Aripiprazole Normon 30 mg orodispersible tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Aripiprazole Normon 30 mg orodispersible tablets EFG

aripiprazole

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Aripiprazole Normon is and what it is used for
2. What you need to know before taking Aripiprazole Normon
3. How to take Aripiprazole Normon
4. Possible side effects
5. How to store Aripiprazole Normon
6. Contents of the pack and other information

1. What Aripiprazole Normon is and what it is used for

Aripiprazole Normon contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who have an illness characterized by symptoms such as hearing, seeing, and feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazole is used to treat adults and adolescents aged 13 years and older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents this condition in patients who have responded to treatment with aripiprazole.

2. What you need to know before starting Aripiprazole Normon

Do not take Aripiprazole Normon

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

Warnings and precautions

Consult your doctor before starting to take Aripiprazole Normon.

Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole have been reported. 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 symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes.
• Seizures, as your doctor may wish to monitor you more closely.
• Irregular and involuntary muscle movements, especially in the face.
• Cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or mini-stroke, or abnormal blood pressure.
• Blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation.
• A history of gambling addiction.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, having difficulty swallowing, or developing allergic symptoms, please inform your doctor.

If you suffer from 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.

Speak with your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior during treatment with aripiprazole have been reported.

Speak with your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental status, or very rapid 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 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 gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping the dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in ability to move and maintain balance, which could lead to falls. Caution should be taken, especially if you are an elderly patient or have some degree of weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is unknown whether it is safe and effective in these patients.

Other medicines and Aripiprazole Normon

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

Medicines that lower blood pressure: Aripiprazole may enhance the effect of medicines used to lower blood pressure. Be sure to inform your doctor if you are taking any medication to control your blood pressure.

If you are taking aripiprazole together with any other medicine, it may be necessary for your doctor to adjust the dose of aripiprazole or of the other medicines. It is especially important to tell your doctor if you are taking:

• Medicines to regulate 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 used to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors like 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 effectiveness of aripiprazole. If you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Medicines that increase serotonin levels are generally used to treat conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• Triptans, tramadol, and tryptophan, used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain.
• Selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine), used for depression, OCD, panic disorder, and anxiety.
• Other antidepressants (such as venlafaxine and tryptophan), used in severe depression.
• Tricyclic antidepressants (such as clomipramine and amitriptyline), used in depressive disorders.
• St. John's wort (Hypericum perforatum), used in herbal 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 adverse effects; if you experience any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazole Normon with food, beverages, and alcohol

This medicine can be taken regardless of meals. Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies whose mothers have been treated with aripiprazole during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you should contact your doctor.

If you are taking aripiprazole, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. If you are being treated with aripiprazole, you should not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

Aripiprazole may cause symptoms such as somnolence, dizziness, or visual disturbances, and may reduce reaction time. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your physician has assessed your response to this medication.

Aripiprazole Normon contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".

3. How to take Aripiprazole Normon

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once daily.

Use in children and adolescents

This medicine should be initiated with the oral solution (liquid) at a low dose. The dose may gradually be increased to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.

If you feel that the effect of aripiprazole is too strong or too weak, tell your doctor or pharmacist.

Try to take aripiprazole at the same time each day. It does not matter whether you take it with or without food. Do not open the blister pack until you are ready to take the tablet. To take a tablet, open the packaging and peel back the aluminum foil so that the tablet becomes visible. Do not push the tablet through the foil, as this may damage it. Once the blister is opened, with dry hands, take the orodispersible tablet and place the whole tablet on the tongue. The tablet disintegrates rapidly in saliva. The orodispersible tablet may be taken with or without liquid. Alternatively, the tablet may be dissolved in water and the resulting suspension swallowed.

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

If you take more Aripiprazole Normon than you should

If you realize you have taken more Aripiprazole Normon than your doctor recommended (or if someone else has taken some of your Aripiprazole Normon), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the packaging with you.

