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?|
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
Certain medicines to treat HIV infection
Anticonvulsants used to treat epilepsy
Taking ABILIFY with food and drink
ABILIFY can be taken regardless of meals. However, the oral solution should not be diluted with other liquids or mixed with any food prior to administration.
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
Each ml of ABILIFY oral solution contains 200 mg of fructose and 400 mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Parahydroxybenzoates may cause allergic reactions (possibly delayed).
Always take ABILIFY exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
- The usual dose for adults is 15 ml solution (corresponding to 15 mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg (i.e. 30 ml) 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.
The dose of ABILIFY oral solution must be measured using the calibrated cup or the 2 ml calibrated dropper supplied in the carton.
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 oral solution at the same time each day. It does not matter whether you take it with or without food. However, you should not dilute with other liquids or mix with other food prior to taking ABILIFY oral solution.
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 oral solution than your doctor has recommended (or if someone else has taken some of your ABILIFY oral solution), 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.
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: 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.
Keep out of the reach and sight of children.
Do not use ABILIFY after the expiry date which is stated on the bottle and on the carton.
This medicinal product does not require any special storage conditions.
Use within 6 months after first opening.
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.
What ABILIFY contains
The active substance is aripiprazole. Each ml contains 1mg of aripiprazole.
The other ingredients are disodium edetate, fructose, glycerin, lactic acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sucrose, purified water, and natural orange cream with other natural flavours.
What ABILIFY looks like and contents of the pack
ABILIFY 1 mg/ml oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 ml, 150 ml or 480 ml per bottle. Each carton contains one bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropper.
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
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
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
Tel: + 370 5 2790 762