Consumer medicine information

Mesasal

Mesalazine

BRAND INFORMATION

Brand name

Mesasal

Active ingredient

Mesalazine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Mesasal.

What is in this leaflet?

This leaflet answers some common questions about MESASAL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MESASAL against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What MESASAL is used for

MESASAL contains the active ingredient mesalazine (5-aminosalicylic acid) which is used to treat:

  • acute inflammatory bowel disease

MESASAL is used for regular treatment of:

  • Crohn's disease
  • ulcerative colitis

This medicine belongs to a group of medicines called salicylates.

It works by suppressing inflammation in the large intestine.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you take MESASAL

When you must not take it

Do not take MESASAL if you have an allergy to:

  • mesalazine
  • any other aspirin-like medicines
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take MESASAL if you:

  • have severe kidney problems
  • have a bleeding disorder or if you are taking medicines to stop your blood from clotting
  • have a stomach or duodenal ulcer
  • are in the last weeks of pregnancy

Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.

Do not breast-feed if you are taking this medicine.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney or liver problems
  • lung or breathing problems such as asthma

You must tell your doctor if:

  • you have taken MESASAL or an aspirin-like medicine before and became unwell
  • you have ever had an allergic reaction (such as rash) to MESASAL, sulfasalazine or aspirin-like medicines in the past

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start taking MESASAL.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and MESASAL may interfere with each other. These include:

  • anti-coagulant medicines such as warfarin, a medicine used to prevent blood clots
  • glucocorticoids, medicines used to treat inflammation or swelling e.g. prednisolone
  • medicines used to treat diabetes by lowering blood sugar levels (e.g. oral hypoglycemics)
  • medicines which contain probenecid and sulphinpyrazone
  • medicines used to increase urine flow, such as spironolactone and frusemide
  • medicines which contain rifampicin
  • medicines used to suppress the immune system such as methotrexate, azathioprine or 6-mercaptopurine

These medicines may be affected by MESASAL or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take MESASAL

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Take MESASAL as directed by your doctor or pharmacist.

The usual dose of MESASAL for acute ulcerative colitis and Crohn's disease is two tablets, three times a day.

To prevent relapses of ulcerative colitis or maintain remission of Crohn's disease, the usual dose is one tablet, three times a day.

How to take it

Swallow the tablets whole with a glass of water.

Do not crush or chew the tablets.

When to take it

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Take your medicine at least 30 minutes before food.

How long to take it

Continue taking your medicine for as long as you doctor tells you to.

This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice , or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much MESASAL. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using MESASAL

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking MESASAL.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not take MESASAL to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how MESASAL affects you.

Side-effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MESASAL.

This medicine helps most people with inflammatory bowel disease, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • headache
  • mild stomach pains
  • excessive gas in the stomach or bowel
  • increased number of bowel motions
  • diarrhoea
  • feeling sick (nausea)
  • itchy skin or rash
  • dizziness
  • common cold

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • fever, muscle aches and pains, painful joints and chest pain (sometimes spreading to the neck and shoulders, and sometimes fever)
  • mild skin rash, itching or hives
  • severe upper stomach pain, often with nausea and vomiting
  • numbness or weakness of the arms and legs
  • wheezing, swelling of the limbs/ lips/ tongue/ mouth/ face/throat, difficulty in breathing or swallowing, hayfever, lumpy rash (hives) or fainting.
    These could be symptoms of an allergic reaction.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Other rare events, which have been reported with mesalazine, include:

  • changes in kidney function and inflammation of the kidney
  • changes in blood test results such as low white blood cell and/or platelet counts
  • changes in liver function tests
  • liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine
  • changes relating to your heart
  • allergic, inflammatory or other lung conditions
  • shortness of breath, difficulty breathing, cough, wheezing, chest pain that worsens when breathing
  • increased sensitivity of the skin to sun and ultraviolet light (photosensitivity)
  • reversible decrease in semen production (oligospermia)
  • hair loss and the development of baldness (alopecia)
  • severe diarrhoea and abdominal pain due to an allergic reaction to this medicine (pancolitis)

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some side effects can only be found when your doctor does tests from time to time to check your progress.

After using MESASAL

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack, they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C. Protect the tablets from light and moisture.

Do not store MESASAL or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

MESASAL tablets are round, biconvex and tan coloured.

Ingredients

MESASAL contains 250 mg of mesalazine as the active ingredient.

The enteric coated tablets also contain the following inactive ingredients:

  • sodium carbonate
  • glycine
  • microcrystalline cellulose
  • calcium stearate
  • povidone
  • colloidal silica anhydrous

The coating on the tablets contains:

  • povidone
  • titanium dioxide
  • red iron oxide (CI77491)
  • yellow iron oxide (CI77492)
  • purified talc
  • Macrogol 6000
  • methacrylic acid
  • triethyl citrate

MESASAL contains 47.7 mg elemental sodium per enteric coated tablet.