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

• Rapid heartbeat, agitation/aggression, speech 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, slowed breathing, suffocation, high or low blood pressure, abnormal heart rhythms.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Aripiprazole Normon

If you forget to take a dose, take the missed dose as soon as you remember. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Aripiprazole Normon

Do not stop your treatment just because you feel better. It is important that you continue taking aripiprazole for as long as your doctor has instructed.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Common adverse effects (may affect up to 1 in 10 patients):

• Diabetes mellitus.
• Sleep disturbances.
• Anxiety.
• Feeling of restlessness and inability to stay still, difficulty remaining seated.
• Akathisia (a distressing sensation of inner restlessness and an urgent need to keep moving).
• Uncontrollable twisting, writhing, or spasmodic movements.
• Tremor.
• Headache.
• Fatigue.
• Somnolence.
• Dizziness.
• Shaking and blurred vision.
• Difficulty passing stools or reduced frequency of bowel movements (constipation).
• Indigestion.
• Nausea.
• Increased saliva production.
• Vomiting.
• Feeling of tiredness.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Increased or decreased 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.
• Ocular photosensitivity.
• Rapid heartbeat.
• Drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting.
• Hiccups.

The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but their frequency 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).
• Onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma.
• High blood sugar.
• Low sodium levels in blood.
• Loss of appetite (anorexia).
• Weight loss.
• Weight gain.
• Suicidal thoughts, suicide attempt, 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 may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness).
• Speech disorder.
• Fixed eye position (oculogyric crisis).
• Unexplained sudden death.
• Potentially life-threatening irregular heartbeat.
• Heart attack.
• Slower heartbeat.
• Blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (if you experience any of these symptoms, contact your doctor immediately).
• High blood pressure.
• Fainting.
• Accidental inhalation of food with risk of pneumonia (lung infection).
• Muscle spasms around the glottis (a part of the larynx).
• Inflammation of the pancreas.
• Difficulty swallowing.
• Diarrhea.
• Abdominal discomfort.
• Stomach upset.
• Liver failure.
• Liver inflammation.
• Yellowing of the skin and whites of the eyes (jaundice).
• Abnormal liver function test results.
• Rash.
• Skin photosensitivity.
• Hair loss.
• Excessive sweating.
• Severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with a facial rash, followed later by generalized rash, high fever, swollen lymph nodes, increased liver enzyme concentrations in blood tests, and increased levels of a type of white blood cell (eosinophilia).
• Abnormal muscle breakdown that may lead to kidney problems.
• Muscle pain.
• Stiffness.
• Involuntary loss of urine (incontinence).
• Difficulty urinating.
• Withdrawal symptoms in newborns due to exposure to medicines during pregnancy.
• Prolonged and/or painful erection.
• Difficulty controlling core body temperature or overheating.
• Chest pain.
• Swelling of hands, ankles, or feet.
• In blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin.
• Inability to resist the impulse, instinct, or temptation to carry out an action that could be harmful to yourself or others, which may include:
  • Strong urge to gamble excessively despite serious personal or family consequences.
  • Increased or heightened sexual interest and behavior concerning to you or others, for example, increased sexual appetite.
  • Uncontrollable excessive shopping.
  • Binge eating (consuming large amounts of food in a short period of time) 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, an increased number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in frequency and type to those in adults, except for somnolence, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (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, particularly when rising from lying or sitting positions, which were common (affects up to 1 in 10 patients).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information Composition of Aripiprazol Normon

• The active substance is aripiprazole. Each tablet contains 30 mg of aripiprazole.
• The other components are mannitol / maize starch, tartaric acid, microcrystalline cellulose, sodium carboxymethylstarch type A (from potato), tutti frutti flavouring, iron oxide red (E172), sodium saccharin, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the container

Aripiprazole Normon 30 mg tablets are pink, round, biconvex, bevelled orodispersible tablets, marked with “A30” on one side and unmarked on the other, with an approximate diameter of 10.1 mm. The tablets are available in unit-dose packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: February 2024

Other sources of information

Up-to-date, detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/