ARIPIPRAZOLE Aurovitas 15 mg Tablets

Introduction

Package Leaflet: Information for the User

Aripiprazole Aurovitas 15 mg tablets 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, pharmacist or nurse. 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. Storage of Aripiprazole Aurovitas
6. Contents of the pack and other information

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

Aripiprazole Aurovitas 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 above 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 above 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 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.

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

Before starting treatment with Aripiprazole Aurovitas, inform 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.
• Irrregular 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.
• A history of gambling addiction.

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

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or the person or caregiver taking care of 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. There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole.

Talk to 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, or caregiver notice that you are developing impulses or urges to behave in an unusual way for you 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 gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings.

Your doctor may need to adjust or suspend 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 of age. It is not known if it is safe and effective in these patients.

Other medicines andAripiprazole Aurovitas

Inform 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 inform your doctor if you use any medicine to control blood pressure.

If you are using Aripiprazole Aurovitas with another 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, e.g., 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 inform 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 herbal 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 using any of these medicines with Aripiprazole Aurovitas, you should inform your doctor.

TakingAripiprazole Aurovitaswith food, drinks, and alcohol

Aripiprazole Aurovitas can be taken independently of meals.

Alcohol consumption should be avoided while taking aripiprazole.

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 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 using machines

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 Aurovitascontains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Aripiprazole Aurovitas

Follow exactly the administration instructions of this medicine given 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 or higher doses up to a maximum of 30 mg once a day.

Use in children and adolescents

This medicine should be started with the oral solution (liquid) at a low dose. Gradually, the dose may be increased to the 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 think the effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.

Try to take yourAripiprazole Aurovitastablet at the same time each day. It does not matter if 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 interrupt the daily dose of aripiprazole without consulting your doctor first.

If you take moreAripiprazole Aurovitasthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

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

• rapid heartbeat, 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;
• muscle 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.

If you forget to useAripiprazole 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 Aurovitas tablets for the time 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,
• torsion, contortion, or spasmodic uncontrollable movements, restless legs,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• shivering 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 the 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 torsion movements (dystonia),
• double vision, ocular photosensitivity,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, fainting, or loss of consciousness,
• hypo.

The following adverse effects have been reported during the post-marketing phase oforal aripiprazole,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, itching, and redness),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma,
• high blood sugar,
• low sodium levels in the 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 of being 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 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 with risk of pneumonia (lung infection),
• spasms of the muscles around the glottis (a part of the larynx),
• pancreatitis,
• difficulty swallowing,
• abdominal discomfort,
• stomach upset,
• liver failure,
• liver inflammation,
• yellowing of the skin and the white part of the eyes,
• abnormal liver values in analysis,
• skin rash,
• photosensitivity,
• hair loss,
• excessive sweating,
• abnormal muscle breakdown that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• symptoms of withdrawal 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 glycosylation,
• 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 worrying 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; they 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 aged 13 and 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 being lying down or sitting, 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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through the drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofAripiprazol Aurovitas

• The active ingredient is aripiprazole. Each tablet contains 15 mg of aripiprazole.
• The other components are: lactose monohydrate, microcrystalline cellulose, cornstarch, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate.

Appearance of the Product and Package Contents

Uncoated white tablet (7 mm in diameter), with the mark "64" on one side and "H" on the other.

Aripiprazol Aurovitas is available in blister packs of Polyamide/Aluminum/PVC/Aluminum foil.

Package sizes: 14 and 28 tablets.

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:December 2022

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