ABILIFY MAINTENA 300MG VIAL

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Product info

Abilify Maintena is a long acting medication that a doctor may prescrible to help relieve the symptoms of schizophrenia. Abilify Maintena helps to correct a chemical imbalance in the brain which may cause schizophrenia. Abilify Maintena belongs to a group of medicines called antipsychotic agents. Abilify Maintena should only be given by a healthcare professional.

 

Abilify Maintena®

Powder and solvent for prolonged release suspension for intramuscular injection

Aripiprazole (ari-pip-rah-zol)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions

about Abilify Maintena. It does not contain

all the available information. It does not take

the place of talking to your doctor or

pharmacist.

All medicines have risks and benefits. Your

doctor has weighed the potential risks of you

receiving Abilify Maintena against the

expected benefits.

If you have any concerns about receiving

this medicine ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

What Abilify Maintena is used for

Abilify Maintena is a long-acting medicine

that is used to treat schizophrenia.

Schizophrenia is characterised by symptoms

such as:

• hallucinations; hearing, seeing or

sensing things that are not there,

• suspiciousness, mistaken beliefs and

• incoherent speech and behaviour and

emotional flatness.

People with this condition may also feel

depressed, guilty, anxious, or tense.

Abilify Maintena belongs to a group of

medicines called antipsychotic agents.

Abilify Maintena helps to correct a chemical

imbalance in the brain which may cause

schizophrenia.

You and your doctor have decided on Abilify

Maintena to help relieve the symptoms of

your condition. Although Abilify Maintena

cannot cure schizophrenia, it can help to

keep the symptoms under control and reduce

the risk of relapse as you continue treatment.

Ask your doctor if you have any questions

about why this medicine has been

prescribed for you.

Abilify Maintena is available only with a

doctor's prescription.

There is no evidence that Abilify Maintena is

addictive.

Abilify Maintena should not be given to

children and adolescents under 18 years of

age as safety and efficacy have not been

established in this age group.

Abilify Maintena should not be taken unless

oral Abilify has previously been tolerated.

Before you receive Abilify Maintena

Abilify Maintena should only be given by

a healthcare professional.

When you must not receive it

Do not receive Abilify Maintena if you

have an allergy to:

• aripiprazole; or

• any of the ingredients listed at the end of

this leaflet

Some of the symptoms of an allergic reaction

may include: shortness of breath; wheezing

or difficulty breathing; swelling of the face,

lips, tongue or other parts of the body; and/or

rash, itching or hives on the skin.

Abilify Maintena should not be used after

the expiry date (EXP) printed on the pack.

The expiry date refers to the last day of

the month.

It may have no effect at all or, an entirely

unexpected effect if you receive it after the

expiry date.

Abilify Maintena should not be used if the

packaging is torn or shows signs of having

been tampered with.

If you are not sure whether Abilify

Maintena would be beneficial for you, talk

to your doctor or pharmacist.

Before you start to receive it

Tell your doctor if you have allergies to

any other medicines, foods, preservatives

or dyes.

Tell your doctor if you are pregnant, think

you are pregnant or plan to become

pregnant.

Abilify Maintena should not be received

during pregnancy unless the benefit

outweighs the risk. If you need to receive

Abilify Maintena during your pregnancy,

your doctor will discuss with you the risks

and benefits of taking it.

The following symptoms may occur in

newborn babies of mothers that receive

Abilify Maintena in the last three months of

their pregnancy: shaking, muscle stiffness

and/or weakness, sleepiness, agitation,

breathing problems, and difficulty in feeding.

If your baby develops any of these symptoms

you need to contact your doctor immediately.

Tell your doctor if you are breast-feeding

or planning to breast-feed.

If you are receiving Abilify Maintena, 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 Abilify

Maintena.

Tell your doctor if you have or have had

any medical conditions, especially the

following conditions:

• Dementia (loss of memory or other

mental abilities) and you are elderly.

• Neuroleptic malignant syndrome -

reaction to some medicines with a

sudden increase in body temperature,

sweating, fast heartbeat, muscle stiffness

and fluctuating blood pressure, which

may lead to coma.

• Tardive dyskinesia - a reaction to some

medicines with abnormal movements of

the tongue, or other uncontrolled

movements of the mouth, tongue, cheeks

or jaw which may progress to the arms

and legs.

• low blood pressure.

• high blood pressure or have rapid

heartbeat and a drop in blood pressure

when getting up.

