ARIPIPRAZOLE FLAS STADA 15 mg ORALLY DISINTEGRATING TABLETS

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

Do not take Aripiprazol Flas Stada

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

Warnings and precautions

Talk to your doctor before starting to take aripiprazole.

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

Before starting treatment with aripiprazole, tell 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
• 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 suffering from 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. 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 a very fast or irregular heartbeat.

Tell 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 Stada

Tell 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 tell 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 medicine. It is especially important that you 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);
• 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 tell 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 at the same time as aripiprazole, you should tell your doctor.

Taking Aripiprazol Flas Stada 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, 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 Stada contains lactose and sodium

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 tablet; it is essentially "sodium-free".

3. How to take Aripiprazol Flas Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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

Aripiprazole should be started with an oral solution (liquid) at a low dose. If an oral solution is required, your doctor will indicate another product with aripiprazole. The dose can be gradually increased to the 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 think that the effect of aripiprazole is too strong or too weak, tell your doctor or pharmacist.

Method of administration

Try to take aripiprazole at the same time every 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.
• Once the blister is opened, with dry hands, take the tablet and place the entire orodispersible tablet on the tongue. The tablet disintegrates quickly with saliva.
• The orodispersible 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 aripiprazole without consulting your doctor first.

If you take more Aripiprazol Flas Stada than you should

If you realize that you have taken more aripiprazole tablets than your doctor recommended (or if someone else has taken some of your aripiprazole tablets), consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone: 91.562.04.20 indicating the medicine and the amount ingested, or go to the nearest hospital with the package.

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 Stada

If you forget a dose, take the forgotten dose as soon as you remember, but do not take two doses on the same day. Do not take a double dose to make up for the forgotten dose.

If you stop taking Aripiprazol Flas Stada

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

If you have any other questions about 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
• akathisia (an uncomfortable feeling of inner restlessness and an urgent need to move constantly)
• twisting, contorting, or spasmodic uncontrollable movements, restless legs
• tremor
• headache
• fatigue
• drowsiness
• dizziness
• shakiness and blurred vision
• difficulty evacuating or decreased frequency of bowel movements
• 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 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 twisting movements (dystonia)
• restless legs
• double vision
• ocular sensitivity to light
• rapid heartbeat
• drop in blood pressure when standing up, causing dizziness, dizziness, or fainting
• hiccups

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

The following adverse effects have been reported during the marketing of 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 hives)

• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;
• high blood sugar
• insufficient sodium levels in 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 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
• swelling of hands, ankles, or feet

• in blood tests: increase or 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;
• 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 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, 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 13 years 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 (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 standing up after sitting or lying down, which were very frequent (affects up to 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 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 Stada

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

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 Stada

• The active ingredient is aripiprazole.

Aripiprazol Flas Stada 10 mg orodispersible tablets EFG: each orodispersible tablet contains 10 mg of aripiprazole.

Aripiprazol Flas Stada 15 mg orodispersible tablets EFG: each orodispersible tablet contains 15 mg of aripiprazole.

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

Aripiprazol Flas Stada 10 mg orodispersible tablets EFG: red iron oxide (E 172).

Aripiprazol Flas Stada 15 mg orodispersible tablets EFG: yellow iron oxide (E 172).

Appearance and Package Contents

Aripiprazol Flas Stada 10 mg orodispersible tablets are round, flat, pale pink tablets with scattered spots and 8 mm in diameter.

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

Aripiprazol Flas Stada 15 mg orodispersible tablets are round, flat, pale yellow tablets with scattered spots and 10 mm in diameter.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

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

DK: Aripiprazol STADA

ES: Aripiprazol Flas Stada 10 mg orodispersible tablets EFG

Aripiprazol Flas Stada 15 mg orodispersible tablets EFG

FI: Aripiprazol STADA

FR: Aripiprazole EG 10 mg orodispersible tablet

Aripiprazole EG 15 mg orodispersible tablet

SE: Aripiprazol STADA

SK: Aripiprazol STADA 10 mg orodispersible tablets

Aripiprazol STADA 15 mg orodispersible tablets

Date of the last revision of this prospectus:March 2023

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