What is Aripirazole used for?

Aripiprazole belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness. Aripiprazole is used to treat symptoms of schizophrenia. Aripiprazole may be given to treat acute episodes of sustained upward mood swings (mania) in adult patients with Bipolar 1 Disorder. 

During mania, patients experience episodes of overactivity, elation or irritability. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. Bipolar disorder is 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.

Your doctor has weighed the risks of you taking ARIPIPRAZOLE against the benefits it is expected to have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Your doctor may have prescribed ARIPIPRAZOLE for another reason. Ask your doctor if you have any questions about why ARIPIPRAZOLE has been prescribed for you. There is no evidence that ARIPIPRAZOLE is addictive.

ARIPIPRAZOLE is not recommended for use in children under the age of 18, as safety and efficacy have not been established in this age group.

Do not take ARIPIPRAZOLE if you have an allergy to:

• aripiprazole
• any of the ingredients listed at the end of this leaflet

Symptoms of an allergic reaction include:

• rash, itching or hives on the skin
• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue, throat or other parts of the body

Do not take ARIPIPRAZOLE after the expiry or use by date printed on the pack. If you take this medicine after this date has passed, it may not work as well.

if you are pregnant or intend to become pregnant. 

ARIPIPRAZOLE is not recommended for use during pregnancy. If you need to take ARIPIPRAZOLE during your pregnancy, your doctor will discuss with you the benefits and risks of taking it. Babies exposed to antipsychotics (including ARIPIPRAZOLE) during the third trimester of pregnancy are at risk of experiencing shaking, muscle stiffness, difficulty in feeding and/or withdrawal symptoms.

It is recommended that you do not breast-feed while taking ARIPIPRAZOLE, as it may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.

Tell your doctor if you have, or have had any medical conditions, especially the following:

• a reaction to some medicines with a sudden increase in body temperature, sweating, fast heart beat, muscle stiffness and fluctuating blood pressure, which may lead to coma. This reaction is called neuroleptic malignant syndrome.
• a reaction to some medicines with abnormal movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks or jaw which may progress to the arms and legs. This reaction is called tardive dyskinesia.
• low blood pressure · problems with your heart or blood vessels
• epilepsy, seizures or fits
• problems with your oesophagus (food pipe) such as difficulty in swallowing.
• high blood sugar or diabetes mellitus
• Alzheimer's disease or dementia
• alcohol or drug abuse or dependence or a history of one of these
• venous thromboembolism or are at risk of venous thromboembolism
• have a history of or are at risk of sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
• lactose intolerance 
• Tell your doctor if you drink alcohol. Your doctor may advise you to avoid alcohol as it can magnify the side effects of this medicine. Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken.

Interactions with other medications

These include:

• medicines used to treat brain disorders such as, anxiety, depression, mood swings, epilepsy or seizures, Parkinson's disease or insomnia
• medicines used to treat high blood pressure
• medicines used to treat fungal infections
• medicines used to treat heart rhythm disturbances
• medicines used to treat bacterial or viral infections · a medicine called cyclosporin (Neoral®; Sandimmun®)
• a medicine called cimetidine (Tagamet®; Magicul®) These medicines may be affected by ARIPIPRAZOLE, or may affect how well it works

Eating grapefruit or drinking grapefruit juice may affect how ARIPIPRAZOLE works.

How to take it

ARIPIPRAZOLE tablets should be swallowed whole and washed down with a glass of water. Take ARIPIPRAZOLE at about the same time each day. It does not matter whether you take ARIPIPRAZOLE with or without food.

How long to take it

Continue taking ARIPIPRAZOLE for as long as your doctor tells you. ARIPIPRAZOLE helps to control your condition but does not cure it. Therefore you must take ARIPIPRAZOLE every day. Improvement in symptoms may take several days to some weeks to occur.

Things to be careful of

Make sure that you know how you react to ARIPIPRAZOLE before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light headed or not alert. ARIPIPRAZOLE may cause some people to become drowsy or less alert than they are normally or cause lightheadedness, dizziness or tiredness. If this occurs do not undertake the activity.

ARIPIPRAZOLE may cause some unwanted side effects.

ARIPIPRAZOLE is generally well-tolerated It is important that you tell your doctor as soon as possible about any unwanted effects

Tell your doctor if you notice any of the following side effects and they worry you:

• headache
• indigestion
• nausea
• vomiting

 · insomnia

• constipation
• light-headedness
• drowsiness
• agitation
• anxiety
• inability to sit or stand still; restless movement of the arms and legs such as tapping, marching in places, rocking, crossing and uncrossing the legs. These are the more common side effects of ARIPIPRAZOLE

Storage

 Store ARIPIPRAZOLE in a cool place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines. Keep it where young children cannot reach it.

Product Description

What it looks like 5mg ARIPIPRAZOLE tablets are blue, rectangular with a bevel edge and are marked on one side with "A-007" and "5"

10mg ARIPIPRAZOLE tablets are pink, rectangular with a bevel edge and are marked on one side with "A-008" and "10".

15mg ARIPIPRAZOLE tablets are yellow, round with a bevel edge and are marked on one side with "A-009" and "15".

20mg ARIPIPRAZOLE tablets are white to pale yellowish white, round with a bevel edge and are marked on one side with "A-010" and "20".

30mg ARIPIPRAZOLE tablets are pink, round with a bevel edge and are marked on one side with "A-011" and "30".

Ingredients

Active ingredients: aripiprazole

Other ingredients:

lactose, starch - maize, cellulose - microcrystalline, hydroxypropylcellulose and magnesium stearate. The following colorants are also present in the tablets: · 5mg tablets - indigo carmine CI73015 aluminium lake · 10mg tablets - iron oxide red CI77491 · 15mg tablets - iron oxide yellow CI77492 · 20mg tablets - no colourants · 30mg tablets - iron oxide red CI77491

ARIPIPRAZOLE does not contain sucrose, gluten, tartrazine or any other azo dyes.