Aripiprazole Aurovitas 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Aurovitas 1 mg/ml oral solution EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. It may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Aripiprazole Aurovitas oral solution 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.

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 recurrence of this condition in patients who have responded to treatment with aripiprazole.

2. What you need to know before taking Aripiprazole Aurovitas

Do not take Aripiprazole Aurovitas

• 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 before starting aripiprazole.

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

If you notice weight gain, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or show allergic symptoms, please inform your doctor.

If you have 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 experience muscle stiffness or numbness with high fever, sweating, altered 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 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 your dose.

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 Aurovitas

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 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 with any other medicine, it may mean that your doctor needs to adjust the dose of aripiprazole or the 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 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; 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 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, 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 amitriptiline), used in depressive disorders.
• St. John's wort (Hypericum perforatum), used in herbal medicines for mild depression.
• painkillers (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, you must inform your doctor.

Taking Aripiprazole Aurovitas 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 during the third 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, 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. You should not do both. 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, e.g., when driving or operating machinery.

Aripiprazole Aurovitas contains fructose

Each ml of aripiprazole contains 200 mg of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, consult your doctor before taking this medicine (or giving it to your child).

Fructose and sucrose may harm teeth.

Aripiprazole oral solution contains sucrose

Each ml of Aripiprazole oral solution contains 400 mg of sucrose. In patients with diabetes mellitus, administration of 12.5 ml or more of Aripiprazole oral solution per dose (containing at least 5 g of sucrose) should be taken into account. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. It may be harmful to teeth.

Aripiprazole Aurovitas oral solution contains parahydroxybenzoates

The oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

These may cause allergic reactions (possibly delayed).

Aripiprazole Aurovitas contains propylene glycol

This medicine contains 53 mg of propylene glycol in each ml of oral solution.

Aripiprazole Aurovitas contains benzyl alcohol

This medicine contains 0.3 mg of benzyl alcohol in each ml of oral solution. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease. Consult your doctor or pharmacist if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Aripiprazole Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; hence, essentially “sodium-free”.

3. How to take Aripiprazole Aurovitas

Follow exactly the instructions for use of 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 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 ml (i.e., 30 mg) 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 must be measured using the calibrated cap or the calibrated 2 ml dropper pipette provided in the packaging.

If you think that the effect of aripiprazole is too strong or too weak, inform your doctor or

pharmacist.

Try to take Aripiprazole Aurovitas at the same time each day. It does not matter whether you take it with or without food. However, it must not be diluted with other liquids or mixed with other foods before taking aripiprazole.

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

doctor.

If you take more Aripiprazole Aurovitas than you should

If you realize that you have taken more aripiprazole than your doctor has recommended (or if someone

else has taken part of your aripiprazole), 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 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 nearest hospital immediately if you experience any of the

above symptoms.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Aripiprazole Aurovitas

If you miss 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 stop taking Aripiprazole Aurovitas

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 will experience them.

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

• diabetes mellitus,
• sleep disturbances,
• anxiety,
• feeling of restlessness and inability to stay still, difficulty remaining seated,
• akathisia (an uncomfortable sensation of inner restlessness and an urgent need to keep moving),
• uncontrolled twisting, writhing, or spasmodic movements,
• tremor,
• headache,
• fatigue,
• somnolence,
• dizziness,
• tremor 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 people):

• increased or decreased levels of the hormone prolactin in the blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sex drive,
• uncontrolled 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, hives),

• 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 stiffness, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate, 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 rigidity),

• speech disorder,

• fixed eye position (oculogyria),

• unexplained sudden death,

• potentially life-threatening irregular heartbeat,

• heart attack,

• slower heartbeat,

• blood clots in the 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 notice any of these symptoms, contact your doctor immediately),

• elevated blood pressure,

• fainting,

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

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

• inflammation of the pancreas,

• difficulty swallowing,

• diarrhoea,

• abdominal discomfort,

• stomach upset,

• liver failure,

• inflammation of the liver,

• 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). DRESS initially presents with flu-like symptoms and a facial rash, followed by a prolonged rash, high fever, enlarged lymph nodes, increased liver enzyme levels 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 following exposure to the drug during pregnancy,

• prolonged and/or painful erection,

• difficulty regulating core body temperature or overheating,

• chest pain,

• swollen hands, ankles, or feet,

• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin,

• inability to resist the impulse, urge, 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 behaviour to 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.

Inform your doctor if you experience any of these behaviours; he/she 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" 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, uncontrolled muscle spasms or contractions, restlessness, and fatigue, which were very common (affect 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 from a lying or sitting position, which were common (affect more than 1 in 100 patients).

Reporting of adverse effects

If you experience any 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Aurovitas

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.

This medicine does not require any special storage conditions.

Once the container is opened, use within 6 months.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazol Aurovitas

• The active substance is aripiprazole. Each ml contains 1 mg of aripiprazole.
• The other components are: glycerol, propylene glycol, sucrose, fructose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, orange flavour containing-aromas,

propylene glycol, benzyl alcohol, concentrated hydrochloric acid, sodium hydroxide, purified water.

Appearance of the product and contents of the container

Aripiprazol Aurovitas 1 mg/ml oral solution EFG is a clear, colourless to pale yellow liquid supplied in polypropylene bottles with child-resistant closures containing 50, 150 or 480 ml per bottle.

Each carton contains 1 bottle, a calibrated polypropylene measuring cap, and a calibrated polypropylene dropper.

The dropper is graduated for dosing at 0.5 ml and 1 ml, and then every 0.5 ml up to 2 ml. The measuring cap is graduated for dosing at 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, and a maximum volume of 30 ml.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorised in the European Economic Area Member States under the following names:

France: Aripiprazole Arrow 1 mg/ml solution buvable
Germany: Aripiprazol PUREN 1 mg/ml Lösung zum Einnehmen
Italy: Aripiprazolo Aurobindo Italia
Portugal: Aripiprazol Aurovitas
Spain: Aripiprazol Aurovitas 1 mg/ml solución oral EFG
Netherlands: Aripiprazol Aurobindo 1 mg/ml, drank

Date of latest revision of this leaflet: January 2023

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