Zabep

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

rabeprazole sodium

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ZABEP 20.

It does not contain all of 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 ZABEP 20 against the benefits they expect it will have 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.

What ZABEP 20 is used for

ZABEP 20 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 the throat, also known as heartburn.

help stop reflux oesophagitis from coming back or relapsing

treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal 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 amoxicillin) for you. When ZABEP 20 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 ZABEP 20 is taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal.

ZABEP 20 belongs to a group of medicines called proton pump inhibitors (PPIs). ZABEP 20 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 ZABEP 20 for another reason. Ask your doctor if you have any questions about why ZABEP 20 has been prescribed for you.

ZABEP 20 is available only with a doctor's prescription.

Before you take ZABEP 20

When you must not take it

Do not take ZABEP 20 if you are allergic to medicines containing rabeprazole sodium, or any other proton inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole) or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take ZABEP 20 if the expiry date (Exp.) printed on the pack has passed.

Do not take ZABEP 20 if the packaging is torn or shows signs of tampering.

ZABEP 20 should not be given to children under 18 years of age. Safety and effectiveness of ZABEP 20 in children has not been established.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breastfeeding or wish to breastfeed.

Your doctor will discuss the risks and benefits of taking ZABEP 20 when breastfeeding.

Tell your doctor if you have, or ever have had, liver disease.

If you have not told your doctor about any of the above, tell them before you start taking ZABEP 20.

Taking other medicines

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

Do not take ZABEP 20 and tell your doctor or pharmacist if you are taking any of the following:

atazanavir, a medicine used (with other antiretrovirals) to treat HIV1 infection.

clopidogrel, an antiplatelet medicine.

You should not take ZABEP 20 while taking these medicines.

Some medicines may be affected by ZABEP 20, or may affect how well it works. These include:

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

mycophenolate mofetil, a medicine used to prevent organ rejection following kidney, liver or heart transplants.

clarithromycin, a medicine used to treat infections.

Your doctor can tell you what to do if you are taking any of these

medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking ZABEP 20.

How to take ZABEP 20

How much to take

The usual dose is one tablet at the same time each day.

The dose of rabeprazole 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.

For treating Helicobacter pylori infections in combinations with antibiotics (clarithromycin and amoxicillin), the dose is one tablet twice each day, morning and evening, for 7 days.

Your doctor may advise you to take a different dose. This depends on your condition and whether or not you are taking any other medicines.

ZABEP 20 should not be given to children under 18 years of age.

Safety and effectiveness of ZABEP 20 in children has not been established.

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

How to take it

Swallow the tablets 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 you crush or chew ZABEP 20 tablets, they will not work as well. It does not matter if you take ZABEP 20 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 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 the missed dose as soon as you remember, and then go back to taking your tablets 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 take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much ZABEP 20. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking ZABEP 20

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking ZABEP 20.

Always swallow ZABEP 20 tablets whole.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking ZABEP 20.

Tell your doctor if you become pregnant while taking ZABEP 20.

Things you must not do

Do not use ZABEP 20 to treat any other conditions unless your doctor tells you to.

Do not give ZABEP 20 to anyone else, even if they have the same condition as you.

Do not crush or chew the tablets.

Do not give ZABEP 20 to children.

Tell your doctor if you need to have a specific blood test (Chromogranin A) while you are taking ZABEP 20. It may affect the results of this test.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ZABEP 20.

Like all other medicines, ZABEP 20 may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the 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 notice any of the following and they worry you:

headache

dizziness

diarrhoea

nausea

constipation

stomach pain

wind

vomiting

cough

runny or blocked nose

sore throat and discomfort when swallowing

muscle weakness, physical weakness or lack of energy

rash or itchy rash accompanied by skin eruptions or blisters

flatulence

dry mouth

flu-like symptoms

sleeplessness (insomnia)

indigestion

belching

leg cramps

pain (including back, chest or joint pain)

swelling of the arms or legs

nervousness

sleepiness (somnolence)

loss of appetite for food

(anorexia)

weight gain

sweating.

These side effects are usually mild.

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

painful and/or frequent urination (common symptoms of a urinary tract infection)

vision or taste disturbance

depression

feeling dizzy, faint, lightheaded or weak (hypotension)

shortness of breath

signs of frequent infections such as fever, 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 ZABEP 20 if you:

experience signs of allergy such as skin rash, reddening, blister or itching, swelling of the face, lips or other parts of the body, shortness of breath or wheezing

pass black (blood-stained) stools.

If you experience symptoms such as severe (watery or bloody) diarrhoea, fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation).

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.

Under rare circumstances supervised by the doctor, proton pump inhibitors (PPIs) might be used for long periods of time.

Low magnesium can occur in some people who take a proton pump inhibitor. Symptoms of low magnesium can include: seizures, dizziness, spasms, cramps or muscle weakness.

Low magnesium can lead to low calcium and/or low potassium levels in blood.

Withdrawal of long-term PPI therapy may lead to worsening of acid-

related symptoms.

People who take proton pump inhibitor 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.

Proton pump inhibitors may reduce the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with

your doctor or pharmacist about the possibility of vitamin B-12

deficiency if you have been taking a proton pump inhibitor for a long time (i.e. more than 3 years).

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 ZABEP 20.

Ask your doctor or pharmacist if you do not understand anything in this list.

After using ZABEP 20

Storage

Keep ZABEP 20 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.

Keep the tablets in their pack until it is time to take them.

If you take the tablets out of the pack they may not keep well.

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

Do not store ZABEP 20 or any other medicine in the bathroom or near a sink.

Do not leave ZABEP 20 in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking ZABEP 20, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.