• 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 800mg MR tablets are and what they are used for
2. What you need to know before you take Asacol 800mg MR tablets
3. How to take Asacol 800mg MR tablets
4. Possible side effects
5. How to store Asacol 800mg MR tablets
6. Contents of the pack and other information

Talk to your doctor before taking Asacol 800mg MR tablets if you have any medical conditions or illnesses. Tell your doctor if you have:

• ever had any problems with your liver or kidneys, especially if you are elderly.
• suffered an allergy to the medicine sulfasalazine in the past.
• ever had allergic reactions of your heart such as inflammation of the heart muscle or heart sac. If you have had previous allergic reactions of your heart from mesalazine, then do not take Asacol 800mg MR tablets. Asacol 800mg MR tablets can be taken with care if you have had a previous allergic reaction of the heart even if not caused by taking mesalazine.
• ever developed a severe skin rash or skin peeling, blistering and/or mouth ulcers after using mesalazine

Serious skin reactions have been seen with mesalazine treatment. If you notice any symptoms of a skin reaction (listed in Section 4), stop taking Asacol and seek medical help immediately.

Asacol can cause red-brown urine in the toilet water. The colour change happens because of a reaction between mesalazine and bleach, but it doesn’t harm you.

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription (over-the-counter).

Tell your doctor if you use any of the following:

• medicines that affect the immune system such as azathioprine, 6-mercaptopurine or thioguanine
• medicines that prevent the formation of blood clots, such as warfarin.

Asacol 800mg MR tablets should NOT be taken with Lactulose, a medicine for constipation.

Certain medicines can increase the risk of kidney reactions. These include:

• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, or naproxen.
• azathioprine, a medicine that weakens the immune system.

Women who are pregnant or breast-feeding should not take Asacol 800mg 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 800mg 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.

Kidney stones may develop with use of mesalazine. Kidney stones are hard lumps that can cause pain in your sides and blood in your urine. Take care to drink enough liquid during treatment with mesalazine. This can help prevent kidney stones from developing.

Asacol 800mg MR tablets are not expected to affect your ability to drive or operate machinery.

• Lactose (a type of sugar contained in milk). This medicine contains a small amount of lactose. If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Sodium (salt). This medicine contains less than 1 mmol (23 mg) sodium per dosage unit, i.e. is essentially “sodium-free”.

Keep taking the 800mg MR 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 take more than 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 two doses together. If it is almost time for your next dose, wait until then and carry on as before.

• Reddish patches on the body that look like targets or circles. These patches might have blisters in the middle and your skin could peel. You may also have ulcers in your mouth, throat, nose, genitals and eyes. This rash can spread all over your body and you might have a fever and other flu-like symptoms (body aches, tiredness).

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

• Diarrhoea
• Stomach pain
• Vomiting
• Nausea (feeling sick)
• Wind
• Headache
• Joint and muscle pain
• Indigestion
• Rectal disorder (issues around the rectum, the part of the body where stool is held and then leaves the body).

Rare side effects (may affect less than 1 in 1,000 people):

• Problems with heart (including inflammation of the heart muscles and associated structures)
• Problems with liver (including inflammation of liver, liver failure, or abnormal liver tests)
• Problems with lung [including eosinophilic pneumonia (a lung disease where certain white blood cells increase in the lungs and bloodstream), bronchospasm (breathing difficulty caused by narrowed airways), unexplained wheezing or shortness of breath]
• Problems with kidney [including inflammation, scarring, or kidney failure, (which may go away if treatment is stopped early)]
• Inflammation of the pancreas, an organ involved in digestion
• Problems with blood (including a decrease in the number of white blood cells (help fight infection), red blood cells (carry oxygen to the body) and/or platelets (help stop bleeding)
• Numbness and tingling of the fingers and toes caused by nerve damage,
• Feeling dizzy or experiencing a spinning sensation (vertigo)
• Chest pain or chest infections
• Sinusitis (inflammation of the sinuses, which can cause pain and pressure in the face)
• Rhinitis (inflammation of the lining of the nose, which can cause a runny or stuffy nose)
• Skin rashes
• Skin blisters filled with fluid.
• Hair loss
• Cough
• Drug fever (having a fever while taking the medicine, which goes away when the medicine is stopped)
• Flu like symptoms such as body aches and tiredness
• Lupus, a long-term disease that can cause swelling and pain in any part of the body.

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

• Symptoms of colitis get worse
• Erythema multiforme (skin disorder that can cause redness and rashes).
• Lung scarring (tissue in the lungs becomes thick and stiff, making it hard to breathe)
• Temporary decrease in sperm count that returns to normal when the medicine is stopped

Not known (frequency cannot be estimated from available data)

• Allergic reactions
• Constipation
• Lung disease (allergic reactions and diseases which can cause difficulty breathing, chest pain, and dry cough)
• Kidney stones and pain in your sides (see also Section 2).
• Increased pressure in the brain: which can cause headaches that start behind the eyes and get worse when moving your eyes. You may also have blurry or dim vision, double vision (seeing two objects when there is only one) see light flashes, difficulty seeing to the side, and brief or permanent vision loss. These symptoms can also come with dizziness, nausea, vomiting, and ringing in your ears.
• Serious illness with blistering of the skin. These blisters can lead to skin peeling and result in painful, raw areas. This condition can also affect your mouth, eyes and genitals.
• Issues tolerating mesalazine. This can make your existing condition worse, causing severe diarrhoea and abdominal pain.

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

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. Each tablet contains 800 mg of mesalazine.

• Other ingredients inside the medicine core: lactose monohydrate (see Section 2), sodium starch glycolate, talc, povidone, magnesium stearate, colloidal anhydrous silica.
• Ingredients that coat the tablet: methacrylic acid-methyl methacrylate copolymer (1:2), talc, dibutyl sebacate, ferric oxide red (E172), methacrylic acid – methyl methacrylate copolymer (1:1), ferric oxide yellow (E172), macrogol.
• Ingredients to label the medicine: propylene glycol, ferric oxide black (E172), ammonium hydroxide, shellac.

Asacol 800mg MR tablets are red-brown, coated, and oblong shaped, marked with WC 800. They are packed in a plastic bottle with a child- resistant closure that contains cotton/silica gel moisture absorbing pouches. Asacol 800mg MR tablets are available in packs of 12, 36, 84 or 180 tablets (not all pack sizes may be marketed).

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