• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What Asacol 400mg MR tablets are and what they are used for
2. Before you take Asacol 400mg MR tablets
3. How to take Asacol 400mg MR tablets
4. Possible side effects
5. How to store Asacol 400mg MR tablets
6. Further information

• Asacol should be used with extreme caution in patients with confirmed mild to moderate kidney impairment.
• Asacol should be used with caution in the elderly.

Serious skin reactions including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Stop using mesalazine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. Asacol 400mg MR tablets should NOT be taken with Lactulose (a medicine for constipation).

Use of non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, aspirin, Cox-II inhibitors) and azathioprine in particular may increase the risk of kidney reactions.

Women who are pregnant or breast-feeding should not take Asacol 400mg MR tablets unless advised otherwise by their doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Before you start treatment with Asacol 400mg tablets you will have a blood and urine test to check how well your kidneys are working and what your blood is doing. During treatment your doctor will check how well your liver, kidney and blood is working by taking blood and urine sample periodically during your treatment.

Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with mesalazine.

Asacol 400mg MR tablets are not expected to affect your ability to drive or operate machinery.

Patients who are intolerant to lactose should note that Asacol 400mg tablets contain a small amount of lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, i.e. is essentially “sodium-free”.

Keep taking the tablets for as long as your doctor tells you. Your symptoms may come back if you stop treatment too early. Remember to get a repeat prescription at the right time so that you do not miss a day of treatment.

Do not exceed the recommended dose. You should only take as many tablets as your doctor has instructed on the pharmacist’s label. If you take too much medicine, tell your doctor immediately or go to your nearest Accident & Emergency Department. Take the tablet pack with you if possible.

If you forget to take a dose at the required time, take it as soon as you remember and continue taking your tablets as before. DO NOT take more than two doses in one hour. If it is almost time for your next dose, wait until then and carry on as before.

if you experience any of the following symptoms:

• fever, sore throat, mouth or lip ulcers, spots underneath your skin anywhere on your body, including the genital and anal regions, become very pale, swollen ankles or have unusual bleeding (e.g. unexpected nosebleeds or bleeding gums)
• skin rash with flaking, boils or sore lips or mouth
• bruising more easily or suspect blood abnormalities
• problems with kidney function

Common side effects (in more than 1 in 100 people but less than 1 in 10 people):

• diarrhoea
• abdominal pain
• nausea (feeling sick)
• headache.

Rare side effects (in less than 1 in 1000 people):

• problems with heart, lung, liver or kidney function
• inflammation of the pancreas
• blood abnormalities
• numbness and tingling of the fingers and toes due to damaged nerves
• hair loss
• fever
• skin rash.

Very rare side effects (in less than 1 in 10,000 people):

• worsening of symptoms of colitis
• Erythema multiforme and Stevens-Johnson syndrome (skin and mucous membrane disease).

Not known (frequency cannot be estimated from available data)

• Inflamed lining of the lung, causing sharp chest pain that feels worse with breathing, dry cough, shortness of breath (pleurisy)
• Kidney stones and associated kidney pain (see also section 2)
• Increased pressure in brain: headache which may originate behind your eyes and worsen with eye movements, with blurred or dimmed vision, double vision, seeing light flashes, difficulty seeing to the side, and brief or permanent vision loss. These may be associated with dizziness, nausea, vomiting, ringing in ears.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom (Northern Ireland)

or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is mesalazine (also known as 5-aminosalicylic acid). Each tablet contains 400mg mesalazine.

The other ingredients are

Core: lactose monohydrate, sodium starch glycollate, magnesium stearate, talc, povidone.

Coating: methacrylic acid-methyl methacrylate copolymer (1:2), dibutyl sebacate, ferric oxide yellow (E172), ferric oxide red (E172) and macrogol 6000.

See also Section 2 on ‘Important information about some of the ingredients of Asacol 400mg MR tablets’.

Asacol 400mg MR tablets are red-brown, coated and oblong shaped. They are packed in a plastic bottle with a child-resistant closure that contains a cotton/silica gel moisture absorbing pouch. Asacol 400mg MR tablets are available in packs of 84, 90, 120 or 168 tablets (not all pack sizes may be marketed).

or