Rabeprazole AN tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Rabeprazole AN.
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 Rabeprazole AN 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 Rabeprazole AN is used for
The name of your medicine is Rabeprazole AN.
It contains the active ingredient rabeprazole sodium.
Rabeprazole is used to treat:
- Reflux oesophagitis
- Peptic ulcers
- Chronic Gastritis
Rabeprazole AN 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.
Rabeprazole AN is also used to help stop reflux oesophagitis from coming back or relapsing
Rabeprazole AN is used to treat peptic ulcers. Depending on the position of the ulcer, it is called a gastric ulcer 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. The 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 Rabeprazole AN 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 Rabeprazole tablets are taken with antibiotics, then will help kill Helocobactor pylori and allow the stomach to heal.
How Rabeprazole AN works
Rabeprazole AN belongs to a group of medicines called proton pump inhibitors (PPIs).
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 the 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 only available with a doctor’s prescription.
Use in children
There is not enough information to recommend the use of this medicine in children.
Before You Take Rabeprazole AN
When you must not take it
Do not take Rabeprazole AN if you have an allergy to:
- Any medicine containing rabeprazole sodium
- any of the ingredients listed at the end of this leaflet
- other proton pump inhibitors (for example: omeprazole, esomeprazole, lansoprazole, pantoprazole)
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 of 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 are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you have or have had any of the following medical conditions:
- liver disease
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or wish to breastfeed. Your doctor will discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking Rabprazole AN.
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.
Some medicines may be affected by Rabeprazole AN 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 will advise you.
Tell your doctor or pharmacist if you are taking any of the following:
- digoxin, a medicine used to treat heart problems
- ketoconazole, a medicine used to treat fungal infections
- atazanavir, a medicine used (with other antivirals) to treat HIV-1 infection
Your doctor and pharmacist will mav more information on medicines to be careful with or avoid taking while on this medicine.
How to take Rabeprazole AN
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 box/bottle, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how many tablets you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.
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 AN 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.
Rabeprazole AN should not be given to children.
How to take it
Swallow the tablets whole with a full 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.
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 Rabeprazole AN 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.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
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. This may increase your chance of getting an unwanted side effect.
If you are not sure what to do, check with 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 you or anyone else may have taken too much
RABEPRAZOLE AN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are using Rabeprazole AN
Things you must do
Use Rabeprazole exactly as your doctor has prescribed.
Always swallow Rabeprazole AN tablets whole.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Rabeprazole AN.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking Rabeprazole AN, tell your doctor immediately.
Things you must not do
Do not take Rabeprazole AN 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 crush or chew the tablets. Do not give Rabeprazole AN to children.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how Rabeprazole AN affects you. This medicine may cause dizziness in some people. If you have this symptom, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, symptoms such as dizziness may be worse.
Things that would be helpful for your condition
Some self help measures suggested below may help your condition. Your doctor or pharmacist can give you more information about these measures.
- Alcohol – your doctor may advise you to limit your alcohol intake.
- Asprin 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.
Rabeprazole AN is usually well tolerated but tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking it.
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.
It can be difficult to tell whether side effects are the result of taking Rabeprazole AN, effects of your condition or side effects of other medicines you may be taking. For this reason, it is important to tell your doctor of any change in your condition.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor of pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- stomach pain
- muscle weakness/pain
- dry mouth
- itchy or /runny nose
- sore throat
- trouble falling/staying asleep
- breast enlargement in men
- itchy rash accompanied by skin eruption
Also tell your doctor if your reflux/heartburn symptoms get worse.
The above list includes some of the more common side effects of your medicine.
They are usually mild and short-lived.
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
- Yellow skin
- Significant mood changes
- Significant weight changes
- Double or blurred vision
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
Tell your doctor immediately (and do not take your next dose of Rabeprazole AN) or go to Accident and Emergency at the nearest hospital if you notice any of the following:
- 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. These side effects are very rare.
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.
Tell your doctor if you notice anything else that is making you feel unwell.
- Other side effects not listed above may also occur in some people.
After taking Rabeprazole AN
Keep your tablets in the pack/bottle until it is time to take them. If you take the tablets out of the pack/bottle they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C
Do not store Rabeprazole AN or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep Rabeprazole AN 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.
If your doctor tells you to stop taking this medicine, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
Rabeprazole AN 10 mg and 20 mg tablets are supplied in blister packs (in pack sizes of 28 and 30 tablets) and in HDPE plastic bottles (in pack sizes of 30 and 90 tablets).
RABEPRAZOLE AN 10 mg
Round, white, biconvex, enteric-coated tablets
Blister pack AUST R 189244
Bottle pack AUST R 189233
RABEPRAZOLE AN 20 mg
Round, yellow, biconvex, enteric-coated tablets
Blister pack AUST R 189226
Bottle pack AUST R 189218
Each tablet contains either 10 mg or 20 mg of rabeprazole sodium as the active ingredient.
- Diacetylated monoglycerides
- Hypromellose phthalate
- Iron oxide yellow
- Heavy magnesium oxide
- Light magnesium oxide
- Magnesium stearate
- Purified talc
- Titanium dioxide
Please read this leaflet carefully before you start taking RABEPRAZOLE AN. You may wish to keep it to read again.
Name and Address of the Sponsor
Amneal Pharma Australia Pty Ltd
12 River Street
South Yarra 3141
Date of Preparation
Doc ID: 92.AN.M.1.0
Published by MIMS February 2017