Abilify 7.5 mg/ml solution for injection (intramuscular)

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

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

• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes
• fits (seizures) since your doctor may want to monitor you more closely
• involuntary, irregular muscle movements, especially in the face
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure
• blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
• past experience with excessive gambling

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:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
• antidepressants or herbal remedy used to treat depression and anxiety ( such as fluoxetine, paroxetine, venlafaxine, St. John’s Wort)
• antifungal medicines (such as ketoconazole, itraconazole)
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

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:

• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
• selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
• other anti-depressants (such as venlafaxine and tryptophan) used in major depression
• tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
• pain killers (such as tramadol and pethidine) used for pain relief
• triptans (such as sumatriptan and zolmitripitan) used for treating migraine

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’.

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:

• rapid heartbeat, agitation/aggressiveness, problems with speech.
• unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.

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 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.

• The active substance is aripiprazole.
  Each mL contains 7.5 mg aripiprazole.
  A vial contains 9.75 mg (1.3 mL) aripiprazole.
• The other ingredients are sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injections.

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: