Package Leaflet: Information for the User

Aripiprazol Normon 1 mg/ml Oral Solution EFG

aripiprazol

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. Do 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 Normoncontains 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 disease 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 state. People in this state may also feel depressed, guilty, restless, or tense.

Aripiprazol Normon 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 Normon.

Do not take Aripiprazol Normon oral solution

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aripiprazol Normon oral solution.

Patients have reported cases of thoughts and behaviors of self-harm during treatment with aripiprazol. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazol Normon, 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; 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.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing thoughts and behaviors of self-harm 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 eating or spending, abnormally high sex drive, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazol may cause drowsiness, low blood pressure when standing, dizziness, and changes in the ability to move and maintain balance, which could cause falls. Caution should be exercised, especially if you are an elderly patient or have weakness.

Children and adolescents

Do not use this medication in children and adolescents under 13 years old. The safety and effectiveness of this medication in these patients are unknown.

Other medications and Aripiprazol Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Medications that lower blood pressure: Aripiprazol Normon may increase the effect of medications used to lower blood pressure. Make sure to inform your doctor if you are using any medication to control blood pressure.

If you are taking Aripiprazol Normon with any other medication, it may mean that your doctor needs to change your dose of Aripiprazol Normon or the dose of the other medications. It is especially important to mention to your doctor if you are taking:

• medications to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based medications used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medications (such as ketoconazole, itraconazole);
• certain medications 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 medications may increase the risk of adverse effects or reduce the effect of Aripiprazol Normon; if you observe any unusual symptoms when taking any of these medications at the same time as Aripiprazol Normon, you should inform your doctor.

Medications that increase serotonin levels are generally used to treat conditions 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 conditions such as depression, generalized anxiety disorder, OCD, and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (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 conditions;
• St. John's Wort (Hypericum perforatum) used in herbal medications for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medications may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medications at the same time as Aripiprazol Normon, you should inform your doctor.

Taking Aripiprazol Normon oral solution with food, drinks, and alcohol

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

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 medication.

The following symptoms may occur in newborn babies, from mothers who have been treated with Aripiprazol Normon 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 Aripiprazol Normon, 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 Normon, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medication.

Driving and operating machinery

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

Aripiprazol Normon oral solution contains sodium, sucrose, fructose, and parahydroxybenzoates

Each ml of Aripiprazol Normon oral solution contains 200 mg of fructose per ml. If your doctor has indicated that you (or your child) have a condition that makes you intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication. Fructose may cause tooth decay.

Parahydroxybenzoates may cause allergic reactions (possibly delayed).

This medication contains sucrose. If your doctor has indicated that you have a condition that makes you intolerant to certain sugars, consult your doctor before taking this medication.

Patients with diabetes mellitus should note that this medication contains 400 mg of sucrose per ml. It may cause tooth decay

This medication contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as 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 10 ml of solution (corresponding to 10 mg of aripiprazole) once a day.

However, your doctor may prescribe lower or higher doses up to a maximum of 30 ml (i.e., 30 mg) once a day.

This dose of Aripiprazol Normon oral solution must be measured using the 3 ml dosifier or syringe that comes in the package.

If you estimate that the action of Aripiprazol Normon is too strong or too weak, inform your doctor or pharmacist.

Try to take Aripiprazol Normon oral solution at the same time every day.It does not matter if you take it with or without food. However, do not dilute with other liquids or mix with other foods before taking Aripiprazol Normon oral solution.

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

If you take more Aripiprazol Normon oral solution than you should

If you realize that you have taken more Aripiprazol Normon oral solution than your doctor recommended (or if someone else has taken some of your Aripiprazol Normon oral solution), 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 somnolence, 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 forget to take Aripiprazol Normon oral solution

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 treatment with Aripiprazol Normon oral solution

Do not interrupt your treatment just because you feel better. It is essential that you continue taking Aripiprazol Normon oral solution 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 (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
• akathisia (an uncomfortable feeling of internal restlessness and an urgent need to move constantly)

• involuntary movements, 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 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;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• restless legs

• double vision;
• rapid heartbeat;
• low blood pressure when standing, causing dizziness, fainting, or loss of consciousness;
• hypotension.
• Ocular photosensitivity

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

• 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 a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
• 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;
• abnormal liver function test results;
• hives;

• cutaneous photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as pseudogripal symptoms with facial rash, and later with generalized rash, high temperature, enlarged lymph nodes, elevated liver enzyme levels observed in blood tests, and increased eosinophil count;

• 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;

- uncontrolled 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.

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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 movements or spasms, restlessness, and fatigue, which were very frequent (affects 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 lying or sitting, which were frequent (affects 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 below 30°C in the original packaging. Once the packaging is opened, use for 6 months.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Aripiprazol Normon

• The active ingredient is aripiprazol. Each ml contains 1 mg of aripiprazol.

Appearance of the product and contents of the packaging

Aripiprazol Normon 1 mg/ml oral solution is a transparent, colorless to pale yellow liquid.

It is presented in 150 ml bottles with child-resistant closures. Each pack contains a bottle, a dosing syringe, and a dosing device.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: April 2021

Other sources of information

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