What is it and how is it used?

ABILIFY is one of a group of medicines called antipsychotics.

ABILIFY solution for injection is used to treat quickly symptoms of agitation and distressing behaviour that may occur in a disease characterised by symptoms such as:
hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.
feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

ABILIFY solution for injection is given when treatment with oral formulations of ABILIFY is not appropriate. Your doctor will change your treatment to ABILIFY tablets, ABILIFY orodispersible tablets or ABILIFY oral solution as soon as appropriate.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use ABILIFY

if you are allergic (hypersensitive) to aripiprazole or any of the other ingredients of ABILIFY.

High blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite, and feeling weak) or family history of diabetes Involuntary, irregular muscle movements, especially in the face
Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, Blood clots, or family history of blood clots, as antipsychotics have been associated with

Take special care with ABILIFY Before treatment with ABILIFY, tell your doctor if you suffer from
Seizure
abnormal blood pressure
formation of blood clots

If you notice you are gaining weight, experience any difficulty in swallowing or allergic symptoms, please tell your doctor.

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.

Tell the doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. The doctor may also want to measure your blood pressure and pulse.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.

Children and adolescents

ABILIFY solution for injection is not for use in children and adolescents under 18 years. Ask your doctor or pharmacist for advice before taking ABILIFY.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

Blood pressure-lowering medicines: ABILIFY may increase the effect of medicines used to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.

Taking ABILIFY with some medicines may need to change your dose of ABILIFY. It is especially important to mention the following to your doctor:
Medicines to correct heart rhythm
Antidepressants or herbal remedy used to treat depression and anxiety
Antifungal agents
Certain medicines to treat HIV infection
Anticonvulsants used to treat epilepsy

A combination of ABILIFY solution for injection with medicines taken for anxiety might make you

feel drowsy or dizzy. Only take other medicines while you are on ABILIFY if your doctor tells you

that you can.

Using ABILIFY with food and drink ABILIFY can be administered regardless of meals.
Alcohol should be avoided when taking ABILIFY.

You should not use ABILIFY if you are pregnant unless you have discussed this with your doctor. Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are

Pregnancy and breast-feeding planning to become pregnant.

Be sure to tell your doctor immediately if you are breast-feeding.

If you are taking ABILIFY, you should not breast-feed.

Do not drive or use any tools or machines if you feel drowsy after receiving ABILIFY solution for

Driving and using machines injection.

How is it used?

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

ABILIFY solution for injection is ready to use. The correct amount of solution will be injected into your muscle by your doctor or nurse.

If you are concerned that you are given more ABILIFY solution for injection than you feel necessary, tell your doctor or nurse of your concern. Only a few doses of ABILIFY solution for injection may be needed. Your doctor will decide when you need another dose of ABILIFY solution for injection.

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

What are possible side effects?

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

The frequency of possible side effects listed below is defined using the following convention very common affects more than 1 user in 10 common uncommon rare very rare not known affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data

Common side effects of ABILIFY solution for injection include sleepiness, dizziness, headache, restlessness, nausea and vomiting.

Uncommon side effects: some people may have changes in blood pressure, may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate, dry mouth or fatigue.

In addition, the following side effects have been seen in patients treated with oral formulations of ABILIFY:

Common side effects: uncontrollable twitching or jerking movements, headache, tiredness, nausea, vomiting, an uncomfortable feeling in the stomach, constipation, increased production of saliva, light-headedness, trouble sleeping, restlessness, feeling anxious, sleepiness, shaking and blurred vision.

Uncommon side effects: some people may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate.
Some people may feel depressed.

The following side effects have been reported since the marketing of ABILIFY but the frequency for them to occur is not known:

Changes in the levels of some blood cells; unusual heart beat, sudden unexplained death, heart attack; allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, rash); hig h blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodiumlevel in the blood; weight gain, weight loss, anorexia; nervousness, agitation, feeling anxious; thoughts of suicide, suicide attempt and suicide; speech disorder, seizure, combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate; fainting, high blood pressure, 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 in breathing (if you notice any of these symptoms, seek medical advice immediately); spasm of the muscles around the voice box, accidental inhalation of food withrisk of pneumonia, difficu lty in swallowing; inflammation of the pancreas; inflammation of the liver, yellowing of the skin and white part of eyes, reports of abnormal liver test values, abdominal and stomach discomfort, diarrhoea; skin rash and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty in passing urine; prolonged and/or painful erection; difficulty controlling core body temperature or

overheating, chest pain, and swelling of hands, ankles or feet.

Adolescents 15 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness and uncontrollable twitching or jerking movements were very common (greater than 1 in 10 patients) and dry mouth, increased appetite, and feeling dizzy, especially when getting up from a lying or sitting position, were common.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,please

tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use ABILIFY after the expiry date which is stated on the carton and on the vial.

Keep the vial in the outer carton in order to protect 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 to protect the environment.

Further information

The active substance is aripiprazole. Each ml contains 7.5 mg aripiprazole. A vial contains The other ingredients are sulfobutylether ?-cyclodextrin (SBECD), tartaric acid, sodium

What ABILIFY contains

9.75 mg (1.3 ml) aripiprazole.
hydroxide, and water for injections.

What ABILIFY looks like and contents of the pack The ABILIFY solution for injection is a clear, colourless, aqueous solution.
Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "flip-off" aluminium seal.

Marketing Authorisation Holder Otsuka Pharmaceutical Europe Ltd.
Hunton House, Highbridge Business Park, Oxford Road
Uxbridge - Middlesex UB8 1HU - United Kingdom

Manufacturer Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone - Italy

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

BelgiqueBelgiëBelgien BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11 LuxembourgLuxemburg BRISTOL-MYERS SQUIBB BELGIUM S.A.N.V. TélTel 32 2 352 76 11

BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Te. 359 800 12 400 Magyarország BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel. 36 1 301 9700

eská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 420 221 016 111 Malta BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61

Danmark BRISTOL-MYERS SQUIBB Tlf 45 45 93 05 06 Nederland BRISTOL-MYERS SQUIBB BV Tel 31 34 857 42 22

Deutschland BRISTOL-MYERS SQUIBB GMBH CO. KGAA Tel 49 89 121 42-0 Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf 47 67 55 53 50

Österreich BRISTOL-MYERS SQUIBB GESMBH Tel 43 1 60 14 30 Eesti BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 372 6827 400

BRISTOL-MYERS SQUIBB A.E. 30 210 6074300 Polska BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel. 48 22 5796666

España OTSUKA PHARMACEUTICAL, S.A. Tel 34 93 550 01 00 Portugal BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, S.A. Tel 351 21 440 70 00

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IrelandSlovenija
BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDBRISTOL-MYERS SQUIBB SPOL. S R.O. Tel: + 353 (1 800) 749 749 Tel: + 386 1 236 47 00

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Italia BRISTOL-MYERS SQUIBB S.R.L. Tel 39 06 50 39 61 SuomiFinland OY BRISTOL-MYERS SQUIBB FINLAND AB PuhTel 358 9 251 21 230

BRISTOL-MYERS SQUIBB A.E 357 800 92666 Sverige BRISTOL-MYERS SQUIBB AB Tel 46 8 704 71 00

United Kingdom BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTDTel 44 0800 731 1736 Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 371 67 50 21 85

Lietuva
BRISTOL-MYERS SQUIBB
GYÓGYSZERKERESKEDELMI KFT.
Tel: + 370 5 2790 762

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