Distributor

MESASAL is distributed in Australia by:

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in December 2022.

Australian registration numbers:
AUST R 289132

MESASAL® is a Viatris company trade mark

mesasal_cmi\Dec22/00

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Mesasal

Active ingredient

Mesalazine

Schedule

S4

 

1 Name of Medicine

Mesalazine.

2 Qualitative and Quantitative Composition

Each enteric-coated tablet contains 250 mg of mesalazine as the active ingredient.

Excipients of known effect.

47.7 mg elemental sodium per enteric coated tablet.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Mesasal 250 mg enteric-coated tablets are round, biconvex and tan coloured.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of acute inflammatory large bowel disease.
Maintenance therapy of Crohn's colitis and ulcerative colitis in patients sensitive to sulfasalazine.

4.2 Dose and Method of Administration

In acute ulcerative colitis, remissions will usually occur within 8 weeks.

Adults.

Treatment of acute ulcerative colitis and Crohn's disease.

500 mg (2 x 250 mg tablets) three times daily, (or as directed by a physician). Total daily dose 1.5 g. The tablets should be taken at least 30 minutes before meals with plenty of fluid.

Prevention of relapses in ulcerative colitis.

250 mg three times daily.

Maintenance of remission of Crohn's disease.

250 mg three times daily.

4.3 Contraindications

A history of hypersensitivity to mesalazine, other salicylates or any of the excipients in Mesasal.
Severe renal impairment (glomerular filtration rate < 20 mL/min).
Pathological tendency to bleeding, or concomitant anticoagulants.
Active peptic ulceration.
Mesasal is contraindicated in the last weeks of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).

4.4 Special Warnings and Precautions for Use

Caution should be exercised when administering mesalazine to patients with:
a history of hypersensitivity to sulfasalazine; although in general, hypersensitivity reactions to mesalazine appear to be less frequent than those observed for sulfasalazine.
Do not administer mesalazine with preparations which lower stool pH, such as lactulose.
If toxic or hypersensitivity reactions occur, mesalazine should be discontinued.
Although rare, blood dyscrasias may develop during therapy. Practitioners should be aware of the possibility of their occurrence and be prepared to cease treatment immediately.
Keratoconjunctivitis sicca has been observed rarely in dogs chronically dosed with mesalazine. There have been no spontaneous clinical reports of keratoconjunctivitis sicca in man.
Long-term administration (> 1 year) of 5-aminosalicylic acid (up to 320 mg/kg/day) to rats resulted in renal nephropathy, gastric ulceration and increased plasma levels of 5-aminosalicylic acid and acetyl-5-aminosalicylic acid. The clinical significance of these findings to man has not been determined.
Mesalazine may produce red-brown urine discolouration after contact with sodium hypochlorite bleach (e.g. in toilets cleaned with sodium hypochlorite contained in certain bleaches).

Use in pulmonary function impairment.

Mesasal should be used with caution in patients with pulmonary function impairment, particularly asthma and in patients with known hypersensitivity to sulfasalazine containing preparations. Treatment in the latter patients should be instituted with careful medical supervision. Treatment should be discontinued immediately if symptoms of acute intolerance e.g. cramps, acute abdominal pain, fever, severe headache and skin rash occur.

Nephrolithiasis.

Cases of nephrolithiasis have been reported with the use of mesalazine, including stones with mesalazine content. Ensure adequate fluid intake during treatment.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCARs), 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. Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reaction, such as skin rash, mucosal lesions, or any other signs of hypersensitivity.

Idiopathic intracranial hypertension.

Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine should be considered.

Special instructions to patients.

Mesasal tablets should be taken with plenty of fluid. The tablets should not be crushed or chewed but swallowed whole.

Use in hepatic impairment.

Caution should be exercised when administering mesalazine to patients with:
hepatic impairment, as mesalazine is metabolised in the liver;
mesalazine might cause blood dyscrasias, although rarely reported, and hepatic impairment due to hypersensitivity reactions. Blood parameters, like blood counts and liver function and cholestasis parameters (e.g. ALT, AST, alkaline phosphatase, γGT) may be monitored like the renal parameters. Epigastric pain, also commonly associated with inflammatory bowel disease and prednisone or sulfasalazine therapy, should be investigated in order to exclude pericarditis, hepatitis and pancreatitis either as adverse drug reactions to 5-ASA or secondary manifestations or inflammatory bowel disease.

Use in renal impairment.

