ABILIFY 7.5 mg/ml INJECTABLE SOLUTION

2. What you need to know before you are given ABILIFY

Do not use ABILIFY

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

Warnings and precautions

Tell your doctor before starting treatment with ABILIFY.

There have been reports of patients experiencing thoughts of suicide and suicidal behaviour while taking aripiprazole. Tell your doctor immediately if you have thoughts of harming yourself or others.

Before starting treatment with ABILIFY, tell your doctor if you have:

• high blood sugar (characterised by symptoms such as excessive thirst, increased amount of urine, increased appetite, and feeling of weakness) or a history of diabetes;
• seizures, as your doctor may want to monitor you more closely;
• irregular muscle movements, especially in the face;
• heart or blood vessel diseases, a history of heart disease, stroke, or mini-stroke, abnormal blood pressure;
• blood clots or a history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• a history of gambling addiction.

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

Tell your doctor or nurse if you feel dizzy or faint 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.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. There have been reports of patients experiencing thoughts of suicide and suicidal behaviour while taking aripiprazole.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental status, or a very fast or irregular heartbeat.

Tell your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to perform certain activities that could harm yourself or others. This is called impulse control disorder and can include behaviours such as gambling addiction, excessive eating or spending, abnormally high sexual desire, or preoccupation with sexual thoughts and feelings.

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. You should be cautious, especially if you are an elderly patient or have some weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

If you are taking ABILIFY with other medicines, it may mean that your doctor needs to change your dose of ABILIFY or the dose of the other medicines. It is especially important that you mention to 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 ABILIFY; if you notice any unusual symptoms while taking any of these medicines at the same time as ABILIFY, you should tell your doctor.

Medicines that increase serotonin levels are usually used in diseases that include depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for diseases such as depression, generalised 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 illnesses;
• 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 at the same time as ABILIFY, you should tell your doctor.

Taking ABILIFY with other medicines used for anxiety could make you feel drowsy or dizzy. Only take ABILIFY with other medicines if your doctor recommends it.

Using ABILIFY with food, drinks, and alcohol

This medicine can be given with or without food.

Alcohol should be avoided.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with ABILIFY in the last trimester (last three months of their pregnancy): trembling, stiffness and/or weakness of the muscles, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

If you are taking ABILIFY, your doctor will discuss with you whether you should breast-feed, considering the benefit of the treatment for you and the benefit of breast-feeding for your baby. If you are being treated with ABILIFY, you should not breast-feed.

Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and using machines

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 sodium

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

3. How ABILIFY is given

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

ABILIFY is ready for use. Your doctor or nurse will inject the correct amount of solution into your muscle.

If you are given more ABILIFY than you should

This medicine will be given to you under medical supervision, so it is unlikely that you will be given too much. If you see more than one doctor, be sure to tell them that you are being treated with ABILIFY.

Patient who have received too much aripiprazole have experienced the following symptoms:

• fast heartbeat, agitation/aggression, problems with speech.
• 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 stiffness and drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

If you miss a dose of ABILIFY

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

If you stop taking ABILIFY

Do not stop your treatment just because you feel better. It is important that you continue to receive ABILIFY for as long as your doctor has told you.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling restless and unable to sit still, difficulty staying seated;
• twisting, writhing, or spasmodic movements that you cannot control, restless legs;
• tremor;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty emptying the bowels or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

• increased levels of the hormone prolactin in the blood;
• high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder that causes twisting movements (dystonia);
• double vision;
• eye photosensitivity;
• rapid heartbeat;
• increased diastolic blood pressure;
• low blood pressure when standing up that causes dizziness, dizziness, or fainting;
• hypo;
• dry mouth.

The following side effects have been reported during the post-marketing period with aripiprazole oral formulation, but the frequency of occurrence 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 the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, 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 can cause intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slower heartbeat;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately);
• high blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• spasm of the muscles around the glottis (a part of the larynx);
• pancreatitis;
• difficulty swallowing;
• diarrhoea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• liver inflammation;
• yellowing of the skin and the white part of the eyes;
• abnormal liver values;
• rash;
• skin photosensitivity;
• hair loss;
• excessive sweating;
• abnormal breakdown of muscles that can cause kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to drugs during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling body temperature or overheating;
• chest pain;
• swelling of the hands, ankles, or feet;
• in blood tests: fluctuation of blood sugar levels, increased haemoglobin A1c;
• inability to resist the impulse, drive, or temptation to perform an action that may be harmful to you or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behaviour that is concerning to you or others, for example, increased sexual desire;
• uncontrollable shopping;
• 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.

Tell your doctor if you experience any of these behaviours; he 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" stroke have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ABILIFY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date refers to the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

ABILIFY Composition

• The active ingredient is aripiprazole.

Each ml contains 7.5 mg of aripiprazole.

One vial contains 9.75 mg (1.3 ml) of aripiprazole.

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

Appearance of ABILIFY and Packaging Contents

ABILIFY injectable solution is a clear, colorless aqueous solution.

Each box contains a single-use type I glass vial with a butyl rubber stopper and a tear-off aluminum seal.

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

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder.

Spain

Otsuka Pharmaceutical, S.A.

Tel: +34 93 550 01 00

Date of the last revision of this leaflet: {MM/AAAA}

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.