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  • Rafassal
    / Rafa


    Active Ingredient
    Mesalazine 1 g, 4 g, 500 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Suppositories

    15 X 1 gr

    full basket chart 9254 18103

    Suppositories

    30 X 500 mg

    full basket chart 8300 18233

    Caplets

    30 X 1 gr

    full basket chart 9126 18071

    Caplets

    60 X 500 mg

    full basket chart 8275 18229

    Enema

    7 X 4 gr/60 gr

    full basket chart 7433 18179

    Enema

    7 X 1 gr/60 gr

    full basket chart 8078 18218

    Dosage

    Adults and the elderly: For the treatment of acute episodes of ulcerative colitis: The usual dose: once daily, 1 sachet of 3 gram, 1-2 sachets of 1.5 gram, or 3 sachets of 1 gram (equivalent to 1.5-3 gram mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement. It is also possible to take the prescribed daily dose in three divided doses (1 sachet of 1 gram 3 times daily) if this is more convenient to the patient.
    For the maintenance of remission of ulcerative colitis: Total dose of 1.5 gram mesalazine per day as a single daily dose. For patients known to be at increased risk for relapse for medical reasons, the dosing schedule can be adapted to 3 gram mesalazine given as a single daily dose, preferably in the morning.
    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 bw/day once daily preferably in the morning or in divided doses. Maximum dose: 75 mg/kg bw/day. The total dose should not exceed the maximum adult dose.
    Maintenance treatment: To be determined individually, starting with 15-30 mg/kg bw/day in divided doses. The total dose should not exceed the recommended adult dose. 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: The contents of the sachets of this drug should not be chewed. The granules should be taken on the tongue and swallowed, without chewing, with plenty of liquid. Both in the treatment of acute inflammatory episodes and during long term treatment, the drug should be used on a regular basis and consistently in order to achieve the desired therapeutic effects. The duration of use is determined by the physician.


    Indications

    For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.


    Contra-Indications

    Known hypersensitivity to salicylates or to any of the excipients. Severe impairment of hepatic or renal function.


    Special Precautions

    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 three months. If additional symptoms occur, these tests should be performed immediately. Caution is recommended in patients with impaired hepatic function. The drug should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment. Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with this drug. Patients with a history of adverse drug reactions to preparations containing sulfasalazine should be kept under close medical surveillance on commencement of a course of treatment with this drug. Should this drug cause acute intolerance reactions, such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.In patients with phenylketonuria, it should be kept in mind that the drug contains aspartame as a sweetening agent.
    See prescribing information for full details.


    Side Effects

    Rare: headache, dizziness, myocarditis, pericarditis, abdominal pain, diarrhoea, flatulence, nausea, vomiting. Very rare: altered blood counts (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia), peripheral neuropathy, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), acute pancreatitis, Impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency; alopecia, myalgia, arthralgia, hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis; changes in liver function parameters (increase in transaminases and parameters of cholestasis);  hepatitis, cholestatic hepatitis, oligospermia.
    See prescribing information for full details.


    Drug interactions

    Specific interaction studies have not been performed. Lactulose or similar preparations which lower stool pH possibly reduce mesalazine release from granules due to decreased pH caused by bacterial metabolism of lactulose. In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine should be taken into account. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data on the use of this drug in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the foetus/newborn child. To date no other relevant epidemiologic data are available. In one single case after long-term use of high dose mesalazine (2-4 gram, 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. This drug should only be used during pregnancy if the potential benefit outweighs the possible risk.
    Lactation: N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk. Only limited experience during lactation in women is available to date. Hypersensitivity reactions, like diarrhoea in the infant, cannot be excluded. Therefore, this drug should only be used during breastfeeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, the breastfeeding should be discontinued.              


    Overdose

    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.


    Important notes

    Store below 30°C. The contents of the sachets of this drug should not be chewed.
    See prescribing information for full details.


    Manufacturer
    Rafa Laboratories Ltd.
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