Aripiprazole Normon 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Normon 1 mg/ml oral solution EFG

aripiprazole

Read the entire 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, ask 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 they are adverse 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 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 and older who have an illness characterized by symptoms such as hearing, seeing, or 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.

Aripiprazol Normon 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 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 Aripiprazol Normon.

2. What you need to know before starting Aripiprazole Normon

Do not take Aripiprazole Normon oral solution

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Aripiprazole Normon oral solution.

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 diseases), 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 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, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

If you suffer from dementia (memory loss 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 muscle stiffness or numbness with high fever, sweating, changes in mental state, 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, low blood pressure upon standing, dizziness, and changes in motor ability and balance, which could lead to falls. Caution should be exercised, especially if you are elderly or have any degree of physical 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

Tell 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 the other medicines. It is especially important to 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 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 side effects or reduce the effect of Aripiprazole Normon; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole Normon, you must 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 must inform your doctor.

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

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

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 Normon during the last trimester of pregnancy (last three months of pregnancy): tremors, 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 using machines

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

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

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

Parahydroxybenzoates may cause allergic reactions (possibly delayed).

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

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

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; this 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 ml of solution (corresponding to 15 mg of aripiprazole) once daily. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg (i.e., 30 ml) once daily.

Use in children and adolescents

The recommended dose for adolescents is 10 ml of solution (corresponding to 10 mg of aripiprazole) once daily.

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

This dose of Aripiprazole Normon oral solution must be measured using the dispenser or the 3 ml dosing syringe provided in the package.

If you feel that the effect of Aripiprazole Normon is too strong or too weak, inform your doctor or pharmacist.

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

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

If you take more Aripiprazole Normon oral solution than you should

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

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, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aripiprazole Normon oral solution

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

If you stop taking Aripiprazole Normon oral solution

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Normon oral solution for the duration 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 will experience them.

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

• diabetes mellitus;

• sleep disturbances;

• anxiety;

• feeling restless and unable to remain still, difficulty remaining seated;

• akathisia (an uncomfortable sensation of inner restlessness and an urgent need to keep moving);

• uncontrollable twisting, writhing, or spasmodic movements;

• tremor;

• headache;

• fatigue;

• somnolence;

• dizziness;

• trembling 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 levels of the hormone prolactin in the blood;

• excessively high blood sugar levels;

• depression;

• altered or increased sexual interest;

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

• muscle disorder causing twisting movements (dystonia);

• restless legs;

• double vision;

• rapid heartbeat;

• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting;

• hiccups;

• Ocular photosensitivity

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;

• elevated blood sugar;

• low sodium levels in the blood;

• loss of appetite (anorexia);

• weight loss;

• weight gain;

• suicidal thoughts, suicide attempt, and suicide;

• aggression;

• agitation;

• nervousness;

• combination of fever, muscle stiffness, 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;

• 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 difficulty breathing (if you experience any of these symptoms, contact your doctor immediately);

• elevated blood pressure;

• fainting;

• accidental inhalation of food with risk of pneumonia (lung infection);

• spasms of muscles around the glottis (a part of the larynx);

• inflammation of the pancreas;

• difficulty swallowing;

• diarrhea;

• abdominal discomfort;

• stomach upset;

• liver failure;

• inflammation of the liver;

• yellowing of the skin and whites of the eyes;

• abnormal liver function test results;

• rash;

• 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 flu-like symptoms with a facial rash, followed later by generalized rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations in blood tests, and increased levels of a type of white blood cell (eosinophilia);

• abnormal breakdown of muscle tissue, which 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 controlling core body temperature or overheating;

• chest pain;

• swollen hands, ankles, or feet;

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

• inability to resist the impulse, instinct, or temptation to perform an action that may 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 concerning behavior for yourself 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.

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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, a higher number of fatal cases have been reported while taking aripiprazole. Additionally, 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, uncontrollable spasms or 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—especially upon standing up after lying down or sitting—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 Medicines: 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 the 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 in the original packaging. After opening the container, use within 6 months.

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

6. Contents of the pack and other information

Composition of Aripiprazole Normon

• The active substance is aripiprazole. Each ml contains 1 mg of aripiprazole.

• The other components are: sucrose, fructose, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), disodium edetate, lactic acid (E270), sodium hydroxide (E524), liquid orange flavour, and purified water.

Appearance of the medicinal product and contents of the pack

Aripiprazole Normon 1 mg/ml oral solution is a clear, colourless to pale yellow liquid.

It is supplied in 150 ml bottles with child-resistant closure. Each package contains one bottle, a dosing syringe, and a dosing device.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: April 2021

Other sources of information

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