Prabez Tablets

Prabez Tablets is a brand of medicine containing the active ingredient rabeprazole sodium.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

PRABEZ

contains the active ingredient rabeprazole sodium


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about PRABEZ.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking PRABEZ against the benefits expected for you.

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

Keep this leaflet with your medicine. You may need to read it again.

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What PRABEZ is used for

The name of your medicine is PRABEZ. It contains the active ingredient rabeprazole sodium.

Reflux Oesophagitis

PRABEZ 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.

PRABEZ is also used to help stop reflux oesophagitis from coming back or relapsing.

Peptic Ulcers

PRABEZ 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 PRABEZ is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal.

Chronic Gastritis

The presence of the bacteria Helicobacter pylori may cause the stomach to become inflamed, resulting in pain, nausea and vomiting.

When PRABEZ tablets are taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal.

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Before you take PRABEZ

When you must not take it

Do not take PRABEZ if you have an allergy to:

  • any medicine containing rabeprazole sodium
  • any of the ingredients listed at the end of this leaflet
  • any proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole).

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
  • add any other specific reactions listed in the PI.

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 have or have had any of the following medical conditions:

  • you have or have ever had liver disease.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. It is not known if PRABEZ passes into breast milk.

If you have not told your doctor about any of the above, tell him/her before you start taking PRABEZ.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and PRABEZ 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 PRABEZ 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.

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How to take PRABEZ

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

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

How much to take

Adults
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 PRABEZ 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.

Children
PRABEZ should not be given to children.

How to take it

Swallow the tablets whole with a full glass of water.

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.

When to take it

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.

It does not matter if you take this medicine before or after food.

If you forget to take it

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

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

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

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 13 11 26) 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 PRABEZ. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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While you are taking PRABEZ

Things you must do

  • Use PRABEZ exactly as your doctor has prescribed.
  • Always swallow PRABEZ tablets whole.
  • Tell your doctor if you become pregnant while you are taking PRABEZ.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking PRABEZ.

Things you must not do

Do not take PRABEZ 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 give this medicine 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.

  • Alcohol - 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.

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Side effects

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

  • headache
  • dizziness
  • diarrhoea
  • constipation
  • stomach pain
  • muscle weakness
  • flatulence
  • dry mouth
  • breast enlargement in men
  • itchy rash accompanied by skin eruption

The above list includes the more common side effects of your medicine. They are usually mild.

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 are rare.

If any of the following happen, tell your doctor immediately or do not take your next dose of PRABEZ 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.

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.

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.

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After taking PRABEZ

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Discard any remaining tablets one month after opening the bottle.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store PRABEZ 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. 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.

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Product description

What it looks like

  • PRABEZ 10 mg - A pink, film-coated, round, biconvex tablet imprinted with R3 in black ink on one side of the tablet and blank on the other side. Available in blister packs of 28 tablets.
  • PRABEZ 20 mg - A yellow, film-coated, round, biconvex tablet imprinted with R4 in black ink on one side of the tablet and blank on the other side. Available in blister packs of 30 tablets.

Ingredients

PRABEZ contains 10 mg or 20 mg of rabeprazole sodium as the active ingredient.

It also contains the following inactive ingredients:

  • mannitol
  • magnesium oxide
  • hydroxypropylcellulose
  • magnesium stearate
  • ethyl cellulose
  • hypromellose phthalate
  • acetylated mono glycerides
  • talc - purified
  • titanium dioxide
  • Opacode black (S-1-17823).
  • The 10 mg tablet also contains iron oxide red and the 20 mg tablet contains iron oxide yellow.
  • This medicine does not contain lactose, sucrose, gluten or tartrazine.

Supplier

PRABEZ is supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Medical Information
Phone: 1800 028 365

Australian registration numbers:
PRABEZ 10 mg: AUST R 187314
PRABEZ 20 mg: AUST R 187312

This leaflet was prepared on
16 November 2012.

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CMI provided by MIMS Australia, June 2013  

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