Aripiprazole Flas CINFA 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole flas cinfa 10 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 and should not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Aripiprazole flas cinfa is and what it is used for
2. What you need to know before taking Aripiprazole flas cinfa
3. How to take Aripiprazole flas cinfa
4. Possible side effects
5. How to store Aripiprazole flas cinfa
6. Contents of the pack and other information

1. What is Aripiprazole flas cinfa and what is it used for?

Aripiprazole flas cinfa 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 have an illness characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazole is also used to treat adults and adolescents aged 13 years and older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with this medicine.

2. What you need to know before taking Aripiprazole flas cinfa

Do not take Aripiprazole flas cinfa

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

Warnings and precautions

Talk to your doctor before starting aripiprazole.

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

Before starting treatment with aripiprazole, tell your doctor if you have:

• high blood sugar levels (characterised by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes;
• seizures, as your doctor may wish to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face;
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or mini-stroke (transient ischaemic attack), or abnormal blood pressure;
• a history of blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
• a history of gambling addiction.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

If you 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.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution should be taken, especially if you are elderly or have some degree of physical weakness.

Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behaviour during treatment with aripiprazole have been reported.

Speak to your doctor immediately if you notice muscle stiffness or numbness 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 and that you 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 behaviours such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping your dose.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.

Other medicines and Aripiprazole flas cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

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 are taking any medicine to control blood pressure.

If you are taking aripiprazole with any other medicine, this may mean your doctor needs to adjust your dose of aripiprazole or the dose of the other medicines. It is especially important to tell your doctor if you are taking:

• medicines to correct heart rhythm such as quinidine, amiodarone, flecainide;
• antidepressants or herbal 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 side effects or reduce the effect of aripiprazole; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Medicines that increase serotonin levels are generally used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
• 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 amitriptiline) used in depressive disorders;
• St. John's wort (Hypericum perforatum) used in herbal medicines for mild depression;
• painkillers (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 while taking any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazole flas cinfa 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies whose mothers have been treated with aripiprazole during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, 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

Dizziness and vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Aripiprazole flas cinfa contains aspartame (E-951).

This medicine contains 2 mg of aspartame per tablet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Aripiprazole flas cinfa contains sodium.

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

3. How to take Aripiprazole flas cinfa

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.

Use in children and adolescents

This medicine should be initiated with the oral solution (liquid) at a low dose. The dose may gradually be increased to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Try to take Aripiprazole flas cinfa at the same time each day. It does not matter whether you take it with or without food.

Do not open the blister pack until you are ready to take the tablet.

Take the orodispersible tablet as follows:

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press on the blister (Figure 1).

1. Separate one blister

Each blister contains fourteen blisters separated by perforations. Separate one blister along the perforated lines, where indicated “fold” (Figure 2).

1. Remove the foil

Carefully peel off the foil, starting at the corner marked with an arrow and where indicated “pull here” (Figures 3 and 4).

1. Remove the orodispersible tablet

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

The tablet will disintegrate rapidly, and once dissolved, it may be swallowed with or without water, according to your preference.

Alternatively, you may dissolve the tablet in water and drink the resulting suspension.

Even if you feel better, do not change or stop your daily dose of aripiprazole without first consulting your doctor.

If you take more Aripiprazole flas cinfa than you should

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

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

• rapid heartbeat, agitation, aggressiveness, and speech difficulties;
• 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, and sweating;
• muscle rigidity and drowsiness, slower breathing, suffocation, high or low blood pressure, and abnormal heart rhythms.

You may also contact your pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aripiprazole flas cinfa

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

Do not take a double dose to make up for missed doses.

If you stop taking Aripiprazole flas cinfa

Do not stop your treatment just because you feel better. It is important that you continue taking aripiprazole for as long as your doctor has instructed.

If you have any further 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 everyone will experience them.

Frequent adverse effects (may affect up to 1 in 10 people):

• diabetes mellitus;
  • difficulty sleeping;
  • anxiety;
  • feeling of restlessness and inability to stay still, difficulty remaining seated;
  • akathisia (an uncomfortable sensation of inner restlessness and an overwhelming need to keep moving constantly);
  • uncontrollable twisting, writhing, or spasmodic movements;
  • tremor;
  • headache;
  • fatigue;
  • drowsiness;
  • dizziness;
  • shakiness and blurred vision;
  • difficulty passing stools or reduced frequency of bowel movements (constipation);
  • indigestion;
  • nausea;
  • increased saliva production;
  • vomiting;
  • feeling of tiredness.

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

• increased or decreased levels of the hormone prolactin in the blood;
  • excessively high blood sugar levels;
  • depression;
  • altered or increased sexual interest;
  • uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
  • muscular disorder causing twisting movements (dystonia);
  • restless legs;
  • double vision;
  • ocular photosensitivity;
  • rapid heartbeat;
  • drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting;
  • hiccups.

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

• low white blood cell count;

• low platelet count;

• allergic reaction (e.g., swelling of 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;

• low sodium levels in the blood;

• loss of appetite (anorexia);

• weight loss;

• weight gain;

• suicidal thoughts, suicide attempt, and suicide;

• aggressiveness;

• 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 may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);

• speech disorder;

• fixation of the eyeballs in one position;

• unexplained sudden death;

• potentially life-threatening 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 may travel through 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 (a part of the larynx);

• inflammation of the pancreas;

• difficulty swallowing;

• diarrhea;

• abdominal discomfort;

• stomach upset;

• liver failure;

• inflammation of the liver;

• yellowing of the skin and whites of the eyes;

• abnormal liver function test results;

• rash;

• skin photosensitivity;

• hair loss;

• excessive sweating;

• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with a facial rash, followed later by generalized rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);

• abnormal breakdown of muscle tissue that may lead to kidney problems;

• muscle pain;

• stiffness;

• involuntary loss of urine (incontinence);

• difficulty urinating;

• withdrawal symptoms in newborns due to exposure to medications during pregnancy;

• prolonged and/or painful erection;

• difficulty controlling core body temperature or overheating;

• chest pain;

• swollen hands, ankles, or feet;

• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin;

• inability to resist the impulse, urge, or temptation to carry out an action that may be harmful to you or others, possibly including:

• strong urge to gamble excessively despite serious personal or family consequences;

• altered or increased sexual interest and concerning behavior for you or others, for example, increased sexual appetite;

• uncontrollable excessive shopping;

• binge eating (consuming large amounts of food in a short period of time) 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, an increased number of fatal cases have been reported while taking aripiprazole. Additionally, cases of stroke or "mini" strokes have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in type and frequency to those in adults, except for drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (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 standing up after lying down or sitting—which were common (may affect up to 1 in 10 patients).

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole flas cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Aripiprazole flas cinfa

• The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole.
• 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 stearyl fumarate and red iron oxide (E-172).

Appearance of the product and contents of the pack

The orodispersible tablets of Aripiprazole flas cinfa 10 mg are cylindrical, biconvex, pink in colour, embossed with the number “10” on one side and 7 mm in diameter.

Presented in ALU/ALU blisters. Each pack contains 28 orodispersible tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

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

Date of the most recent review of this leaflet: January 2026

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79373/P_79373.html

QR code: https://cima.aemps.es/cima/dochtml/p/79373/P_79373.html