ASACOLON® (mesalazine) 500mg and 1000mg Suppositories

 

INDICATIONS: 500mg suppositories – For the treatment of mild to moderate proctitis and proctosigmoiditis in adults. As an adjunct to oral therapy in severe generalised ulcerative colitis affecting the rectum or rectosigmoid colon. 1000mg suppositories – Treatment of acute mild to moderate ulcerative colitis limited to the rectum (ulcerative proctitis).

 

DOSAGE AND ADMINISTRATION: Rectal use. 500mg suppositories – Adults: One suppository up to three times daily, after defaecation. Titrate dose according to response. In severe generalised ulcerative colitis affecting the rectum or rectosigmoid and in cases slow to respond to oral therapy, one suppository may be used morning and evening as an adjunct to oral therapy. 1000mg suppositories – Adults: One suppository once daily. All strengths – Elderly: As for adults, unless hepatic or renal function is severely impaired. Children: Limited data available.

 

CONTRAINDICATIONS: All strengths – Hypersensitivity to salicylates, mesalazine or any excipient. Severe renal or hepatic impairment. 500mg suppositories: Allergy to peanut or soya oil. Children under 2 years of age.

 

SPECIAL WARNINGS AND PRECAUTIONS: All strengths – Blood tests (differential blood count, liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician. Caution in patients with raised serum creatinine or proteinuria. Stop treatment immediately if renal impairment is evident. Cases of nephrolithiasis have been reported with mesalazine treatment. Ensure adequate fluid intake during treatment. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus and consider stopping mesalazine if any are present. Monitor patients with pulmonary disease, in particular asthma, very carefully. In patients with a history of adverse drug reactions to sulphasalazine, discontinue immediately if acute intolerance reactions occur (e.g. abdominal cramps, acute abdominal pain, fever, severe headache and rash). Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g. in toilets cleaned with sodium hypochlorite contained in certain bleaches). Severe cutaneous adverse reactions (SCARS), including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TENS) have been reported. Stop treatment immediately if signs and symptoms of severe skin reactions are seen. Caution in patients with hepatic impairment. 500mg suppositories – Haematological investigations are recommended prior to and during treatment, at discretion of treating physician. Stop treatment immediately if blood dyscrasias are suspected or evident. Do not use in patients with previous mesalazine-induced cardiac hypersensitivity and use caution in patients with previous myo- or pericarditis of allergic background. Use with caution in patients with gastric or duodenal ulcers. Use with caution in the elderly, subject to patients having normal or non-severely impaired renal and liver function. Limited data in children (aged 6 to 18 years).

 

INTERACTIONS: No interaction studies have been performed. All strengths – May decrease the anticoagulant activity of warfarin. May increase the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. Life threatening infection can occur. Monitor closely for signs of infection and myelosuppression. Monitoring of blood cell counts is recommended if these are used concomitantly.

 

USE DURING PREGNANCY AND LACTATION: All strengths – Only to be used during pregnancy and lactation when the potential benefit outweighs the possible risk

 

UNDESIRABLE EFFECTS: All strength – Rare: headache, dizziness, myocarditis, pericarditis, abdominal pain, diarrhoea, flatulence, nausea, vomiting, photosensitivity. Very rare: altered blood counts (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia), hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, peripheral neuropathy, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), acute pancreatitis, changes in liver function parameters (increase in transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis. Alopecia, myalgia, arthralgia, impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, oligospermia (reversible). Frequency not known: idiopathic intracranial hypertension, nephrolithiasis, drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN). 500mg suppositories – Frequency not known: pleuris, intolerance to mesalazine with C-reactive protein increased and/or exacerbation of symptoms of underlying disease, local reaction.  1000mg suppositories – Rare: constipation.

LEGAL CATEGORY: POM. MARKETING AUTHORISATION NUMBER: Asacolon® 500 mg Suppositories PA2018/001/003, Asacolon® 1000 mg Suppository PA2018/005/001. MA HOLDER: TILLOTTS PHARMA GMBH, Warmbacher Strasse 80, DE- 79618 Rheinfelden, Germany. DATE OF PREPARATION: July 2025

 

ADDITIONAL INFORMATION IS AVAILABLE ON REQUEST FROM THE MARKETING AUTHORISATION HOLDER OR FROM TILLOTTS PHARMA LIMITED, SPACES, 1ST FLOOR BUILDING 2, THE GREEN, DUBLIN AIRPORT CENTRAL, DUBLIN AIRPORT, SWORDS, COUNTY DUBLIN, K67 E2H3, TEL: (00 353 1) 294 2015. Asacolon® is a trademark.

 

ASACOLON® (mesalazine) 400 mg and 800 mg GR Tablets, ASACOLON® 1600 mg MR Tablets

 

INDICATIONS: All strengths: Ulcerative Colitis – For the treatment of mild to moderate acute disease. For the maintenance of remission. 400mg & 800mg only: Crohn’s Disease – For the maintenance of surgically-induced remission.

 

DOSAGE AND ADMINISTRATION: Oral use. To be swallowed whole with liquid before food.