Caution should be exercised when administering mesalazine to patients with:
renal failure, elevated blood urea nitrogen (BUN) and proteinuria;
renal impairment (given that 5-ASA is primarily eliminated through acetylation and subsequent urinary excretion). Interstitial nephritis has been reported following treatment with mesalazine. Hence, patients with compromised renal function, impaired renal reserve or individuals with an increased risk of developing renal dysfunction due to use of nephrotoxic drugs or other co-morbid conditions should be carefully monitored throughout the duration of therapy, and especially during the early months of treatment. Treatment with mesalazine should be discontinued promptly if renal function significantly deteriorates. Care should be taken to ensure adequate hydration in patients with compromised renal function during exacerbations of inflammatory bowel disease.
In view of the rare risk of interstitial nephritis associated with mesalazine treatment, it is recommended that all patients have their renal function monitored (with serum creatinine levels measured) prior to treatment start. Renal function should then be periodically monitored during chronic treatment, based on individual patient history. Treatment with mesalazine should be discontinued promptly if renal function deteriorates.

Use in the elderly.

Regular monitoring of renal function in the elderly is essential as renal function deteriorates with age (see Section 4.3 Contraindications).

Paediatric use.

Administration in children is not recommended.

Effects on laboratory tests.

False-positive liquid chromatography assay results for urinary normetanephrine have been reported in patients receiving sulfasalazine or its metabolite, mesalazine.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There have been no specific studies on interactions of mesalazine with other drugs that may be coadministered.
In common with other salicylates, mesalazine may potentiate the effect of coumarin anticoagulants and the blood sugar reducing effect of sulfonylureas. Mesalazine may delay the excretion of methotrexate and may antagonise the effects of probenecid and sulfinpyrazone. There is also the theoretical possibility that mesalazine may decrease the diuretic effect of furosemide and spironolactone and may affect the action of rifampicin. Lactulose or similar preparations may cause a possible reduction of mesalazine release from tablets due to decreased pH caused by bacterial metabolism.
There is in vitro evidence that mesalazine is a weak inhibitor of the azathioprine metabolising enzyme thiopurine methyltransferase (TPMT). Enhancement of the myelosuppressive effects of azathioprine or 6-mercaptopurine may occur rarely in patients who are treated concomitantly with mesalazine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Decreased sperm count and impaired sperm motility, which may affect male fertility, have been reported with mesalazine. This effect may be reversible when treatment is discontinued (see Section 4.8 Adverse Effects (Undesirable Effects)).
(Category C)
Adequate human data on use during pregnancy are not available. There is a small theoretical risk that, in common with other nonsteroidal anti-inflammatory agents, mesalazine may produce premature closure of the ductus arteriosus; may cause fetal renal impairment; and may, if given at term, prolong labour and delay parturition. The intake of aspirin (acetylsalicylic acid) increases the bleeding tendency both in the newborn child and in the mother.
Mesalazine is a salicylate and therefore is not recommended during pregnancy unless in the physician's opinion, benefits outweigh the potential risk in the first stages of pregnancy. Mesalazine is contraindicated in the last weeks of pregnancy.
 It is recommended that breastfeeding be discontinued during maternal use of mesalazine. While adequate human data on use during lactation and adequate animal reproduction studies are not available, there are reports of mesalazine and its acetylated metabolite being excreted in human breast milk.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

In clinical trials totalling 2,164 patients, adverse reactions related to treatment with mesalazine occurred in 5.3% of patients; these were severe enough to lead to withdrawal in 1.4% of patients. A further 1.5% of patients had adverse reactions that were possibly drug related. The incidence of adverse reactions was lower amongst patients receiving mesalazine than the comparator drug (sulfasalazine).

Gastrointestinal system.

Common: nausea, abdominal pain and diarrhoea have been reported. Acute, reversible pancreatitis and exacerbation of the symptoms of colitis have been reported rarely.

Nervous system.

Headache, neuropathy.
Frequency unknown: idiopathic intracranial hypertension (see Section 4.4 Special Warnings and Precautions for Use).

Skin and appendages.

Rash (including pruritus and urticaria).

Renal.

There have been rare reports of renal disorders including cases of acute and chronic interstitial nephritis and renal failure with various mesalazine formulations. Cases of nephrolithiasis have also been reported.

Hepatobiliary.

In common with other salicylates, transitory abnormal liver function tests or hepatitis may occur rarely.

Haematological effects.

Alterations in peripheral blood counts (e.g. leucopenia, neutropenia, thrombocytopenia, aplastic anaemia, agranulocytosis) have been reported rarely for various mesalazine formulations.

Reproductive system disorders.

Oligospermia (reversible) and impaired sperm motility (see Section 4.6 Fertility, Pregnancy and Lactation, Effects on fertility).

