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Abilify (aripiprazole) – Package leaflet - N05AX12

Updated on site: 05-Oct-2017

Package leaflet: Information for the user

ABILIFY 5 mg tablets

ABILIFY 10 mg tablets

ABILIFY 15 mg tablets

ABILIFY 30 mg tablets

aripiprazole

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

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.

What is in this leaflet

1.What ABILIFY tablets are and what they are used for

2.What you need to know before you take ABILIFY tablets

3.How to take ABILIFY tablets

4.Possible side effects

5 How to store ABILIFY tablets

6.Contents of the pack and other information

1.What ABILIFY tablets are and what they are used for

ABILIFY tablets contain the active substance aripiprazole and belong to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from 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 or tense.

ABILIFY tablets are used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY tablets.

2. What you need to know before you take ABILIFY tablets

Do not take ABILIFY tablets

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

Warnings and precautions

Talk to your doctor before taking ABILIFY tablets 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

seizure

involuntary, irregular muscle movements, especially in the face

cardiovascular diseases, 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 of 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 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 heart beat.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Blood pressure-lowering medicines: ABILIFY tablets 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.

Taking ABILIFY tablets with some medicines may need to change your dose of ABILIFY tablets. It is especially important to mention the following to your doctor:

Medicines to correct heart rhythm

Antidepressants or herbal remedy used to treat depression and anxiety

Antifungal agents

Certain medicines to treat HIV infection

Anticonvulsants used to treat epilepsy

Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY tablets, you should see your doctor.

ABILIFY tablets with food, drink and alcohol

ABILIFY tablets can be taken regardless of meals.

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 taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used ABILIFY tablets 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.

Be sure to tell your doctor immediately if you are breast-feeding.

If you are taking ABILIFY tablets, you should not breast-feed.

Driving and using machines

Do not drive or use any tools or machines, until you know how ABILIFY tablets affect you.

ABILIFY tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.How to take ABILIFY tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents

This medicinal product may be started at a low dose with the oral solution (liquid) form.

The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effects of your ABILIFY tablets are too strong or too weak, talk to your doctor or pharmacist.

Try to take your ABILIFY tablets at the same time each day. It does not matter whether you take it with or without food. Always take the tablet with water and swallow it whole.

Even if you feel better, do not alter or discontinue the daily dose of ABILIFY tablets without first consulting your doctor.

If you take more ABILIFY tablets than you should

If you realise you have taken more ABILIFY tablets than your doctor has recommended (or if someone else has taken some of your ABILIFY tablets), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

If you forget to take your ABILIFY tablets

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

If you stop taking ABILIFY tablets

Do not stop your treatment just because you feel better. It is important that you carry on taking your ABILIFY tablets 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 pharmacist.

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 10 people):

diabetes mellitus,

difficulty sleeping,

feeling anxious,

feeling restless and unable to keep still, difficulty sitting still,

uncontrollable twitching, jerking or writhing movements, restless legs,

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 affect up to 1 in 100 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),

double vision,

fast heart beat,

a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,

hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them 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,

excessive gambling,

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,

sudden unexplained death,

life-threatening irregular heart beat,

heart attack,

slower heart beat,

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,

abdominal discomfort,

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,

sensitivity to light,

baldness,

excessive sweating,

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,

difficulty controlling core body temperature or overheating,

chest pain,

swelling of hands, ankles or feet,

in blood tests: fluctuating blood sugar, increased glycosylated haemoglobin.

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.

Additional side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store ABILIFY tablets

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 blister and on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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.

6. Contents of the pack and other information

What ABILIFY tablets contain

The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.

Each tablet contains 10 mg of aripiprazole. Each tablet contains 15 mg of aripiprazole. Each tablet contains 30 mg of aripiprazole.

The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.

Tablet coat

ABILIFY 5 mg tablets: ABILIFY 10 mg tablets: ABILIFY 15 mg tablets: ABILIFY 30 mg tablets:

Indigo carmine aluminium lake (E 132) Red iron oxide (E 172)

Yellow iron oxide (E 172) Red iron oxide (E 172)

What ABILIFY tablets looks like and contents of the pack

ABILIFY 5 mg tablets are rectangular and blue, marked with ‘A-007’ and ‘5’ on one side. ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008’ and ‘10’ on one side. ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009’ and ‘15’ on one side. ABILIFY 30 mg tablets are round and pink, marked with ‘A-011’ and ‘30’ on one side.

