Aripiprazol normon 15 mg comprimidos bucodispersables efg

Package Insert: Information for the User

Aripiprazol Normon 10 mg Buccodispersible Tablets EFG

Aripiprazol Normon 15 mg Buccodispersible Tablets EFG

aripiprazol

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Aripiprazol Normoncontains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics.

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

Do not take Aripiprazol Normon

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

Warnings and precautions

Consult your doctor before starting to take aripiprazol.

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

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

• • high levels of sugar in your blood (characterized by symptoms such as 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 disease and circulation), 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 the formation of blood clots
• history of addiction to gambling

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal 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 the person caring for you or a 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 aripiprazol 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 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 up, dizziness, and changes in the ability to move and maintain balance, which could cause 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 are unknown.

Other medicines and aripiprazol

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

Medicines that lower blood pressure: aripiprazol 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 aripiprazol with any other medicine, it may mean that your doctor needs to change your dose of aripiprazol or the dose of 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 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 adverse effects or reduce the effect of Aripiprazol; if you observe any unusual symptoms when taking any of these medicines at the same time as Aripiprazol, 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;

• 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 to treat depressive diseases;

• St. John's Wort (Hypericum perforatum) used in herbal medicines to treat 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 adverse effects; if you observe any unusual symptoms when taking any of these medicines at the same time as Aripiprazol, inform your doctor.

Aripiprazol Normon with food, drinks, and alcohol

Aripiprazol can be taken regardless of meals.

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 medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazol 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, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit to you of your treatment and the benefit to your baby of breastfeeding. If you are being treated with Aripiprazol, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

During treatment with this medicine, 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 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

This medication should be started with the oral solution (liquid) at a low dose. Gradually, the dose can 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 aripiprazole is too strong or weak, inform your doctor or pharmacist.

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

Do not open the blister pack until you are about to take it. To take a tablet, open the package and remove the aluminum from the blister, leaving the tablet visible. Do not press the tablet through the aluminum because this could damage it. Once the blister is open, with dry hands, take the tablet and place the buccodispersable tablet completely on the tongue. The tablet disintegration occurs quickly with saliva. The buccodispersable tablet can be taken with or without liquid.

Another option is to dissolve the tablet in water and drink the resulting suspension.

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 than you should

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

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.

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,

accelerated 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.

If you forgot to take Aripiprazol Normon

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

Do not stop treatment just because you feel better. It is essential that you continue taking Aripiprazol Normon 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;

• difficulty sleeping;

• anxiety;

• restlessness and inability to remain still, difficulty staying seated;

• akathisia (an uncomfortable feeling of internal restlessness and an overwhelming need to move constantly);

• involuntary movements, twisting, contorting, or spasmodic movements, restless legs;

• tremor;

• headache;

• fatigue;

• drowsiness;

• dizziness;

• shakiness and blurred vision;

• difficulty urinating 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;

• extremely high blood sugar levels;

• depression;

• altered or increased sex drive;

• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia);

• muscle disorder causing twisting movements (dystonia);

restless legs

• double vision;

• photosensitivity of the eyes

• rapid heartbeat;

• sudden drop in blood pressure when standing, causing dizziness, confusion, or fainting;

• hiccups.

• Photosensitivity of the eyes

The following side effects have been reported during the marketing of oral aripiprazole, but the frequency of their occurrence 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);

• 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;

• 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 and unexplained death;

• potentially fatal irregular heartbeat;

• heart attack;

• slower 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 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 enzyme values in blood tests;

• hives;

skin photosensitivity;

• light sensitivity;

• hair loss;

• excessive sweating;

• severe allergic reactions, such as the drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). The DRESS syndrome initially appears as pseudogripal symptoms with a rash on the face, and later with a generalized rash, high fever, swollen lymph nodes, elevated liver enzyme values in blood tests, and increased eosinophil count;

• 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 the drug during pregnancy;

• prolonged and 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;

– uncontrolled excessive 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.

– fixation of the eyeballs in a position.

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 movements, 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 of 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 medicine.

Keepthismedicationoutofsightandreachofchildren.

DonotusethismedicationaftertheexpirationdatethatappearsonthecontainerafterCAD.Theexpirationdateisthelastdayofthemonthindicated.

Storeintheoriginalpackagingtoprotectitfrommoisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. In this way, you will help protect the environment.

Aripiprazol NORMON 10 mg contains:

• The active ingredient is aripiprazol. Each buccal dispersible tablet contains 10 mg of aripiprazol.
• The other components are Mannitol/Corn Starch, Tartaric Acid (E-334), Microcrystalline Cellulose, Sodium Glycolate Starch, Tutti Frutti Essence, Iron Oxide Red (E-172), Sodium Saccharin (E-954), Anhydrous Silica, Magnesium Stearate.

Aripiprazol NORMON 15 mg contains:

• The active ingredient is aripiprazol. Each buccal dispersible tablet contains 15 mg of aripiprazol.
• The other components are Mannitol/Corn Starch, Tartaric Acid (E-334), Microcrystalline Cellulose, Sodium Glycolate Starch, Tutti Frutti Essence, Iron Oxide Yellow (E-172), Sodium Saccharin (E-954), Anhydrous Silica, Magnesium Stearate.

Appearance of the leaflet and content of the container

The buccal dispersible tablets of Aripiprazol NORMON 10 mg are pink, round, flat, and engraved with “A10” on one face.

Aripiprazol NORMON 10 mg is available in containers of 14, 28, and 49 buccal dispersible tablets.

The buccal dispersible tablets of Aripiprazol Normon 15 mg are yellow, round, bicongruous, and marked with “A15” on one face.

Aripiprazol Normon 15 mg is available in containers of 14, 28, and 49 buccal dispersible tablets.

Only some container sizes may be commercially marketed.

Holder of the Marketing Authorization and Responsible for Manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet:September 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/