Rabeprazole Sandoz

Rabeprazole (as sodium) enteric coated tablets
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Rabeprazole Sandoz. It does not contain all the information that is known about Rabeprazole Sandoz. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

WHAT RABEPRAZOLE SANDOZ IS USED FOR

This medicine is used to treat:
Gastro-oesophageal reflux disease (GORD)
This can be caused by food and acid from the stomach flowing the wrong way (reflux) back up the food pipe, also known as the oesophagus.
Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.
This medicine is also used to help stop reflux oesophagitis from coming back or relapsing.
Gastric and duodenal 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 of the stomach. These ulcers can be caused by too much acid being made in the stomach.
Chronic Gastritis
Most people who have a peptic ulcer also have a bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (clarithromycin and amoxycillin) for you.
When this medicine is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal.
The presence of the bacteria Helicobacter pylori may cause the stomach to become inflamed, resulting in pain, nausea and vomiting.
When this medicine is taken with antibiotics, it will help kill Helicobacter pylori and allow the stomach to heal.
This medicine contains the active ingredient rabeprazole sodium. Rabeprazole belongs to a group of medicines called proton pump inhibitors.
It works by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place. Your food will still be digested in a normal way.
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.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
There is not enough information to recommend the use of this medicine in children.

BEFORE YOU TAKE RABEPRAZOLE SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:
rabeprazole, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
any other similar medicines (such as other proton pump inhibitors - omeprazole, esomeprazole, lansoprazole, pantoprazole)
Or if you are pregnant and during breastfeeding.
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.
Do not take this medicine 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 for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you have or have had any of the following medical conditions:
liver disease.
If you have not told your doctor about any of the above, tell him/her before you start taking Rabeprazole Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Rabeprazole Sandoz may interfere with each other. These include:
digoxin, a medicine used to treat heart problems
ketoconazole, a medicine used to treat fungal infections
atazanavir, a medicine used (with other antiretrovirals) to treat HIV-1 infection.
These medicines may be affected by Rabeprazole Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE RABEPRAZOLE SANDOZ

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, ask your doctor or pharmacist for help.

How much to take

The usual dose is one tablet at the same time each day.
For treating Helicobacter pylori infections in combination with antibiotics (clarithromycin and amoxycillin), the dose is one tablet twice each day, morning and evening.
The dose of Rabeprazole Sandoz tablets is usually 20mg, but may vary from 10mg to 40mg per day depending on what condition you are being treated for and how severe it is.
Your doctor may have prescribed a different dose.
This medicine should not be given to children.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions they give you.
If you take the wrong dose, Rabeprazole Sandoz may not work as well and your problem may not improve.

How to take it

Swallow the tablet whole with a full glass of water with or without food.
Do not crush or chew them.
The tablets have a special coating to stop them dissolving until they have gone through the stomach and into the intestines, where they can start to work. If you chew them, the coating is destroyed.

When to take Rabeprazole Sandoz

Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take Rabeprazole Sandoz

Continue taking your medicine for as long as your doctor tells you.

If you forget to take it

Take your dose as soon as you remember, and continue to take 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.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Rabeprazole Sandoz. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

WHILE YOU ARE TAKING RABEPRAZOLE SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Rabeprazole Sandoz.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

Do not take Rabeprazole Sandoz 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 lower the dosage without checking with your doctor.
Do not give this medicine to children.
Do not chew or crush the tablets.

Things to be careful of

Be careful when drinking alcohol while you are taking this medicine. Your doctor may advise you to limit your alcohol intake.
Aspirin and many other medicines used to treat arthritis / period pain/ headaches - these medicines may irritate the stomach and may make your condition worse. Your doctor or pharmacist may suggest other medicines you can take.
Caffeine - Your doctor may advise you to limit the number of drinks which contain caffeine, such as coffee, tea, cocoa and cola drinks, because they contain ingredients that may irritate your stomach.
Eating habits - eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.
Smoking - your doctor may advise you to stop smoking or at least cut down.
Weight - your doctor may suggest losing some weight to help your condition.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Rabeprazole Sandoz.
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 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 or pharmacist if you notice any of the following and they worry you:
headache
dizziness
diarrhoea
constipation
stomach pain
muscle weakness
flatulence
dry mouth
breast enlargement in men
itchy rash accompanied by skin eruption.
These are mild side effects of the medicine.
Tell your doctor as soon as possible if you notice any of the following:
bleeding or bruising more easily than normal
signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers.
The above list includes 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:
signs of allergy such as skin rash, reddening, blisters or itching, swelling of the face, lips or other parts of the body, shortness of breath or wheezing.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell when you are taking, or soon after you have finished taking this medicine.
Other side effects not listed above may also occur in some people.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
Contact your doctor immediately if you notice any of the following:
pain or indigestion
you begin to vomit blood or food
you pass black (blood stained) motions.
Ask your doctor or pharmacist to answer any questions you may have.

AFTER TAKING RABEPRAZOLE SANDOZ

Storage

Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Rabeprazole Sandoz 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 children cannot reach it.
Do not keep it in the refrigerator.
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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Rabeprazole Sandoz comes in two types of tablets:
Rabeprazole Sandoz 10mg - pink, biconvex shaped enteric coated tablets.
Rabeprazole Sandoz 20mg - yellow, biconvex shaped enteric coated tablets.
Rabeprazole Sandoz 10mg is available in blister packs of 28 enteric coated tablets.
Rabeprazole Sandoz 20mg is available in blister packs of 30 enteric coated tablets.

Ingredients

Active ingredients:
Rabeprazole Sandoz 10mg - 10mg rabeprazole sodium
Rabeprazole Sandoz 20mg - 20mg rabeprazole sodium
Inactive ingredients:
calcium hydroxide
mannitol
hydroxypropylcellulose
sodium stearyl fumarate
hypromellose
talc-purified
hypromellose phthalate
dibutyl sebacate
iron oxide- yellow
iron oxide - red
titanium dioxide.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Australia
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Auckland 0754
New Zealand
Tel: 0800 354 335
This leaflet was prepared in July 2013
Australian Registration Number:
Rabeprazole Sandoz 10 mg enteric coated tablet: AUST R 173081
Rabeprazole Sandoz 20 mg enteric coated tablet: AUST R 173080
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