Label: information for the user

ABILIFY 7.5 mg/ml injectable solution

aripiprazole

Read this label carefully before receiving this medication, as it contains important information for you.

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

1. What is ABILIFY and for what it is used

2. What you need to know before ABILIFY is administered

3. How to administer ABILIFY

4. Possible adverse effects

5. Storage of ABILIFY

6. Contents of the package and additional information

ABILIFY contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics. ABILIFY is used to quickly treat symptoms of agitation and behavioral changes that may occur in a disease 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 behavior. People in this state may also feel depressed, guilty, restless, or tense.
• feeling euphoric, having excessive energy, needing to sleep much less than usual, speaking very quickly with flight of ideas, and sometimes, severe irritability.

ABILIFY is administered when oral formulations are not suitable. Your doctor will change your treatment to ABILIFY by mouth as soon as possible.

No use ABILIFY

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

Warnings and Precautions

Consult your doctor before starting to receive ABILIFY.

Possible 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 ABILIFY, tell your doctor if you have:

• high blood sugar levels (characterized by excessive thirst, increased urine production, increased appetite, and feeling weak) or a family history of diabetes;
• seizures, as your doctor may want to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face;
• cardiovascular diseases (heart and circulation diseases), a 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 addiction to gambling.

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 the person caring for you or a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Inform your doctor or nurse if you feel dizzy or lightheaded after the injection. You may need to lie down until you feel better. Your doctor may also need to take your blood pressure and pulse.

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

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 in you 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 addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about increased sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

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

Children and Adolescents

Do not use this medication in children and adolescents under 18 years old. The safety and effectiveness of this medication in these patients are unknown.

Other Medications and ABILIFY

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Blood pressure-lowering medications: ABILIFY may increase the effect of medications used to lower blood pressure. Make sure to inform your doctor if you are using any medication to control blood pressure.

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

• medications to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based medications used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• antifungal medications (such as ketoconazole, itraconazole);
• certain medications 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 medications may increase the risk of adverse effects or reduce the effect of ABILIFY; if you observe any unusual symptoms when taking any of these medications with ABILIFY, inform your doctor.

Medications 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:

• triptans, tramadol, and tryptophan used to treat 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 to treat 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 plant-based medications for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

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

The combination of ABILIFY with other medications used to treat anxiety may make you feel drowsy or dizzy. Only take ABILIFY with other medications if your doctor recommends it.

Use of ABILIFY with Food, Beverages, and Alcohol

This medication can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, Breastfeeding, and Fertility

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

The following symptoms may occur in newborn babies of mothers who have been treated with ABILIFY in the last trimester of pregnancy (last three months of pregnancy): 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 receiving 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. Discuss with your doctor the best way to feed your baby if you are receiving this medication.

Driving and Operating Machinery

During treatment with this medication, 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 sodium

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

Your doctor will decide how much ABILIFY you need and for how long. The recommended dose is 9.75 mg (1.3 ml) in the first injection. Up to three injections can be administered in 24 hours. The total dose of ABILIFY (all formulations) should not exceed 30 mg per day.

ABILIFY is ready for use. The doctor or nurse will administer the correct amount of solution intramuscularly.

If you are given more ABILIFY than you should

This medication will be administered under medical supervision, so it is unlikely that you will be given too much. If you see more than one doctor, make sure to tell them that you are receiving ABILIFY.

Patients who have received too much aripiprazol 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, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

If you did not receive your ABILIFY dose

It is essential not to forget your scheduled dose. If you forget an injection, contact your doctor to schedule the next injection as soon as possible.

If ABILIFY administration is stopped

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

If you have any other questions about the use of this medication, ask your doctor or nurse.

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):

• diabetes mellitus;
• sleep problems;
• anxiety;
• sensation of restlessness and inability to remain still, difficulty staying seated;
• involuntary twisting, contorting or spasmodic movements, restless legs;
• shaking;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• sensation of fatigue.

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

• increased 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);
• double vision;
• eye sensitivity to light;
• rapid heart rate;
• increased diastolic blood pressure;
• drop in blood pressure upon standing, causing dizziness, confusion, or fainting;
• hypotension;
• dry mouth.

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 heart rhythm;
• 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 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 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, for example, increased sex drive;
• excessive and uncontrolled buying;
• binge eating (ingesting 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 more reported cases of fatal outcomes while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Reporting 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 the national notification system included in theAppendix V. By reporting 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.

Store the vial in the outer packaging to protect it from light.

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

Composition of ABILIFY

• The active ingredient is aripiprazol.

Each ml contains 7.5 mg of aripiprazol.

A vial contains 9.75 mg (1.3 ml) of aripiprazol.

• The other components are sulfobutyl ether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injectable preparations.

Appearance of ABILIFY and contents of the packaging

ABILIFY injectable solution is a transparent, colorless aqueous solution.

Each box contains a type I glass vial for single use with a butyl rubber stopper and an aluminum desiccant.

Marketing authorization holder and manufacturer

Marketing authorization holderOtsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Manufacturer

Zambon S.p.A.

Via della Chimica, 9

I-36100 Vicenza (VI) Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Spain

Otsuka Pharmaceutical, S.A.

Tel: +34 93 550 01 00

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

Other sources of information

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