Abilify Maintena contains the active substance aripiprazole in a pre-filled syringe. Aripiprazole belongs to a class of medicines called antipsychotics. Abilify Maintena is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things that 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 stabilized on aripiprazole.
If you have responded well to treatment with oral aripiprazole or the medicine Abilify Maintena, your doctor may start you on Abilify Maintena. It can help improve your symptoms and reduce the risk of your symptoms coming back.

Do not use Abilify Maintena:
• if you are allergic to aripiprazole or any of the other ingredients of this medicine.

Talk to your doctor or nurse before using Abilify Maintena.

Pregnancy, lactation and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.

You should not be given Abilify Maintena if you are pregnant unless you have discussed this with your doctor. Make sure to tell your doctor straight away if you are pregnant, think you may be pregnant or are planning to become pregnant.

The following symptoms may occur in newborn babies whose mothers were given Abilify Maintena in the last trimester (last three months of pregnancy):
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding.

If your child develops any of these symptoms, you should contact your doctor.

If you are taking Abilify Maintena, your doctor will discuss with you whether you should breast-feed, taking into account the benefit of the treatment for you and the benefit of breast-feeding for your baby. You should not do both. Ask your doctor for information on the best way to feed your baby if you are taking Abilify Maintena.

Driving and using machines:
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4).
This should be taken into account in cases where full attention is required, for example, when driving a car or using machinery.

Abilify Maintena comes as a suspension in a pre-filled syringe, which will be administered by your doctor or nurse.

Your doctor will decide which dose is right for you. The recommended starting dose is 960 mg, injected once every 2 months (56 days after the previous injection), unless your doctor has decided to give you a lower starting or subsequent dose (720 mg), injected once every 2 months (56 days after the previous injection).

There are three ways to start treatment with Abilify Maintena 960 mg; your doctor will decide which is right for you.
• If you were given Abilify Maintena 400 mg 1 or more months before your doctor started you on Abilify Maintena 960 mg, your next dose may be replaced with an injection of Abilify Maintena 960 mg.
• If you are given an injection of Abilify Maintena 960 mg on the first day without having been given Abilify Maintena 400 mg 1 month before, treatment with oral aripiprazole continues for 14 days after the first injection.
• If you are given two injections (one of Abilify Maintena 960 mg and one of Abilify Maintena 400 mg) on ​​the first day, you will also take one oral aripiprazole tablet at this visit. Your doctor will give you the injections in two different places.

After that, treatment is given as injections of Abilify Maintena 960 mg or 720 mg, unless your doctor tells you otherwise.
Your doctor will give you the suspension as a single injection into the gluteal muscle (buttock) once every two months. You may feel a slight pain during the injection. Your doctor will alternate the injection site between the left and right sides of your body. The injections will not be given intravenously.

- The active substance is aripiprazole.
Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe
Each pre-filled syringe contains 720 mg of aripiprazole.
Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe
Each pre-filled syringe contains 960 mg of aripiprazole.
- The other components are:
Carmellose sodium, macrogol, povidone (E1201), sodium chloride, sodium dihydrogen phosphate monohydrate (E339), sodium hydroxide (E524), water for injections (see section 2 “Abilify Maintena contains sodium”).

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Each 960 mg pack contains one pre-filled syringe and two sterile safety needles: one 38 mm (1.5 inches), 22 gauge, and one 51 mm (2 inches), 21 gauge.

1 pre-filled syringe