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The product code(s) for this leaflet is: PL36633/0002.
Octasa 400 mg MR Tablets
Octasa 400 mg Modified Release Tablets
mesalazine
1. What Octasa is and what it is used for
2. What you need to know before you take Octasa
3. How to take Octasa
4. Possible side-effects
5. How to store Octasa
6. Contents of the pack and other information
Octasa contains the active substance mesalazine. This is an anti-inflammatory medicine used to treat ulcerative colitis and Crohn’s ileo-colitis.
Octasa is used:
Ulcerative colitis is a disease of the large bowel (colon) or back passage (rectum), in which the lining of the bowel becomes inflamed (red and swollen).
Crohn’s ileo-colitis is a disease that affects the small bowel (terminal ileum) and the large bowel (colon) in which the lining of the bowel becomes inflamed. This can lead to ulcers, abscesses and narrowing (strictures) in the bowel.
Octasa acts locally at the site of inflammation (colon, rectum and terminal ileum) to reduce this inflammation.
Talk to your doctor before taking Octasa if you have any medical conditions or illnesses, particularly if you have:
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.
If you have an ulcer of the stomach or intestine, you may take Octasa with care.
Kidney stones may develop with use of Octasa. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with Octasa.
Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.
Before and while you are taking Octasa, your doctor may want to monitor you from time to time, to check that your liver, kidneys, blood and lungs are all right.
There have been a few reports of intact tablets in the stool. What appear to be intact tablets may sometimes be the remains of the tablet coating. If you often observe tablets or tablet shells in the stool, you should consult your doctor.
Octasa is only recommended for use in children 6 years and older.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines such as:
You may eat and drink normally (including alcohol), when taking Octasa.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Octasa is not expected to affect your ability to drive or operate machinery. However, if you are affected in anyway, do not drive or operate machinery.
Patients who are intolerant to lactose should note that Octasa contains 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”.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Octasa should be taken before meals. This medicine must be swallowed whole preferably with some liquid. Do not chew, crush or break the tablets before swallowing them.
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 kidney.
Adults (including the elderly):
To treat ulcerative colitis, your daily dose is 6 to 12 tablets. 6 tablets may be taken once daily or in divided doses (as advised by your doctor). Above 6 tablets a day should be taken in divided doses.
To prevent Crohn’s ileo-colitis or ulcerative colitis your daily dose is 3 to 6 tablets once daily or in divided doses. Follow your doctor’s instructions. Do not take more than 12 tablets a day and do not take more than 6 tablets at the same time.
Octasa is only recommended for use in children 6 years and older.
The daily dose depends on the child’s weight.
20-30 kg weight: two to three tablets per day.
30-40 kg weight: two to four tablets per day in divided doses. 40 kg weight: three to five tablets per day in divided doses. The total dose should not exceed 4 g/day.
20-30 kg weight: one tablet per day.
30-40 kg weight: one to 2 tablets per day
40 kg weight: one to three tablets per day in divided doses. The total dose should not exceed 2 g/day.
It is generally recommended that half the adult dose may be given to children up to 40 kg weight; and the normal adult dose to those above 40 kg.
You should not take a higher dose than your doctor has prescribed for you. Contact your nearest hospital casualty department or a doctor for advice if you or anyone else has swallowed too many tablets or if you think a child has swallowed any. Take this leaflet, and any tablets that you still have to show the doctor.
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Octasa without talking to your doctor first even if you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Organ specific side effects affecting the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue have been reported.
The following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Very rare (may affect up to 1 in 10000 people)
Not known (frequency cannot be estimated from available data)
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 any side effects directly via the Yellow Card Scheme online at yellowcard.mhra.gov.uk or via the free Yellow Card app. By reporting side effects you can help provide more information on the safety of this medicine.
Do not use this medicine after the expiry date which is stated on the outer packaging. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
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The active substance is mesalazine. Each tablet contains 400 mg mesalazine The other ingredients are: lactose monohydrate, sodium starch glycolate (Type A), triethyl citrate, E553b, methacrylic acide – methylmethacrylate copolymer (1:2), povidone E1201, magnesium stearate (vegetable origin), iron oxides E172, macrogol 6000
Octasa 400 mg Modified Release Tablets are red-brown, oblong, tablets.
They are available in pack sizes of 90 or 120 tablets.
Not all pack sizes may be marketed.
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Please be ready to give the following information:
Product name Octasa 400 mg Modified Release Tablets
Reference number PL 36633/0002
This leaflet was last revised in January 2023