ARIPIPRAZOLE AUROVITAS 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Aripiprazole Aurovitas 1 mg/ml Oral Solution EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Aripiprazole Aurovitas is and what it is used for

Aripiprazole Aurovitas oral solution contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 and older who suffer from a disease characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and emotional and behavioral monotony. People in this state may also feel depressed, guilty, restless, or tense.

Aripiprazole is used to treat adults and adolescents aged 13 and older who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking 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 aripiprazole.

2. What you need to know before you take Aripiprazole Aurovitas

Do not take Aripiprazole Aurovitas

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

Warnings and precautions

Talk to your doctor before starting to take aripiprazole.

There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole. Tell your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with aripiprazole, tell your doctor if you suffer from:

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling of weakness) 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.

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

• history of addiction to gambling.
• aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. You should be cautious, especially if you are an elderly patient or have some weakness.

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

If you suffer from 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. There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole.

Talk to your doctor immediately if you experience numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast or irregular heartbeat.

Tell your doctor if you, your family/caregiver notice that you are developing impulses or urges to behave in an unusual way and that you 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 eating or spending, abnormally high sexual appetite, or 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 of age. It is not known if it is safe and effective in these patients.

Other medicines and Aripiprazole Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Medicines that lower blood pressure: aripiprazole may increase the effect of medicines used to lower blood pressure. Make sure to tell your doctor if you use any medicine to control blood pressure.

If you are taking aripiprazole with another medicine, it may mean that your doctor needs to change your dose of aripiprazole or the other medicine. It is especially important that you 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).

certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as 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 side effects or reduce the effect of aripiprazole; if you notice any unusual symptoms when taking any of these medicines at the same time as aripiprazole, you should tell your doctor.

Medicines that increase serotonin levels are commonly used in 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 for diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain.
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine), used for depression, OCD, panic, and 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 side effects; if you notice any unusual symptoms when taking any of these medicines at the same time as aripiprazole, you should tell your doctor.

Taking Aripiprazole Aurovitas with food, drinks, and alcohol

This medicine can be taken with or without food. However, the oral solution should not be diluted with other liquids or mixed with food before administration.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazole 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, you should contact your doctor.

If you are taking aripiprazole, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you 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 using 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, e.g., when driving or operating machinery.

Aripiprazole Aurovitas contains fructose

Each ml of aripiprazole 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 this medicine.

Fructose and sucrose can harm teeth.

Aripiprazole oral solution contains sucrose

Each ml of Aripiprazole oral solution contains 400 mg of sucrose. In patients with diabetes mellitus, the administration of 12.5 ml or more of Aripiprazole oral solution per dose (containing 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 with them before taking this medicine. It may be harmful to teeth.

Aripiprazole Aurovitas oral solution contains parahydroxybenzoates

The oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

They may cause allergic reactions (possibly delayed).

Aripiprazole Aurovitas contains propylene glycol

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

Aripiprazole 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 can accumulate in your body and cause side effects (metabolic acidosis).

Aripiprazole Aurovitas contains sodium

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

3. How to take Aripiprazole Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 ml of solution (corresponding 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.

Use in children and adolescents

The recommended dose for adolescents is 10 ml of solution (corresponding to 10 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.

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

If you think that the effect of aripiprazole is too strong or too weak, tell your doctor or pharmacist.

Try to take Aripiprazole Aurovitas at the same time every day.It does not matter if you take it with or without food. However, it should not be diluted with other liquids or mixed with food before taking aripiprazole.

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

If you take more Aripiprazole Aurovitas than you should

If you realize that 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 contact your doctor, go to the nearest hospital and take the packaging with you.

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

• rapid heartbeat, agitation/aggressiveness, 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.

stiffness and drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or the 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Aripiprazole Aurovitas

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

If you stop taking Aripiprazole Aurovitas

Do not stop your treatment just because you feel better. It is important that you continue taking aripiprazole for the time that your doctor has indicated.

If you have any further questions on 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 all people suffer from them.

Frequent adverse effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• sleeping problems,
• anxiety,
• feeling of restlessness and inability to stay still, difficulty staying seated,
• akathisia (an uncomfortable feeling of inner restlessness and an urgent need to move constantly),
• twisting, contorting, or spasmodic uncontrollable movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• tremor and blurred vision,
• difficulty evacuating or decreased frequency of bowel movements (constipation),
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of fatigue.

Uncommon adverse effects (may affect up to 1 in 100 people):

• increase or decrease in prolactin hormone levels in blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sexual interest,
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• ocular photosensitivity,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, lightheadedness, or fainting,
• hypo.

The following adverse effects have been reported during the post-marketing phase of

oral aripiprazole, but the frequency of occurrence is unknown:

• low white blood cell count,
• low platelet count,
• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma,
• high blood sugar,
• low sodium levels in blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, attempted suicide, and suicide,
• aggression,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, 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 feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness),

• speech disorder,
• fixation of the eyeballs in a position,
• sudden unexplained death,
• potentially fatal irregular heartbeat,
• heart attack,
• slower heartbeat,
• blood clots in the veins, especially in the legs (symptoms include

swelling, pain, and redness of the leg), which can travel through the bloodstream 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 with risk of pneumonia (lung infection),
• muscle spasms around the glottis (a part of the larynx),
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• liver inflammation,
• yellowing of the skin and the white part of the eyes,
• abnormal liver values in blood tests,
• rash,
• skin photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms with a rash on the face and then with a prolonged rash, high temperature, enlarged lymph nodes, increased liver enzyme levels in blood tests, and increased eosinophilia,
• abnormal muscle breakdown that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns due to exposure to drugs during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling 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 sexual interest and disturbing behavior for yourself or others, for example, increased sexual appetite,
• uncontrollable excessive shopping,
• binge eating (consuming large amounts of food in a short period) or

compulsive eating (consuming more food than normal and more than necessary to satisfy hunger),

• tendency to wander.

Inform your doctor if you experience any of these behaviors; he/she will explain how to manage or reduce the symptoms.

In elderly patients with dementia, a higher number of fatal cases have been reported while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other Adverse Effects in Children and Adolescents

Adolescents 13 years or older experienced adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrollable 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 standing up after sitting or lying down, which were frequent (affecting more than 1 in 100 patients).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aripiprazol Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Once the package is opened, use within 6 months.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aripiprazol 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 Package Contents

Aripiprazol Aurovitas 1 mg/ml oral solution EFG is a clear, colorless to light yellow liquid available in child-resistant polypropylene bottles containing 50, 150, or 480 ml per bottle.

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

The dropper is graduated for dosing of 0.5 ml and 1 ml, and then each 0.5 ml up to 2 ml. The measuring cap 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 under 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 oral solution EFG

Netherlands: Aripiprazol Aurobindo 1 mg/ml, drank

Date of the Last Revision of this Leaflet:January 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)