Protium

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How does it work?

Protium tablets and injection contain the active ingredient pantoprazole, which is a type of medicine called a proton pump inhibitor.

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

Stomach acid is produced in the stomach as a normal part of the digestive process. Normally the linings of the stomach and duodenum (an area of the small intestine directly after the stomach) are protected by a layer that resists attack from this acid. However, if this layer is damaged, or large amounts of stomach acid are formed, an ulcer can develop on the lining of the stomach or duodenum. This is called a peptic ulcer.

Acid produced in the stomach can also sometimes flow back into the food pipe (oesophagus). This is called gastro-oesophageal reflux, and can cause pain and a burning sensation known as heartburn. It can also irritate and damage the lining of the oesophagus, causing a condition called reflux oesophagitis.

By reducing the production of stomach acid and hence the amount of acid in the stomach and duodenum, pantoprazole can be used to treat these and other conditions.

Pantoprazole stops excess acid flowing back into the foodpipe and can be used to relieve heartburn symptoms associated with acid reflux. It allows the oesophagus to heal in reflux oesophagitis. It also allows peptic ulcers to heal.

Pantoprazole can also be used to prevent peptic ulcers that can occur as a side effect of non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac. NSAIDs relieve pain and inflammation in condition like arthritis by reducing the production of substances called prostaglandins. Unfortunately, prostaglandins are also produced in the stomach and help to protect the stomach lining from acid, so NSAIDs can allow the acid to irritate the stomach. Pantoprazole is sometimes prescribed in combination with NSAIDs to help prevent peptic ulcers from developing due to this irritation.

Pantoprazole is also given together with antibiotics (usually clarithromycin plus metronidazole or amoxicillin) to help eradicate a type of bacteria called Helicobacter pylori from the stomach of people with a duodenal ulcer, or inflammation of the stomach (gastritis). These bacteria can contribute to the formation of peptic ulcers. Pantoprazole allows the ulcers to heal and helps create an environment in the gut in which the antibiotics can be more effective at killing the bacteria.

Pantoprazole is used in varying doses and for varying lengths of time depending on the condition being treated.

What is it used for?

- Gastro oesophageal reflux disease, including treatment of symptoms such as heartburn, acid regurgitation and pain on swallowing and long-term management of reflux oesophagitis
- Treating peptic ulcers
- Preventing peptic ulcers in people who need continued treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and are at risk of ulcers
- Eradicating a type of bacteria called Helicobacter pylori from the gut of people with a duodenal ulcer or inflammation of the stomach (gastritis) (in combination with antibiotics)
- Excessive secretion of stomach acid due to a tumour or enlargement of the pancreas (Zollinger-Ellison syndrome)

Warning!

- Pantoprazole is broken down by stomach acid. For this reason, Protium tablets have a special 'enteric coat' to protect the pantoprazole from the acid. This allows the tablet to pass through the stomach into the intestine, where the tablet dissolves and the pantoprazole is absorbed into the bloodstream. The tablets should not be broken, chewed or crushed, as this would stop the special coating from working. The tablets should be swallowed whole with water before a meal.
- As pantoprazole decreases the acidity in the stomach, it may lead to a slightly increased risk of stomach infections such as Salmonella and Campylobacter.
- Stomach cancer can have similar symptoms to stomach ulcers, and these symptoms can be relieved by pantoprazole. For this reason, if it is suspected that you have a stomach ulcer, your doctor should exclude the possibility of stomach cancer before you start treatment with this medicine. Otherwise, this medicine could mask the symptoms of stomach cancer and therefore delay diagnosis of this condition. This is particularly important if you are middle aged or older and have new or recently changed symptoms.
- If you have any liver problems, your liver function should be monitored regularly while you are having treatment with this medicine.
- In people having long-term treatment with this medicine, eg for Zollinger-Ellison syndrome, the medicine may reduce the absorption of vitamin B12 (cyanocobalamin) from the gut into the bloodstream.

Use with caution in

- Decreased kidney function
- Decreased liver function
- Vitamin B12 deficiency

Not to be used in

- Children

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 during pregnancy has not been established. It should be used with caution during pregnancy, and only if the expected benefit to the mother is greater than any possible risk to the developing baby. Seek medical advice from your doctor.
- It is not known if this medicine passes into breast milk. It should be used with caution by breastfeeding mothers, and only if the expected benefit to the mother is greater than any possible risk to the nursing infant. Seek medical advice from your doctor.

Label warnings

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

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