Prospect: information for the user

ABILIFY 1 mg/ml oral solution

aripiprazol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who 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 prospect. See section 4.

ABILIFY contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents 15 years of age or older who suffer from a condition characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and monotony of emotional and behavioral state. People in this state may also feel depressed, guilty, restless, or tense.

ABILIFY is used to treat adults and adolescents 13 years of age or older who suffer from a condition characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep 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 ABILIFY.

Do not take ABILIFY

Warnings and precautions

Consult your doctor before starting to take ABILIFY.

There have been cases of patients who experience suicidal thoughts and behaviors during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Tell your doctor if you have:

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your 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 your caregiver should inform your doctor if you have ever had a stroke or "mini" stroke.

Tell your doctor immediately if you have thoughts or feelings of harming yourself. There have been cases of patients who experience suicidal thoughts and behaviors during treatment with aripiprazole.

Tell 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 that you cannot resist, known as impulse control disorder, which may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about increased thoughts and feelings of sex.

Your doctor may consider adjusting or stopping the dose.

Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Be cautious, especially if you are an elderly patient or have weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years old. Its safety and effectiveness in these patients are unknown.

Other medicines and ABILIFY

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

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

If you are taking ABILIFY with any other medicine, it may mean that your doctor needs to change your dose of ABILIFY or the dose of the other medicines. It is especially important to mention to your doctor if you are taking:

• 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 adverse effects or reduce the effect of ABILIFY; if you observe any unusual symptoms when taking any of these medicines with ABILIFY, inform your doctor.

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

These medicines may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medicines with ABILIFY, inform your doctor.

Taking ABILIFY with food, drinks, and alcohol

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

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 medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with ABILIFY in the last three months of pregnancy (last trimester): 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 ABILIFY, 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 ABILIFY, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

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

ABILIFY contains fructose and sucrose

This medicine contains 200 mg of fructose and 400 mg of sucrose per ml. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. Fructose may damage teeth. Sucrose may harm teeth.

ABILIFY contains parahydroxybenzoates

They may cause allergic reactions (possibly delayed).

ABILIFY contains sodium

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

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 ml of solution (which corresponds to 15 mg of aripiprazole) once a day.Your doctor may prescribe lower or higher doses up to a maximum of 30 mg (i.e., 30 ml) once a day.

Use in children and adolescents

The recommended dose for adolescents is 10 ml of solution (which corresponds to 10 mg of aripiprazole) once a day.Your doctor may prescribe lower or higher doses up to a maximum of 30 ml (i.e., 30 mg) once a day.

This dose of ABILIFY must be measured using the calibrated stopper or the calibrated 2 ml dropper that comes in the package.

If you estimate that the action of ABILIFY is too strong or too weak, inform your doctor or pharmacist.

Try to take ABILIFY at the same time every day. It does not matter if you take it with or without food.However, do not dilute with other liquids or mix with other foods before taking ABILIFY.

Even if you feel better, do not alter or interrupt the daily dose of ABILIFY without consulting your doctor first.

If you take more ABILIFY than you should

If you realize that you have taken more ABILIFY than your doctor recommended (or if someone else has taken part of your ABILIFY), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the package with you.

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

Other symptoms may include:

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

If you forget to take ABILIFY

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt treatment with ABILIFY

Do not stop treatment just because you feel better. It is essential that you continue taking ABILIFY for the time your doctor has indicated.

Ifyou have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side effects (can affect up to 1 in 10 patients):

Rare side effects (can affect up to 1 in 100 patients):

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;
• insufficient sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• aggression;
• agitation;
• anxiety;
• 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 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;
• heart attack;
• slow heart rate;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek immediate medical attention);
• high blood pressure;
• 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;
• inflammation of the liver;
• yellowing of the skin and the white part of the eyes;
• abnormal liver analysis;
• hives;
• skin sensitivity to light;
• hair loss;
• excessive sweating;
• 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;
• in blood tests: fluctuations in blood sugar levels, increased hemoglobin A1c;
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sex drive and concerning behavior for yourself or others, such as 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 from lying or sitting, which were frequent (affects up to 1 in 10 patients).

Reporting 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 thenational notification system included in the Appendix V.Mediante the reporting of side effects, you can contribute to providing more information on the safety of this medication.

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.

This medication does not require special storage conditions.

Once the packaging is opened, use within 6 months.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of ABILIFY

• The active ingredient is aripiprazol.

Each ml contains 1 mg of aripiprazol.

• The other components are edetate disodium, fructose, glycerin, lactic acid, methyloparaben (E 218), propylene glycol, propylparaben (E 216), sodium hydroxide, sucrose, purified water, and orange flavor.

Appearance of ABILIFY and packaging contents

ABILIFY 1 mg/ml oral solution is a transparent, colorless to pale yellow liquid, presented in polypropylene child-resistant closures containing 50 ml, 150 ml, or 480 ml per bottle.

Each carton contains a bottle and a calibrated polypropylene child-resistant closure and a calibrated low-density polyethylene dropper and polypropylene.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Responsible for manufacturing

Elaiapharm

2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,

06560 Valbonne

France

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet: {MM/YYYY}

Other sources of information

More detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.