aurovitasat the same time every day.You can take it with or without food. However, do not dilute it with other liquids or mix it with other foods before taking aripiprazole.

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

If you take moreAripiprazole Aurovitasthan you should

If you realize you have taken more aripiprazole than your doctor recommended (or if someone else has taken part of your aripiprazole), contact your doctor immediately. If you cannot communicate with 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:

• rapid heartbeats, agitation/aggression, language problems.
• unusual movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating.

rigidity, somnolence, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to takeAripiprazole 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 withAripiprazole Aurovitas

Do not interrupt your treatment just because you feel better. It is essential to continue taking aripiprazole 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,
• akathisia (an uncomfortable feeling of inner restlessness and an overwhelming need to move constantly),
• involuntary movements of twisting, contorting, or spasmodic movements,
• tremors,
• headaches,
• fatigue,
• drowsiness,
• dizziness,
• tremors and blurred vision,
• difficulty passing stools or decreased frequency of bowel movements (constipation),
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling tired.

Rare 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,
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye sensitivity to light,
• rapid heartbeat,
• low blood pressure when standing, causing dizziness, confusion, or fainting,
• hypotension.

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

• low white blood cell count,
• low platelet count,
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, rashes),
• 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 and 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 of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you experience any of these symptoms, seek immediate medical attention),

High blood pressure,

• fainting,
• accidental inhalation of food, with a risk of 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,
• hives,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as the drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with symptoms similar to the flu, with a rash on the face, followed by a prolonged rash, high temperature, swollen lymph nodes, elevated liver enzyme levels in blood tests, and increased eosinophils,
• abnormal muscle degradation that can cause kidney problems,
• muscle pain,
• rigidity,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns due to exposure to the drug during pregnancy,
• prolonged and painful erection,
• difficulty controlling central body temperature or overheating,
• chest pain,
• swollen hands, ankles, or feet,
• abnormal blood test results: 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 buying,
• binge eating (eating 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 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 (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 lying or sitting, 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: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.

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.

This medication does not require special storage conditions.

Once the container is opened, use within 6 months.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Aripiprazole Aurovitas

• The active ingredient is aripiprazole. Each ml contains 1 mg of aripiprazole.
• The other components are: glycerol, propylene glycol, sucrose, fructose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, orange flavor contains aromas,

propylene glycol, benzyl alcohol, concentrated hydrochloric acid, sodium hydroxide, purified water.

Appearance of the product and contents of the package

Aripiprazole Aurovitas 1 mg/ml oral solution EFG is a transparent, colorless to light yellow liquid available inbottles with child-resistant closures made of polypropylene containing 50, 150 or 480 ml perbottle.

Each carton contains 1 bottle, a calibrated polypropylene stopper and a calibrated polypropylene dropper.

Thedropper is graduated for dosing of 0.5 ml and 1 ml, and then every 0.5 ml up to 2 ml. The stopper is graduated for dosing of 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and a maximum volume of 30 ml.

Only some package 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

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 avenue Tony Garnier

69007 Lyon

France

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

France:Aripiprazole Arrow 1 mg/ml solution buvable

Germany:Aripiprazol PUREN 1 mg/ml Lösung zum Einnehmen

Italy:Aripiprazolo Aurobindo Italia

Portugal:Aripiprazol Aurovitas

Spain:Aripiprazol Aurovitas 1 mg/ml solución oral EFG

Netherlands:Aripiprazol Aurobindo 1 mg/ml, drank

Last review date of this leaflet:January 2023

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