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Abilify 7.5 mg/ml solution for injection (intramuscular)
ABILIFY 7.5 mg/mL solution for injection
1. What ABILIFY is and what it is used for
2. What you need to know before you are given ABILIFY
3. How ABILIFY is given
4. Possible side effects
5. How to store ABILIFY
6. Contents of the pack and other information
ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. ABILIFY is used to treat quickly symptoms of agitation and distressing behaviour that may occur in a disease characterised by symptoms such as:
ABILIFY is given when treatment with oral formulations is not appropriate. Your doctor will change your treatment to oral ABILIFY as soon as appropriate.
Talk to your doctor before you are given ABILIFY.
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 ABILIFY, 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 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 the doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. The doctor may also want to measure your blood pressure and pulse.
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 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, particularly if you are an elderly patient or have some debility.
Do not use this medicine in children and adolescents under 18 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.
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.
Receiving ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY 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 ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY 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 and pain:
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY, you should see your doctor.
A combination of ABILIFY with medicines taken for anxiety might make you feel drowsy or dizzy. Only take other medicines while you are on ABILIFY if your doctor tells you that you can.
This medicine can be given regardless of meals. 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 ABILIFY 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 receiving ABILIFY, 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 receiving 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.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
Your doctor will decide how much ABILIFY you need and how long you need it for. The recommended dose is 9.75 mg (1.3 mL) for the first injection.
Up to three injections in 24 hours may be given. The total dose of ABILIFY (all formulations) should not exceed 30 mg per day.
ABILIFY is ready to use. The correct amount of solution will be injected into your muscle by your doctor or nurse.
This medicine will be given to you under medical supervision; it is therefore unlikely that you will be given too much. If you see more than one doctor, be sure to tell them that you are receiving ABILIFY.
Patients who have been given 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.
It is important not to miss your dose. If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
Do not stop your treatment just because you feel better. It is important that you carry on receiving ABILIFY solution for injection 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 nurse.
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:
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 you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 effects, 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 carton and on the vial after EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
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.
The ABILIFY solution for injection is a clear, colourless, aqueous solution.
Each carton contains one single-use type I glass vial with a rubber butyl stopper and a “tear-off” aluminium seal.
For any information about this medicine, please contact:
This leaflet was last revised in 06/2022