How does it work?

Nexium tablets and injection contain the active ingredient esomeprazole, which is a type of medicine called a proton pump inhibitor. It acts in the stomach to decrease the production of stomach acid.

Proton pumps are found on cells that line the stomach and are used by these cells to produce stomach acid. Esomeprazole works by inhibiting the action of the proton pumps, and this reduces the production of stomach acid.

Acid is produced in the stomach as a normal part of the digestive process. However, in the condition known as gastro-oesophageal reflux disease or acid reflux, this acid is allowed to flow back into the food pipe (oesophagus), where it causes pain and a burning sensation known as heartburn. The acid can also irritate and cause inflammation of the lining of the foodpipe (reflux oesophagitis).

Esomeprazole reduces the production of stomach acid and thus reduces acid flowing back into the foodpipe. It is used to relieve the symptoms of gastro-oesophageal reflux disease, such as heartburn. It is also used to treat reflux oesophagitis, because stopping the acid flowing back into the foodpipe allows the lining of the foodpipe to heal. Esomeprazole is also used for the long-term management of people with healed oesophagitis, as suppressing the production of stomach acid helps prevent this condition recurring.

Esomeprazole is also used to treat ulcers in the stomach or upper intestine (peptic ulcers) that are associated with a type of bacteria called Helicobacter pylori. This type of bacteria is the most common cause of peptic ulcers. The bacteria cause the stomach to produce too much acid, which irritates the lining of the stomach and upper intestine and causes ulcers.

Esomeprazole is used in combination with antibiotics to eradicate Helicobacter pylori from the gut. The esomeprazole creates an environment in the gut in which the antibiotics can work effectively against the H pylori bacteria. The reduced acid in the gut allows the ulcer to heal, and both actions help prevent the ulcer from recurring.

Esomeprazole can also be used to prevent and treat peptic ulcers that occur as a side effect of non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, for example diclofenac.

What is it used for?

• Gastro-oesophageal reflux disease.
• Treatment and prevention of peptic ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs).
• Eradicating Helicobacter pylori bacteria from the gut (in combination with antibiotics), which helps to heal peptic ulcers and prevent them from recurring.
• Excessive secretion of stomach acid due to a tumour or enlargement of the pancreas (Zollinger-Ellison syndrome).

Warning!

• Nexium tablets should be swallowed whole; do not chew or crush them. If you have difficulty swallowing the tablets whole they can be dispersed in a glass of still water. Stir until the tablets disintegrate. The mixture will not be clear, as it will contain solid granules from the tablet. These granules should not be crushed or chewed, as they contain the medicine and are covered with a special coating. Drink the mixture immediately or at least within 30 minutes (stir again before drinking), then rinse the glass around with water and drink to make sure you have taken all the medicine. Do not use any liquid other than still water to disperse the tablets, as this may affect the medicine.
• Stomach cancer can have similar symptoms to stomach ulcers, and these symptoms can also be relieved by esomeprazole. For this reason, if your doctor thinks you have a stomach ulcer, they should make sure you don't have stomach cancer before you start treatment with this medicine. Otherwise, this medicine could mask the symptoms of stomach cancer and therefore delay the diagnosis. This is particularly important if you are middle aged or older and have new or recently changed symptoms.
• If you are taking this medicine only when needed to relieve symptoms of acid reflux, you should let your doctor know if your usual symptoms change in character.
• Treatment with this medicine may lead to a slightly increased risk of stomach infections such as salmonella, due to the decreased acidity in the stomach.

Use with caution in

• Severely decreased kidney function.
• Severely decreased liver function.

Not to be used in

• Children under 12 years of age.
• Breastfeeding.
• Nexium tablets contain sucrose and as a result are not suitable for people with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine in pregnancy has not been fully established. It should be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus. Seek medical advice from your doctor.
• It is not known of this medicine passes into breast milk. For this reason, the manufacturer states that it should not be used by women who are breastfeeding. Seek medical advice from your doctor.

Label warnings

• This medication is to be swallowed whole, not chewed.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Headache.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Excess gas in the stomach and intestines (wind or flatulence).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Dry mouth.
• Dizziness or spinning sensation.
• Pins and needles sensations (paraesthesia).
• Sleepiness.
• Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).
• Difficulty sleeping (insomnia).
• Increased liver enzymes.
• Skin reactions such as rash, itching, hives or dermatitis.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Taste disturbance.
• Blurred vision.
• Agitation.
• Confusion.
• Depression.
• Inflammation of the liver (hepatitis).
• Inflammation of the mouth (stomatitis).
• Thrush infection (candidiasis) in the stomach or intestines.
• Hair loss.
• Increased sensitivity of the skin to UV light (photosensitivity).
• Increased sweating.
• Pain in the muscles and joints.
• Decreased numbers of white blood cells or platelets in the blood (leucopenia or thrombocytopenia).
• Decreased level of sodium in the blood (hyponatraemia).

Very rare (affect less than 1 in 10,000 people)

• Decreased numbers of all types of blood cells in the blood (agranulocytosis or pancytopenia).
• Aggression.
• Hallucinations.
• Liver failure.
• Muscle weakness.
• Kidney inflammation (interstitial nephritis).
• Severe skin reactions.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

This medicine should not be taken by people taking atazanavir for HIV infection. This is because esomeprazole decreases the amount of atazanavir in the blood and could therefore make it less effective against HIV.

Esomeprazole may prevent the breakdown of the following medicines by the liver, which could increase the level of these medicines in the blood and thus increase the risk of their side effects:

• citalopram
• clomipramine
• diazepam
• escitalopram
• imipramine
• phenytoin (the manufacturer recommends that people taking phenytoin should have their phenytoin blood level checked after starting or stopping esomeprazole)
• raltegravir (esomeprazole should be avoided in people taking raltegravir).

Esomeprazole may increase the anti-blood-clotting effect of the anticoagulant medicine warfarin. If you are taking warfarin it is recommended that your blood clotting time (INR) is checked after starting and stopping this medicine.

Esomeprazole may decrease the absorption of the following medicines from the gut, and thus may make them less effective:

• itraconazole
• ketoconazole
• lapatinib.

The following medicines may prevent the breakdown of esomeprazole by the liver, which could increase the level of esomeprazole in the blood:

• clarithromycin
• voriconazole.

This is not usually a problem, but your doctor may consider lowering your dose of esomeprazole if you are having long-term treatment with esomeprazole and either of these medicines, or if you have severe liver problems.

The anti-HIV medicine tipranavir may reduce the amount of esomeprazole in the blood and could make it less effective.

Proton pump inhibitors such as this one are not recommended for people taking the antiplatelet medicine clopidogrel. This is because recent evidence has shown that proton pump inhibitors can make the clopidogrel less effective at preventing heart attacks and strokes. If you are currently taking this medicine in combination with clopidogrel, you should consult your doctor to discuss this. This medicine should only be used in combination with clopidogrel if your doctor feels it is essential.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain esomeprazole as the active ingredient.