ABILIFY tablets are supplied in perforated unit dose blisters packed in cartons containing 14 x 1, 28 x 1, 49 x 1, 56 x 1, or 98 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

Manufacturer

Bristol-Myers Squibb S.r.l.

Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone - Italy

AndersonBrecon (UK) Limited

Wye Valley Business Park, Brecon Road, Hay-on-Wye

Hereford - Herefordshire HR3 5PG - United Kingdom

Elaiapharm

2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis, 06560 Valbonne - France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

България

Luxembourg/Luxemburg

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Česká republika

Magyarország

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Danmark

Malta

Otsuka Pharma Scandinavia AB

Otsuka Pharmaceutical Europe Ltd.

Tlf: +46 854 528 660

Tel: + 44 (0)203 747 5000

Deutschland

Nederland

Otsuka Pharma GmbH

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Eesti

Norge

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tlf: +46 854 528 660

Ελλάδα

Österreich

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

España

Polska

Otsuka Pharmaceutical, S.A.

Otsuka Pharmaceutical Europe Ltd.

Tel: +34 93 550 01 00

Tel: + 44 (0)203 747 5000

France

Portugal

Otsuka Pharmaceutical France SAS

Lundbeck Portugal Lda

Tél: +33(0)1 47 08 00 00

Tel: +351 21 00 45 900

Hrvatska

România

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: +44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ireland

Slovenija

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ísland

Slovenská republika

Vistor hf.

Otsuka Pharmaceutical Europe Ltd.

Sími: +354 535 7000

Tel: + 44 (0)203 747 5000

Italia

Suomi/Finland

Otsuka Pharmaceutical Italy S.r.l.

Otsuka Pharma Scandinavia AB

Tel: +39 02 00 63 27 10

Puh/Tel: +46 854 528 660

Κύπρος

Sverige

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tel: +46 854 528 660

Latvija

United Kingdom

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceuticals (UK) Ltd.

Tel: + 44 (0)203 747 5000

Tel: +44 (0)203 747 5300

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

ABILIFY 10 mg orodispersible tablets

ABILIFY 15 mg orodispersible tablets

ABILIFY 30 mg orodispersible tablets

aripiprazole

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

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.

What is in this leaflet

1.What ABILIFY orodispersible tablets are and what they are used for

2.What you need to know before you take ABILIFY orodispersible tablets

3.How to take ABILIFY orodispersible tablets

4.Possible side effects

5 How to store ABILIFY orodispersible tablets

6.Contents of the pack and other information

1.What ABILIFY orodispersible tablets are and what they are used for

ABILIFY orodispersible tablets contain the active substance aripiprazole and belong to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from 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 or tense.

ABILIFY orodispersible tablets are used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY orodispersible tablets.

2.What you need to know before you take ABILIFY orodispersible tablets

Do not take ABILIFY orodispersible tablets

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

Warnings and precautions

Talk to your doctor before taking ABILIFY orodispersible tablets 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

seizure

involuntary, irregular muscle movements, especially in the face

cardiovascular diseases, 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 of 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 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 heart beat.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY orodispersible tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Blood pressure-lowering medicines: ABILIFY orodispersible tablets 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.

Taking ABILIFY orodispersible tablets with some medicines may need to change your dose of ABILIFY orodispersible tablets. It is especially important to mention the following to your doctor:

Medicines to correct heart rhythm

Antidepressants or herbal remedy used to treat depression and anxiety

Antifungal agents

Certain medicines to treat HIV infection

Anticonvulsants used to treat epilepsy

Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY orodispersible tablets, you should see your doctor.

ABILIFY orodispersible tablets with food, drink and alcohol

ABILIFY orodispersible tablets can be taken regardless of meals.

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 taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used ABILIFY orodispersible tablets 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.

Be sure to tell your doctor immediately if you are breast-feeding.

If you are taking ABILIFY orodispersible tablets, you should not breast-feed.

Driving and using machines

Do not drive or use any tools or machines, until you know how ABILIFY orodispersible tablets affect you.

ABILIFY orodispersible tablets contain aspartame

Patients who cannot take phenylalanine should note that ABILIFY orodispersible tablets contain aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.

ABILIFY orodispersible tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.How to take ABILIFY orodispersible tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents

This medicinal product may be started at a low dose with the oral solution (liquid) form.

The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effects of your ABILIFY orodispersible tablets are too strong or too weak, talk to your doctor or pharmacist.

Try to take your ABILIFY orodispersible tablets at the same time each day. It does not matter whether you take it with or without food.

Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid.

Alternatively, disperse the tablet in water and drink the resulting suspension.

Even if you feel better, do not alter or discontinue the daily dose of ABILIFY orodispersible tablets without first consulting your doctor.

If you take more ABILIFY orodispersible tablets than you should

If you realise you have taken more ABILIFY orodispersible tablets than your doctor has recommended (or if someone else has taken some of your ABILIFY orodispersible tablets), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

If you forget to take ABILIFY orodispersible tablets

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

If you stop taking ABILIFY orodispersible tablets

Do not stop your treatment just because you feel better. It is important that you carry on taking ABILIFY orodispersible tablets 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 pharmacist.

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 10 people):

diabetes mellitus,

difficulty sleeping,

feeling anxious,

feeling restless and unable to keep still, difficulty sitting still,

uncontrollable twitching, jerking or writhing movements, restless legs,

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 affect up to 1 in 100 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),

double vision,

fast heart beat,

a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,

hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them 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,

excessive gambling,

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,

sudden unexplained death,

life-threatening irregular heart beat,

heart attack,

slower heart beat,

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,

abdominal discomfort,

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,

sensitivity to light,

baldness,

excessive sweating,

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,

difficulty controlling core body temperature or overheating,

chest pain,

swelling of hands, ankles or feet,

in blood tests: fluctuating blood sugar, increased glycosylated haemoglobin.

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.

Additional side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.How to store ABILIFY orodispersible tablets

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 blister and on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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.

6. Contents of the pack and other information

What ABILIFY orodispersible tablets contain

The active substance is aripiprazole.

Each orodispersible tablet contains 10 mg of aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole. Each orodispersible tablet contains 30 mg of aripiprazole.

The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour, tartaric acid and magnesium stearate.

Tablet coat

ABILIFY 10 mg orodispersible tablets: ABILIFY 15 mg orodispersible tablets: ABILIFY 30 mg orodispersible tablets:

Red iron oxide (E 172) Yellow iron oxide (E 172) Red iron oxide (E 172)

What ABILIFY orodispersible tablets looks like and contents of the pack

ABILIFY 10 mg orodispersible tablets are round and pink, marked with ‘"A" over "640"’ on one side and ‘10’ on the other.

ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"’ on one side and ‘15’ on the other.

ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"’ on one side and ‘30’ on the other.

ABILIFY orodispersible tablets are supplied in perforated unit dose blisters packed in cartons containing 14 x 1, 28 x 1, or 49 x 1 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

Manufacturer

Bristol-Myers Squibb S.r.l.

Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone - Italy

Elaiapharm

2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,

06560 Valbonne - France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

България

Luxembourg/Luxemburg

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Česká republika

Magyarország

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Danmark

Malta

Otsuka Pharma Scandinavia AB

Otsuka Pharmaceutical Europe Ltd.

Tlf: +46 854 528 660

Tel: + 44 (0)203 747 5000

Deutschland

Nederland

Otsuka Pharma GmbH

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Eesti

Norge

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tlf: +46 854 528 660

Ελλάδα

Österreich

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

España

Polska

Otsuka Pharmaceutical, S.A.

Otsuka Pharmaceutical Europe Ltd.

Tel: +34 93 550 01 00

Tel: + 44 (0)203 747 5000

France

Portugal

Otsuka Pharmaceutical France SAS

Lundbeck Portugal Lda

Tél: +33(0)1 47 08 00 00

Tel: +351 21 00 45 900

Hrvatska

România

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: +44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ireland

Slovenija

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ísland

Slovenská republika

Vistor hf.

