SUMMARY CMI
ESOMEPRAZOLE-WGR
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using ESOMEPRAZOLE-WGR?
ESOMEPRAZOLE-WGR contains the active ingredient esomeprazole magnesium. ESOMEPRAZOLE-WGR is used to treat Reflux Oesophagitis, Upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs (NSAIDs) therapy, Peptic Ulcers Associated with Helicobacter pylori Infection, Zollinger-Ellison Syndrome and prevention of rebleeding of gastric or duodenal ulcers.
For more information, see Section 1. Why am I using ESOMEPRAZOLE-WGR? in the full CMI.
2. What should I know before I use ESOMEPRAZOLE-WGR?
Do not use if you have ever had an allergic reaction to ESOMEPRAZOLE-WGR or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use ESOMEPRAZOLE-WGR? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with ESOMEPRAZOLE-WGR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use ESOMEPRAZOLE-WGR?
- ESOMEPRAZOLE-WGR is available as tablets. The dose of ESOMEPRAZOLE-WGR tablets is usually 20 mg or 40 mg a day depending on what condition you are being treated for and how severe it is.
- Follow all directions given to you by your doctor and pharmacist carefully.
More instructions can be found in Section 4. How do I use ESOMEPRAZOLE-WGR? in the full CMI.
5. What should I know while using ESOMEPRAZOLE-WGR?
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using ESOMEPRAZOLE-WGR? in the full CMI.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. These include headache, stomach pain, constipation, diarrhoea, wind, nausea, vomiting, itching, skin rash, dizziness, dry mouth, swelling of hands, ankles or feet. However, some serious side effects may need urgent medical attention. These include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin, signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
ESOMEPRAZOLE-WGR
Active ingredient: esomeprazole magnesium
Consumer Medicine Information (CMI)
This leaflet provides important information about using ESOMEPRAZOLE-WGR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ESOMEPRAZOLE-WGR.
Where to find information in this leaflet:
1. Why am I using ESOMEPRAZOLE-WGR?
2. What should I know before I use ESOMEPRAZOLE-WGR?
3. What if I am taking other medicines?
4. How do I use ESOMEPRAZOLE-WGR?
5. What should I know while using ESOMEPRAZOLE-WGR?
6. Are there any side effects?
7. Product details
1. Why am I using ESOMEPRAZOLE-WGR?
ESOMEPRAZOLE-WGR contains the active ingredient esomeprazole magnesium. ESOMEPRAZOLE-WGR is a type of medicine called proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.
Reflux Oesophagitis
ESOMEPRAZOLE-WGR is taken to treat reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. ESOMEPRAZOLE-WGR is also taken to help stop reflux oesophagitis coming back or relapsing.
Upper gastrointestinal symptoms associated with non-steroidal anti-Inflammatory drugs (NSAIDs) therapy
ESOMEPRAZOLE-WGR is taken to treat the symptoms of pain or discomfort in the stomach caused by NSAIDs, a type of medicine for pain or inflammation.
ESOMEPRAZOLE-WGR is also taken to help heal and prevent ulcers caused by NSAIDs.
Peptic Ulcers Associated with Helicobacter pylori Infection
Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach.
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 from the stomach.
If you have a peptic ulcer, your doctor will prescribe ESOMEPRAZOLE-WGR with antibiotics. When ESOMEPRAZOLE-WGR and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.
Zollinger-Ellison syndrome
ESOMEPRAZOLE-WGR is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.
Prevention of rebleeding of gastric or duodenal ulcers
ESOMEPRAZOLE-WGR is also used as prolonged treatment after prevention of rebleeding of ulcers of stomach or gut with intravenous esomeprazole.
When peptic ulcers become severe enough, they start to bleed. You may receive treatment injected into your veins initially. This treatment may be followed with ESOMEPRAZOLE-WGR tablets prescribed by your doctor for a longer period of time. This is to help your ulcer/s to heal.
2. What should I know before I use ESOMEPRAZOLE-WGR?
Warnings
Do not use this medicine if:
- you are allergic to esomeprazole magnesium, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
- You are allergic to any medicines containing proton-pump inhibitors.
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 ESOMEPRAZOLE-WGR if you are taking atazanavir or cilostazol. Please check with your doctor or pharmacist if you are taking these medicines. These medicines will be affected by ESOMEPRAZOLE-WGR.
Check with your doctor if you:
- allergies to any other medicines, foods, dyes or preservatives
- any problems with your liver
- experienced any significant weight loss, difficulty in swallowing or dark tarry stools
- severe kidney problems
- any other medical conditions
- been diagnosed with osteoporosis
- ever had a skin reaction after treatment with a medicine similar to ESOMEPRAZOLE-WGR that reduces stomach acid
There is no evidence that ESOMEPRAZOLE-WGR is addictive.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if it is safe for you to take ESOMEPRAZOLE-WGR while you are pregnant. It may affect your baby.
It is not known if it is safe for you to take ESOMEPRAZOLE-WGR from breast milk if you are breastfeeding.
Do not take ESOMEPRAZOLE-WGR if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.
