A valid prescription must be provided before we can send this product out via mail or courier. This medicine requires an Authority prescription for it to be subsidised under the PBS. Approval can be obtained by the prescriber simply by entering a special streamlined authorisation code to indicate that you meet the eligibility requirements, alternatively approval is obtained by telephone or by sending in an authority prescription for PBS authorisation. If you do not meet the authority prescription eligibility requirements, your doctor can only prescribe the medicine for you on a private prescription. This means that you will pay the full price for the medicine with no PBS subsidy. If you are unsure if your script meets the requirements please send an email and attach a picture of the script to firstname.lastname@example.org.
- Product info
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Aclasta.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. You can also download the most up-to- date leaflet from www.novartis.com.au.
Those updates may contain important information about the medicine and
its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you having Aclasta against the benefits they expect it will have for you.
If you have any concerns about having this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Aclasta is used for
The active ingredient in Aclasta is zoledronic acid, which belongs to a group of medicines called bisphosphonates.
Aclasta is used to treat osteoporosis in postmenopausal women and in men, to prevent additional fractures in men or women who have recently had a hip fracture, or to treat or prevent osteoporosis in men and women caused by treatment with
steroid medicines such as prednisone. Aclasta is also used to treat Paget's disease of bone.
Osteoporosis is a disease which causes bones to become less dense, gradually making them weaker, more brittle and likely to break. This is common in women after menopause, when a woman's ovaries stop producing the female hormone, oestrogen, which keeps bones
healthy. It also occurs in men and women with increasing age. Broken bones may result from injury or simple falls. Breaks may occur during normal everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Fractures in people
with osteoporosis usually occur at the hip, spine or wrist. These can lead
not only to pain, but also to considerable deformity and disability, such as stooped posture from curvature of the spine, and loss of mobility.
Paget's disease is a chronic disorder which may affect various bones of the skeleton. Bone is a living tissue and, just like other parts of the body, it is constantly being renewed. This process is called bone remodelling. In Paget's disease, the bone material breaks down more quickly than usual, and new bone material grows more quickly than usual and in a
disordered way. The new bone that is formed may be thicker but weaker
than normal, which can cause pain
and may lead to fractures (broken bones).
How does it work
Aclasta works by slowing down bone resorption, which allows the bone- forming cells time to rebuild normal bone. This allows bone remodelling
to go back to normal and protects the bones from being weakened.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Aclasta is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend the use of this medicine for children or adolescents.
Before you have
When you must not have it
You must not have Aclasta if you have an allergy to:
• zoledronic acid (the active ingredient in Aclasta) or any of the other ingredients listed at the end of this leaflet
• any other bisphosphonate medicine such as alendronate (e.g. Fosamax) or risedronate (e.g. Actonel).
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;
rash, itching or hives on the skin.
If you are not sure whether you are allergic to other bisphosphonate medicines, talk to your doctor.
Other bisphosphonate medicines have been shown to cause breathing difficulties in people with asthma who are allergic to aspirin.
Do not have Aclasta if you have
low levels of calcium in your blood.
Your doctor may do a blood test to check your calcium levels before you have Aclasta.
Do not have Aclasta if you are pregnant.
There is no information on use of this medicine in pregnancy.
Do not breast-feed while you are having treatment with Aclasta.
It is not known if the active ingredient, zoledronic acid, passes into the breast milk and could affect your baby.
Do not have Aclasta after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before you have it
Tell your doctor if you have been or are being treated with:
• Zometa® which contains the same active ingredient as in Aclasta
• another bisphosphonate medicine prior to Aclasta
• diuretic therapy (commonly called 'fluid tablets')
Tell your doctor if:
• you have a kidney problem. This medicine is not suitable for some people with a kidney problem.
• you have a calcium deficiency or a vitamin D deficiency
• you are unable to take daily calcium or vitamin D supplements
• you have had some or all of your parathyroid or thyroid glands in your neck surgically removed
• you have had sections of your intestine removed
• you have or have had pain, swelling or numbness of the jaw or loosening of a tooth
• you are under dental treatment or will undergo dental surgery. Your doctor will check your oral health before you start treatment with Aclasta. Discuss with him or her any planned dental surgery such
as a tooth extraction. Tell your dentist that you are being treated with Aclasta.