Otsuka Pharmaceutical Europe Ltd.

Sími: +354 535 7000

Tel: + 44 (0)203 747 5000

Italia

Suomi/Finland

Otsuka Pharmaceutical Italy S.r.l.

Otsuka Pharma Scandinavia AB

Tel: +39 02 00 63 27 10

Puh/Tel: +46 854 528 660

Κύπρος

Sverige

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tel: +46 854 528 660

Latvija

United Kingdom

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceuticals (UK) Ltd.

Tel: + 44 (0)203 747 5000

Tel: +44 (0)203 747 5300

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

ABILIFY 1 mg/ml oral solution aripiprazole

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

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.

What is in this leaflet

1.What ABILIFY oral solution is and what it is used for

2.What you need to know before you take ABILIFY oral solution

3.How to take ABILIFY oral solution

4.Possible side effects

5 How to store ABILIFY oral solution

6.Contents of the pack and other information

1.What ABILIFY oral solution is and what it is used for

ABILIFY oral solution contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from 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 or tense.

ABILIFY oral solution is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY oral solution.

2. What you need to know before you take ABILIFY oral solution

Do not take ABILIFY oral solution

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

Warnings and precautions

Talk to your doctor before taking ABILIFY oral solution 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

seizure

involuntary, irregular muscle movements, especially in the face

cardiovascular diseases, 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 of 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 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 heart beat.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY oral solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Blood pressure-lowering medicines: ABILIFY oral solution 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.

Taking ABILIFY oral solution with some medicines may need to change your dose of ABILIFY oral solution. It is especially important to mention the following to your doctor:

Medicines to correct heart rhythm

Antidepressants or herbal remedy used to treat depression and anxiety

Antifungal agents

Certain medicines to treat HIV infection

Anticonvulsants used to treat epilepsy

Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY oral solution, you should see your doctor.

ABILIFY oral solution with food, drink and alcohol

ABILIFY oral solution can be taken regardless of meals. However, the oral solution should not be diluted with other liquids or mixed with any food prior to administration.

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 taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used ABILIFY oral solution 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.

Be sure to tell your doctor immediately if you are breast-feeding.

If you are taking ABILIFY oral solution, you should not breast-feed.

Driving and using machines

Do not drive or use any tools or machines until you know how ABILIFY oral solution affects you.

ABILIFY oral solution contains fructose, sucrose and parahydroxybenzoates

Each ml of ABILIFY oral solution contains 200 mg of fructose and 400 mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Parahydroxybenzoates may cause allergic reactions (possibly delayed).

3.How to take ABILIFY oral solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 15 ml solution (corresponding to 15 mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg (i.e. 30 ml) once a day.

Use in children and adolescents

The recommended dose for adolescents is 10 ml solution (corresponding to 10 mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 ml (i.e. 30 mg) once a day.

The dose of ABILIFY oral solution must be measured using the calibrated cup or the 2 ml calibrated dropper supplied in the carton.

If you have the impression that the effect of ABILIFY oral solution is too strong or too weak, talk to your doctor or pharmacist.

Try to take the ABILIFY oral solution at the same time each day. It does not matter whether you take it with or without food. However, you should not dilute with other liquids or mix with other food prior to taking ABILIFY oral solution.

Even if you feel better, do not alter or discontinue the daily dose of ABILIFY oral solution without first consulting your doctor.

If you take more ABILIFY oral solution than you should

If you realise you have taken more ABILIFY oral solution than your doctor has recommended (or if someone else has taken some of your ABILIFY oral solution), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

If you forget to take ABILIFY oral solution

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

If you stop taking ABILIFY oral solution

Do not stop your treatment just because you feel better. It is important that you carry on taking ABILIFY oral solution 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 pharmacist.

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 10 people):

diabetes mellitus,

difficulty sleeping,

feeling anxious,

feeling restless and unable to keep still, difficulty sitting still,

uncontrollable twitching, jerking or writhing movements, restless legs,

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 affect up to 1 in 100 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),

double vision,

fast heart beat,

a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,

hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them 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,

excessive gambling,

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,

sudden unexplained death,

life-threatening irregular heart beat,

heart attack,

slower heart beat,

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,

abdominal discomfort,

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,

sensitivity to light,

baldness,

excessive sweating,

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,

difficulty controlling core body temperature or overheating,

chest pain,

swelling of hands, ankles or feet,

in blood tests: fluctuating blood sugar, increased glycosylated haemoglobin.

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.

Additional side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store ABILIFY oral solution

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 bottle and on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Use within 6 months after first opening.

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.

6. Contents of the pack and other information

What ABILIFY oral solution contains

The active substance is aripiprazole. Each ml contains 1 mg of aripiprazole.

The other ingredients are disodium edetate, fructose, glycerin, lactic acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sucrose, purified water, and natural orange cream with other natural flavours.

What ABILIFY oral solution looks like and contents of the pack

ABILIFY 1 mg/ml oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 ml, 150 ml or 480 ml per bottle.

Each carton contains one bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropper.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

Manufacturer

Bristol-Myers Squibb S.r.l.

Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone - Italy

Elaiapharm

2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis, 06560 Valbonne - France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

България

Luxembourg/Luxemburg

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Česká republika

Magyarország

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Danmark

Malta

Otsuka Pharma Scandinavia AB

Otsuka Pharmaceutical Europe Ltd.

Tlf: +46 854 528 660

Tel: + 44 (0)203 747 5000

Deutschland

Nederland

Otsuka Pharma GmbH

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Eesti

Norge

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tlf: +46 854 528 660

Ελλάδα

Österreich

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

España

Polska

Otsuka Pharmaceutical, S.A.

Otsuka Pharmaceutical Europe Ltd.

Tel: +34 93 550 01 00

Tel: + 44 (0)203 747 5000

France

Portugal

Otsuka Pharmaceutical France SAS

Lundbeck Portugal Lda

Tél: +33(0)1 47 08 00 00

Tel: +351 21 00 45 900

Hrvatska

România

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: +44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ireland

Slovenija

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ísland

Slovenská republika

Vistor hf.

Otsuka Pharmaceutical Europe Ltd.

Sími: +354 535 7000

Tel: + 44 (0)203 747 5000

Italia

Suomi/Finland

Otsuka Pharmaceutical Italy S.r.l.

Otsuka Pharma Scandinavia AB

Tel: +39 02 00 63 27 10

Puh/Tel: +46 854 528 660

Κύπρος

Sverige

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tel: +46 854 528 660

Latvija

United Kingdom

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceuticals (UK) Ltd.

Tel: + 44 (0)203 747 5000

Tel: +44 (0)203 747 5300

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

ABILIFY 7.5 mg/ml solution for injection aripiprazole

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

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.

What is in this leaflet

1.What ABILIFY solution for injection is and what it is used for

2.What you need to know before you are given ABILIFY solution for injection

3.How ABILIFY solution for injection is given

4.Possible side effects

5.How to store ABILIFY solution for injection

6.Contents of the pack and other information

1.What ABILIFY solution for injection is and what it is used for

ABILIFY solution for injection contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. ABILIFY solution for injection is used to treat quickly 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 or tense.

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

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

2.What you need to know before you are given ABILIFY solution for injection

Do not use ABILIFY solution for injection

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

Warnings and precautions

Talk to your doctor before you are given ABILIFY solution for injection.

Before treatment with ABILIFY solution for injectio, 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 of 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 heart beat.

Children and adolescents

ABILIFY solution for injection is not for use in children and adolescents under 18 years. Ask your doctor or pharmacist for advice before taking ABILIFY solution for injection.

Other medicines and ABILIFY solution for injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Blood pressure-lowering medicines: ABILIFY solution for injection 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.

Using ABILIFY solution for injection with some medicines may need to change your dose of ABILIFY solution for injection. It is especially important to mention the following to your doctor:

Medicines to correct heart rhythm

Antidepressants or herbal remedy used to treat depression and anxiety

Antifungal agents

Certain medicines to treat HIV infection

Anticonvulsants used to treat epilepsy

Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY solution for injection, you should see your doctor.

