Consumer Medicine Information
These medicines may be affected by ABILIFY™, or may affect how well it works. Your doctor This leaflet answers some common questions may need to adjust your dose of Abilify or of the about ABILIFY™. It does not contain all the available information. Some of the information Tell your doctor if you are pregnant or intend
Eating grapefruit or drinking grapefruit juice may contained in this leaflet may not apply to you.
to become pregnant.
It does not take the place of talking to your doctor ABILIFY™ is not recommended for use during pregnancy. If you need to take ABILIFY™ information on medicines to be careful with or All medicines have risks and benefits. Your during your pregnancy, your doctor will discuss with you the benefits and risks of taking it.
doctor has weighed the risks of you takingABILIFY™ against the benefits it is expected to Tell your doctor or pharmacist if you are
breast-feeding or plan to breast-feed.
If you have any concerns about taking this
It is recommended that you do not breast-feed Follow all directions given to you by your
medicine, ask your doctor or pharmacist.
while taking ABILIFY™, as it may pass into doctor or pharmacist carefully.
breast milk and therefore there is a possibility that Keep this leaflet with the medicine.
They may differ from the information contained the breast-fed baby may be affected.
Tell your doctor if you have, or have had any
Your doctor or pharmacist will tell you how medical conditions, especially the following
much you will need to take each day. This will • a reaction to some medicines with a sudden depend on your condition and whether you are ABILIFY™ is a trade name (manufacturer's increase in body temperature, sweating, fast name) for the medicine aripiprazole (Ari-pip-rah- heart beat, muscle stiffness and fluctuating The label put on the carton by the pharmacist will blood pressure, which may lead to coma.
ABILIFY™ belongs to a group of medicines This reaction is called neuroleptic malignant If you do not understand the instructions on
called antipsychotic agents which improve the the carton, ask your doctor or pharmacist for
symptoms of certain types of mental illness.
• a reaction to some medicines with abnormal movements of the tongue, or otheruncontrolled movements of the mouth, tongue, cheeks or jaw which may progress to ABILIFY™ tablets should be swallowed whole the arms and legs. This reaction is called and washed down with a glass of water.
disturbances in thinking, feelings and behaviour.
Take ABILIFY™ at about the same time each
Your doctor may have prescribed ABILIFY™ for another reason. Ask your doctor if you have any • problems with your heart or blood vessels Unless your doctor gives you other directions, you should take ABILIFY™ only once a day.
• problems with your oesophagus (food pipe) Taking the medicine at the same time each day will have the best effect. It will also help youremember when to take it.
This medicine is available only with a doctor's • high blood sugar or diabetes mellitus It does not matter whether you take ABILIFY™ • alcohol or drug abuse or dependence or a children under the age of 18, as safety and efficacy have not been established in this age Tell your doctor if you drink alcohol.
If it is almost time for your next dose, skip the
dose you missed and take your next dose when
Your doctor may advise you to avoid alcohol as it you are meant to.
can magnify the side-effects of this medicine.
Otherwise, take it as soon as you remember,
If you have not told your doctor or pharmacist
and then go back to taking your medicine as
about any of the above, tell them before you
you would normally.
Do not take ABILIFY™ if you have an allergy
start taking ABILIFY™.
Do not take a double dose to make up for the
dose that you missed.
Tell your doctor or pharmacist if you are
This may increase the chance of you getting an • any of the ingredients listed at the end of this taking any other medicines, including any that
you buy without a prescription from your
If you are not sure what to do, ask your doctor
Symptoms of an allergic reaction include: pharmacy, supermarket or health food shop.
or pharmacist.
Some medicines and ABILIFY™ may interfere If you have trouble remembering to take your
shortness of breath, wheezing or difficulty medicine, ask your pharmacist for some hints.
• medicines used to treat brain disorders such swelling of the face, lips, tongue, throat or epilepsy or seizures, Parkinson's disease or Continue taking ABILIFY™ for as long as
your doctor tells you.
Do not take ABILIFY™ after the expiry or use
• medicines used to treat high blood pressure by date printed on the pack.
ABILIFY™ helps to control your condition but • medicines used to treat fungal infections does not cure it. Therefore you must take If you take this medicine after this date has medicines used to treat heart rhythmdisturbances symptoms may take several days to some weeks Do not take ABILIFY™ if the packaging is
to occur. Even if you feel better do not stop medicines used to treat bacterial or viral torn or shows signs of tampering.
taking ABILIFY™ unless your doctor tells you If this is the case, return it to your pharmacist.
• a medicine called cyclosporin (Cysporin®; If you are not sure whether you should start
taking ABILIFY™, talk to your doctor or
• a medicine called cimetidine (Tagamet®; pharmacist.
Tell your doctor or pharmacist if you have
allergies to:

• take cool baths or showers and avoid hot • allergic reaction (rash, itching or hives on the Immediately telephone your doctor or
difficulty breathing; swelling of the face, pharmacist or the Poisons Information Centre
• try to restrict exercise or heavy work to cool lips, tongue, throat or other parts of the (telephone 131126), or go to the Accident
Emergency Centre at your nearest hospital, if
you or anyone else may have taken too much

ABILIFY™. Do this even if there are no signs
of discomfort or poisoning.
Tell your doctor or pharmacist as soon as
• inflammation of the pancreas, severe upper possible if you do not feel well while you are
You may need urgent medical attention.
taking ABILIFY™.
Like other medicines ABILIFY™ may cause some unwanted side effects. These are likely to resulting in low body temperature or high vary from patient to patient. ABILIFY™ is generally well-tolerated and the side effects are Tell any doctors, dentists or pharmacists who
often hard to distinguish from disease symptoms.
are treating you that you are taking
It is important that you tell your doctor as soon as ABILIFY™.
possible about any unwanted effects.
• yellowing of the skin and/or eyes, also called If you are about to be started on any new
Ask your doctor or pharmacist to answer any
jaundice with or without nausea, vomiting, medicine, tell your doctor, dentist and
questions you may have.
loss of appetite, feeling generally unwell, pharmacist that you are taking ABILIFY™.
fever, itching and dark coloured urine.
Tell your doctor if you notice any of the
If you plan to have any kind of surgery that
following side effects and they worry you:
serious lung infection with fever, chills, needs a general anaesthetic, tell your doctor or
shortness of breath, cough, chest pain and dentist that you are taking ABILIFY™.
If you become pregnant while taking
• thoughts or talk about death or suicide; ABILIFY™, tell your doctor immediately.
thoughts or talk about self-harm or doing harm to others; any recent attempts at self- Be sure to keep all of your doctor's
harm; an increase in aggressive behaviour, appointments so that your progress can be
irritability or agitation. If you or someone checked.
your doctor or a mental health advisor rightaway or go to the nearest hospital for Do not give ABILIFY™ to anyone else, even if
their symptoms seem similar or they have the
same condition as you.
These are very serious side effects.
Do not take ABILIFY™ to treat any other
These are the more common side effects of complaints unless your doctor or pharmacist
tells you to.
All of these side effects are very rare.
Do not stop taking ABILIFY™ or lower the
Other side effects not listed above may occur
dosage, even if you are feeling better, without
in some patients.
checking with your doctor.
Also, while taking ABILIFY™, some elderly If you stop taking ABILIFY™ suddenly your patients with dementia have suffered serious side effects such as a "mini" stroke, stroke, pneumonia or heart problems. These serious side effects can Do not take more of this medicine and do not
Tell your doctor if you notice the following
take it more often than your doctor has
side effects:
Tell your doctor or pharmacist if you notice
• feeling dizzy especially when getting up anything that is making you feel unwell.
Do not be alarmed by this list of possible side
Make sure that you know how you react to
ABILIFY™ before you drive a car, operate
machinery or do anything else that could be
You may not experience any or only some of dangerous if you are dizzy or light headed or
not alert.
• frequent infections such as fever, severe ABILIFY™ may cause some people to become drowsy or less alert than they are normally or • bleeding or bruising more easily than normal cause light-headedness, dizziness or tiredness. If • high blood sugar (excessive thirst, hunger this occurs do not undertake the activity.
Store ABILIFY™ in a cool place where the
and weakness) or the onset or worsening of temperature stays below 30°C.
If ABILIFY™ makes you feel light-headed,
dizzy or faint, be careful when getting up from
Do not store it or any other medicine in the
a sitting or lying position.
bathroom. Do not leave it in the car or on
window sills.
Heat and dampness can destroy some medicines.
Be careful when drinking alcohol while taking
Keep it where young children cannot reach it.
Tell your doctor immediately or go to Accident
Your doctor may suggest you avoid alcohol while A locked cupboard at least one-and-a-half metres and Emergency at your nearest hospital if you
you are being treated with ABILIFY™.
above the ground is a good place to store notice any of the following:
medicines. Do not keep outdated medicine or Make sure you keep cool in hot weather and
keep warm in cool weather.
ABILIFY™ may affect the way your body reacts to temperature changes. It may prevent sweating, abnormal movements of the tongue, or other If your doctor tells you to stop taking
even during heatwaves. You may feel dizzy or ABILIFY™ or the medicine has passed its
faint if you are too hot. To stay cool in hot mouth, cheeks, or jaw which may progress to expiry date, ask your pharmacist what to do
with any left over medicine.
Be sure that any discarded medicine is out of
sweating, fast heart beat, muscle stiffness, spend time in air-conditioned environments the reach of children.
high blood pressure and convulsions.
(or keep windows open and use electric fans) 5mg ABILIFY™ tablets are blue, rectangularwith a bevel edge and are marked on one sidewith "A-007" and "5" 10mg ABILIFY™ tablets are pink, rectangularwith a bevel edge and are marked on one sidewith "A-008" and "10".
15mg ABILIFY™ tablets are yellow, round witha bevel edge and are marked on one side with "A-009" and "15".
20mg ABILIFY™ tablets are white to paleyellowish white , round with a bevel edge and aremarked on one side with "A-010" and "20".
30mg ABILIFY™ tablets are pink, round with abevel edge and are marked on one side with "A-011" and "30".
ABILIFY™ tablets are packed in aluminiumblisters in a carton. Each carton contains 30tablets.
Other ingredients: lactose, maize starch,microcrystalline cellulose,hydroxypropylcellulose and magnesium stearate.
The following colorants are also present in thetablets: 5mg tablets - indigo carmine CI73015 aluminiumlake ABILIFY™ does not contain sucrose, gluten,tartrazine or any other azo dyes.
This product is distributed in Australia by:Bristol-Myers, Squibb Australia Pty Ltd, ACN004 333 322556 Princes Highway, Noble Park 3174 VIC,Australia AUST R 90925 5mg tabletsAUST R 90997 10mg tabletsAUST R 90998 15mg tabletsAUST R 90999 20mg tabletsAUST R 91000 30mg tablets Product under license from OtsukaPharmaceutical Co., Ltd., Tokyo 101-8535 Japan

Source: http://ivsafe.files.wordpress.com/2009/06/aripiprazole.pdf


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