ACIMAX TAB 20MG 30

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Product info

ACIMAX® TABLETS

Multiple Unit Pellet System

Omeprazole magnesium


Consumer Medicine Information


What is in this leaflet



This leaflet answers some of the common questions people ask about ACIMAX. It does not contain all the information that is known about ACIMAX.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ACIMAX against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.


What ACIMAX is used for


Reflux Oesophagitis

ACIMAX is used to treat the symptoms of reflux oesophagitis or reflux disease. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus).
Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.
ACIMAX is also taken to help stop reflux oesophagitis coming back or relapsing.

Peptic Ulcers

ACIMAX is used to treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or
duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach.
These ulcers can be caused by too much acid being made in the stomach.
ACIMAX is also used to help stop gastric or duodenal ulcers coming back.

Peptic Ulcers Associated with

Helicobacter pylori Infection

Most people who have a peptic ulcer also have a bacterium called Helicobacter pylori in their stomach.
When ACIMAX is taken with antibiotics, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.

Peptic Ulcers Associated with Non- steroidal Anti-Inflammatory Drugs (NSAIDs)

Some peptic ulcers are caused by taking medicines called non-steroidal anti-inflammatory drugs (NSAIDs), a type of medicine used to treat pain or inflammation.
ACIMAX is also used to heal and prevent ulcers associated with NSAIDs.

Zollinger-Ellison Syndrome

ACIMAX is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.

How ACIMAX Works

ACIMAX is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may prescribe this medicine for another reason.
There is no evidence that ACIMAX
is addictive.
This medicine is only available on prescription.


Before you take

ACIMAX


When you must not take it

Do not take ACIMAX if you have an allergy to:

• omeprazole or any ingredient listed at the end of this leaflet
• any medicine containing a proton-pump inhibitor
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.


ACIMAX® TABLETS 1

Do not take ACIMAX if you are also taking cilostazol.

Please check with your doctor or pharmacist if you are taking cilostazol. This medicine will be affected by ACIMAX.

Do not take ACIMAX after the use by (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 for disposal.

If you are not sure whether you should take this medicine, talk to your doctor.

Before you start to take it

You must tell your doctor if you have:

• allergies to any other medicines, foods, dyes or preservatives
• any problems with your liver
• any other medical condition

Do not take ACIMAX if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.

It is not known if it is safe for you to take ACIMAX while you are pregnant. It may affect your baby.
It is not known if your baby can take in ACIMAX from breast milk if you are breastfeeding.

Taking other medicines

Do not take ACIMAX if you are taking the following medicine:

• cilostazol - a medicine used to treat intermittent claudication
• warfarin and clopidogrel - medicines used to prevent blood clots
• digoxin - a medicine used to treat heart conditions
• diazepam - a medicine used to treat anxiety and some other conditions
• St John's wort - a herbal remedy used to treat mood disorders
• ketoconazole, itraconazole, voriconazole - medicines used to treat fungal infection
• clarithromycin or rifampicin - medicines used to treat infections
• atazanavir and nelfinavir - medicines used to treat viral infections such as HIV
• tacrolimus - a medicine used to assist in organ transplants
• methotrexate - a medicine used to treat arthritis and some types of cancer
• erlotinib or related medicines used to treat cancer
These medicines may be affected by ACIMAX or may affect how well it works. You may need different amounts of your medicine or you
may need to take different medicines. Your doctor can tell you what to do if you are taking any other medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

If you have not told your doctor about any of these things, tell them before you take ACIMAX.

How to take it

Take one ACIMAX tablet each day, unless your doctor has told you otherwise.

Adults:

The dose of ACIMAX is usually 20 mg a day. The dose may vary from
10 mg to 40 mg a day depending on what condition you are being treated for and how severe it is.

Children (1 year or older):

The dose of ACIMAX is 10 mg a day for children 10 to 20 kg. This dose may be increased to 20 mg if
required. For children more than 20 kg the dose is 20 mg a day. This dose may be increased to 40 mg if required.

Swallow ACIMAX whole with a glass of water. Do not crush or chew the tablets.

If the tablets are chewed or crushed, they will not work properly.

If you have difficulty swallowing the tablets:

1. Place the tablet in half a glass of non-carbonated water or fruit juice. Mineral water, carbonated fruit juices, or other liquids are not suitable.
2. Gently mix the tablet and liquid by stirring, taking care not to crush the tablet.
3. Stir until the tablet disperses into little pellets.
4. Drink the liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets.
5. Rinse the glass with half a glass of water and drink.

