How does it work?

Pentasa tablets, granules, suppositories and enema all containthe active ingredient mesalazine, which is a type of medicine called anaminosalicylate. It is used to reduce inflammation in the intestines in acondition called ulcerative colitis.

Ulcerative colitis is a condition in which there is inflammationof the large intestine. This results in ulceration and bleeding in theintestine and causes symptoms that include abdominal pain and diarrhoea that ismixed with blood, pus and mucus.

Mesalazine works by reducing the inflammation in the intestine,which in turn reduces the symptoms of the disease. The way in which mesalazinedoes this is not fully understood.

Pentasa enema is administered into the back passage (rectum) todeliver the mesalazine directly to the site of inflammation in the lower end ofthe large intestine and rectum. It is used for the short-term treatment ofattacks of ulcerative colitis, particularly when the inflammation is largely inthis area of the bowel.

Pentasa suppositories are administered into the back passage(rectum) to treat disease affecting the rectum (ulcerativeproctitis).

Pentasa tablets and granules are taken by mouth. Both these doseforms have a special coating that allows the medicine to pass through thestomach and be released in the intestine. They are used for the short-termtreatment of symptoms and can also be taken on a continuous basis to controlthe inflammation in the intestine and help prevent attacks.

What is it used for?

• Ulcerative colitis.

Pentasa tablets, granules and enema can be used to treat mildto moderate symptoms of ulcerative colitis. Pentasa tablets and granules canalso be used continuously to help prevent attacks.

Pentasa suppositories are used to treat symptoms affecting therectum (ulcerative proctitis).

Warning!

• Pentasa tablets must not be chewed or crushed. They should be swallowed with fluid, either whole or broken up. The tablets can also be dispersed in 50ml of cold water. Stir and drink immediately.
• Pentasa granules should be taken on the tongue and swallowed, without chewing. They should be washed down with some water or orange juice.
• Pentasa suppositories and enema are for administration into the back passage and must not be taken by mouth.
• 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: 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.
• If you are taking mesalazine by mouth, your kidney function should be checked before you start treatment. Your kidney function should then be monitored every three months for the first year of treatment, every six months for the next four years and once a year thereafter.

Use with caution in

• Decreased kidney function.
• Decreased liver function.
• Asthma.
• Active peptic ulcer.

Not to be used in

• Allergy to salicylates (eg aspirin).
• Blood clotting abnormalities.
• Severely decreased kidney function.
• Severely decreased liver function.
• Pentasa tablets and suppositories are not recommended for children under 15 years of age. Pentasa granules and enema are not recommended for children under 12 years of age.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

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

• This medicine should be used with caution during pregnancy, and only if the expected benefit to the mother is greater than any possible risk to the foetus. Seek medical advice from your doctor.
• This medicine passes into breast milk in small amounts. The effect of this on the breastfed baby is unknown, therefore this medicine should be used with caution in breastfeeding mothers. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

• Abdominal pain.
• Diarrhoea and vomiting.
• Nausea.
• Excess gas in the stomach and intestines (flatulence).
• Rectal itching or discomfort with the enema or suppositories.
• Headache.
• Dizziness.
• Allergic skin rashes.
• Worsening of colitis symptoms.
• Pain in the muscles or joints.
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the liver (hepatitis).
• Kidney problems.
• Decreases in the normal numbers of blood cells in the blood.

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whileusing this one, to ensure that thecombination is safe.

There may be an increased risk of side effects on the bloodcells if mesalazine is used in combination with azathioprine ormercaptopurine.

Other medicines containing the same active ingredient