HIGHLIGHT
Salofalk

Salofalk Dosage/Direction for Use

mesalazine

Manufacturer:

Falk

Distributor:

DCH Auriga
Full Prescribing Info
Dosage/Direction for Use
Tablet: For treatment of inflammatory bowel diseases (Crohn's disease, ulcerative colitis), Salofalk 250- and 500-mg tablets are available.
With a dosage recommendation of mesalazine 1.5 g/day, 3 x two 250-mg tab can be taken. If the recommended dosage is mesalazine >1.5 g/day, Salofalk 500-mg tabs should be taken, if possible. Depending on the clinical requirements in the individual case, the following dosages are recommended: Crohn's Disease: Acute Attack: 1.5-4.5 g.
Ulcerative Colitis: Acute Attack: 1.5-3 g. Remission/Long-Term Treatment: 1.5 g.
The required number of tablets shall be taken 1 hr before meals in the morning, at midday and in the evening. The tablets shall be swallowed whole with sufficient liquid.
In patients with bowel resection of the ileocoecal region with resection of the ileocoecal valve, it was observed in rare cases that Salofalk 500-mg tabs were excreted undissolved with the faeces due to the too fast intestinal passage. In case of this observation, contact the physician.
Granules: Posology: Adults and the elderly: For the treatment of acute episodes of ulcerative colitis: Once daily, 1 sachet of Salofalk 3g granules, 1-2 sachets of Salofalk 1.5g granules, 3 sachets of Salofalk 1000mg granules or 3 sachets of Salofalk 500mg granules (equivalent to 1.5-3.0 g 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 Salofalk 500mg granules 3 times daily or 1 sachet of Salofalk 1000mg granules 3 times daily) if this is more convenient to the patient.
For the maintenance of remission of ulcerative colitis: The standard treatment is 0.5 g mesalazine 3 times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day.
For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses, the dosing schedule can be adapted to 3.0 g 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 Salofalk granules 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, Salofalk granules 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.
This product is not interchangeable with other brand or dosage form of products containing mesalazine.
Suppository: Insert one 500-mg supp into the anus in the morning, at midday and in the evening when acute signs of inflammation are present.
As soon as remission occurs, the dose should be reduced to one 250-mg supp 3 times daily to avoid recurrences.
Enema: Unless otherwise prescribed, the contents of 2 enemas (2 x 30-mL susp) is given once daily rectally before retiring. If there are problems to retain the large quantity of liquid, the enema may also be applied in 2 doses eg, during the night (after a bowel movement which discharges the 1st dose) or early in the morning.
The duration of Salofalk therapy is determined by the physician.
Treatment with Salofalk demands reliability and consistency from the side of the patient both on the acute inflammatory stage and during long-term therapy to enable therapeutic success.
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