Children younger than 1 year:
ESOMEPRAZOLE-WGR is not approved for use in children younger than 1 year of age. There is no specific information about use in children younger than 1 year of age, so ESOMEPRAZOLE-WGR is not recommended in these patients.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Do not take ESOMEPRAZOLE-WGR if you are taking the following medicines:
- atazanavir and nelfinavir (used to treat viral infections such as HIV)
- cilostazol (used to reduce leg pain when walking caused by blood circulation disease)
Some medicines may interfere with ESOMEPRAZOLE-WGR and affect how it works. These include:
- Ketoconazole, itraconazole and voriconazole – medicines used to treat fungal infection
- Diazepam – a medicine used to treat anxiety and some other conditions
- Phenytoin – a medicine used to treat epilepsy or fits
- Citalopram, clomipramine and imipramine – medicines used to treat depression
- St. John's wort – a herbal remedy used to treat mood disorders
- Clarithromycin and rifampicin – medicines used to treat bacterial infections
- Warfarin and clopidogrel – medicines used to prevent blood clots
- Digoxin – a medicine used to treat heart conditions
- Methotrexate – a medicine used to treat arthritis and some types of cancer
- Tacrolimus and mycophenolate mofetil – medicines used to assist in organ transplants
- erlotinib or related medicines used to treat cancer
- cisapride
These medicines may be affected by ESOMEPRAZOLE-WGR or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
Your doctor can tell you what to do if you are taking any other medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ESOMEPRAZOLE-WGR.
4. How do I use ESOMEPRAZOLE-WGR?
How much to take
- Take one ESOMEPRAZOLE-WGR tablet each day, unless your doctor has told you otherwise.
- The dose of ESOMEPRAZOLE-WGR tablets is usually 20 mg or 40 mg a day depending on what condition you are being treated for and how severe it is.
When to take ESOMEPRAZOLE-WGR
- Take ESOMEPRAZOLE-WGR at about the same time each day.
- Keeping a regular time for taking ESOMEPRAZOLE-WGR will help to remind you to take it.
- ESOMEPRAZOLE-WGR can be taken with food or on an empty stomach.
- Keep taking ESOMEPRAZOLE-WGR for as long as your doctor recommends.
- In most patients, ESOMEPRAZOLE-WGR relieves symptoms rapidly and healing is usually complete within 4 weeks. Continue taking ESOMEPRAZOLE-WGR for as long as your doctor tells you to.
How to take ESOMEPRAZOLE-WGR
Swallow ESOMEPRAZOLE-WGR tablets whole with a glass of water. Do not crush or chew the tablets. If the tablets are chewed or crushed they will not work properly.
If you have difficulty swallowing the tablets:
- Place the tablet in half a glass of non-carbonated water. Mineral water or other liquids are not suitable.
- Gently mix the tablet and water by stirring, taking care not to crush the tablet.
- Stir until the tablet dissolves into little pellets.
- Drink the liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets.
- Rinse the glass with half a glass of water and drink.
If you cannot swallow at all, follow steps 1-3 above to disperse the tablets and administer the liquid and pellets through a gastric tube.
If you forget to use ESOMEPRAZOLE-WGR
ESOMEPRAZOLE-WGR should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking 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 you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you use too much ESOMEPRAZOLE-WGR
If you think that you have used too much ESOMEPRAZOLE-WGR, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using ESOMEPRAZOLE-WGR?
Things you should do
Take ESOMEPRAZOLE-WGR exactly as your doctor has prescribed.
If you are about to start on any new medicine, tell your doctor, dentist or pharmacist that you are taking ESOMEPRAZOLE-WGR.
Tell all doctors, dentists and pharmacists who are treating you that you are taking ESOMEPRAZOLE-WGR.
Tell your doctor if you become pregnant while you are taking ESOMEPRAZOLE-WGR.
Tell your doctor if your symptoms return.
Although ESOMEPRAZOLE-WGR can heal ulcers successfully, it may not prevent them recurring at a later date.
If you need to have any medical tests while you are taking ESOMEPRAZOLE-WGR, tell your doctor.
It may affect the results of some tests.
Things you should not do
- Do not take it to treat any other complaints unless your doctor tells you to.
- Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ESOMEPRAZOLE-WGR affects you.
Looking after your medicine
- Keep your ESOMEPRAZOLE-WGR in the blister pack until it is time to take them. If you take ESOMEPRAZOLE-WGR out of the blister pack it will not keep well.
- Keep it in a cool, dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
| Speak to your doctor immediately if you notice any of these side effects. These side effects may require medical attention |
Serious side effects
| Serious side effects | What to do |
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
| Contact your doctor immediately if you notice any of these side effects. |
Occasionally, ESOMEPRAZOLE-WGR may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Other problems are more likely to arise from the condition itself rather than the treatment.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ESOMEPRAZOLE-WGR contains
| Active ingredient (main ingredient) | esomeprazole magnesium |
| Other ingredients (inactive ingredients) |
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| Potential allergens | sugars |
Do not take this medicine if you are allergic to any of these ingredients.
What ESOMEPRAZOLE-WGR looks like
ESOMEPRAZOLE-WGR 20 mg tablets are light brick red to brown, oval, biconvex, enteric-coated tablets with ‘E5’ debossed on one side and plain on other side. (AUST R 432110)
ESOMEPRAZOLE-WGR 40 mg tablets are light brick red to brown, oval, biconvex, enteric-coated tablets with ‘E6’ debossed on one side and plain on other side. (AUST R 432111)
Who distributes ESOMEPRAZOLE-WGR
Wagner Pharmaceuticals Pty Ltd
6 Albert Street
Preston VIC 3072
Tel: 1800 936 140
This leaflet was prepared in May 2024.
Published by MIMS March 2025