Mezavant XL (Mesalamine)

• Mezavant XL tablets are taken once a day, at the same time each day. The tablets should be taken with food.
• The tablets should be swallowed whole with a glass of water. They must not be broken, crushed or chewed, as this would damage the special coating of the tablets that allows them to work in the intestine.
• The number of tablets to take will vary from person to person. It is important to follow the instructions given by your doctor. These will also be printed on the dispensing label that your pharmacist has put on the packet of medicine.
• If you forget to take a dose don't worry, just take your next daily dose as usual. Do not take a double dose to make up for a missed dose.

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. The more serious side effects listed here occur rarely.

• Diarrhoea.
• Nausea and vomiting.
• Abdominal pain or bloating.
• Excess gas in the stomach and intestines (flatulence).
• Headache.
• Dizziness.
• Inflammation around the heart. Tell your doctor if you experience chest pains or palpitations.
• Decrease in the normal numbers of blood cells in the blood - see the warning section above for symptoms to look out for.
• Allergic skin rashes.
• Worsening of colitis symptoms.
• Pain in the muscles or joints.
• Hair loss.
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the liver (hepatitis).
• Kidney problems, such as inflammation of the kidneys or kidney failure.
• Lung problems, such as shortness of breath, cough or breathing difficulties.

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.

• Your kidney and liver function should be checked before you start treatment with this medicine. Your kidney function should then be monitored every three months for the first year of treatment and at least once a year thereafter, or as your doctor feels necessary.
• This medicine may rarely cause a decrease in the normal amounts of blood cells in the blood. For this reason you should consult your doctor immediately if you experience any of the following symptoms while using this medicine: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness. Your doctor may want to take a blood test to check your blood cells.
• There are several different brands and forms of mesalazine available in the UK (see end of factsheet). The way that the mesalazine is released from these different products varies and allows the mesalazine to be released in specific areas of the intestine. You will be prescribed the brand that allows the mesalazine to be released in the part of your intestine that needs it most. For this reason, it is important that you always use the same brand of mesalazine. You should make sure you know which brand you normally have and check that you have been given the correct one each time your medicine is dispensed. (Your pharmacist will usually ask you, or call your doctor if this is not written on your prescription).

Use with caution in

• Elderly people.
• Decreased kidney function.
• Decreased liver function.
• Asthma.
• People who are allergic to a related medicine called sulfasalazine.
• People with any narrowing or blockage of the stomach or the gut.

Not to be used in

• People who are allergic to salicylates (eg aspirin).
• People with blood disorders.
• Severely decreased kidney function.
• Severely decreased liver function.
• Mezavant XL tablets are not recommended for children under 18 years of age. There are other forms of mesalazine available for treating children - see end of page.

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.

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 using this one, to make sure that the combination is safe.

There may be an increased risk of side effects on the blood cells if mesalazine is used in combination with azathioprine or mercaptopurine.

There may be an increased risk of side effects on the kidneys if mesalazine is used in combination with other medicines that can affect kidney function, for example non-steroidal anti-inflammatory painkillers (NSAIDs) such as diclofenac.