Salofalk 500mg 1 Tablet
₱82.75
| Generic Name | Mesalazine |
| Strength | 500 mg |
| Indication/Usage | Salofalk® is used for the treatment of: – Ulcerative colitis and proctitis (treatment of acute attack or to prevent relapse) – Crohn’s disease (treatment of acute attack) |
| Dosage and Administration | Adults and elderly Depending upon the clinical requirements in individual cases, the following daily doses are recommended (please refer to table in package insert) Salofalk® 500mg gastro-resistant tablets should be taken in the morning, at midday and in the evening, 1 hour before meals. They should be swallowed whole, not chewed, and taken with plenty of fluid. Treatment with Salofalk® 500mg gastro-resistant tablets should be administered regularly and consistently, both in the acute inflammatory stage and during maintenance therapy in order to achieve the desired therapeutic effect. The duration of therapy is determined by the physician. In patients with bowel resection of the ileocoecal region with resection of the ileocoecal valve, in rare cases it was observed that Salofalk® 500mg gastro-resistant tablets were excreted undissolved with the faeces due to the too fast intestinal passage. In case of this observation, please contact your physician. 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. The total dose should not exceed the maximum adult dose. Maintenance treatment (ulcerative colitis): To be determined individually, starting with 15-30 mg/kg/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. |
| Warning and Precautions | Salofalk® 500mg gastro-resistant tablets should be taken under medical supervision. Blood tests (differential blood count; liver function parameters such as transaminases; serum creatinine) and urine status (dip sticks / sediments) should be checked before and during treatment, at the discretion of your doctor. As a guideline, controls are recommended 14 days after starting treatment, then a further two to three times at intervals of 4 weeks. If the findings are normal, follow-up tests are required every three months. If additional symptoms develop, tests must be performed immediately. Caution is recommended in patients with impaired hepatic function. Salofalk® 500mg gastro-resistant tablets should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment. 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 patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine. Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARs), including 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. Treatment with Salofalk® 500mg gastro-resistant tablet should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulphasalazine. If acute signs of intolerability e.g. abdominal cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be discontinued immediately. In patients with bowel resection of the ileocoecal region with resection of the ileocoecal valve, in rare cases it was observed that Salofalk® 500mg Gastro-resistant tablets were excreted undissolved with the faeces due to the too fast intestinal passage. In case of this observation, please contact your physician. This medicinal product contains 49 mg sodium per tablet, equivalent to 2.5% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 22% of the WHO recommended maximum daily intake for sodium. Salofalk 500mg tablets are considered high in sodium. This should be particularly taken into account for those on a low salt diet. |
| Drug Interaction | Specific interaction studies have not been performed. 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. |
| Requires Prescription? (Yes or No) | Yes |
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