• problems with your heart or blood

vessels, including stroke, "mini" stroke,

or family history of heart or blood vessel

problems.

• epilepsy, seizures or fits.

• problems with your oesophagus (food

pipe/gullet) such as difficulty in

swallowing.

• high blood sugar or diabetes mellitus or

a family history of diabetes or high

blood sugar.

• blood clots, or you have any of the

following risk factors for developing

blood clots: family history of blood

clots, 65 years of age or older, smoking,

obese, recent major surgery such as hip

or knee replacement, immobility due to

air travel or other reason, or you take

oral contraceptives.

• past experience with excessive gambling

or other compulsive behaviours.

• have or had low white blood cell count.

• other medical conditions including

conditions that may affect you receiving

an injection in your arm or buttocks.

Tell your doctor if you drink alcohol.

You should avoid alcohol as it could magnify

the side effects of this medicine.

If you have not told your doctor about any

of the above, tell them before you receive

Abilify Maintena.

Ask your doctor or pharmacist for advice

before taking any medicine.

Taking other medicines

Tell your doctor or pharmacist if you are

taking any other medicines, including any

that you buy without a prescription from a

pharmacy, supermarket or health food

shop.

Some medicines and Abilify Maintena may

interfere with each other. These include:

• medicines and herbal remedies used to

treat depression and anxiety.

• certain medicines used to treat nicotine

dependence.

• anticonvulsants used to treat epilepsy.

• medicines used to treat high blood

pressure.

• medicines used to treat heart rhythm

disturbances.

• medicines used to treat bacterial, fungal

or viral infections.

These medicines may be affected by

Abilify Maintena, or may affect how well

it works. You may need to use different

amounts of medicines, or take different

medicines.

Your doctor and pharmacist have more

information on medicines to be careful

with or avoid while receiving this

medicine.

If you have not told your doctor or

pharmacist about any of these things, tell

them before you receive Abilify Maintena.

How to use Abilify Maintena

Abilify Maintena is a long-acting medicine

that a healthcare professional will give to you

by injection.

The medicine is slowly released from the

injection site, which means you do not have

to take it every day, but only once a month.

Abilify Maintena can be received regardless

of meals.

How it is given

Abilify Maintena is a kit that includes a

powder which your healthcare

professional will make into a suspension

that will then be injected into the muscle

in your buttock or shoulder. You may feel

a little pain during the injection, which

may become less over time.

The usual dose is 400 mg every 4 weeks.

Your healthcare professional may

administer a lower dose if required. Your

doctor will decide on the dose of Abilify

Maintena that is right for you.

After your first dose you must take 10 mg

to 20 mg of oral aripiprazole (or

prescribed dose of other oral

antipsychotic) for 14 days in a row.

It is important you take your oral

antipsychotic exactly as directed by your

doctor, because the first injection will not

start to work straight away.

How many injections you will need

Abilify Maintena should be administered

to you once monthly to help reduce your

symptoms and the risk of relapse. Do not

stop your treatment just because you feel

better. It is important that you carry on

receiving Abilify Maintena for as long as

your doctor has told you to.

It may take several days to some weeks,

sometimes longer, before you feel any

improvement.

Your doctor will check your progress at

regular intervals.

What if you miss a dose

If you miss an injection, you should

contact your doctor to arrange your next

injection as soon as you can. You should

be given an injection every 4 weeks. Ask

your doctor if you have any further

questions on the use of this medicine.

If you receive too much (overdose)

This medicine will be given to you under

medical supervision. Therefore, it is

unlikely that you will be given too much. If

you see more than one doctor, be sure to

tell them that you are receiving Abilify

Maintena.

If you have received too much aripiprazole

you may experience:

• rapid beating of the heart,

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.

If you think that you or anyone else may

have received too much Abilify Maintena,

immediately telephone your doctor or

Poisons Information Centre (Telephone 13

11 26) for advice, or go to the Accident

and Emergency department at your

nearest hospital. Do this even if there are

no signs of discomfort or poisoning. Keep

the telephone number handy.

You may need urgent medical attention.

While you are receiving Abilify

Maintena

Things you must do

Tell your doctor immediately if you

become pregnant while taking Abilify

Maintena.

If you are about to be started on any new

medicine, remind your doctor and

pharmacist that you are receiving Abilify

Maintena.

Tell all doctors, dentists and pharmacists

who are treating you that you are

receiving Abilify Maintena.

If you are going to have surgery that

requires a general anaesthetic, tell your

doctor or dentist that you are receiving

Abilify Maintena.

