Package Insert: Information for the User

Aripiprazol Vir 15 mg Tablets 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 refer to 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 even if they 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 Vir belongs to a group of medications known as 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, restless, 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 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 take Aripiprazol Vir

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

Warnings and precautions

Consult your doctor before starting to take Aripiprazol Vir.

There have been cases of patients who experience suicidal thoughts and behaviors during treatment with aripiprazol. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazol Vir, tell your doctor if you have:

• high levels of sugar in the blood (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 disease and circulation), 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.

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, 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 harming yourself. There have been cases of patients who experience suicidal thoughts and behaviors during treatment with aripiprazol.

Tell your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, changes in 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 eating or spending, abnormally high sex drive, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazol may cause drowsiness, a drop in 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 and have some weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. The safety and effectiveness of this medicine in these patients are unknown.

Other medicines and Aripiprazol Vir

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription.

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 are using any medicine to control blood pressure.

If you are taking this medicine with any other medicine, it may mean that your doctor needs to change your dose of aripiprazol or the dose of the other medicine. 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 herbal remedies 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)
• 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 with 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.
• Other antidepressants (such as venlafaxine and tryptophan) used to treat severe depression.
• Tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depressive diseases.
• St. John's Wort (Hypericum perforatum) used in herbal remedies to treat 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 with aripiprazol, you should inform your doctor.

Taking Aripiprazol Vir with food, drinks, and alcohol

This medicine can be taken regardless of meals.

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.

The following symptoms may occur in newborn babies, from mothers who have been 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, you should 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. If you are being treated with aripiprazol, you should not breastfeed. 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, you may feel dizzy or have vision problems (see section 4).

This should be taken into account when requiring maximum attention, for example, when driving or operating machinery.

Aripiprazol Vir contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which 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 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 medication should be started at a low dose 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 too weak, inform your doctor or pharmacist.

Try to take the aripiprazole tablet at the same time every 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 alter or interrupt the daily dose of aripiprazole without consulting your doctor first.

If you take more Aripiprazol Vir than 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 ingested.

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

• Fast heart rate, 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;
• Muscle rigidity and 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.

If you forgot to take Aripiprazol Vir

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 stop taking Aripiprazol Vir

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

If you have any other questions 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 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• akathisia (feeling of restlessness and inability to stay still, difficulty staying seated);
• uncontrollable twisting, contorting, or spasmodic movements;
• tremors;
• headaches;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty passing stools or decreased frequency of bowel movements (constipation);
• indigestion;
• discomfort;
• ;
• increased saliva production;
• vomiting;
• feeling of fatigue.

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

• 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 oral aripiprazole butthe 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, and redness);
• appearance or worsening of diabetes, ketoacidosis (ketones in the blood and urine), or coma;
• high blood sugar;
• insufficient sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• aggression;
• agitation;
• anxiety;
• combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and 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 stiffness);
• 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 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 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 discomfort;
• liver failure;
• inflammation of the liver;
• yellowing of the skin and white part of the eyes;
• abnormal liver function test results;
• hives;
• sensitivity of the skin to light;
• hair loss;
• excessive sweating;
• severe allergic reactions such as a pharmacological reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS appears as symptoms similar to the flu with a rash on the face and later with prolonged rash, high temperature, lymph node enlargement, increased liver enzyme levels in blood tests, and increased levels of a type of white blood cell (eosinophilia);
• 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 medications during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling central body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: fluctuations in 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 (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; he 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, involuntary spasms or contractions, restlessness, and fatigue, which were very frequent (affected 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 (affected up to 1 in 100 patients).

Reporting of 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 prospectus. 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aripiprazol Vir

- The active ingredient is aripiprazol. Each tablet contains 15 mg of aripiprazol.

- The other components are potato starch glycolate, microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, magnesium stearate and yellow iron oxide (E172)

Appearance of the product and contents of the package

Rounded tablets (approximately 7 mm) and yellow. With possible darker points, engraved with “ARZ” and 15 on one side.

Single-dose blister pack of aluminum (OPA/Aluminum/PVC/Aluminum) in boxes of 10, 14, 28, 30, 49, 50, 56, 98 or 100 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible manufacturers

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

or

Synthon S.R.O

Brnenska 32/cp. 597 67801

Blansko, Czech Republic

or

Synthon Hispania S.L

Castello 1, Polígono Las Salinas

Sant De Llobregat (Barcelona), Spain

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

NetherlandsAripiprazol Synthon 15 mg, tablets

AustriaAripiprazol Aristo 15 mg Tablets

FinlandAripiprazole Avansor15 mg tablets

SpainAripiprazol Vir 15 mg tablets

Last review date of this leaflet: May 2023

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