A combination of ABILIFY solution for injection with medicines taken for anxiety might make you feel drowsy or dizzy. Only take other medicines while you are on ABILIFY solution for injection if your doctor tells you that you can.

ABILIFY solution for injection with food, drink and alcohol

ABILIFY solution for injection can be administered regardless of meals.

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 taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used ABILIFY solution

for injection 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.

Be sure to tell your doctor immediately if you are breast-feeding.

If you are taking ABILIFY solution for injection, you should not breast-feed.

Driving and using machines

Do not drive or use any tools or machines if you feel drowsy after receiving ABILIFY solution for injection.

3.How ABILIFY solution for injection is given

Your doctor will decide how much ABILIFY solution for injection 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 solution for injection is ready to use. The correct amount of solution will be injected into your muscle by your doctor or nurse.

If you are given more ABILIFY solution for injection 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 ABILIFY solution for injection.

If you miss an injection of ABILIFY solution for injection

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.

If you stop receiving ABILIFY solution for injection

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.

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 10 people):

diabetes mellitus,

difficulty sleeping,

feeling anxious,

feeling restless and unable to keep still, difficulty sitting still,

uncontrollable twitching, jerking or writhing movements, restless legs,

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 affect up to 1 in 100 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),

double vision,

fast heart beat,

increased diastolic blood pressure,

a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,

hiccups,

dry mouth.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them 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,

excessive gambling,

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,

sudden unexplained death,

life-threatening irregular heart beat,

heart attack,

slower heart beat,

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,

abdominal discomfort,

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,

sensitivity to light,

baldness,

excessive sweating,

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,

difficulty controlling core body temperature or overheating,

chest pain,

swelling of hands, ankles or feet,

in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.

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.

Additional side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store ABILIFY solution for injection

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.

6. Contents of the pack and other information

What ABILIFY solution for injection contains

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.

What ABILIFY solution for injection looks like and contents of the pack

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 "flip-off" aluminium seal.

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 Europe Ltd.

Gallions, Wexham Springs, Framewood Road,

Wexham, SL3 6PJ - United Kingdom

Manufacturer

Bristol-Myers Squibb S.r.l.

Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone - Italy

Zambon S.p.A.

Via della Chimica, 9

I-36100 Vicenza(VI) - Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

България

Luxembourg/Luxemburg

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Česká republika

Magyarország

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Danmark

Malta

Otsuka Pharma Scandinavia AB

Otsuka Pharmaceutical Europe Ltd.

Tlf: +46 854 528 660

Tel: + 44 (0)203 747 5000

Deutschland

Nederland

Otsuka Pharma GmbH

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Eesti

Norge

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tlf: +46 854 528 660

Ελλάδα

Österreich

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

España

Polska

Otsuka Pharmaceutical, S.A.

Otsuka Pharmaceutical Europe Ltd.

Tel: +34 93 550 01 00

Tel: + 44 (0)203 747 5000

France

Portugal

Otsuka Pharmaceutical France SAS

Lundbeck Portugal Lda

Tél: +33(0)1 47 08 00 00

Tel: +351 21 00 45 900

Hrvatska

România

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: +44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ireland

Slovenija

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceutical Europe Ltd.

Tel: + 44 (0)203 747 5000

Tel: + 44 (0)203 747 5000

Ísland

Slovenská republika

Vistor hf.

Otsuka Pharmaceutical Europe Ltd.

Sími: +354 535 7000

Tel: + 44 (0)203 747 5000

Italia

Suomi/Finland

Otsuka Pharmaceutical Italy S.r.l.

Otsuka Pharma Scandinavia AB

Tel: +39 02 00 63 27 10

Puh/Tel: +46 854 528 660

Κύπρος

Sverige

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharma Scandinavia AB

Tel: + 44 (0)203 747 5000

Tel: +46 854 528 660

Latvija

United Kingdom

Otsuka Pharmaceutical Europe Ltd.

Otsuka Pharmaceuticals (UK) Ltd.

Tel: + 44 (0)203 747 5000

Tel: +44 (0)203 747 5300

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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