It may affect other medicines used during

surgery.

Keep all of your doctor's appointments so

that your progress can be checked.

Your doctor will check your progress and

may want to take some blood tests from

time-to-time. This helps reduce unwanted

effects. Abilify Maintena may be associated

with changes in:

• liver blood values,

• muscle enzyme blood levels,

• sodium blood levels,

• blood sugar levels,

• lipid blood levels, or

• white blood cell levels.

Your doctor may check your body weight

before starting Abilify Maintena and

continue to monitor it for as long as you are

being treated.

Patients and care givers should pay

attention to any of the warning signs of

suicide-related behaviour such as thoughts

or talk about death or suicide; or thoughts

or talk about self-harm or doing harm to

others. Tell your doctor immediately if

you have any of these signs.

Things to be careful of

Driving or operating machinery should be

avoided until you know how Abilify

Maintena affects you. If Abilify Maintena

makes you feel light-headed, dizzy or

faint, be careful when getting up from a

sitting or lying position.

Getting up slowly may help.

Avoid alcohol while you are taking Abilify

Maintena.

Abilify Maintena can increase the effects of

alcohol.

Abilify Maintena may affect the way your

body reacts to temperature changes. It

may prevent sweating, even during

heatwaves. You may feel dizzy or faint if

you are too hot. To stay cool in hot

weather, try to do the following:

• wear light clothing.

• spend time in air-conditioned

environments (or keep windows open

and use electric fans).

• drink plenty of water.

• take cool baths or showers and avoid hot

baths and saunas.

• try to restrict exercise or heavy work to

cool parts of the day.

Side effects

Tell your doctor or pharmacist as soon as

possible if you do not feel well while you

are receiving Abilify Maintena.

All medicines can have side effects.

Sometimes they are serious, most of the time

they are not. You may need medical

treatment if you get some of the side effects.

Do not be alarmed by the following lists of

side effects. You may not experience any

of them.

Ask your doctor or pharmacist to answer

any questions you may have.

Tell your doctor if you notice any of the

following side effects and they worry you:

• headache

• fatigue, drowsiness or sleepiness

• speech disorder

• agitation or restlessness

• inability to sit or stand still; restless

movement of the arms and legs such as

tapping, marching in places, rocking,

crossing and uncrossing legs

• pain or swelling at the site of injection

• weight loss or gain

• decreased appetite

• shaking

• muscle ache or stiffness

• dry mouth

• difficulty in passing urine or

incontinence

• inability for a man to have an erection or

a persistent and painful erection

• depression

• blurred or double vision

• abnormal hair loss

• constipation or diarrhoea

• high blood pressure

• abnormal liver blood values

• low sodium levels in the blood

• abnormally low or high body

temperature or excessive sweating

• excessive compulsive urges such as

gambling, sexual urges, spending, binge

or compulsive eating

Tell your doctor as soon as possible if you

notice any of the side effects listed below.

• feeling dizzy or fainting, especially

when getting up from a lying or sitting

position.

• frequent infections such as fever, severe

chills, sore throat or mouth ulcers.

• difficulty swallowing or accidental

inhalation of food or liquids with risk of

pneumonia.

• bruise easily.

Tell your doctor immediately, or go to

Accident and Emergency at your nearest

hospital, if you notice any of the side

effects listed below.

• serious allergic reaction (symptoms of

an allergic reaction may include swelling

of the face, lips, mouth or throat which

may cause difficulty in swallowing or

breathing, or rash, itching or hives).

• abnormal movements of the tongue, or

other uncontrolled movements of the

tongue, mouth, cheeks, or jaw which

may progress to the arms and legs.

• high fever, stiff muscles, confusion,

sweating, and changes in pulse, heart

rate, and blood pressure, which may lead

to coma. This reaction is called

neuroleptic malignant syndrome.

• convulsions or seizures.

• chest pain.

• rapid pulse

• swelling, pain or redness in the leg, chest

pain or difficulty in breathing.

• a combination of any of the following:

excessive sleepiness, dizziness,

confusion, disorientation, difficulty

talking, difficulty walking, muscle

stiffness or shaking, fever, weakness,

irritability, aggression, anxiety, increase

in blood pressure, or seizures that lead to

loss of consciousness.

• high or unstable blood sugar levels

(feeling very thirsty and/or hungry,

needing to urinate more often than usual,

feeling weak or tired, feeling sick to

your stomach, feeling confused, have

fruity smelling breath) ), or the onset or

worsening of diabetes.

