How does it work?

Protium tablets contain the active ingredientrabeprazole, which is a type of medicine called a proton pump inhibitor. Rabeprazole acts in the stomach to decrease the production of stomach acid.

Proton pumps are found on cells that line the stomach and areused by these cells to produce stomach acid. Rabeprazole works by inhibitingthe action of the proton pumps, which reduces the production of stomachacid.

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

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

By reducing the production of stomach acid and hence the amountof acid in the stomach and duodenum, rabeprazole can be used to treat theseand other conditions.

Rabeprazole stops excess acid flowing back into the foodpipeand can be used to relieve heartburn symptoms associated with acid reflux. Itallows the oesophagus to heal in reflux oesophagitis. It also allows pepticulcers to heal.

Rabeprazole is also given together with antibiotics to help eradicate a type ofbacteria called Helicobacter pylori from the stomach of people with a pepticulcer. These bacteria cancontribute to the formation of peptic ulcers. Rabeprazole allows the ulcers toheal and helps create an environment in the gut in which the antibiotics can bemore effective at killing the bacteria.

Rabeprazole is used in varying doses and for varying lengths oftime 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.
• Eradicating a type of bacteria called Helicobacter pylori from the gut of people with a peptic ulcer (in combination with antibiotics).
• Excessive secretion of stomach acid due to a tumour or enlargement of the pancreas (Zollinger-Ellison syndrome).

Warning!

• Swallow these tablets whole with water - do not chew, crush or break them.
• Stomach cancer can have similar symptoms to stomach ulcers, and these symptoms can be relieved by rabeprazole. 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.
• As rabeprazole decreases the acidity in the stomach, it may lead to a slightly increased risk of getting stomach infections such as Salmonella and Campylobacter.

Use with caution in

• Severely decreased liver function.

Not to be used in

• Pregnancy.
• Breastfeeding.
• This medicine is not recommended for children, as it has not been studied in this age group.

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 for use during pregnancy has not been established. It should not be used by pregnant women. Ask your doctor for further advice.
• It is not known if this medicine passes into breast milk. For this reason, the manufacturer states that it should not be used during 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.
• Difficulty sleeping (insomnia).
• Dizziness.
• Cough.
• Inflammation of the throat (pharyngitis).
• Inflammation of the lining of the nose (rhinitis) causing a blocked or runny nose.
• Infections.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Excess gas in the stomach and intestines (flatulence).
• Weakness or loss of strength (asthenia).
• Back pain.
• Flu-like symptoms.

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

• Nervousness.
• Sleepiness.
• Dry mouth.
• Inflammation of the sinuses (sinusitis).
• Rash.
• Flushing of the skin due to widening of the small blood vessels (erythema).
• Pain in the muscles or joints.
• Leg cramps.
• Chest pain.
• Chills or fever.
• Increased liver enzymes.

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

• Decreased number of white blood cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia).
• Inflammation of the stomach (gastritis).
• Inflammation of the mouth (stomatitis).
• Taste disturbance.
• Loss of appetite.
• Depression.
• Visual disturbances.
• Sweating.
• Itching.
• Weight gain.
• Inflammation of the liver (hepatitis).
• Kidney inflammation (interstitial nephritis).

Very rare or frequency not known

• Swollen ankles due to fluid retention (peripheral oedema).
• Confusion.
• Decreased level of sodium in the blood (hyponatraemia).
• 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.

Rabeprazole should not be taken by people taking the anti-HIV medicine atazanavir. This is because rabeprazole decreases the blood level of atazanavir and could make it less effective at treating HIV infection.

Proton pump inhibitors such as this one are not recommended for people taking the anti-HIV medicine raltegravir, because they may increase the blood level of raltegravir and may therefore increase the risk of its side effects.

Due to its effect on the acidity in the stomach, rabeprazolemay reduce the absorption of the following medicines from thestomach, which could make them less effective:

• itraconazole
• ketoconazole
• lapatinib.

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 rabeprazole as the active ingredient.