ARIPIPRAZOLE FLAS SANDOZ 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Aripiprazol Flas Sandoz 10 mg orodispersible tablets EFG

Aripiprazol Flas Sandoz 15 mg orodispersible tablets EFG

Aripiprazol Flas Sandoz 30 mg orodispersible 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Aripiprazol Flas Sandoz is and what it is used for

Aripiprazol Flas Sandoz contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged 15 years 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.

Aripiprazol Flas Sandoz orodispersible tablets are used to treat adults and adolescents aged 13 years 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 orodispersible tablets.

2. What you need to know before you take Aripiprazol Flas Sandoz

Do not take Aripiprazol Flas Sandoz

• 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 or pharmacist before starting treatment with Aripiprazol Flas Sandoz.

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 Aripiprazol Flas Sandoz, 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,
• 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,
• a history of gambling addiction.

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

If you are an elderly patient and suffer from dementia (loss of memory and other mental abilities), you or your caregiver or 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.

Inform your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or rapid 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 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 gambling addiction, 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.

Aripiprazole may cause somnolence, a drop in blood pressure when standing up, dizziness, and

changes in the ability to move and maintain balance, which could lead to falls.

Caution should be exercised, especially if you are an elderly patient or suffer from 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 and Aripiprazol Flas Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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 taking aripiprazole with another medicine, it may mean that your doctor needs 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),
• medicines to treat fungal infections (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 experience any unusual symptoms when taking any of these medicines with 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 taking any of these medicines with aripiprazole, you should inform your doctor.

Taking Aripiprazol Flas Sandoz with food, drinks, and alcohol

This medicine can be taken with or without food.

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, somnolence, 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 your baby, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. If you are being treated with aripiprazole, you should not breastfeed. 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, for example, when driving or operating machinery.

Aripiprazol Flas Sandoz contains lactose, sodium, aspartame, benzyl alcohol, and propylene glycol

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

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

Aripiprazol Flas Sandoz 10 mg

This medicine contains 1.0 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains up to 0.0036 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Aripiprazol Flas Sandoz 15 mg

This medicine contains 1.5 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains up to 0.0054 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Aripiprazol Flas Sandoz 30 mg

This medicine contains 3 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains up to 0.0108 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

3. How to take Aripiprazol Flas Sandoz

Follow exactly the administration instructions of this medicine given 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 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 that the effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.

Try to take the aripiprazole orodispersible tablet at the same time each day.It does not matter if you take it with or without food.

Do not open the blister until you are ready to take it. To take a tablet, open the package and remove the aluminum from the blister, leaving the tablet visible. Do not press the tablet through the aluminum because this could damage it. Once the blister is open, with dry hands, take the tablet and place the entire orodispersible tablet on your tongue. The disintegration of the tablet occurs rapidly with saliva. The orodispersible tablet can be taken with or without liquid.

Alternatively, disperse the tablet in water and drink the resulting suspension.

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

If you take more Aripiprazol Flas Sandoz than you should

If you realize that you have taken more aripiprazole than your doctor has recommended (or if someone else has taken part of your aripiprazole orodispersible tablets), contact your doctor immediately. If you cannot contact your doctor, go to the nearest hospital and take the package with you.

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 ingested.

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,

• muscle stiffness and somnolence, 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 take Aripiprazol Flas Sandoz

If you forget a dose, take the forgotten dose as soon as you remember, but do not take two doses on the same day.

If you stop taking Aripiprazol Flas Sandoz

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

If you have any further questions on the use of this product, 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.

Common adverse effects (may affect up to 1 in 10 patients):

• 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),
• torsion, contortion, or uncontrolled spasmodic movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• shivering and blurred vision,
• difficulty evacuating or decreased intestinal movements,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of fatigue.

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

• increase or decrease in prolactin hormone levels in the blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sexual interest,
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscular disorder causing torsion movements (dystonia),
• double vision,
• restless legs,
• ocular sensitivity to light,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, dizziness, 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 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,
• insufficient 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, sudden changes in blood pressure and heart rate, and 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 move 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),
• muscle spasms around the glottis,
• 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 sensitivity to light,
• 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 widespread rash, high temperature, swollen 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: fluctuation of blood sugar levels, increase in

hemoglobin A1c,

• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you 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 you or others, for example, increased sexual appetite,
• uncontrolled shopping,
• binge eating (ingesting large amounts of food in a short period) or

compulsive eating (ingesting 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 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.

Additional Adverse Effects in Children and Adolescents

Adolescents 13 years and older experienced adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrolled contractions, restlessness, and fatigue, which were very frequent (more than 1 in 10 patients), and abdominal upper 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 (may affect up to 1 in 10 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 prospectus. 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 Flas Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the blister pack and carton after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, 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 of Aripiprazol Flas Sandoz

• The active ingredient is aripiprazole.

Aripiprazol Flas Sandoz 10 mg orodispersible tablets: Each orodispersible tablet contains 10 mg of aripiprazole.

Aripiprazol Flas Sandoz 15 mg orodispersible tablets: Each orodispersible tablet contains 15 mg of aripiprazole.

Aripiprazol Flas Sandoz 30 mg orodispersible tablets: Each orodispersible tablet contains 30 mg of aripiprazole.

• The other components of Aripiprazol Flas Sandoz 10 and 30 mg orodispersible tablets are: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, anhydrous colloidal silica, aspartame (E 951), magnesium stearate (E 470b), red iron oxide (E 172), and vanilla flavor (contains maltodextrin, gum arabic, propylene glycol, benzyl alcohol, vanilla flavoring).

• The other components of Aripiprazol Flas Sandoz 15 mg orodispersible tablets are: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, anhydrous colloidal silica, aspartame (E 951), magnesium stearate (E 470b), yellow iron oxide (E 172), and vanilla flavor (contains maltodextrin, gum arabic, propylene glycol, benzyl alcohol, vanilla flavoring).

See section 2, Aripiprazol Flas Sandoz contains lactose, sodium, aspartame, and benzyl alcohol.

Appearance of the Product and Package Contents

Aripiprazol Flas Sandoz 10 mg orodispersible tablets:

Round, flat tablets, pink in color, engraved with "10" on one side and smooth on the other side, with a diameter of 8.0 mm ± 0.1 mm.

Aripiprazol Flas Sandoz 15 mg orodispersible tablets:

Round, flat tablets, yellow in color, engraved with "15" on one side and smooth on the other side, with a diameter of 9.0 mm ± 0.1 mm.

Aripiprazol Flas Sandoz 30 mg orodispersible tablets:

Round, flat tablets, pink in color, engraved with "30" on one side and smooth on the other side, with a diameter of 10.0 mm ± 0.1 mm.

The orodispersible tablets are packaged in push-through blisters of paper/polyethylene terephthalate (PET)/aluminum/polyvinyl chloride (PVC)/aluminum/oriented polyamide (OPA) in cardboard boxes.

Package sizes:

Blister: 10, 14, 28, 30, 49, 56, 98 orodispersible tablets.

Unit dose blister: 10 x 1, 14 x 1, 28 x 1, 30 x 1, 49 x 1, 56 x 1, 98 x 1 orodispersible tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

Products Area of Larissa,

P.O. Box 3012

GR-41004 Larissa

Greece

or

Genepharm S.A.

18th km Marathonos Ave,

Pallini Attiki, 15351

Greece

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

Date of the Last Revision of this Prospectus:February 2023

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./