Leaflet: information for the user

Aripiprazole cinfa 1 mg/ml oral solution EFG

Read this leaflet carefully before you start taking this medicine, as 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.

1. What aripiprazole cinfa is and what it is used for

2. What you need to know before you start taking aripiprazole cinfa

3. How to take aripiprazole cinfa

4. Possible side effects

5. Storage of aripiprazole cinfa

6. Contents of the pack and additional information.

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

It is used to treat adults and adolescents aged 15 years or more who suffer from a condition 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 cinfais used to treat adults and adolescents aged 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 cinfa.

Do not take aripiprazole cinfa

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

Warnings and precautions

Consult your doctor before starting to take aripiprazole cinfa.

There have been cases of patients who experience suicidal thoughts and behaviors during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Tell your doctor if you have any of the following before starting treatment with aripiprazole:

• 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 blood clot formation.
• A history of addiction to gambling.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness 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.

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

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 that you cannot resist, known as impulse control disorder, which may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping the dose.

Aripiprazole may cause drowsiness, low 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.

Children and adolescents

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

Taking aripiprazole 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: 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 taking aripiprazole with any other medicine, it may mean that your doctor needs 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:

These medicines may increase the risk of side 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:

• 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 in 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 side effects; if you observe any unusual symptoms when taking any of these medicines with aripiprazole, inform your doctor.

Taking aripiprazole cinfa with food, drinks, and alcohol

This medicine can be taken regardless of meals. However, the oral solution should not be diluted with other liquids or mixed with any food before administration.

Avoid consuming alcohol.

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 trimester of pregnancy (last three months of 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 visual disturbances, and may decrease your reaction time. 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.

Aripiprazole cinfa contains propylene glycol (E-1520).

This medicine contains 80 mg of propylene glycol per ml.

Aripiprazole cinfa contains sodium benzoate (E-211).

This medicine contains 1 mg of sodium benzoate per ml.

Aripiprazole cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; 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 ml of solution (corresponding to 15 mg of aripiprazole) once a day.However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg (i.e., 30 ml) once a day.

Use in children and adolescents

The recommended dose for adolescents is 10ml of solution (corresponding to 10mgof aripiprazole)once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30ml (i.e., 30mg) once a day.

This aripiprazole cinfa oral solution must be measured using the 30 ml dosing cup or the calibrated 5 ml syringe that comes in the package. See section 6.

If you estimate that the actionof aripiprazole istoo strong or too weak, inform your doctor or pharmacist.

Try to take aripiprazole oral solution at the same time every day.You can take it with or without food. However, do not dilute it with other liquids or mix it with other foods before taking aripiprazole oral solution.

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

If you take more aripiprazole cinfa than you should

If you realize 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 communicate with 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 rigidity and drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.

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 take aripiprazole 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 doses.

If you interrupt treatment with aripiprazole cinfa

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

Ifyou 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 (can affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• restlessness and inability to stay still, difficulty staying seated;
• involuntary movements, twisting, contorting or spasmodic movements, restless legs;
• 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 (can affect up to 1 in 100 patients):

• increased levels of prolactin hormone in the blood.
• very 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 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 (cannot be estimated with 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, suicide 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), 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 the white part of the eyes;
• abnormal liver function test results;
• hives;
• light sensitivity;
• hair loss;
• excessive sweating;
• abnormal muscle degradation that can cause kidney problems;
• muscle pain;
• stiffness;
• 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 can be harmful to you 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 you 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; he 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 (can 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 (can 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 Pharmacovigilance 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.

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.

Do not refrigerate or freeze. Once opened, use within 6 months of opening. Store the packaging in the outer packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Deposit the 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 the 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 ml contains 1 mg of aripiprazol.
• The other components are propylene glycol (E-1520), macrogol 4000, concentrated phosphoric acid, hypromellose 2910, erythritol (E-968), sucralose (E-955), sodium benzoate (E-211) and disodium edetate, grape flavor, purified water.

Appearance of the product and contents of the packaging

Aripiprazol cinfa 1 mg/ml oral solution is a transparent, colorless liquid, presented in amber-colored glass bottles of 150 ml, with a child-resistant closure, a HDPE/PE screw cap and a 5 ml polyethylene syringe adapter (graduated every 0.5 ml). A polypropylene dosing cup of 30 ml (graduated every 5 ml) is also included.

Each carton contains a bottle, a dosing cup and a syringe.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)-Spain

Responsible for manufacturing

Balkanpharma Troyan AD,

Bulgaria1, Krayrechna Str.

5600 Troyan

Bulgaria

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate 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/80788/P_80788.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80788/P_80788.html