Leaflet: information for the user

Aripiprazol Flas cinfa 30 mg buccodispersible 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.

Aripiprazol flas cinfacontains the active ingredient aripiprazol andbelongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents of 15 years or more 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 behavior. People in this state may also feel depressed, guilty, restless or tense.

Aripiprazol is used to treat adults and adolescents of 13 years or more 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 cinfa

• 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.

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 have 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.

Aripiprazol may cause drowsiness, a drop in blood pressure when standing, 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.

Talk to 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.

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.

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 consumption 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.

Children and adolescents

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

Taking Aripiprazol flas cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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 aripiprazol with any other medicine, it may mean that your doctor needs to change your dose of aripiprazol or the dose of the other medicines. 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 plant-based medicines 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 adverse effects or reduce the effect of aripiprazol; if you observe any unusual symptoms when taking any of these medicines at the same time as 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;

•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 to treat depressive diseases;

•St. John's Wort (Hypericum perforatum)used in plant-based 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 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 cinfa with food, drinks, and alcohol

This medicinecan 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 trimester of pregnancy (last three months of pregnancy): tremor, 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 medicine.

Driving and operating machinery

Aripiprazol may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Aripiprazol flas cinfa contains aspartame (E-951).

This medicinecontains 6 mg of aspartame in each 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 cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) 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

This medicationshould be started 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 weak, inform your doctor or pharmacist.

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 pack until you are about to take it.

Take the buccal tablet in the following way:

1. Do not crush the buccal tablet

To prevent the buccal tablet from being crushed, do not press the blister (Figure 1).

1. Separate a blister

Each blister pack contains 14 blisters, which are separated by perforations. Separate a blister following the perforated lines, where it is indicated “fold” (Figure 2).

1. Remove the foil

Remove the foil carefully, starting from the corner marked with an arrow and where it is indicated “pull here” (Figures 3 and 4).

1. Remove the buccal tablet

Remove the buccal tablet with dry hands and place it on the tongue (Figure 5).

The tablet will dissolve quickly, and once dissolved, it can be swallowed with or without water, as desired.

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 cinfa than you should

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

Patients who have taken too much aripiprazole 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 stiffness and drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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.

If you forget to take Aripiprazol flas cinfa

If you forget a dose, take the missed dose as soon as you remember.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Aripiprazol flas cinfa

Do not stop treatment just because you feel better. It is essential to 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;
  • sensation of restlessness and inability to remain still, difficulty staying seated;
  • involuntary twisting, contorting, or spasmodic movements, restless legs;
  • tremors;
  • headache;
  • fatigue;
  • drowsiness;
  • dizziness;
  • shaking and blurred vision;
  • difficulty evacuating or decreased frequency of bowel movements (constipation);
  • indigestion;
  • nausea;
  • increased saliva production;
  • vomiting;
  • sensation of fatigue.

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

• increased 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);
  • double vision;
  • rapid heart rate;
  • low blood pressure upon standing, causing dizziness, confusion, or fainting;
  • hypotension;
  • photosensitivity of the eyes.

The following side effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency of occurrence is unknown:

• suicidal thoughts, attempts, 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 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, which can lead to 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 white part of the eyes;
• abnormal liver analysis results;
• hives;
• light sensitivity;
• hair loss;
• excessive sweating;
• 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 medication 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 (ingesting large amounts of food in a short period) or compulsive eating (ingesting 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 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 (may affect 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 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 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.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aripiprazol flas cinfa

• The active ingredient is aripiprazol. Each buccal dispersible tablet contains 30 mg of aripiprazol.
• The other components are maltose, crospovidone, microcrystalline cellulose, anhydrous colloidal silica, purified water, sodium croscarmellose, xylitol, aspartame (E-951), potassium acesulfame, cherry powder, talc, sodium stearate fumarate, red iron oxide (E-172).

Appearance of the product and contents of the packaging

Aripiprazol flas cinfa 30 mg buccal dispersible tablets are cylindrical, biconvex, and pink in color, with the number “30” engraved on one face and a diameter of 10 mm.

They are presented in ALU/ALU blisters. Each package contains 28 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Pharmaten, S.A.

6, Dervenakion Str., Pallini Attiki

Greece

or

Pharmaten International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No. 5, Rodopi 69300

Greece

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: June 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79375/P_79375.html

QR code to: https://cima.aemps.es/cima/dochtml/p/79375/P_79375.html