Tell your doctor if you are taking

any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with
ACIMAX tablets. These include:
• phenytoin - a medicine used to treat epilepsy or fits

How to take ACIMAX


Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

When to take it

Take ACIMAX at about the same time each day.

Keeping a regular time for taking ACIMAX will help to remind you to take it.
ACIMAX can be taken with food or on an empty stomach.


ACIMAX® TABLETS 2

How long to take it

Keep taking ACIMAX for as long as your doctor recommends.

In most patients, ACIMAX relieves symptoms rapidly and healing is usually complete within 4 weeks. Continue taking ACIMAX for as long as your doctor tells you to.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much

(Overdose)

Telephone your doctor or the

Poisons Information Centre (13 11

26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much ACIMAX even if there are no signs of discomfort or poisoning.


While you are taking

ACIMAX


Things you must do

Take ACIMAX exactly as your doctor has prescribed.

If you are about to start any new medicine, remind your doctor and pharmacist that you are taking ACIMAX.

Tell all doctors, dentists and pharmacists who are treating you that you are taking ACIMAX.

Tell your doctor if you become pregnant while you are taking ACIMAX.

Tell your doctor if your symptoms return.

Although ACIMAX can heal ulcers successfully, it may not prevent them recurring at a later date.

If you need to have any medical tests while you are taking ACIMAX, tell your doctor.

It may affect the results of some tests.

Things you must not do

Do not take ACIMAX to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or change the dosage without checking with your doctor.

If you stop taking it suddenly or change the dose, your condition may worsen or you may have unwanted side effects.


Side effects


Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ACIMAX.

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.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• constipation
• nausea or vomiting
• diarrhoea
• headache
• skin rash, itchy skin
• wind
• stomach pain
• dizziness
• dry or sore mouth
These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

• muscle pain or weakness, joint pain
• "pins and needles"
• changes in sleep patterns
• mood changes, confusion or depression
• blurred vision
• increase in breast size (males)
• fever
• increased bruising
• increased sweating
• hair loss
• tremor
These are serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing
• shortness of breath or difficulty in breathing
• skin reaction which may include rash, itching, redness, blistering or peeling of the skin
• ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
• blood in the urine
• swelling of hands, feet or ankles
• signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.


ACIMAX® TABLETS 3

Occasionally, ACIMAX may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some people.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
For this reason, contact your doctor immediately if you notice any of the following:
• pain or indigestion that occurs during treatment with ACIMAX
• you begin to vomit blood or food
• you pass black (blood-stained)
motions


After using it


Storage

Keep your ACIMAX in the blister pack until it is time to take them.

If you take ACIMAX out of the blister pack they will not keep well.

Keep it in a cool, dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a window

sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking ACIMAX or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you have left over.


Product description


What ACIMAX looks like

ACIMAX 20 mg tablets are pink, oblong shaped, marked with 20mg on one side and a logo on the other side.

Ingredients

Each ACIMAX tablet contains omeprazole magnesium as the active ingredient equivalent to omeprazole
20 mg.
Plus the following inactive ingredients:
• Glyceryl monostearate (E 471)
• Hydroxypropylcellulose
• Hypromellose
• Magnesium stearate (E 572)
• Methacrylic acid copolymer
• Microcrystalline cellulose (E 460)
• Paraffin synthetic
• Macrogol 6000
• Polysorbate 80 (E 433)
• Crospovidone
• Sodium stearylfumarate
• Purified talc (E 553(b))
• Titanium dioxide (E 171)
• Triethyl citrate
• Sodium hydroxide
• Sugar spheres (maize starch and sucrose)
• iron oxide red CI77491 (E 172)
ACIMAX are available in blister packs of 30 tablets.
ACIMAX tablets do not contain gluten.


Sponsor



AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113
Australian Registration Number:
ACIMAX 20 mg - 67306
ACIMAX 10 mg and 40 mg tablets are not available in Australia.
This leaflet was prepared in
December 2014.
ACIMAX® is a registered trademark of the AstraZeneca group of companies.
Doc ID-001946210 V4.0

ACIMAX® TABLETS 4

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

VICTORIA

Melbourne Metro areas 1 day

VIC country 2-3 days

QUEENSLAND

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

TASMANIA

Hobart/ Launceston Metro Areas 1-2 days

Regional Tasmania 3-4 days

SOUTH AUSTRALIA

Adelaide Metro Areas 1-2 days

SA country 3-4 days

NORTHERN TERRITORY

Darwin Metro Areas 3-4 days 

Alice Springs 4-5 days 

NT country 8-12 days

WESTERN AUSTRALIA

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

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.