ABILIFY 10 mg tablets

 

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.

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
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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 tablet at the same time each day. It does not matter whether you take it with or without food. Always take the tablet with water and swallow it whole.

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 tablets than your doctor has recommended (or if someone else has taken some of your ABILIFY 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 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 sodium level 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 with risk 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.

What is it?

Abilify is a medicine that contains the active substance aripiprazole. It is available as tablets (rectangular and blue: 5 mg; rectangular and pink: 10 mg; round and yellow: 15 mg; round and pink: 30 mg), round, orodispersible tablets (tablets that dissolve in the mouth; pink: 10 and 30 mg; yellow: 15 mg), an oral solution (1 mg/ml) and a solution for injection (7.5 mg/ml).

What is it used for?

Abilify is used in patients with the following mental illnesses:
- schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). Abilify is used to treat patients aged 15 years or over;
- bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood. They may also have episodes of depression. Abilify is used to treat moderate to severe manic episodes and to prevent manic episodes in patients who have responded to the medicine in the past. Abilify is used in adults (aged 18 years or over).
The solution for injection is used for the rapid control of agitation or disturbed behaviour in adults when taking the medicine by mouth is not appropriate.
The medicine can only be obtained with a prescription.

How is it used?

For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance’ dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting dose is 2 mg a day, which is gradually increased to the recommended dose of 10 mg once a day. For bipolar disorder, the recommended starting dose is 15 mg by mouth once a day, either on its own or in combination with other medicines. To prevent manic episodes, the same dose should be continued. For both illnesses, higher doses may benefit some patients.
The oral solution or orodispersible tablets can be used in patients who have difficulty swallowing tablets. The orodispersible tablets are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing. The solution for injection is only for short-term use in adults and should be replaced by the tablets, orodispersible tablets or oral solution as soon as possible: the usual dose is 9.75 mg as a single injection into the shoulder or buttock muscle, but effective doses range between 5.25 and 15 mg. A second injection can be given from two hours after the first if necessary, but no more than three injections should be given in any 24-hour period.
Abilify can be taken with or without food. The dose should not exceed 30 mg a day. The dose of Abilify should be adjusted in patients who are taking other medicines that are broken down in the same way as Abilify. For more information, see the Package Leaflet.

How does it work?

The active substance in Abilify, aripiprazole, is an antipsychotic medicine. Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by ‘neurotransmitters’, chemicals that allow nerve cells to communicate with each other. Aripiprazole is thought to act mainly by being a ‘partial agonist’ for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.

How has it been studied?

For the treatment of schizophrenia, there were three main short-term studies lasting four to six weeks, which involved 1,203 adults and compared Abilify tablets with placebo (a dummy treatment). The effectiveness of Abilify in preventing symptoms from returning was assessed in three studies lasting up to a year, two of which used haloperidol (another antipsychotic medicine) as a comparator. Abilify tablets were also compared with placebo in one study involving 302 patients aged between 13 and 17 years. The solution for injection was compared with placebo over a period of two hours in two studies involving 805 adults with schizophrenia or related conditions who were experiencing symptoms of agitation. All of the studies measured the change in the patient’s symptoms using a standard scale for schizophrenia.
For the treatment of bipolar disorder, there were eight main studies looking at Abilify taken by mouth. Five of these compared Abilify with placebo over three weeks in a total of 1,900 patients, two of which continued for a further nine weeks to look at the maintenance of the effect and used haloperidol and lithium (another antipsychotic medicine) as comparators. The sixth study compared Abilify with haloperidol over 12 weeks in 347 patients, and the seventh compared Abilify with placebo in the prevention of recurrence in 160 patients whose manic symptoms had already been stabilised using Abilify. The eighth study looked at the effect of adding Abilify or placebo to existing treatment with lithium or valproate (another antipsychotic medicine) in 384 patients. Abilify solution for injection was compared with lorazepam (another antipsychotic medicine) and placebo over two hours in one study involving 301 patients experiencing symptoms of agitation. All of these studies looked at the change in symptoms using a standard scale for bipolar disorder or at the number of patients who responded to treatment.
The company also carried out studies looking at the absorption of the orodispersible tablets and oral solution by the body.

What benefits has it shown during the studies?

When used to treat schizophrenia, Abilify was more effective than placebo in the short-term adult studies. In the long-term studies, Abilify was more effective than placebo, and as effective as haloperidol, after up to a year of treatment. Abilify was also more effective than placebo over six weeks in the study of adolescents, and the effect of Abilify was maintained for at least six months in patients aged over 15 years. In both studies of the solution for injection, patients receiving Abilify had a greater reduction in symptoms of agitation than those receiving placebo.
When used to treat bipolar disorder, Abilify was more effective than placebo at reducing manic symptoms in four of the five short-term studies. Abilify also had a similar effect to haloperidol and to lithium over three weeks. This effect was maintained for up to 12 weeks. Abilify was also more effective than placebo at preventing manic episodes returning in previously treated patients for up to 74 weeks, and when it was used as an add-on to existing treatment. Injections of Abilify were also more effective than placebo in reducing the symptoms of agitation, and were of similar effectiveness to lorazepam.

What is the risk associated?

In adults, the most common side effects when taking Abilify by mouth (seen in between 1 and 10 patients in 100) are restlessness, insomnia (difficulty sleeping), anxiety, extrapyramidal disorder (uncontrolled twitching or jerking), akathisia (a constant urge to move), tremor (shaking), dizziness, somnolence (sleepiness), sedation (drowsiness), headache, blurred vision, dyspepsia (heartburn), vomiting, nausea (feeling sick), constipation, salivary hypersecretion (increased production of saliva) and fatigue (tiredness). Akathisia is more common in patients with bipolar disorder than in those with schizophrenia. The side effects are similar in adolescents, but somnolence, sedation and extrapyramidal disorder are more common than in adults. The most common side effects with the injection (seen in between 1 and 10 patients in 100) are somnolence, dizziness, headache, akathisia, nausea and vomiting. For the full list of all side effects reported with Abilify, see the Package Leaflet. Abilify should not be used in people who may be hypersensitive (allergic) to aripiprazole or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Abilify’s benefits are greater than its risks for the treatment of schizophrenia in adults and in adolescents 15 years and older and of moderate to severe manic episodes in bipolar I disorder, and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. The CHMP also decided that the benefits of the solution for injection are greater than its risks for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in bipolar I disorder, when oral therapy is not appropriate. The Committee recommended that Abilify be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Abilify to Otsuka Pharmaceutical Europe Ltd. on 4 June 2004. The marketing authorisation was renewed on 4 June 2009.