Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Mesalazine Tillotts 800 mg MR tablets contain the active substance mesalazine. This is an antiinflammatory medicine used to treat ulcerative colitis and Crohn's ileo-colitis. Mesalazine Tillotts 800 mg MR tablets are used: • to treat and prevent further episodes of ulcerative colitis • to prevent further episodes of Crohn's ileo-colitis once the disease has been brought under control. 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. Mesalazine Tillotts 800 mg MR tablets acts locally at the site of inflammation (colon, rectum and terminal ileum) to reduce this inflammation.
section 6)
• If you are allergic to salicylates (e. g. aspirin)
• If you have severe kidney problems
• If you have severe liver problems Warnings and precautions Talk to your doctor before taking Mesalazine Tillotts 800 mg MR tablets if you have any medical conditions or illnesses, particularly if you have:
• ever had any problems with your kidneys. This is especially important if you are elderly.
• any lung problems, e. g. asthma.
• suffered an allergy to 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 suspected mesalazine-induced allergic reactions of your heart, then Mesalazine Tillotts 800 mg MR tablets must not be taken. Mesalazine Tillotts 800 mg MR tablets can be taken with care if you have had a previous allergic reaction of the heart not caused by mesalazine.
• ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine. If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears contact your doctor immediately. 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 Mesalazine Tillotts 800 mg MR tablets with care. Kidney stones may develop with use of Mesalazine Tillotts 800 mg MR tablets. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with Mesalazine Tillotts 800 mg MR tablets. 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. Test for your liver, kidney and blood Before and while you are taking Mesalazine Tillotts 800 mg MR tablets, 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. Children and adolescents Mesalazine Tillotts 800 mg MR tablets is only recommended for use in children 6 years and older.
Other medicines and Mesalazine Tillotts 800 mg MR tablets Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines such as:
• drugs affecting the immune system (e. g. azathioprine, or 6-mercaptopurine or thioguanine)
• drugs that prevent the formation of blood clots (anticoagulants, e.g., warfarin) Mesalazine Tillotts 800 mg MR tablets with food, drink and alcohol You may eat and drink normally (including alcohol), when taking Mesalazine Tillotts 800 mg MR tablets. Pregnancy and breast-feeding and fertility 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. Driving and using machines Mesalazine Tillotts 800 mg MR tablets are not expected to affect your ability to drive or operate machinery. However, if you are affected in anyway do not drive or operate machinery. Important information about some of the ingredients of Mesalazine Tillotts 800 mg MR tablets People who are intolerant to lactose should note that Mesalazine Tillotts 800 mg MR tablets contain a small amount of lactose. If you 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 "sodiumfree".
at the same time. Use in children and adolescents Mesalazine Tillotts 800 mg MR tablets are only recommended for use in children 6 years and older. The daily dose depends on the child's weight.
• To treat acute phases of ulcerative colitis: 20-30 kg weight: one tablet per day. 30-40 kg weight: one to two tablets per day in divided doses. Above 40 kg weight: two to three tablets per day in divided doses. The total dose should not exceed 4 g/day.
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These serious skin rashes can be preceded by fever and flu-like symptoms
• Unexplained bruising (without injury), bleeding under your skin, purple spots or patches
• To prevent ulcerative colitis or Crohn's ileo-colitis: 30-40 kg weight: one tablet per day. Above 40 kg weight: one to two 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. If you take more Mesalazine Tillotts 800 mg MR tablets than you should 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 Mesalazine Tillotts 800 mg MR tablets If you forget to take a dose at the right time, 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. If you stop taking Mesalazine Tillotts 800 mg MR tablets Do not stop taking Mesalazine Tillotts 800 mg MR tablets 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. 4. Possible side-effects 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. Stop taking the medicine and seek urgent medical advice immediately if you experience any of the following:
• Lung disease (scarring of lung tissue, allergic reaction) resulting in difficulty in breathing, cough, wheezing and collection of fluid in the lungs, pneumonia
• Abnormal liver function tests, hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice)
• Inflammation of the heart with signs like chest pains or palpitations
• Disorder of the immune system (lupus-like syndrome) which can cause inflammation of the heart sac or membranes around the lungs and heart, rash and /or joint pain
• rash
• indigestion Uncommon (may affect up to 1 in 100 people)
• fever
• high number of white blood cells called eosinophil granulocytes
• sensation of tingling, pricking and numbness
• hives, itching skin
• chest pain Rare (may affect up to 1 in 1000 people)
• headache
• dizziness
• diarrhoea, stomach pain, wind (flatulence), feeling of unease and discomfort in the stomach with an urge to vomit and vomiting
• increased sensitivity of your skin to sun and ultraviolet light (photosensitivity). Very rare (may affect up to 1 in 10000 people)
• severe reduction in blood cells which can cause weakness, bruising or make infections more likely, low blood cell counts; reduction in blood platelets which increases the risk of bleeding
• allergic reactions such as rash or skin eruption
• fever that occurs while taking the medicine and which disappears when the medicine is stopped (drug fever)
• immune system disease that can involve organs and joints
• ulcerative colitis involving the entire large intestine
• abnormal or damaged nerves giving a sensation of numbness or tingling
• inflamed pancreas (associated with pain in upper abdomen and back and feeling sick)
• abnormal liver function tests, hepatitis (inflammation of the liver giving rise to flu-like symptoms and jaundice)
• muscle or joint pain
• hair loss
• reversible decrease in sperm production
under your skin, anaemia (feeling tired, weak and looking pale, especially on lips, nails and inside of eyelids), fever (high temperature), sore throat or unusual bleeding (e.g. nose bleeds).
