Leaflet: information for the user

Aripiprazole Cinfa 15 mg film-coated tablets

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, ask 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.

6. Contents of the pack and additional information

aripiprazol cinfabelongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents of 15 years or more who suffer from a disease characterised by symptoms such as hearing, seeing and feeling things that do not exist, distrust, false beliefs, incoherent speech and monotony of emotional and behavioural state. 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 characterised 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 takearipiprazole cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take aripiprazole cinfa.

Patients have been reported to experience suicidal thoughts and behaviors 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 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), a 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;
• a history of addiction to gambling.

Aripiprazole may cause drowsiness, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Be cautious, especially if you are an elderly patient or have weakness.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your daily normal 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 or family member 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 aripiprazole 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 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 intake or expenditure, 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.

Other medicines andaripiprazole cinfa

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: aripiprazole 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 using this medicine with any other medicine, your doctor may need to change your dose of aripiprazole 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 aripiprazole; if you observe any unusual symptoms when taking any of these medicines with aripiprazole, 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:

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

Takingaripiprazole cinfawith food, drinks, and alcohol

Aripiprazole can be taken regardless of meals.

It is recommended to avoid consuming alcohol while taking this medicine.

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, from mothers who have been treated with aripiprazole in the last three months of pregnancy (last three months of your 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 aripiprazole, 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 aripiprazole, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machines

Aripiprazole may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction time. These effects, as well as the disease itself, 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 evaluates your response to this medicine.

Aripiprazole cinfa contains lactose

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

Aripiprazole 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

Aripiprazol should be initiated 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 aripiprazol is too strong or weak, inform your doctor or pharmacist.

Try to take the aripiprazol tablet at the same time every day. It does not matter if you take it with or without food.

Take the tablets always with water and swallow them whole.

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

If you take morearipiprazol cinfathan you should

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

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

Other symptoms may include:

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 forgot to takearipiprazol cinfa

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with aripiprazol cinfa

Do not interrupt your 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 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• feeling restless and unable to stay still, difficulty staying seated;
• akathisia (an uncomfortable feeling of internal restlessness and an overwhelming need to move constantly);
• involuntary movements of twisting, contorting, or spasmodic movements;
• tremors;
• headaches;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty passing stools or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling tired.

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;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• double vision;
• rapid heartbeat;
• low blood pressure when standing, causing dizziness, fainting, or lightheadedness;
• hypotension;
• photosensitivity of the eyes.

The following side effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency with which they occur is unknown (the frequency cannot be estimated from the available data):

• low white blood cell count;
• low platelet count;
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, and redness);
• 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;
• anxiety;
• 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 stiffness);
• speech disorder;
• 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 experience 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;
• fixation of the eyeballs in a position;
• anemia with abnormal liver values;
• hives;
• skin photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug-induced eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as pseudogripal symptoms with a rash on the face, followed by a generalized rash, high fever, swollen lymph nodes, elevated liver enzyme levels observed in blood tests, and increased eosinophil counts;
• 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 medications 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 buying;
• binge eating (eating large amounts of food in a short period) 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, there have been reported cases of fatal outcomes 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 medication.

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

This medication does not require special conditions for conservation.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of 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 cinfa

• The active ingredient is aripiprazol. Each tablet contains 15 mg of aripiprazol.
• The other components are lactose monohydrate, maize pregelatinised starch, povidone, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, yellow iron oxide (E-172).

Appearance of the product and content of the packaging

aripiprazol cinfa 15 mg are yellow, cylindrical, biconvex tablets marked with the code “15” on one side.

Each package contains 14, 28, 49, 56 and 98 tablets, packaged in PA/AL/PVC-Aluminium blisters.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: May 2021

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/79318/P_79318.html

QR code to: https://cima.aemps.es/cima/dochtml/p/79318/P_79318.html