Leaflet: information for the user

Aripiprazol Flas Stada 10 mg buccal dispersible tablets EFG

Aripiprazol Flas Stada 15 mg buccal dispersible tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Aripiprazol Flas Stada

4.Possible side effects

5.Storage of Aripiprazol Flas Stada

6.Contents of the pack and additional information

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

Do not take Aripiprazol Flas Stada

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

Warnings and precautions

Consult your doctor before starting to take aripiprazol.

Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with aripiprazol, tell 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 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 family history of blood clots, as antipsychotics have been associated with blood clot formation

•history of addiction to gambling

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

If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver 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. Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazol have been reported.

Tell 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 that you cannot resist, known as impulse control disorder, which may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about increased thoughts and feelings of sex.Your doctor may consider adjusting or stopping the dose.

Aripiprazol 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 weakness.

Children and adolescents

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

Other medications and Aripiprazol Flas Stada

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

Medications that lower blood pressure:

Aripiprazol may increase the effect of medications used to lower blood pressure. Make sure to inform your doctor if you are using any medication to control blood pressure.

If you are taking aripiprazol with any other medication, it may mean that your doctor needs to change your dose of aripiprazol or the dose of the other medications. It is especially important to mention to your doctor if you are taking:

•medications 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);

•antifungal medications (such as ketoconazole, itraconazole);

•certain medications 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 medications may increase the risk of adverse effects or reduce the effect of aripiprazol; if you observe any unusual symptoms when taking any of these medications with aripiprazol, you should inform your doctor.

Medications that increase serotonin levels are generally used to treat conditions 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 conditions 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 conditions;

•St. John's Wort (Hypericum perforatum)used in herbal remedies for mild depression;

•analgesics (such as tramadol and pethidine) used to relieve pain;

•triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medications may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medications with aripiprazol, you should inform your doctor.

Taking Aripiprazol Flas Stada with food, drinks, and alcohol

This medication 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 medication.

Cases of the following symptoms have been reported in newborn babies of mothers 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, contact your doctor.

If you are taking aripiprazol, 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. If you are being treated with aripiprazol, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medication.

Driving and operating machinery

During treatment with this medication, 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.

Aripiprazol Flas Stada contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it 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

Aripiprazol should be initiated with an oral solution (liquid) at a low dose. If an oral solution is required, your doctor will indicate another product with aripiprazol. The dose can gradually be increased tothe recommended dose for adolescents, 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 aripiprazol is too strong or too weak, inform your doctor or pharmacist.

Administration method

Try to take aripiprazol 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.
• Once the blister pack is opened, with dry hands, take the tablet and place the buccal dispersible tablet completely on the tongue. The tablet disintegrates quickly with saliva.
• The buccal dispersible tablet can be taken with or without liquid. Another option is to dissolve the tablet in water and drink the resulting suspension.

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

If you take more Aripiprazol Flas Stada than you should

If you realize that you have taken more buccal dispersible tablets of aripiprazol than your doctor has recommended (or if someone else has taken some of your buccal dispersible tablets of aripiprazol), consult your doctor or pharmacist immediately, call the Toxicological Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested or go to the nearest hospital bringing the packaging with you.

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

• rapid heartbeats, 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 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 Stada

If you forget a dose, take the missed dose as soon as you remember, but do not take two doses in one day. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Aripiprazol Flas Stada

Do not stop treatment just because you feel better. It is essential that you continue taking aripiprazol 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 people):

• diabetes mellitus
• sleep problems
• anxiety
• feeling of restlessness and inability to stay still, difficulty staying seated
• akathisia (an uncomfortable feeling of inner restlessness and a pressing need to move constantly)
• involuntary movements, twisting, contorting or spasmodic movements, restless legs
• tremors
• headache
• fatigue
• drowsiness
• lethargy
• shaking and blurred vision
• difficulty passing urine or decreased frequency of bowel movements
• indigestion
• nausea
• increased saliva production
• vomiting
• feeling of fatigue