• thoughts of suicide, attempts at suicide

or suicide. See also section "Things you

must do".

• yellowing of the skin and/or eyes, also

called jaundice with or without nausea,

vomiting, loss of appetite, feeling

generally unwell, fever, itching and dark

coloured urine.

• inflammation of the pancreas or liver,

severe upper stomach pain often with

nausea and vomiting.

• muscle pain, muscle weakness or muscle

cramps, high blood levels of the enzyme

creatine phosphokinase.

• spasm of the muscles around the voice

box.

Elderly patients with dementia may suffer

serious side effects such as "mini" stroke,

stroke, pneumonia, or heart problems. These

serious side effects can be life threatening.

Other side effects not listed above may

also occur in some people. Tell your

doctor or pharmacist if you notice

anything else that is making you unwell.

Storage of Abilify Maintena

Storage

Abilify Maintena will be stored by your

healthcare professional until it is time for

them to administer the injection to you.

Abilify Maintena should be stored in its

package in a dry place where the

temperature stays below 30°C. Do not

freeze. Your healthcare professional will

not use Abilify Maintena beyond the

expiry date printed on the carton.

Abilify Maintena description

What Abilify Maintena looks like

Abilify Maintena is available in one-month

therapeutic kits. A single kit contains either

400 mg or 300 mg of aripiprazole (as

monohydrate). The therapeutic kit contains

all that is required for your healthcare

professional to reconstitute and administer

the required dose of medicine to you. After

reconstitution, each mL of suspension

contains 200 mg of aripiprazole.

The therapeutic kit contains the following

items:

• one vial containing a white to off-white

powder containing aripiprazole (as

monohydrate);

• one vial containing water for injections

for mixing with the powder;

• one sterile syringe with a needle;

• one sterile syringe without a needle;

• three safety needles; and

• one vial adapter.

Ingredients

Active ingredients

• Abilify Maintena 400 mg therapeutic kit

contains 400 mg aripiprazole (as

monohydrate) per vial.

• Abilify Maintena 300 mg therapeutic kit

contains 300 mg aripiprazole (as

monohydrate) per vial.

Inactive ingredients

Abilify Maintena also contains:

• mannitol

• carmellose sodium

• sodium hydroxide

• monobasic monohydrate sodium

phosphate

Abilify Maintena does not contain lactose,

gluten, sucrose, tartrazine or any other azo

dyes.

Sponsor

Lundbeck Australia Pty Limited

Ground Floor, 1 Innovation Road

North Ryde NSW 2113

Ph: 02 8669 1000

Abilify Maintena is co-marketed by

Lundbeck Australia and Otsuka Australia

Pharmaceutical:

Otsuka Australia Pharmaceutical Pty.

Limited

'Tower A The Zenith'

Level 20, 821 Pacific Highway

Chatswood NSW 2067

This leaflet was prepared in October 2016.

Australian Registration Numbers:

Abilify Maintena 400 mg: AUST R 211150

Abilify Maintena 300 mg: AUST R 211122

Abilify Maintena is a registered trade

mark of Otsuka Pharmaceutical Co., Ltd.

Copyright© 2016 Otsuka Pharmaceutical

Co., Ltd.

Delivery info

Please note that Public Holidays will add on extra delivery time for orders

Superpharmacy Orders will be packaged in plain, impervious packaging that is unmarked for security and privacy reasons. Orders will be dispatched as soon as possible once payment is received. For Orders containing prescription items please see the prescription processing procedure. Orders for both prescription and non-prescription items will most likely be delivered separately, unless otherwise directed, where we do not hold the prescription paperwork at the time of placing the order.

Australia Wide shipment details

On all Australian orders less than $75 in value (and under 3kgs) we have a flat rate shipping fee of $8.95.

All Australian orders $75 or more in value (and under 3kgs) will qualify for FREE DELIVERY.

Any orders over 3kgs will have our Online Team be in contact with further information regarding shipping.

All orders of Prescription items will receive FREE DELIVERY regardless of order value.

All orders of compounding items will qualify for FREE DELIVERY.

