Aripiprazole Normon 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Aripiprazole Normon 10 mg orodispersible tablets EFG

Aripiprazole Normon 15 mg orodispersible tablets EFG

aripiprazole

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

Contents of the package 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 adverse effects
5. How to store Aripiprazole Normon
6. Contents of the pack and other information

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

Aripiprazol 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 or older who have an illness characterized by symptoms such as hearing, seeing, or feeling things that do not exist, distrust, 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 or 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 recurrence of 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

Talk to 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 Normon, 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 disorders), 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 gambling addiction

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop 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 to 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 to 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 are unable to resist the impulse, instinct, or temptation to carry out certain activities that could 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 your dose.

Aripiprazole may cause drowsiness, drop in blood pressure upon standing, dizziness, and changes in ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are elderly or have any weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known 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 medicines.

Medicines that lower blood pressure: Aripiprazole Normon may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control blood pressure.

If you are taking Aripiprazole Normon with any other medicine, it may mean that your doctor needs to adjust your dose of Aripiprazole Normon or of other medicines. It is especially important that you tell 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 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 side effects or reduce the effect of Aripiprazole; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole, you should inform your doctor.

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

• Triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain.

• Selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for 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 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 side effects; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole Normon, you should inform your doctor.

Taking Aripiprazole Normon with food, drinks, and alcohol

Aripiprazole 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 plan 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): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

If you are taking Aripiprazole Normon, 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 Normon, 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

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

Aripiprazole Normon contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Aripiprazole NORMON

Follow exactly the instructions for administering this medicine as 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. Gradually, the dose may 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 NORMON is too strong or too weak, inform your doctor or pharmacist.

Try to take the Aripiprazole NORMON orodispersible tablet 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 from the blister so that the tablet becomes visible. Do not push the tablet through the aluminum foil, as this may damage it. Once the blister is opened, with dry hands, take the tablet and place the entire orodispersible 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 drunk.

Even if you feel better, do not change or stop the daily dose of Aripiprazole NORMON 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 has recommended (or if someone else has taken part of your Aripiprazole NORMON), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and bring the packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91.562.04.20, indicating the medication and the amount ingested.

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

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

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

If you forget to take Aripiprazole NORMON

If you miss a dose, take the missed dose as soon as you remember. However, do not take a double dose to make up for the missed dose.

If you stop taking Aripiprazole NORMON

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole NORMON for the length of time prescribed by your doctor.

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 restless and unable to stay still, difficulty remaining seated.
• Akathisia (a distressing 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 defecating 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 post-marketing use 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.
• Aggressiveness.
• Agitation.
• Nervousness.
• Combination of fever, muscle rigidity, rapid breathing, sweating, decreased level of

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.

• Unexplained sudden death.

• Potentially life-threatening irregular heartbeat.

• Heart attack.

• Slower heartbeat.

• Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing (if you experience any of these symptoms, contact your doctor immediately).

• Elevated blood creatinine.

• 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.

• Abnormal liver function test results.

• Rash.

• Skin photosensitivity.

• Light sensitivity.

• 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 facial rash, followed later by generalized rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations in blood tests, and elevated levels of a type of white blood cell (eosinophilia).

• Abnormal breakdown of muscle tissue that may lead to kidney problems.

• Muscle pain.

• Stiffness.

• Involuntary loss of urine (incontinence).

• Difficulty urinating.

• Withdrawal symptoms in newborns due to exposure to medication during pregnancy.

• Prolonged and/or painful erection.

• Difficulty regulating core body temperature or overheating.

• Chest pain.

• Swollen hands, ankles, or feet.

• In blood tests: fluctuations in blood sugar levels, increased glycosylated hemoglobin.

• Inability to resist the impulse, urge, or temptation to perform an action that could be harmful to yourself or others, which may include:

  • Strong urge to gamble excessively despite serious personal or family consequences;
  • Altered or increased sexual interest and behavior that is concerning to you or others, for example, increased sex drive.
  • 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, a higher number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" strokes 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 effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, 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 in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Aripiprazole Normon 10 mg contains:

• The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole.
• The other components are mannitol/corn starch, tartaric acid (E-334), microcrystalline cellulose, sodium starch glycolate from potato, tutti frutti flavour, iron oxide red (E-172), sodium saccharin (E-954), anhydrous colloidal silica, magnesium stearate.

Aripiprazole Normon 15 mg contains:

• The active substance is aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole.
• The other components are mannitol/corn starch, tartaric acid (E-334), microcrystalline cellulose, sodium starch glycolate from potato, tutti frutti flavour, iron oxide yellow (E-172), sodium saccharin (E-954), anhydrous colloidal silica, magnesium stearate.

Appearance of the leaflet and contents of the pack

Aripiprazole Normon 10 mg orodispersible tablets are pink, round, flat tablets, engraved with “A10” on one side.

Aripiprazole Normon 10 mg is available in packs of 14, 28 and 49 orodispersible tablets.

Aripiprazole Normon 15 mg orodispersible tablets are yellow, round, biconvex tablets, marked with “A15” on one side.

Aripiprazole Normon 15 mg is available in packs of 14, 28 and 49 orodispersible tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of the most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/