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

• increased or decreased levels of prolactin hormone in the blood
• excessively high blood sugar levels
• depression
• altered or increased sex drive
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia)
• muscle disorder causing twisting movements (dystonia)
• restless legs
• double vision
• light sensitivity
• rapid heartbeat
• low blood pressure upon standing, causing dizziness, lethargy, or fainting
• hypotension

Unknown frequency (frequency cannot be estimated from available data):

The following side effects have been reported during the marketing of aripiprazol, 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 urticaria)

• 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
• 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 a feeling of intense 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 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 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 (a part of the larynx)
• pancreatitis
• difficulty swallowing
• diarrhea
• abdominal discomfort
• stomach upset
• liver failure
• inflammation of the liver
• yellowing of the skin and the white part of the eyes
• abnormal liver function test results
• 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 fever, swollen lymph nodes, elevated liver enzymes, and increased eosinophils.
• abnormal muscle degradation that can cause kidney problems
• muscle pain
• stiffness
• involuntary loss of urine (incontinence)
• difficulty urinating
• symptoms of withdrawal in newborns due to exposure to the drug during pregnancy
• prolonged and/or painful erection
• difficulty controlling central body temperature or overheating
• chest pain
• swollen hands, ankles, or feet

• in blood tests:increased orfluctuating blood sugar levels, increased 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 sex drive and concerning behavior for you or others, such as increased sex drive;

- uncontrolled excessive buying;

- binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming 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 reported cases of fatal outcomes while taking aripiprazol. 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 (affects 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 a lying or sitting position, which were very frequent (affects up to 1 in 100 patients).

Reporting side effects

If you experienceany 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 through the Spanish System for Pharmacovigilance 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.

This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at 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 Aripiprazole Flas Stada

•The active ingredient is aripiprazole.

Aripiprazole Flas Stada 10 mg buccal dispersible tablets EFG: each buccal dispersible tablet contains 10 mg of aripiprazole.

Aripiprazole Flas Stada 15 mg buccal dispersible tablets EFG: each buccal dispersible tablet contains 15 mg of aripiprazole.

•The other components are:mannitol, maltodextrin, microcrystalline cellulose, crospovidone Type B, sodium hydrogen carbonate, tartaric acid, anhydrous colloidal silica, sodium saccharin, vanilla cream flavor (aroma substances, natural aroma substances, lactose, magnesium carbonate hydroxide), magnesium stearate.

Aripiprazole Flas Stada 10 mg buccal dispersible tablets EFG:red iron oxide (E 172).

Aripiprazole Flas Stada 15 mg buccal dispersible tablets EFG:yellow iron oxide (E 172).

Appearance of the product and contents of the package

Aripiprazole Flas Stada 10 mgbuccal dispersible tabletsare round, flat, pale pink tablets with scattered spots and 8 mm in diameter.

They are presented in blisterspacked in a cardboard box containing 7, 14, 28, 30, 49, 56, 60, 84, 90, 98 or 100 buccal dispersible tablets or 7x1, 14x1, 28x1, 30x1, 49x1, 56x1, 60x1, 84x1, 90x1, 98x1 or 100x1 buccal dispersible tablets.

Aripiprazole Flas Stada 15 mgbuccal dispersible tabletsare round, flat, pale yellow tablets with scattered spots and 10 mm in diameter.

They are presented in blisterspacked in a cardboard box containing 7, 14, 28, 30, 49, 56, 60, 84, 90, 98 or 100 buccal dispersible tablets or 7x1, 14x1, 28x1, 30x1, 49x1, 56x1, 60x1, 84x1, 90x1, 98x1 or 100x1 buccal dispersible tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer responsible

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA M&D SRL?

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania?

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

DK:Aripiprazol STADA

ES:Aripiprazol Flas Stada 10 mg buccal dispersible tablets EFG

Aripiprazol Flas Stada 15 mg buccal dispersible tablets EFG

FI:Aripiprazol STADA

FR:Aripiprazole EG 10 mg comprimé orodispersible

Aripiprazole EG 15 mg comprimé orodispersible

SE:Aripiprazol STADA

SK:Aripiprazol STADA 10 mg orodispergovatelné tablety

Aripiprazol STADA 15 mg orodispergovatelné tablety

Last review date of this leaflet:March 2023

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