Hypersensitivity.

In common with other salicylates, hypersensitivity reactions including pulmonary and cardiac changes may occur rarely. These reactions include fever, myalgia, arthralgia, alveolitis, myocarditis and pericarditis although these have also been reported as extra-intestinal manifestations of the underlying bowel disease.

Skin and subcutaneous tissue disorders.

Severe cutaneous adverse reactions (SCARs), 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 (see Section 4.4 Special Warnings and Precautions for Use). Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reaction, such as skin rash, mucosal lesions, or any other signs of hypersensitivity.
Frequency unknown: drug reaction with eosinophilia and systemic symptoms (DRESS).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

There is no specific pattern of symptoms following overdose with mesalazine. Possible symptoms may include nausea, vomiting and diarrhoea and symptoms similar to salicylate overdose.

Treatment.

Treatment consists of supportive and symptomatic measures. Further management should be as clinically indicated or as recommended by the national poisons centre, where available. There is no specific antidote.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mesalazine has been identified as the active component of sulfasalazine in inflammatory bowel disease and is thought to have a topical action.
In clinical studies, mesalazine has shown clinical efficacy similar to sulfasalazine.
The mode of the anti-inflammatory action of mesalazine is unknown. Inhibition of prostaglandin synthesis (via inhibition of cyclooxygenase), inhibition of chemotactic leukotriene synthesis (via inhibition of lipoxygenase), and direct inhibition of leukocyte motility may contribute to activity. More recent data suggest that the activity of mesalazine is based on a scavenging of oxygen free radicals, and that mesalazine is a biological antioxidant.
Mesasal enteric-coated tablets have an acrylic based resin coating which disintegrates when the surrounding pH is consistently above 6.4, permitting release of mesalazine in the terminal ileum and colon. The tablet coating is not affected by gastric contents or gastric residence time; but the presence of food tends to delay onward passage of the tablet.
Food may also delay the rate of absorption of mesalazine. In view of the probable topical action of mesalazine, however, this may not be therapeutically relevant.
Disintegration of the coating typically occurs about 5 hours after leaving the stomach. The simultaneous administration of agents which raise the gastric pH above 6.4, and the presence of achlorhydria, may decrease the time to release of mesalazine (also see Section 4.4 Special Warnings and Precautions for Use).

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Healthy volunteers.

In fasted, healthy subjects given a single oral dose of mesalazine (500 mg), time to peak plasma concentration was 6.5 hours for mesalazine and 7 hours for acetyl-5-aminosalicylic acid (Ac-5-ASA). Urinary recovery was approximately 35%, and faecal recovery 26.5% of total dose.

Patients with Crohn's disease or ulcerative colitis.

Absorption.

After oral administration of mesalazine 500 mg tid, the mean steady-state plasma concentrations of 5-ASA and Ac-5-ASA averaged 0.7 and 1.2 microgram/mL, respectively.
After oral doses of mesalazine 250 mg tid, the mean steady-state plasma concentration of 5-ASA and Ac-5-ASA averaged 0.4 and 1.0 microgram/mL, respectively.
Peak concentrations of 5-ASA and Ac-5-ASA occurred at 4 to 6 hours after dosing.
Urine recovery data indicate that up to 44% of the dose is absorbed. Up to 35% of the dose remains unabsorbed and is excreted in the faeces.

Distribution.

About 80% of Ac-5-ASA is bound to plasma proteins.

Metabolism.

Acetylation of mesalazine takes place in the liver and in the wall of the colon independently of acetylator status. The acetylation process appears to be saturable; however, at therapeutic doses (250 - 500 mg) neither maximum plasma concentration, nor area under the plasma concentration versus time curve for mesalazine indicated any deviation from dose linearity at steady state.

Excretion.

The mean elimination half-life of 5-ASA is 1.4 hours. Following oral administration, mesalazine is eliminated to a large extent as N-acetyl-5-aminosalicylic acid, both in the urine and the faeces. Following rectal administration, mesalazine is eliminated mainly as parent drug in the faeces. A poorer absorption of mesalazine from the distal colon has been suggested.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The enteric-coated tablets also contain: calcium stearate, colloidal anhydrous silica, glycine, iron oxide red, iron oxide yellow, macrogol 6000, methacrylic acid copolymer, microcrystalline cellulose, povidone, purified talc, sodium carbonate, titanium dioxide and triethyl citrate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Container type: blister pack (PVC/PVDC/Al).
Pack sizes: 100.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 289132 - Mesasal mesalazine 250 mg enteric-coated tablet blister pack.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: 5-amino-2- hydroxybenzoic acid.
Molecular weight: 153.1.

CAS number.

89-57-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes