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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0985.
Aripiprazole 1mg/ml Oral Solution
Aripiprazole 1 mg/ml Oral Solution
Aripiprazole
1. What Aripiprazole oral solution is and what it is used for
2. What you need to know before you take Aripiprazole oral solution 3. How to take Aripiprazole oral solution
4. Possible side effects
5. How to store Aripiprazole oral solution
6. Contents of the pack and other information
The active ingredient in Aripiprazole oral solution is aripiprazole and belongs 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.
Aripiprazole oral solution 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 Aripiprazole oral solution.
Talk to your doctor before taking Aripiprazole oral solution.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Before treatment with Aripiprazole oral solution, tell your doctor if you suffer from
If you notice you are gaining weight, develop unusual movements, experience somnolence that interferes with normal daily activities, any diffculty 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 heartbeat.
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.
Your doctor may need to adjust or stop your dose.
Aripiprazole my 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 particularly if you are an elderly patient or have some debility.
Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Blood pressure-lowering medicines: Aripiprazole oral solution 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 Aripiprazole oral solution with some medicines may mean the doctor will need to change your dose of Aripiprazole oral solution or the other medicines. It is especially important to mention the following to your doctor:
These medicines may increase the risk of side effects or reduce the effect of Aripiprazole oral solution; if you get any unusual symptom taking any of these medicines together with Aripiprazole oral solution you should see your doctor.
Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine pain:
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole oral solution, you should see your doctor.
Aripiprazole oral solution 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole oral solution in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
If you are taking Aripiprazole oral solution, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You should not do both. Talk to your doctor about the best way to feed your baby if you are taking this medicine.
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Each ml of Aripiprazole oral solution contains 200 mg of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Fructose may damage teeth.
Each ml of Aripiprazole oral solution contains 400 mg of sucrose.
This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Sucrose may be harmful to the teeth.
Parahydroxybenzoates may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
This medicine contains 0.93 mg of alcohol (ethanol) in 1 ml of the oral solution. The amount of alcohol in 30 ml of this medicine (maximum daily dose) is equivalent to less than 1 ml beer or 1 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
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 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.
The recommended dose for adolescents is 10 ml solution (corresponding to 10 mg aripiprazole) once a day. However, your doctor may prescribe a lower or higher dose to a maximum of 30 ml (i.e. 30 mg) once a day.
The dose of Aripiprazole oral solution must be measured using the calibrated cup or calibrated syringe in the carton.
If you have the impression that the effect of Aripiprazole oral solution is too strong or too weak, talk to your doctor or pharmacist.
Try to take the Aripiprazole 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 Aripiprazole oral solution.
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole oral solution without first consulting your doctor.
If you realise you have taken more Aripiprazole oral solution than your doctor has recommended (or if someone else has taken some of your Aripiprazole oral solution), 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:
Other symptoms may include:
Contact your doctor or hospital immediately if you experience any of the above.
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
Do not stop your treatment just because you feel better.
It is important that you carry on taking Aripiprazole oral solution 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.
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):
Uncommon side effects (may affect up to 1 in 100 people):
The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known (frequency cannot be estimated from the available data):
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.
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).
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the UK Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
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 bottle and on the carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Store in the original bottle in order to protect from light.
Do not refrigerate or freeze.
Use within 6 months after first opening.
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.
Aripiprazole 1 mg/ml oral solution is a clear, colourless to light yellow liquid solution supplied in bottles with polypropylene tamper-evident and child-resistant closure containing 150 ml per bottle.
Each carton contains a bottle with measuring cup and syringe.
This leaflet was last revised in 07/2022
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