ABILIFY 7.5 MG / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

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Package leaflet: Information for the user

ABILIFY 7.5 mg/mL solution for injection

for you.

• Keep this leaflet. You may need to read it again.
• If you have any further guestions, 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.

What is in this leaflet

1. what abilify is and what it is used for

Whatyou need to know before you are given ABILIFY

How ABILIFY is given

Possible side effects

How to store ABILIFY medicines called antipsychotics. ABILIFY is used to treat guickly symptoms of agitation and distressing behaviour that may occur in 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 ortense.

feeling “high”, having excessive amounts of energy needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

ABILIFY is given when treatment with oral formulations is not appropriate. Your doctor will change your treatment to oral ABILIFY as soon as appropriate.

BE 2. What you need to know before you are given ABILIFY

Do not use ABILIFY

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

Warnings and precautions

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

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 doctoror 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 sufferfrommuscle stiffne:s orinfle ’bilit 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 orfeelings.

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

Tell your doctoror 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 guinidine, amiodarone, flecainid

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 11¹² (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, rironavir)
• 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
• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (ODD) and social phobia as well as migraine and pain
• selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, ODD, panic and anxiety
• other antklepressants (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 fortreating migraine These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines togetherwith ABILIFY, you should see your doctor.

A combination of ABILIFYwith medicines taken for anxiety might make you

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 taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used ABILIFY in the lasttrimester (lastthree months of their pregnancy): shaking, muscle stiffness and/orweakness, 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 ABI LIFY 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. Talkto your doctor about the best way to feed your baby if you are receiving this medicine.

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 reguired, e.g., when driving a car or handling machines.

ABILIFY contains sodium

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) forthe 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 doctoror nurse.

If you are given more ABILIFY than you need

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 ABI LI FY.

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.

If you stop receiving ABILIFY

Do not stop your treatment just because you feel better. It is important that you carry on receiving ABILIFYsolution for injection for as long as your doctor has told you to.

If you have any further guestions on the use of this medicine, askyour doctor or nurse.

A

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 19 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to keep still, difficulty sitting still,
• akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
• uncontrollable twitching, jerking or writhing movements,
• trembling,
• headache,
• tiredness,
• sleepiness,
• light-headedness,
• shaking and blurred vision,
• decreased number of or difficulty making bowel movements,
• indigestion,
• feeling sick,
• more saliva in mouth than normal,
• vomiting,
• feeling tired.

Uncommon side effects (may attecC (31 in 199 people):

• increased blood levels of the hormone prolactin,
• too much sugar in the blood,
• depression,
• altered or increased sexual interest,
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), muscle disorder causing twisting movements (dystonia), restless legs,

double vision, eye sensitivity to light, fast heartbeat,

increased diastolic blood pressure,

• a fall in blood pressure on standing up which causes dizziness, light-headedness orfainting,
• hiccups,
• dry mouth.

The following side effects have been reported since the marketing of oral aripiprazole but the freguency forthem to occur is not known:

• low levels of white blood cells,
• low levels of blood platelets,
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and

urine) or coma, high blood sugar not enough sodium in the blood, loss of appetite (anorexia), weight loss, weight gain, thoughts of suicide, suicide attempt and suicide, feeling aggressive, agitation, nervousness, combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),

seizure,

serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),

speech disorder,

fixation of the eyeballs in one position,

sudden unexplained death,

life-threatening irregular heartbeat,

heart attack,

slower heartbeat,

blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately), high blood pressure,

fainting,

accidental inhalation of food with risk of pneumonia (lung infection), spasm of the muscles around the voice box,

inflammation of the pancreas,

difficulty swallowing,

diarrhoea,

abdom ina l d iooomfort,

stomach discomfort, liver failure, inflammation of the liver, yellowing of the skin and white part of eyes, reports of abnormal liver tests values, skin rash,

skin sensitivity to light,

baldness,

excessive sweating,

serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),

abnormal muscle breakdown which can lead to kidney problems, muscle pain,

stiffness,

involuntary loss of urine (incontinence),

difficulty in passing urine,

withdrawal symptoms in newborn babies in case of exposure during pregnancy,

prolonged and/or painful erection,

0 5. How to Store ABILIFY

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 vQi^ewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measureswill help protect the environment.

(D 6. Contents of the pack and other information

What ABILIFY contains

What ABILIFY looks like and contents of the pack

The ABILIFY solution for injection is a clear, colourless, agueous solution.

Each carton contains one single-use type I glass vial with a rubber butyl stopper and a “tear-off” aluminium seal.

Marketing Authorisation Holder

Otsuka Pharmaceutical Netherlands B.V.

Heri kerbergweg 292

1191 CT, Amsterdam

Netherlands

Manufacturer

ZambonS.p.A.

Via della Chimica, 9

1–36100 Vicenza(VI)

IS130BV – B

Draft 1

29 Jun 2016

450mm (150) x 370mm (185)

DO NOT REMOVE FROM ARTWORK