Consumer medicine information

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.

5. What should I know while using ESOMEPRAZOLE-WGR?

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.

1 Name of Medicine

Esomeprazole magnesium.

2 Qualitative and Quantitative Composition

Esomeprazole is a proton pump inhibitor. The active ingredient in Esomeprazole-WGR is esomeprazole magnesium, a substituted benzimidazole.
Each enteric-coated tablet of Esomeprazole-WGR comprises enteric-coated pellets with esomeprazole magnesium equivalent to esomeprazole 20 mg or 40 mg.
Contains excipient of known effect. Sugars.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Esomeprazole-WGR esomeprazole (as magnesium) 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.
Esomeprazole-WGR esomeprazole (as magnesium) 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.

4 Clinical Particulars

4.9 Overdose

The symptoms described in connection with deliberate esomeprazole overdose are transient. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg esomeprazole were uneventful. No specific antidote is known. Esomeprazole is extensively protein bound and is therefore not readily dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Esomeprazole was negative in a bacterial gene mutation assay. In clastogenicity tests, esomeprazole was positive (as was omeprazole) in an in vitro chromosome aberration test in human lymphocytes. However, two in vivo tests (a mouse micronucleus test and an in vivo chromosome aberration test in rat bone marrow) in the presence of long and high systemic exposure to esomeprazole, showed that esomeprazole was not clastogenic under in vivo conditions. Exposure levels in man are well below those at which clastogenic effects occurred in vitro.
Carcinogenicity. Preclinical bridging studies between the enantiomer esomeprazole and the racemate (omeprazole) showed that these compounds are pharmacologically and toxicologically similar at equivalent systemic exposure. Thus, the extensive preclinical database for omeprazole is also relevant for the safety assessment of esomeprazole.
No carcinogenicity studies have been conducted on esomeprazole. However, omeprazole (the racemate) produced enterochromaffin-like (ECL) cell hyperplasia and gastric carcinoids in rats. In a 104-week study in rats, carcinoids were observed at doses (on a mg/m² basis) which ranged from 0.4 to 30-fold the maximum clinical dose for adults. However, a no-effect dose level was not determined in female rats. A similar effect was not observed in a 78-week mouse carcinogenicity study with omeprazole. These gastric effects in the rat are believed to be the result of sustained, pronounced hypergastrinaemia secondary to reduced production of gastric acid. Similar effects are elicited by other proton pump inhibitors, H₂-receptor antagonists and by partial fundectomy.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Esomeprazole is the S-isomer of omeprazole. It is optically stable in vivo, with negligible conversion to the R-isomer.
Chemical structure. Chemical name: 5-Methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridyl)- methyl]sulfinyl]benzimidazole, magnesium salt (2:1).
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSESOMAG.gif Molecular formula: C₃₄H₃₆MgN₆O₆S₂. Molecular weight: 713.12.
CAS number. CAS number: 161973-10-0.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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