Salofalk

Salofalk Special Precautions

mesalazine

Manufacturer:

Falk

Distributor:

Zuellig

Marketer:

A. Menarini
Full Prescribing Info
Special Precautions
Tablet: 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 the 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. The recommended kidney function tests are serum urea (BUN) and creatinine assay as well as urine sediment test.
Caution is recommended in patients with impaired hepatic function.
Salofalk 500 mg enteric coated tablets should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
In patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine.
Treatment with Salofalk 500 mg Enteric-coated tablet should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulphasalazine. If acute signs of intolerability e.g. cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.
Enema: Salofalk should be taken under medical supervision. A blood count and urine status should be performed at the attending physician's discretion during treatment. As a general guideline, tests are recommended 14 days after beginning of treatment and then another 2-3 times at 4-weekly intervals.
If the findings are normal, follow-up tests are required every 3 months or if additional signs of illness occur. The recommended kidney function tests are serum urea (BUN) and creatinine assays as well as urine sediment tests.
Patients should be monitored for elevated methemoglobin values.
In patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine (5-aminosalicylic acid).
Treatment with Salofalk should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulfasalazine. If acute signs of intolerability eg, cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.
Use in Children: Salofalk should not be used to treat infants and small children because of insufficient experience with this age group.
Granules: Blood tests (differential blood count; liver function parameters eg, 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 2-3 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.
Caution is recommended in patients with impaired hepatic function.
Salofalk granules 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 Salofalk granules.
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 Salofalk granules. Should Salofalk granules cause acute intolerance reactions eg, 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 Salofalk granules contain aspartame as a sweetening agent, equivalent to 1.68 mg (Salofalk 1.5 g granules).
Effects on the Ability to Drive or Operate Machinery: Granules/Suppository: Salofalk have no influence on the ability to drive and use machines.
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