PRESCRIPTION PROCESSING PROCEDURE

Orders for prescription items can only be processed once we physically receive your prescription paperwork. Prescription product orders will be dispensed and dispatched on the business day the prescription or valid repeat authorisation is received at the SUPERPHARMACY registered premises.Please send your prescription paperwork to the appropriate store

NSW, NT and TAS:  SUPERPHARMACY PO Box 1877 Hornsby Westfield 1635

QLD: Superpharmacy 187 Days Road, Grange QLD 4051

SA: Superpharmacy 41 Hindley Street, Adelaide SA 5000

VIC: Superpharmacy 92 Lygon Street, East Brunswick NSW 3057

WA: Superpharmacy 259 Walcott Street, North Perth WA 6006

Ensure to allow sufficient time for the delivery of your prescription or repeat authorisation paperwork to us and the subsequent order delivery via our specialised delivery network. We recommend considering a total of up to 7 days for metro areas or 10 days in remote areas. If we do not already hold your prescription paperwork, it will be necessary for you to send the prescription paperwork to us before we can dispatch your order. Please also allow appropriate time for the prescription to reach us and for the order to be sent back so as to avoid running out of your ongoing prescription medicine.

We partner with well-known and trusted delivery services to minimise delivery times. These include:

  • Our own personal delivery driver
  • StarTrack
  • Auspost
  • Local delivery couriers

The end goal is to get your order to you as fast and as securely as possible.

Details of the delivery process and conditions are included in the Superpharmacy Terms and Conditions found here

Superpharmacy will dispatch most orders within ONE business day on Monday to Friday assuming all items are in stock. All other orders will be dispatched as quickly as possible thereafter. It may be necessary for some orders to be shipped in more than one box from different distribution sites and therefore you may obtain these parcels at different times. We will notify you via email if there is a delay in the delivery of an item in your Order and what action we have taken. Please contact our Customer Service on 13004MEDICINE during business hours if you would like an alternative product or arrangement. Order processing and delivery times may vary in peak times with special arrangements during peak volume times such as Christmas, Mother's Day and Superpharmacy promotions. Contact our Customer Service on 1300 4MEDICINE during business hours or email customerservice@superpharmacy.com.au for more information.

Postage and handling for international orders

We do not currently deliver outside of Australia 

Returns & exchanges

Returns Policy

The SUPERPHARMACY Returns Policy applies to all purchases of Products using the Site and forms part of the terms and conditions. If you wish to return a Product in accordance with our Returns Policy, then you must:

(a) Check your Goods as soon as they are delivered to you in order to ensure that: (i) they are what you ordered; and (ii) they are not damaged or faulty. If this is not the case you should contact Customer Service by telephone 13004MEDICINE to make arrangements to return that Product. The return of a Product must be authorised by the appointed SUPERPHARMACY

Customer Service officer prior to taking any action to return the Product. We will provide a

Return Authorisation Number which must be quoted when authorised to return a Product.

Damaged or Defective Goods

We will replace or refund (at our discretion) any items delivered to you that are damaged or defective at no charge.

A Product refund will be arranged as follows:

(1) You may return the Product to us at the time we deliver your next Order. Upon confirmation from the driver that the goods have been received in the condition supplied, we will refund your card of purchase with the funds being available within 3-5 business days.

(2) You may return the Product to a “Click & Collect” location as arranged with you, by our Customer Service Officer, for return back to SUPERPHARMACY, or

(3) By using a Free Post Postal Address provided by the Customer Service officer where there is no nearby “Click & Collect” location. The Product returned must include details of the Order and the Return Authorisation Number. Upon receipt of the returned Product we will refund your card of purchase with the funds being available within 3-5 business days.

A Product replacement will be arranged as follows:

(1) We may replace the Product at the time we are able to facilitate the next delivery. Upon confirmation from the driver that the goods have been received in the condition supplied, we will replace the Product.

(2) You may return the Product to a “Click & Collect” location as arranged with you by our Customer Service Officer for replacement by SUPERPHARMACY.

Incorrect Items Ordered

We will issue a full refund for items you ordered incorrectly if you notify us within 7 days of placing the order on the Site, this Product return refund is conditional on all item(s) being returned to SUPERPHARMACY unopened and in the original packaging. Postage costs will not be refunded. Please send the Product by registered mail as no item will be refunded until received by us. If we have sent you the incorrect product from what you ordered please contact our Customer Service on 13004MEDICINE.

When you return a Product please ensure it is packed to avoid damage in transit. We highly recommend you photograph the Product inside the packing prior to sending.

Prescription Returns

Due to NSW Health Regulations, prescription items cannot be returned for refund.

The SUPERPHARMACY Returns Policy applies in addition to any other rights to which you may be entitled under the consumer guarantees provisions of the Australian Consumer Law.