Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about RABZOLE tablets. 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 risks of you taking RABZOLE against the benefits this medicine is expected to have for you.
If you have any concerns about using RABZOLE ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What RABZOLE is used for
The name of your medicine is RABZOLE. It contains the active ingredient rabeprazole sodium.
RABZOLE is used to treat reflux oesophagitis or reflux disease. 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.
RABZOLE is also used to help stop reflux oesophagitis from coming back or relapsing.
RABZOLE 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 of the stomach.
These ulcers can be caused by too much acid being made in the stomach.
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 RABZOLE 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 RABZOLE tablets are taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal.
How RABZOLE works
RABZOLE belongs to a group of medicines called proton pump inhibitors (PPIs). RABZOLE 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 the normal way.
Your doctor may have prescribed RABZOLE for another reason. Ask your doctor if you have any questions about why RABZOLE has been prescribed for you.
RABZOLE is only available with a doctor’s prescription.
Before you take RABZOLE
When you must not take it:
Do not take RABZOLE if you have an allergy to:
- rabeprazole sodium
- any of the ingredients listed at the end of this leaflet.
- other proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole).
Symptoms of an allergic reaction may include:
- rash, itching or hives on the skin
- shortness of breath, wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
Do not take RABZOLE if:
- the packaging is torn or shows signs of tampering.
- the expiry date (month and year) printed on the pack has passed. If you take RABZOLE after the expiry date it may not work.
Before you start to take it:
You must tell your doctor if:
- you are pregnant or intend to become pregnant.
- you are breast-feeding or intend to breast-feed. It is not known if RABZOLE passes into breast milk.
- you have or have ever had liver disease.
Taking other medicines:
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
Do not take RABZOLE and tell your doctor or pharmacist if you are taking any of the following:
- atazanavir, a medicine used (with other antiretrovirals) to treat HIV-1 infection.
- clopidogrel, an antiplatelet medicine.
You should not take RABZOLE while taking these medicines.
Also tell your doctor or pharmacist if you are taking any of the following:
- cyclosporin, a medicine used to treat several conditions including prevention of graft rejection following kidney, liver or heart transplantation; severe, active rheumatoid arthritis; severe skin diseases; kidney disease where other treatments have failed.
- methotrexate, a medicine used to treat some kinds of cancer. It is also used to treat psoriasis (skin disease) and rheumatoid arthritis.
- digoxin, a medicine used to treat heart problems.
- ketoconazole, a medicine used to treat fungal infections.
- clarithromycin, a medicine used to treat infections.
These medicines may be affected by RABZOLE or may affect how well RABZOLE works. Your doctor or pharmacist can tell you what to do if you are taking any other medicines.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking RABZOLE. Your doctor will advise you whether or not to take RABZOLE or if you need to have your dose adjusted.
Follow the directions given to you by your doctor and pharmacist.
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 RABZOLE tablets is usually 20 mg, but may vary from 10 mg to 40 mg per day depending on what condition you are being treated for and how severe it is.
RABZOLE should not be given to children.
How to take it:
- RABZOLE should be swallowed whole, with a glass of water or other liquid.
- Do NOT crush or chew the tablets. They have a special coating, which protects them from the acid in your stomach. If the coating is broken by chewing, the tablets may not work.
- It does not matter if you take RABZOLE with food or on an empty stomach.
Ask your doctor or pharmacist for help if you do not understand the instructions provided with this medicine.
If you forget to take it:
If you forget to take your tablet take it as soon as you remember, and then continue to take it as you would normally.
However, 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 you missed. If you are not sure what to do, check with your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you have taken too much (overdose):
Immediately telephone your doctor or the Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Poisons Information Centre telephone numbers:
- Australia: 13 11 26
- New Zealand: 0800 POISON or 0800 764 766
Keep these telephone numbers handy.
While you are using RABZOLE
Things you must do:
- Use RABZOLE exactly as your doctor has prescribed.
- Always swallow RABZOLE tablets whole.
- Tell your doctor if you become pregnant while you are taking RABZOLE
Tell your doctor or pharmacist that you are taking RABZOLE if you are about to start taking a new medicine.
Things you must not do:
- Do not use RABZOLE to treat any other complaint unless your doctor says to.
- Do not give this medicine to anyone else, even if they have the same symptoms as you.
- Do not crush or chew the tablets.
- Do not give RABZOLE to children.
Things that may help your condition
Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist for more information about these measures.
– 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.
– 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.
– your doctor may advise you to stop smoking or at least cut down.
– your doctor may suggest losing some weight to help your condition.
RABZOLE is usually well tolerated but tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking RABZOLE.
RABZOLE helps most people with peptic ulcers or reflux disease, but it may have unwanted side effects in a few people.
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 side effects.
Do not be alarmed by this list of possible 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 experience any of the following and they worry you:
- abdominal pain
- unusual weakness
- dry mouth
- runny or blocked nose
- sore throat and discomfort when swallowing
- chest pain
- back pain
- muscle weakness
- breast enlargement in men
- itchy rash accompanied by skin eruption
These side effects are usually mild.
People who take proton pump inhibitor (PPI) medicines at high doses for a long period of time (1 year or longer) may have an increased risk of fractures of the hip, wrist, or spine.
Tell your doctor immediately 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.
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
Tell your doctor immediately and do not take your next dose of RABZOLE if you experience:
- 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.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice anything making you feel unwell when you are taking, or soon after you have finished taking RABZOLE.
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
- you begin to vomit blood or food
- you pass black (blood-stained) motions.
Ask your doctor or pharmacist if you do not understand anything in this list.
After using RABZOLE
RABZOLE tablets are packaged a double-sided aluminium blister strip.
Do not take RABZOLE tablets out of the blister pack until it is time to take them. If you take them out of the blister they may not keep well.
Keep RABZOLE tablets in a cool dry place where the temperature is below 25°C. Do not keep RABZOLE in the refrigerator.
Do not store RABZOLE, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.
Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.
If your doctor tells you to stop taking RABZOLE tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
What RABZOLE looks like:
- RABZOLE 10 mg tablets are pink and have “E241” in black ink marked on one side.
- RABZOLE 20 mg tablets are pale yellow, and have “E243” in red ink marked on one side.
RABZOLE 10 mg tablets are supplied in blister packs of 28 tablets.
RABZOLE 20 mg tablets are supplied in blister packs of 30 tablets
Each RABZOLE tablet contains 10 mg or 20 mg of rabeprazole sodium as the active ingredient.
Each tablet also contains the following other ingredients:
- magnesium oxide,
- magnesium stearate,
- hypromellose phthalate,
- acetylated monoglycerides,
- purified talc,
- titanium dioxide and carnauba wax.
- the 20 mg tablets also contain yellow iron oxide (E172) and are printed with dawn red ink (Edible Ink Red A1).
the 10 mg tablets contain red iron oxide (E172) and are printed with gray ink (Edible Ink Gray F6).
- the tablets do not contain lactose or gluten.
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: Toll Free 1800 226 334
ARTG Number: Aust R 194561 & Aust R 196814
This leaflet was prepared in August 2013.
Published by MIMS November 2013