• Kidney problems (associated with blood in urine and/or swelling in feet and ankles), kidney failure, which may be reversible if treatment is stopped early Tell your doctor immediately if you experience strong or recurrent headache, disturbed vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure within your skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from the available data]). The following side effects have been reported at the approximate frequencies shown: Common (may affect up to 1 in 10 people)
Not known (frequency cannot be estimated from available data)
• inflammation of the membranes of the pleural cavity surrounding the lungs (pleurisy)
• intolerance to mesalazine sometimes with worsening symptoms of underlying disease
• kidney stones and associated kidney pain (see also section 2)
• weight loss
• laboratory test results out of normal range 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 any side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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.
e-mail: [email protected] The manufacturers are: Haupt Pharma Wülfing GmbH,31028 Gronau,Germany Rottendorf Pharma GmbH, 59320 Ennigerloh, Germany Tillotts Pharma GmbH, 79618 Rheinfelden, Germany To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Mesalazine Tillotts 800 mg Modified-release tablets Reference number PL 36633/0017 This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in January 2026.
Mesalazine Tillotts 800 mg Modified-release tablets comes as tablet containing 800 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Mesalazine Tillotts 800 mg Modified-release tablets is mesalazine.
Medicines with the same active substance include: Asacol 800mg MR Tablets, Mesalazine Dr Falk Pharma 2g Enema (previously known as Salofalk), Mesalazine Dr Falk Pharma 500mg suppositories (previously known as Salofalk), Mesalazine Ferring 1 g Rectal Suspension, Mesalazine Ferring 1g Suppositories, Mesalazine Tillotts 1g Suppositories. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Mesalazine Tillotts 800 mg Modified-release tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Mesalazine Tillotts 800 mg is indicated in adults, children and adolescents above 6 years for:
Ulcerative Colitis:
For the treatment of mild to moderate acute exacerbations. For the maintenance of remission.
Crohn's ileo-colitis:
For the maintenance of remission.
Posology
Adults
Mild acute disease: 2.4 g (three tablets) once daily or in divided doses, with concomitant corticosteroid therapy to be taken when clinically indicated.
Moderate acute disease: 2.4 g to 4.8 g (three to six tablets) a day in divided doses, with concomitant corticosteroid therapy where clinically indicated. 2.4 g may be taken once daily or in divided doses. Above 2.4 g should be taken in divided doses.
Maintenance therapy: 1.6 g to 2.4 g (two to three tablets) taken once daily or in divided doses.
The maximum adult dose should not exceed six tablets a day and not exceed 3 tablets taken together at any one time.
Elderly population
The normal adult dosage may be taken unless liver or renal function is severely impaired (see section 4.3 and 4.4). No studies have been carried out in the elderly population.
Paediatric population
There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older
• Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day.
• Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/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 a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Method of administration: Oral.
The tablets must be swallowed whole preferably with some liquid before food intake. They must not be chewed, crushed or broken before swallowing. If one or more doses have been missed, the next dose is to be taken as usual.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Known hypersensitivity to salicylates
- Severe liver impairment
- Severe renal impairment (GFR less than 30 mL/min/1.73 m2).
No interaction studies have been performed.
There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.
In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, or 6-mercaptopurine or thioguanine should be taken into account. As a result, life-threatening infection can occur. Patients should be closely observed for signs of infection and myelosuppression. Haematological parameters, especially the leucocyte, thrombocyte, and lymphocyte cell counts should be monitored regularly (weekly), especially at initiation of such combination therapy, see section 4.4. If white blood cells are stable after 1 month, testing every 4 weeks for the following 12 weeks followed by 3 monthly monitoring intervals appears to be justified.
Pregnancy
There are no adequate data on the use of Mesalazine Tillotts 800 mg in pregnant women. However, data on a limited number (627) of exposed pregnancies indicate no adverse effect of mesalazine on the pregnancy or on the health of the fetus/newborn child. To date no other relevant epidemiologic data are available.
In one single case, after long-term use of a high dose of mesalazine (2-4 g, orally) during pregnancy, renal failure in a neonate was reported.
Animal studies on oral mesalazine do not indicate direct or indirect harmful effects, with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Mesalazine Tillotts 800 mg should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breast-feeding
N-acetyl-mesalazine and, to a lesser degree, mesalazine are excreted in breast milk. The clinical significance of this has not been determined. Only limited experience in women during lactation is available to date. Hypersensitivity reactions like diarrhoea in the infant cannot be excluded. Therefore, Mesalazine Tillotts 800 mg should only be used during breast‑feeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, the breast-feeding should be discontinued.
Fertility
No effects on fertility have been observed.
Mesalazine Tillotts 800 mg has no or negligible influence on the ability to drive and use machines.
There are rare data on overdose (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive.
Ask anything about Mesalazine Tillotts 800 mg Modified-release tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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