What Abilify is and what it is used for
ABILIFY contains the active substance aripiprazole and belong to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 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 and adolescents aged 13 years and older 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. In adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.
How to take Abilify
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended 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 and adolescents
This medicinal product may be started at a low dose with the oral solution (liquid) form.
The dose may be gradually increased to the recommended 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
Try to take ABILIFY at the same time each day. It does not matter whether you take it with or
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
If you take more ABILIFY than you should
If you realise you have taken more ABILIFY than your doctor has recommended (or if someone else
has taken some of your ABILIFY), contact your doctor right away. If you cannot reach your doctor, go
to the nearest hospital and take the pack with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:
• rapid heartbeat, agitation/aggressiveness, problems with speech.
• unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may include:
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital immediately if you experience any of the above. 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 stop taking ABILIFY Do not stop your treatment just because you feel better. It is important that you carry on taking ABILIFY for as long as your doctor has told you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to keep still, difficulty sitting still,
• uncontrollable twitching, jerking or writhing movements, restless legs,
• shaking and blurred vision,
• decreased number of or difficulty making bowel movements,
• feeling sick,
• more saliva in mouth than normal,
• feeling tired.
Uncommon side effects (may affect up to 1 in 100 people):
• increased blood levels of the hormone prolactin,
• too much sugar in the blood,
• altered or increased sexual interest,
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• double vision,
• fast heartbeat,
• a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,
The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:
• low levels of white blood cells,
• low levels of blood platelets,
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• high blood sugar,
• not enough sodium in the blood, 6
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, suicide attempt and suicide,
• feeling aggressive,
• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
• speech disorder,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slower heartbeat,
• 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),
• high blood pressure,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the voice box,
• inflammation of the pancreas,
• difficulty swallowing,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and white part of eyes,
• reports of abnormal liver tests values,
• skin rash,
• sensitivity to light,
• excessive sweating,
• abnormal muscle breakdown which can lead to kidney problems,
• muscle pain,
• involuntary loss of urine (incontinence),
• difficulty in passing urine,
• withdrawal symptoms in newborn babies in case of exposure during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling core body temperature or overheating,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
• Inability to resist the impulse, drive or temptation to perform an action that could 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 of significant concern to you or to others, for example, an increased sexual drive ‐ uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) ‐ a tendency to wander away. Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms. 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. Additional side effects in children and adolescents Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).
Reporting of side effects If you get 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine
How to Store 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 blister and on the carton after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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