Consumer medicine information

1. Why am I using NEXIUM?

NEXIUM contains the active ingredient esomeprazole magnesium trihydrate. NEXIUM 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 Bleeding Peptic Ulcers.
For more information, see Section 1. Why am I using NEXIUM? in the full CMI.

2. What should I know before I use NEXIUM?

Do not use if you have ever had an allergic reaction to NEXIUM 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 NEXIUM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NEXIUM 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 NEXIUM?

• NEXIUM is available as either tablets or as granules for suspension in sachets. The dose of NEXIUM tablets is usually 20 mg or 40 mg a day. The dose of NEXIUM sachets is 10 mg to 20 mg a day. The dose for tablets or sachets depends 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 NEXIUM?

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 nausea or vomiting, constipation, diarrhoea, headache, wind, stomach pain, skin rash, itchy skin, dizziness or dry mouth. 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, blood in the urine and increased or decreased urine output.
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 trihydrate.

2 Qualitative and Quantitative Composition

The active ingredient in Nexium is esomeprazole magnesium trihydrate, a substituted benzimidazole.
The Nexium 20 mg and 40 mg tablets are comprised of enteric coated pellets containing esomeprazole (as magnesium trihydrate). Contains sugars.
Nexium 10 mg granules for oral suspension are comprised of enteric coated pellets containing esomeprazole (as magnesium trihydrate). Contains sugars.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nexium 20 mg tablets are a light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A/EH on the other side. Each tablet contains esomeprazole magnesium trihydrate 22.3 mg as enteric-coated pellets.
Nexium 40 mg tablets are a pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A/EI on the other side. Each tablet contains esomeprazole magnesium trihydrate 44.5 mg as enteric-coated pellets.
Nexium 10 mg granules for oral suspension are pale yellow fine granules (brownish granules may be visible) in a unit dose sachet. Each sachet contains esomeprazole magnesium trihydrate 11.1 mg as enteric-coated pellets.

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 dialyzable. 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

Chemical structure. The chemical name is di-(S)-5-methoxy-2- [[(4-methoxy-3,5- dimethyl-2-pyridinyl)methyl] sulfinyl]- 1H-benzimidazole magnesium salt trihydrate. Esomeprazole is the S-isomer of omeprazole. It is optically stable in vivo, with negligible conversion to the R-isomer.
The chemical structure of esomeprazole magnesium trihydrate is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSESOMEP.gif CAS number. 217087-09-7.
Molecular formula. C₃₄H₃₆N₆O₆S₂Mg.3H₂O.
Molecular weight. 767.2 (trihydrate).

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NEXIUMST.gif