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OCTASA is a brand name for Mesalamine (also known as Mesalazine). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ulcerative colitis. For the treatment of mild to moderate acute disease. For the maintenance of remission.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults, including the elderly (>65 years) The dose should be adjusted according to the severity of the disease and tolerance.
Acute disease:
In the event of exacerbation, the dose can be increased to 4800 mg daily, once daily or in 2-3 divided doses. Once clinical remission is achieved, the dose should gradually be decreased to maintenance dose. Continued therapy should be carefully considered in subjects not responding by week 8.
Maintenance treatment: 1600 mg once daily. Other oral mesalazine formulations are available if an alternative dose for maintenance treatment is considered more appropriate. Elderly population No studies have been carried out in older people.
Paediatric population The safety and efficacy of Mesalazine ESPL in children and adolescents aged younger than 18 years of age has not been established. Method of administration: oral. The tablets must be swallowed whole with a glass of water.
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.
a) Summary of the safety profile Organ specific adverse drug reactions affecting the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue have been reported. 5%) are the most commonly reported drug related adverse events in the clinical development programme.
Treatment must be stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache and rash. 4). b) Tabulated summary of adverse reactions Undesirable effects reported from clinical studies and other sources are listed below: Common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very Rare (< 1/10,000) Not known (Cannot be estimated from the available data) Blood and Lymphatic System Disorders Eosinophilia (as part of an allergic reaction).
Altered blood counts (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia), blood dyscrasia. Immune System Disorders Hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis Nervous System Disorders Paresthesia Headache, dizziness Peripheral neuropathy Cardiac Disorders Myocarditis, pericarditis Respiratory, thoracic and mediastinal disorders Allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), interstitial pneumonia, eosinophilic pneumonia, lung disorder.
Pleurisy Gastrointestinal Disorders Dyspepsia Abdominal pain, diarrhoea, flatulence, nausea, vomiting Acute pancreatitis Hepatobiliary Disorders Changes in liver function parameters (increase in transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis Skin and Subcutaneous Tissue Disorders Rash Urticaria, pruritus Photosensitivity* Alopecia Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) Musculoskeletal, connective tissue and bone disorders Myalgia, arthralgia Lupus-like syndrome with pericarditis and pleuropericarditis as prominent symptoms as well as rash and arthralgia System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very Rare (< 1/10,000) Not known (Cannot be estimated from the available data) Renal and Urinary Disorders Impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, nephrotic syndrome, renal failure which may be reversible on early withdrawal.
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.
As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow-up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately.
Renal impairment Octasa should not be used in patients with renal impairment. Mesalazine- induced renal toxicity shall be suspected if the renal function is impaired during the treatment and the treatment should be stopped immediately.
It is recommended that the renal function is monitored prior to and repeatedly whilst on Octasa therapy. Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content.
It is recommended to ensure adequate fluid intake during treatment. , in toilets cleaned with sodium hypochlorite contained in certain bleaches). 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 reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. Blood dyscrasia Very rarely have serious blood dyscrasia been reported.
Octasa therapy should be stopped immediately if there is a suspicion or evidence of blood dyscrasia (signs of unexplained bleeding, bruising, purpura, anaemia, persistent fever or sore throat), and the patient should seek immediate medical advice.
1. • Severe liver impairment. 73 m2)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mesalamine in United Kingdom.
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Nephrolithiasis** Reproductive system and breast disorders Oligospermia (reversible) General disorders and administration site conditions Pyrexia, chest pain Intolerance to mesalazine and/or exacerbation of disease, C-reactive protein increased Investigations Blood creatinine increased, weight decreased, creatinine clearance decreased, amylase increased, red blood cell sedimentation rate increased, lipase increased, BUN increased.
4 for further information c) Description of selected adverse reactions An unknown number of the above mentioned undesirable effects are probably associated to the underlying IBD rather than Octasa medication. This holds true especially for gastrointestinal undesirable effects, arthralgia, and alopecia.
4. 5. Photosensitivity More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema. d) Paediatric population There is no safety experience with the use of Octasa tablets in the paediatric population.
It is expected that the target organs of possible adverse reactions in the paediatric population are the same as for adults (heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Liver impairment There have been reports of increased liver enzyme levels in patients taking preparations containing Octasa. Caution is recommended if Octasa is administered to patients with liver impairment. Cardiac hypersensitivity reactions Mesalazine-induced hypersensitivity reactions (myo- and pericarditis) have been reported rarely with Octasa.
In case of a suspected cardiac hypersensitivity, Octasa must not be reintroduced. Caution should be taken in patients with previous myo- or pericarditis of allergic background regardless of its origin. Pulmonary disease Patients with pulmonary disease, in particular asthma, should be very carefully monitored during treatment with Octasa.
Hypersensitivity to sulphasalazine Patients with a history of adverse drug reactions to sulphasalazine, therapy should be kept under close medical supervision. Treatment must be stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache and rash.
Gastric and duodenal ulcers Caution is recommended when treating patients with active gastric or duodenal ulcer. Asacol contains sodium Each tablet contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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