• you have or have had uveitis or iritis (inflammatory conditions of the eye).
Taking other medicines
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Aclasta can interfere with each other. These include:
• medicines that may affect your kidneys such as fluid tablets
• aminoglycoside medicines used to treat severe infections.
You may need to take different amounts of these medicines or you may need to take different medicines. Your doctor or pharmacist has more information.
How Aclasta is given
Follow all directions given to you by your doctor, nurse and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor, nurse or pharmacist for help before treatment starts.
Make sure you drink enough fluids before and after the treatment with Aclasta as directed by your doctor.
Two glasses of fluid (such as water) before and after the infusion are usually enough. This will help to prevent dehydration.
You may eat normally on the day you are treated with Aclasta.
How it will be given
Aclasta will be given to you by infusion into a vein by your doctor or nurse once a year. The infusion will take at least 15 minutes.
How much is given
A 100mL infusion will last at least
How long treatment will last
• For osteoporosis, each dose of Aclasta lasts one year. Your doctor will check your condition and may prescribe further annual doses.
• For Paget's disease, each dose of Aclasta may work for longer than one year. Your doctor will let you know if you need to be treated again.
If you have too much
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that
an overdose has happened. Do this even if there are no signs of discomfort or poisoning.
Tell your doctor if you have any of the following symptoms:
• muscle spasms
• numbness or tingling sensation, especially around the mouth
• shortness of breath.
These symptoms may mean the level of calcium in your blood has fallen too far.
While you are being given Aclasta
Things you must do
If you get a headache, fever or other flu-like symptoms in the first three days after you are given Aclasta, take paracetamol if your doctor has told you to.
Some people get short-lasting flu-like symptoms after having Aclasta. Paracetamol can provide some relief.
Take calcium and vitamin D supplements if your doctor has told you to.
• Most people with osteoporosis do not get enough calcium and vitamin D in their diet and supplements are needed to help strengthen your bones.
• If you are being treated with Aclasta for Paget's disease, your doctor should advise corrective treatment for a vitamin D deficiency and that you take calcium and vitamin D supplements for at least the first ten days after you have Aclasta to reduce the risk of low calcium levels in your blood.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may want you to have X-rays, bone density scans or blood tests from time to time to make sure Aclasta is working and to prevent unwanted side effects from happening.
Tell your doctor immediately if
you become pregnant while having treatment with this medicine.
Your doctor can discuss with you the risks of having it while you are pregnant.
Tell your doctor and dentist immediately about any dental
symptoms you get while you are being treated with Aclasta. This may include persistent pain and/or non-healing sores of the mouth or jaw.
A dental condition called jaw osteonecrosis has been reported, primarily in patients being treated with this type of medicine for other illnesses.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with Aclasta.
Tell any other doctor, dentist or pharmacist who treats you that you are having Aclasta.
Things to be careful of
Be careful driving or operating machinery until you know how Aclasta affects you.
Aclasta has no known effect on the ability to drive or use machines but, as a general precaution, if you are travelling home by car after the infusion, arrange to have someone else drive.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are having Aclasta.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list 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 or pharmacist if you notice any of the following and they worry you:
• short-lasting fever, sometimes with flu-like symptoms,
headache, chills, pain or aching in
the muscles or joints. Take
paracetamol if your doctor has told you to. Paracetamol can provide some relief.
• redness, swelling or pain where the needle for the infusion was inserted
• upset stomach, abdominal pain, loss of appetite or other eating disorder, thirst or heartburn
• nausea, vomiting, diarrhoea, with possible dehydration
• dry mouth, toothache or sore throat
• lack of energy, tiredness and lack of interest, weakness, dizziness, low blood pressure
• pain in your back, neck, shoulders, arms, legs or chest muscles, swollen or stiff joints, muscle stiffness, weakness or spasm, tingling or numbness of your hands or feet
• swollen fingers or lower legs due to fluid build-up
• swollen, red, painful or itchy eyes or sensitivity of the eyes to light
• pink eye (conjunctivitis)
• palpitations (feeling of fast, forceful and/or irregular heartbeat), which may be accompanied by dizziness and breathlessness
• excessive sweating
• difficulty sleeping.
Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur.
Tell your doctor and dentist immediately about any dental symptoms you get after you have Aclasta. This may include:
• pain in the mouth, teeth and jaw, swelling of sores inside the mouth, numbness or a feeling of
heaviness in the jaw, or loosening of a tooth. These could be signs
of bone damage in the jaw
Tell your doctor immediately or go to Accident and Emergency at
your nearest hospital if you notice any of the following after you have Aclasta:
• signs of allergy such as rash, itching or hives on the skin; swelling of the face, throat, lips, tongue or other part of the body; shortness of breath, difficulty breathing or swallowing; tightness of the chest
• signs that the level of calcium in your blood may have fallen too far, such as muscle spasms, numbness or tingling sensation, especially around the mouth, shortness of breath
• signs that your kidneys may not be working properly, such as decreased urine output.
The above side effects may be serious. You may need urgent medical attention.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of these (e.g. effects on kidney function and on the level of calcium in the blood) can only be found by laboratory testing.
After having Aclasta
It is unlikely you will have to store
Aclasta at home.
If you do have to store it:
• Store the medicine in a cool dry place at room temperature
• Do not store Aclasta or any other medicine in the bathroom or near a sink
• Do not leave it in the car or on a window sill.
Heat and dampness can destroy some medicines.
Keep the medicine where young children cannot reach it.
A locked cupboard at least one-and- a-half metres above the floor is a good place to store medicines.
Each Aclasta vial is to be used for one injection only and then discarded.
If you no longer need Aclasta or it has passed its expiry date, return any unused medicine to your pharmacist.
What it looks like
Aclasta solution for infusion is supplied in a transparent plastic vial containing 100mL of a clear, colourless solution. Aclasta is supplied as packs containing one vial.
Each vial of Aclasta contains 5mg of zoledronic acid. Each vial also contains:
• sodium citrate
• water for injections.
Aclasta is supplied in Australia by: Novartis Pharmaceuticals Australia
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Web site: www.novartis.com.au
Date of preparation This leaflet was prepared in May 2014.
AUST R 134664
® = Registered trademark
(acl090514c.doc) based on PI (acl090514i.doc)
- Delivery info
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.
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 St, 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.
SUPERPHARMACY uses various means of delivery to minimise delivery wait times, the services of: Star Track Couriers, localised contract Courier services and Australia Post are contracted for all deliveries. All Orders will be delivered to the stated address and will require a recipient photo identification and a signature confirming receipt. Due to security procedures and legal requirements all Order goods will not be left unattended. Where no one is present at the delivery address to sign for the parcel, a card will be left detailing how the Order will be subsequently delivered, details of the delivery process and conditions are included in the SUPERPHARMACY Terms and Conditions found on the Site.
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 1300 4MEDICINE if you would like an alternative product or an alternative 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 or more information.
Australia Wide shipment details
Standard Australia Post shipping within Australia
Please allow between 1-8 working days from the date we ship your order (by location in Australia).
FLAT RATE SHIPPING - Australian Orders
Less than $75.00: $8.95
ORDER VALUE of $75.00 or greater, FREE Delivery (Delivery Waiver)
PBS Concession Card Holders who Order a prescription item will receive FREE Delivery (Delivery Waiver) regardless of Order value
Anticipated Delivery Times by location
Standard Parcel Delivery Times in business days
NEW SOUTH WALES / AUSTRALIAN CAPITAL TERRITORY
Sydney metropolitan 1 day
NSW country 1-2 days
Canberra Metro Areas 1-3 days
Melbourne Metro areas 1 day
VIC country 2-3 days
Brisbane Metro Areas 1-2 days
South East QLD 1-2 days
Central QLD 2-3 days
Far North QLD2-4 days
Far North QLD (Remote Islands) 8-10 days
Hobart/ Launceston Metro Areas 1-2 days
Regional Tasmania 3-4 days
Adelaide Metro Areas 1-2 days
SA country 3-4 days
Darwin Metro Areas 3-4 days
Alice Springs 4-5 days
NT country 8-12 days
Perth metropolitan 1-2 days
WA country 1-4 days
Postage and handling for international orders
We do not currently deliver outside of Australia
- Returns & exchanges
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.
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.