Aripiprazol normon 30 mg comprimidos bucodispersables efg
About the medicationIntroduction
Package Insert: Information for the User
Aripiprazol Normon 30 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 doubts, consult your doctor or pharmacist.
- This medicine has been prescribed only for you, 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.
1. What isAripiprazol Normonand for what it is used
2. What you need to know before starting to takeAripiprazol Normon
3. How to takeAripiprazol Normon
4. Possible adverse effects
5. Storage ofAripiprazol Normon
6. Contents of the package and additional information
1. What is Aripiprazol Normon and what is it used for
Aripiprazol Normon contains the active ingredient aripiprazol and belongs 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, anxious or tense.
Aripiprazol is 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.
2. What you need to know before starting to take Aripiprazol Normon
Do not take Aripiprazol Normon
- 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 before starting to take Aripiprazol Normon.
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 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.
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.
Talk to 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.
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, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could cause falls. You should be cautious, especially if you are an elderly patient or have some weakness.
Children and adolescents
Do not use this medication in children and adolescents under 13 years old. Its safety and effectiveness 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 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 with any other medication, it may mean that your doctor needs to change your dose of aripiprazol 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).
- Medications to treat fungal infections (antifungals) (such as ketoconazole, itraconazole).
- Certain medications to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as, for example, 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; if you observe any unusual symptoms when taking any of these medications at the same time as aripiprazol, you should inform your doctor.
Medications 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 in depressive diseases.
- St. John's Wort (Hypericum perforatum)used in plant-based 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, you should inform your doctor.
Taking Aripiprazol Normon with food, drinks, and alcohol
This medication can be taken regardless of meals. 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 medication.
The following symptoms may occur in newborn babies, from mothers who have been treated with aripiprazol in the last trimester 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 aripiprazol, 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, 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
Aripiprazol 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 machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.
Aripiprazol Normon contains sodium
This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".
3. How to take Aripiprazol Normon
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 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. The dose can gradually 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 too weak, inform your doctor or pharmacist.
Try to take aripiprazole 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 pack and remove the aluminum from the blister, leaving the tablet visible. Do not press the tablet through the aluminum as this could damage it. Once the blister pack is opened, with dry hands, take the tablet and place the buccal dispersible tablet completely on the tongue. The disintegration of the tablet occurs quickly with saliva. The buccal dispersible 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 aripiprazole 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 packaging with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:
- Fast heart rate, 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 stiffness 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forget 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 make up 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 aripiprazole for the time your doctor has indicated.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
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.
- Feeling restless and unable to stay still, difficulty staying seated.
- Acatisia (an uncomfortable feeling of internal restlessness and an urgent need to move constantly).
- Uncontrollable twisting, contorting, or spasmodic movements.
- Tremors.
- Headache.
- 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.
Rare side effects (may affect up to 1 in 100 patients):
- Increased or decreased levels of prolactin hormone in the blood.
- Very high levels of sugar in the blood.
- Depression.
- Altered or increased sex drive.
- Uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia).
- Muscle disorder causing twisting movements (dystonia).
- Restless legs.
- Diplopia (double vision).
- Photophobia (sensitivity to light).
- Accelerated heart rate.
- Orthostatic hypotension (low blood pressure when standing up, causing dizziness, fainting, or syncope).
- Hiccup.
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.
- Inadequate sodium levels in the blood.
- Loss of appetite (anorexia).
- Weight loss.
- Weight gain.
- Thoughts of suicide, attempted suicide, and suicide.
- Aggression.
- Agitation.
- Anxiety.
- Neuroleptic malignant syndrome (a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting).
- 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.
- Myocardial infarction.
- Bradycardia (slow heart rate).
- Deep vein thrombosis (blood clots in the veins, especially in the legs, which can cause swelling, pain, and redness, and can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing).
- Hypertension.
- 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.
- Hepatitis (inflammation of the liver).
- Yellowing of the skin and the white part of the eyes.
- Abnormal liver function test results.
- Urticaria.
- Skin photosensitivity.
- Male pattern baldness.
- Excessive sweating.
- Severe allergic reactions, such as the 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 fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased eosinophils.
- 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.
- Abnormal blood test results: increased or fluctuating blood sugar levels, increased hemoglobin A1c.
- Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to oneself or others, which may include:
- Strong impulse to gamble excessively despite serious personal or family consequences.
- Increased or altered sex drive and concerning behavior for oneself or others, for example, increased sex drive.
- Uncontrollable 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.
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 (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 after being lying down or sitting, which were frequent (affects up to 1 in 10 patients).
Communication 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 Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Aripiprazol Normon
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.
Store in the original packaging to protect it from moisture.
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 of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information Composition of Aripiprazol Normon
- The active ingredient is aripiprazol. Each tablet contains 30 mg of aripiprazol.
- The other components are mannitol / cornstarch, tartaric acid, microcrystalline cellulose, sodium carboxymethylcellulose type A (from potato), tutti frutti essence, iron oxide red (E172), sodium saccharin, anhydrous colloidal silica, magnesium stearate.
Aspect to the product and contents of the packaging
Aripiprazol Normon 30 mg tablets are buccal dispersible tablets, pink in color, round, biconvex, and bisected, marked with “A30” on one face and anonymous on the other, with an approximate diameter of 10.1 mm. There are blister packs of 28 tablets.
Holder of the marketing authorization and responsible for manufacturing
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Fecha of the last review of this leaflet: February 2024
Other sources of information
The 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/
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