What is it and how is it used?

ABILIFY is one of a group of medicines called antipsychotics.

Itis used to treat adults and adolescents 15 years and older who suffer from 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.

ABILIFY is used to treat adults who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. It also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.

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 take ABILIFY

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

Take special care with ABILIFY

Before treatment with ABILIFY, tell your doctor if you suffer from
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 Seizure
Involuntary, irregular muscle movements, especially in the face
Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Blood clots, or family history of blood clots, as antipsychotics have been associated with 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 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 is not for use in children and adolescents under 15 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

Taking ABILIFY with food and drink

ABILIFY can be taken regardless of meals.
Alcohol should be avoided when taking ABILIFY.

Pregnancy and breast-feeding
You should not take 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 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.

Driving and using machines

Do not drive or use any tools or machines, until you know how ABILIFY affects you.

Important information about some of the ingredients of ABILIFY

Patients who cannot take phenylalanine should note that ABILIFY orodispersible tablets contain aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.

How is it used?

Always take ABILIFY exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults:

  • The usual dose for adults is 15 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Use in children:

  • For adolescents 15 years and older, ABILIFY may be started at a low dose with the oral solution (liquid) form. The dose may be gradually increased to the usual dose for adolescents of 10 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.

Try to take the ABILIFY orodispersible tablet at the same time each day. It does not matter whether you take it with or without food.

Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid.
Alternatively, disperse the tablet in water and drink the resulting suspension.

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

If you take more ABILIFY than you should

If you realise you have taken more ABILIFY orodispersible tablets than your doctor has recommended (or if someone else has taken some of your ABILIFY orodispersible tablets), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

If you forget to take ABILIFY

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

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 affects 1 to 10 users in 100 uncommon rare very rare not known 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: 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 blister and on the carton.

Store in the original package in order to protect from moisture.

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

What ABILIFYcontains
The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole. The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour, tartaric acid, magnesium stearate, red iron oxide (E172).

What ABILIFYlooks like and contents of the pack
ABILIFY 10 mgorodispersible tablets are round and pink, marked with ?"A" over "640"? on one side and ?10? on the other. They are supplied in perforated unit dose blisters packed in cartons containing 14, 28, or 49 orodispersible tablets.
Not all pack sizes may be marketed.

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

France OTSUKA PHARMACEUTICAL FRANCE SAS Tél 33 0811 740 400 România BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel 40 021 272 16 00

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

Ísland VISTOR HF Sími 354 535 7000 Slovenská republika BRISTOL-MYERS SQUIBB SPOL. S R.O. Tel 421 2 59298411

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

This leaflet was last approved in

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