Package Insert: Information for the Patient

Aripiprazol Flas Sandoz 10 mg buccal tablets EFG

Aripiprazol Flas Sandoz 15 mg buccal tablets EFG

Aripiprazol Flas Sandoz 30 mg buccal 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 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 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.

1.What is Aripiprazol Flas Sandoz and how is it used

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

3.How to take Aripiprazol Flas Sandoz

4.Possible adverse effects

5.Storage of Aripiprazol Flas Sandoz

6.Contents of the package and additional information

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

It is used to treat adults and adolescents aged 15 years or more who suffer from a condition characterised by symptoms such as hearing, seeing and feeling things that do not exist, distrust, false beliefs, incoherent speech and monotony of emotional and behavioural state. People in this state may also feel depressed, guilty, restless or tense.

Aripiprazol Flas Sandoz buccal tablets are used to treat adults and adolescents aged 13 years or more who suffer from a disorder characterised 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 buccal tablets.

Do not take Aripiprazol Flas Sandoz

• 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 or pharmacist before starting to takeAripiprazol Flas Sandoz.

Possible thoughts and behaviors of self-harm have been reported in patients taking aripiprazol. 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 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 it more closely,
• irregular and involuntary muscle movements, especially in the face,
• cardiovascular diseases (heart and circulation diseases), 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 daily normal activities, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor.

If you are an elderly patient and 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.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. Possible thoughts and behaviors of self-harm have been reported in patients taking aripiprazol.

Inform your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered 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 called impulse control disorder and may include behaviors such as addiction to gambling, excessive intake or spending, abnormally high sexual appetite, 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 cause falls.

Caution should be exercised, especially if you are an elderly patient or have some weakness.

Children and adolescents

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

Other medicines and Aripiprazol Flas Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those obtained 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 takingaripiprazolwith any other medicine, it may mean that your doctor needs to change your dose of aripiprazol 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, for example, 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 adverse effects or reduce the effect of aripiprazol; if you experience 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 in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive diseases,

depression,

• St. John's wort (Hypericum perforatum) used in herbal remedies for 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 Flas Sandoz 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 of mothers who have been treated with aripiprazol in the last three months of pregnancy (last three months of your 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 for you of your treatment and the benefit for 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, 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 certain sugars, consult with him before taking this medicine.

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

Aripiprazol Flas Sandoz 10 mg

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

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

Aripiprazol Flas Sandoz 15 mg

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

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

Aripiprazol Flas Sandoz 30 mg

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

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

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 with the oral solution (liquid) at a low dose. Gradually, the dose can 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 ofaripiprazolis too strong or weak, inform your doctor or pharmacist.

Try to take the aripiprazol buccodispersible tablet at the same time every day.It does not matter if you take it with or without food.

Do not open the blister pack until you are about to take it. To take a tablet, open the package and remove the aluminum from the blister pack, leaving the tablet visible. Do not press the tablet through the aluminum as this could damage it. Once the blister pack is opened, with dry hands, take the tablet and place the buccodispersible tablet whole on the tongue. The disintegration of the tablet occurs quickly with saliva. The buccodispersible 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 ofaripiprazol buccodispersable tabletswithout consulting your doctor first.

If you take more Aripiprazol Flas Sandoz than you should

If you realize that you have taken more aripiprazol than your doctor has recommended (or if someone else has taken part of your aripiprazol buccodispersable tablets), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the box with you.

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 aripiprazol have experienced the following symptoms:

• rapid heartbeats, 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,

accelerated sweating,

• muscle rigidity and drowsiness, 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 Flas Sandoz

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

If you interrupt treatment withAripiprazol Flas Sandoz

Do not interrupt your treatment just because you feel better. It is essential that you continue taking Aripiprazol Flas Sandoz 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 patients):

• 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 urge to move constantly),
• involuntary movements of twisting, contorting, or spasmodic movements,
• tremors,
• headaches,
• fatigue,
• drowsiness,
• dizziness,
• shaking and blurred vision,
• difficulty passing urine or decreased bowel movements,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling tired.

Rare 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),
• double vision,
• restless legs,
• light sensitivity,
• rapid heartbeat,
• low blood pressure when standing, causing dizziness, fainting, or loss of consciousness,
• hypotension.

The following side 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),
• 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, attempted suicide, and suicide,
• aggression,
• agitation,
• nervousness,
• 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 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 notice 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,
• pancreatitis,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and white part of the eyes,
• abnormal liver enzyme levels in blood tests,
• hives,
• light sensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as 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 widespread rash, high temperature, swollen lymph nodes, elevated liver enzyme levels in blood tests, and increased eosinophil levels,
• 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 medications during pregnancy,
• prolonged and 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, for example, increased sex drive,
• uncontrollable buying,
• binge eating (ingesting 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 a higher number of fatal cases while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Additional 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 (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 after lying down or sitting, which were frequent (may affect up to 1 in 10 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 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 medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and packaging after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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 point of the pharmacy.SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Aripiprazol Flas Sandoz

• The active ingredient is aripiprazol.

Aripiprazol Flas Sandoz 10 mg buccal tablets: Each buccal tablet contains 10 mg of aripiprazol.

Aripiprazol Flas Sandoz 15 mg buccal tablets: Each buccal tablet contains 15 mg of aripiprazol.

Aripiprazol Flas Sandoz 30 mg buccal tablets: Each buccal tablet contains 30 mg of aripiprazol.

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

• The other components of Aripiprazol Flas Sandoz 15 mg buccal 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, arabic gum, propylene glycol, benzyl alcohol, and vanilla flavoring).

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

Appearance of the product and contents of the package

Aripiprazol Flas Sandoz 10 mg buccal tablets:

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

Aripiprazol Flas Sandoz 15 mg buccal tablets:

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

Aripiprazol Flas Sandoz 30 mg buccal tablets:

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

The buccal tablets are packaged in blisters of paper/ PET /aluminum //PVC /aluminum /OPA in cartons.

Package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

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

LekPharmaceuticalsd.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

Last revision date of this leaflet:February 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./