Aripiprazole Flas Cinfa 30 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole flas cinfa 30 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

What is in 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 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 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 behaviors 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 (characterized 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 ischemic attack), or abnormal blood pressure;
• 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 weight gain, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or show 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 motor function and balance, which could lead to falls. Caution should be exercised, 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 behavior have been reported during treatment with aripiprazole.

Speak to your doctor immediately if you notice muscle stiffness or numbness with high fever, sweating, altered mental state, or very rapid 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 are unable to resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors 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 medicines to control blood pressure.

If you are taking aripiprazole with any other medicine, it may mean that your doctor needs to adjust your dose of aripiprazole or the other medicines. It is especially important to inform 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, e.g., 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 effectiveness 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, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety 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 amitriptyline) used in depressive disorders;
• 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 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, breastfeeding, think you may be pregnant, or plan 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 third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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 6 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 use of 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 pack contains fourteen blisters, separated by perforations. Separate one blister by following the perforated lines, where "fold" is indicated (Figure 2).

1. Remove the foil

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

1. Remove the orodispersible tablet

Take the orodispersible tablet with dry hands and place it on your 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 you have taken more aripiprazole than prescribed by your doctor (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, restlessness, aggression, 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, slowed 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 the 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 the length of time prescribed by your doctor.

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 urge to keep moving);
  • 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);
  • muscle 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;

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

• speech disorder;

• fixed eye 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 in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, contact your doctor 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;

• diarrhoea;

• 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 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 muscle breakdown that may lead to kidney problems;

• muscle pain;

• stiffness;

• involuntary loss of urine (incontinence);

• difficulty urinating;

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

• prolonged and/or painful erection;

• difficulty regulating core body temperature or overheating;

• chest pain;

• swollen hands, ankles, or feet;

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

• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:

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

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

• uncontrollable excessive spending;

• 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. In addition, 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 frequency and type 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 limb movements, and dizziness—especially upon standing up from lying or sitting down—which were common (may affect up to 1 in 10 patients).

Reporting of adverse effects

If you experience any 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. Aripiprazole flas cinfa Storage

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 is the last day of the month indicated.

Store in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Aripiprazole Flas Cinfa

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

Appearance of the product and contents of the pack

Aripiprazole Flas Cinfa 30 mg orodispersible tablets are cylindrical, biconvex, pink in colour, marked with the number “30” on one side and 10 mm in diameter.

The tablets are 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 revision of this leaflet: January 2026

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (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 package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79375/P_79375.html

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