POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL45496/0002.
Asacol 800mg MR Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Asacol® 800mg MR tablets
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Asacol 800mg MR tablets are and what they are used for
2. 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. Further information
1. 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:
2. BEFORE YOU TAKE ASACOL 800MG MR TABLETS
Do not take the Asacol 800mg MR tablets if you:
DO NOT give the tablets to children unless directed by a doctor.
Take special care with Asacol 800mg MR tablets
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-II 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.
Tests on your liver, kidney and blood
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 periodically during your treatment.
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
3. HOW TO TAKE ASACOL 800MG MR TABLETS
Always take Asacol 800mg MR tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.
The tablets should be swallowed whole with water without breaking, crushing or chewing the tablet. You can take them at any time of the day, with or without meals.
Whilst taking this medicine ensure you drink adequate fluids to remain well hydrated, especially after severe or prolonged episodes of vomiting and /or diarrhoea, high fever or heavy sweating. This is to avoid problems with your kidneys.
The usual dose is:
DO NOT take more than 6 tablets a day.
Asacol 800mg MR tablets are not recommended for use in children.
If you stop taking Asacol 800mg MR tablets
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Asacol 800mg MR tablets can cause side effects, although not everybody gets them.
Allergic reactions can occur. Tell your doctor if you get:
Tell your doctor immediately
if you experience any of the following symptoms:
Common side effects (in more than 1 in 100 people but less than 1 in 10 people):
Rare side effects (in less than 1 in 1,000 people):
Very rare side effects (in less than 1 in 10,000 people):
Reporting of side effects
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ASACOL 800MG MR TABLETS
Keep out of the sight and reach of children.
Please keep the moisture absorbing pouch in 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.
6. 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 methacrylate copolymer (1:2), talc, dibutyl sebacate, 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, shellac.
See also end of Section 2 on ‘Important information about some of the ingredients of Asacol 800mg MR tablets’.
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, 84 or 180 tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder
Getting more advice about ulcerative colitis or Crohn’s ileo-colitis
In addition to advice and information available from your doctor and pharmacist, you may wish to contact Crohn’s and Colitis UK for Colitis and Crohn’s Disease which offers information, advice and local support groups.
Telephone Information Line:
0845 130 2233 (Monday to Friday 10am - 1pm)
Crohn’s and Colitis Support Line:
0845 130 3344 (Monday to Friday 1.00pm- 3.30pm / 6.30pm - 9pm)
Large print, braille, audio format leaflet
To obtain this leaflet in large print, braille or audio format, please call the following freephone number: 0800 198 5000.
Asacol® is a Trademark
Asacol® is a Trademark Marketing Authorisation Number:
This leaflet was last revised in