400mg & 800mg tablets – Ulcerative colitis – Induction of remission (Adults): 2.4 g daily. If required, the dose may be increased to 4.8 g daily (above 2.4g in divided doses only). Crohn’s disease – Maintenance of remission (Adults): 2.4 g per day once daily or in divided doses. 400mg tablets – Ulcerative colitis – Maintenance of remission (Adults): 1.2 to 2.4 g per day once daily or in divided doses. 800mg tablets – Ulcerative colitis – Maintenance of remission (Adults): 1.6 to 2.4 g per day once daily or in divided doses. 1600mg tablets – Ulcerative colitis – Acute disease (Adults): Adjust the dosage to the severity of the disease and tolerance. During exacerbation, the dose may be increased to 4800 mg daily, once daily or in 2-3 divided doses. Once remission is achieved, reduce dose gradually to maintenance dose. Monitor by week 8. Elderly: 400mg & 800mg tablets – normal adult dose may be used unless liver or renal function is severely impaired. 1600mg tablets – no studies in elderly patients have been conducted. Children ≥6: 400mg & 800mg tablets – 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 4.0 g/day. Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2.0 g/day.

CONTRAINDICATIONS: All strengths – Hypersensitivity to salicylates, mesalazine or any of the excipients, severe impairment of hepatic or renal function (GFR less than 30 ml/min/1.73m2). 400mg & 800mg tablets – Children under the age of 2 years. 1600mg tablets: Children under the age of 18 years.

 

SPECIAL WARNINGS AND PRECAUTIONS: All strengths – Blood tests (differential blood count, liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician. Caution in patients with raised serum creatinine or proteinuria. Stop treatment immediately if renal impairment is evident. Cases of nephrolithiasis have been reported with mesalazine treatment. Ensure adequate fluid intake during treatment. Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g. in toilets cleaned with sodium hypochlorite contained in certain bleaches). Severe cutaneous adverse reactions (SCARS), including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TENS) have been reported. Stop treatment immediately if signs and symptoms of severe skin reactions are seen. Haematological investigations are recommended prior to and during treatment, at discretion of treating physician. Stop treatment immediately if blood dyscrasias are suspected or evident. Caution in patients with hepatic impairment. Do not use in patients with previous mesalazine-induced cardiac hypersensitivity and use caution in patients with previous myo- or pericarditis of allergic background. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus and consider stopping mesalazine if any are present. Monitor patients with pulmonary disease, in particular asthma, very carefully. In patients with a history of adverse drug reactions to sulphasalazine, discontinue immediately if acute intolerance reactions occur (e.g. abdominal cramps, acute abdominal pain, fever, severe headache and rash). Use with caution in patients with gastric or duodenal ulcers. Use with caution in the elderly, subject to patients having normal or non-severely impaired renal and liver function. Limited data in children (aged 6 to 18 years). Contains less than 1mmol sodium (23mg) per dosage unit, i.e. is essentially “sodium free”. 400mg & 800mg tablets – Intact 400mg & 800mg tablets in the stool may be largely empty shells. If this occurs repeatedly patients should consult their physician. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take the 400mg & 800mg tablets.

 

INTERACTIONS: No interaction studies have been performed.

All strengths – May decrease the anticoagulant activity of warfarin. May increase the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine. Life threatening infection can occur. Monitor closely for signs of infection and myelosuppression. Monitoring of blood cell counts is recommended if these are used concomitantly. 1600mg tablets – Caution is recommended for the concomitant use of mesalazine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, or methotrexate as these may increase the risk of renal adverse reactions.

 

USE DURING PREGNANCY AND LACTATION: All strengths – Only to be used during pregnancy and lactation when the potential benefit outweighs the possible risk. No effects on fertility have been observed.

 

UNDESIRABLE EFFECTS: All strengths – Common: dyspepsia, rash. Uncommon: eosinophilia (as part of an allergic reaction), paresthesia, urticaria, pruritus, pyrexia, chest pain. Rare: headache, dizziness, myocarditis, pericarditis, abdominal pain, diarrhoea, flatulence, nausea, vomiting, photosensitivity. Very Rare: altered blood counts (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia), hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, peripheral neuropathy, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), interstitial pneumonia, eosinophilic pneumonia, lung disorder, acute pancreatitis, changes in liver function parameters (increase in transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis, alopecia, myalgia, arthralgia, impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, nephrotic syndrome, renal failure which may be reversible on early withdrawal, oligospermia (reversible). Frequency not known: Idiopathic intracranial hypertension, pleurisy, drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), lupus-like syndrome with pericarditis and pleuropericarditis as prominent  symptoms as well as rash and arthralgia, nephrolithiasis, intolerance to mesalazine with C-reactive protein increased and/or exacerbation of symptoms of underlying disease, blood creatinine increased, weight decreased, creatinine clearance decreased, amylase increased, red blood cell sedimentation rate increased, lipase increased, BUN increased. 1600mg tablets – Very rare: blood dyscrasia Consult the Summary of Product Characteristics in relation to other adverse reactions.

 

LEGAL CATEGORY: POM. MARKETING AUTHORISATION NUMBER: Asacolon® 400 mg GR Tablets PA 2018/001/001, Asacolon® 800 mg GR Tablets PA 2018/001/002, Asacolon® 1600 mg MR Tablets PA 2018/004/001. MA HOLDER: TILLOTTS PHARMA GMBH, Warmbacher Strasse 80, DE- 79618 Rheinfelden, Germany. DATE OF PREPARATION: July 2025

 

ADDITIONAL INFORMATION IS AVAILABLE ON REQUEST FROM THE MARKETING AUTHORISATION HOLDER OR FROM TILLOTTS PHARMA LIMITED, SPACES, 1ST FLOOR BUILDING 2, THE GREEN, DUBLIN AIRPORT CENTRAL, DUBLIN AIRPORT, SWORDS, COUNTY DUBLIN, K67 E2H3, TEL: (00 353 1) 294 2015. Asacolon® is a trademark.