Active ingredient
- aripiprazole
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 are: EU/1/13/882/008, EU/1/13/882/006.
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Package leaflet: Information for the user
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
aripiprazole
Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
What is in this leaflet
1. What Abilify Maintena is and what it is used for
2. What you need to know before you are given Abilify Maintena
3. How Abilify Maintena is given
4. Possible side effects
5. How to store Abilify Maintena
6. Contents of the pack and other information
1. What Abilify Maintena is and what it is used for
Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat schizophrenia - a disease with 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 Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole.
2. What you need to know before you are given Abilify Maintena
Do not use Abilify Maintena
Warnings and precautions
Talk to your doctor or nurse before you are given Abilify Maintena.
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 Maintena, tell your doctor if you suffer from
If you notice you are gaining weight, develop unusual movements, experience sleepiness that interferes with normal daily activities, any difficulty in swallowing or have allergic symptoms, please talk to your doctor immediately.
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.
Children and adolescents
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.
Other medicines and Abilify Maintena
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Blood pressure-lowering medicines: Abilify Maintena 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 Maintena with some medicines may mean the doctor will need to change your dose of Abilify Maintena 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 Maintena; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, 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 Maintena, you should see your doctor.
Abilify Maintena with alcohol
Alcohol should be avoided.
Pregnancy, breast-feeding and fertility
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 receiving this medicine.
You should not be given Abilify Maintena 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.
The following symptoms may occur in new-born babies, of mothers that have received Abilify Maintena 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 need to contact your doctor.
If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breastfeed 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 Abilify Maintena.
Driving and using machines
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.
Abilify Maintena contains sodium
Abilify Maintena contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is essentially ‘sodium-free’.
3. How Abilify Maintena is given
Abilify Maintena comes as a pre-filled syringe.
Your doctor will decide on the dose of Abilify Maintena that is right for you. The recommended starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose (300 mg, 200 mg or 160 mg).
There are two ways to start Abilify Maintena, your doctor will decide which way is right for you.
After that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise.
Your doctor will give it to you as a single injection into the gluteal or deltoid muscle (buttock or shoulder) every month. You may feel a little pain during the injection. Your doctor will alternate the injections between your right and left side. The injections will not be given intravenously.
If you are given more Abilify Maintena than you should
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 Maintena.
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.
If you miss an injection of Abilify Maintena
It is important not to miss your scheduled dose. You should be given an injection every month but not before the 26 days has passed from the last injection. If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
If you stop receiving Abilify Maintena
Do not stop your treatment just because you feel better. It is important that you carry on receiving Abilify Maintena 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you have any of the following serious side effects:
The side effects listed below may also occur after receiving Abilify Maintena.
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):
Reporting of side effects
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 Website: 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.
5. How to store Abilify Maintena
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 the pre-filled syringe. The expiry date refers to the last day of that month.
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours.
6. Contents of the pack and other information
What Abilify Maintena contains
What Abilify Maintena looks like and contents of the pack
Abilify Maintena comes in a pre-filled syringe containing a white to off-white powder in the front chamber and a clear solvent in the rear chamber. Your doctor will make it into a suspension that will be given as an injection.
Single pack
Each single pack containing one pre-filled syringe and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.
Multipack
Bundle pack of 3 single packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 10/2020.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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