Asacol (Mesalamine)

Asacol 800mg MR Tablets. (Mesalazine)

WHAT ASACOL 800MG MR TABLETS ARE AND WHAT THEY ARE USED FOR

Asacol 800mg MR Tablets contain the active substance mesalazine (also known as 5-aminosalicylic acid) which is an anti-inflammatory drug used in the treatment of:

• Ulceratlve colitis – a disease of the large bowel (colon) and back passage (rectum) in which the lining of the bowel becomes inflamed (red and swollen). Symptoms can include rectal bleeding frequent diarrhoea and abdominal pain. Asacol 800mg MR Tablets act locally in the colon to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis
• Crohn’s ileo-colitis – a disease affecting the small bowel (terminal ileum) and colon in which the lining of the bowel becomes swollen and sore. This may lead to the development of ulcers abscesses and narrowing (strictures) in the bowel. Asacol 800mg MR Tablets act locally in the terminal ileum and colon to control the disease and prevent further flares of Crohn’s ileo-colitis

BEFORE YOU TAKE ASACOL 800MG MR TABLETS

Do not take the Asacol 800mg MR Tablets if you

• are allergic (hypersensitive) to any of the ingredients in the product
• are allergic to aspirin or any other salicylate
• had kidney problems or blood abnormalities while taking other medicines such as sulphasalazine
• have confirmed severe kidney or liver impairment
• have stomach ulcers, with or without bleeding

DO NOT give the tablets to children unless directed by a doctor

Take special care with Asacol 800mg MR Tablets

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, and in patients who ever had any blood disorder, especially while taking medicines such as sulphasalazines

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription

Asacol 800mg 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-ll inhibitors) and azathioprine in particular may increase the risk of kidney reactions

Pregnancy and breast-feeding

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

Driving and using machines

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

Important information about some of the ingredients of Asacol 800mg MR Tablets

Lactose – if you know you have an intolerance to some sugars, contact your doctor before taking this medicine

HOW TO TAKE ASACOL 800MG MR TABLETS

Always take Asacol 800mg MR Tablets exactly as you doctor has told you. You should check with your doctor if you are not sure

The tablets should be swallowed whole with water; do not break, crush or chew them. You can take them at any time of the day, with or without meals

The usual dose is

• Treating ulcerative colitis – up to 6 tablets each day divided throughout the day (as advised by your doctor)
• Preventing a flare of ulcerative colitis or Crohn’s ileo-colitis – up to 3 tablets each day divided throughout the day (as advised by your doctor)

DO NOT take more than 6 tablets a day

Asacol 800mg MR Tablets are not recommended for use in children.

When you start taking the tablets, your doctor may test your blood from time to time. Treatment should be stopped if there is suspicion or evidence of kidney or blood abnormalities

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

If you take more Asacol 800mg MR Tablets than you should

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 Asacol 800mg MR Tablets

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

If you have any further questions on the use of this product, ask your doctor or pharmacist

POSSIBLE SIDE EFFECTS

Like all medicines, Asacol 800mg MR Tablets can cause side effects although not everybody gets them

Allergic reactions to the tablets can occur. Tell your doctor If you get a rash (with or without Itching), any shortness of breath, palpitations (rapid heart beat) or chest pain. These effects will usually disappear when you stop taking the medicine.

Tell your doctor IMMEDIATELY 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
• vomiting
• nausea (feeling sick) •wind
• headache
• joint and muscular pain
• indigestion
• rectal disorder

Rare side effects

(in less than 1 in 1,000 people):

• problems with heart, liver, lung or kidney function
• inflammation of the liver or kidney
• inflammation of the pancreas
• blood abnormalities
• nerve ending damage, vertigo or dizziness
• chest pain or chest infections
• sinusitis (inflammation of lining of sinuses) or rhinitis (inflammatior of lining of nose)
• skin rashes
• hair loss
• unexplained wheezing or shortness of breath
• cough
• fever
• flu like symptoms

Very rare side effects

(in less than 1 in 10,000people):

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

If any of the side effects gets serious, or if your notice any side effects not listed in this leaflet, please tell your doctor.

HOW TO STORE ASACOL 800MG MR TABLETS

Keep out of the reach and sight of children

Do not remove the moisture absorbing pouch from the bottle

The pouch is not part of your medicine and is marked DO NOT EAT

Keep the bottle tightly closed

Do not use Asacol 800mg MR Tablets after the expiry date which is stated on the pack after ‘Exp’. The expiry date refers to the last day of that month

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

FURTHER INFORMATION

What Asacol 800mg MR Tablets contain

The active substance is mesalazine (also known as 5-aminosalicylic acid). Each tablet contains 800mg mesalazine

The other ingredients are

Core: lactose monohydrate, sodium starch glycolate, talc, povidone magnesium stearate, colloidal anhydrous silica

Coating: methacrylic acid – methyl mefhacrylate copolymer (1:2) talc, dibutylphthalate, ferric oxide red (E172), methacrylic acid -methyl methacrylate copolymer (1:1), ferric oxide yellow (E172) macrogol

Black ink containing: propylene glycol, ferric oxide black (E172) ammonium hydroxide, ethanol, shellac glaze (bleached, de-waxed)

What Asacol 800mg MR Tablets look like and contents of the pack

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 or 180 tablets (not all pack sizes may be marketed)

Getting more advice about Inflammatory Bowel Disease

In addition to advice and information available from your doctor and pharmacist, you may wish to contact the National Association for Colitis and Crohn’s Disease which offers information, advice and local support groups: