Gastro-resistant tablet: Adults: For the therapy of chronic inflammatory bowel disorders (Crohn's disease, ulcerative colitis), both Salofalk 250 mg, gastro-resistant tablets, and Salofalk 500 mg, gastro-resistant tablets, are available. If the recommended dose exceeds 1.5 g mesalazine daily, Salofalk 500 mg should preferably be used. Depending upon the clinical requirements in individual cases, the following daily doses are recommended: (See Table 2.)
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Suppository: Adults and elderly: For the treatment of acute episodes of ulcerative colitis: Two Salofalk 250 mg suppositories or 1 Salofalk 500 mg suppository are inserted into the rectum three times daily (equivalent to 1500 mg mesalazine daily), according to the individual clinical requirement.
For the maintenance of remission of ulcerative colitis: One Salofalk 250 mg Suppository three times daily (equivalent to 750 mg mesalazine daily) inserted into the rectum.
Children under 6 years of age: There is little experience and only limited documentation for an effect in children.
Enema: Adults and elderly: The following dosage guidelines are generally applicable: In patients with symptoms of acute inflammation, the contents of one enema bottle (Salofalk 4 g/60 ml enemas) resp. two enema bottles (Salofalk 2 g/30 ml enemas) are administered into the intestine as an enema once daily at bedtime.
Children: Salofalk 4 g/60 ml enemas should not be used in children with a body weight below 40 kg because there is very limited experience with this patient group.
Gastro-resistant prolonged release granules: Adults and the elderly: For the treatment of acute episodes of ulcerative colitis: Once daily, 1 sachet of Salofalk granules 3 g, 1-2 sachets of Salofalk granules 1.5 g, 3 sachets of Salofalk granules 1g or 3 sachets of Salofalk granules 500 mg (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 granules 500mg 3 times daily or 1 sachet of Salofalk granules 1g 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.
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: Gastro-resistant tablet: Salofalk 250 mg/500 mg 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 250 mg/500 mg should be administered regularly and consistently, both during the acute inflammatory stage and during maintenance therapy in order to achieve the desired therapeutic effect.
The duration of use is determined by the physician.
An acute exacerbation of ulcerative colitis or Crohn's disease generally subsides after 8-12 weeks.
For relapse prophylaxis of ulcerative colitis the dose can usually be reduced to 1.5 g mesalazine/day.
Note: In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileocoecal region with removal of the ileocoecal valve, it has been observed that Salofalk 250 mg/500 mg, gastro-resistant tablets, were excreted undissolved in the stool, due to an excessively rapid intestinal passage.
Suppository: When used three times a day, Salofalk 250 mg and 500 mg suppositories should be inserted into the rectum in the morning, at midday and at bedtime.
Treatment with Salofalk suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.
An acute episode of ulcerative colitis generally subsides within 8 - 12 weeks. The duration of use is determined by the physician.
Enema: Rectal use.
The best results are achieved if the bowel is emptied before administration of the Salofalk enema.
The desired therapeutic result can only be achieved if Salofalk enemas are used regularly and consistently. The duration of treatment is determined by the patient's doctor.
Acute attacks of ulcerative colitis usually regress after 8-12 weeks, after which Salofalk 2 g/30 ml/4 g/60 ml enemas should not generally be used.
Preparation: The bottle should be shaken for 30 seconds.
Then the protective cap of the applicator removed.
The bottle should be held around its side.
The correct position for administration is as follows: The patient should lie down on his/her left side with his/her left leg stretched out and right leg bent. This makes it easier for the enema to be administered and for the enema to be effective.
Administration of the rectal suspension: The tip of the applicator should be inserted deep into the rectum.
The bottle should be tipped downwards slightly and then squeezed slowly.
Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum.
The patient should remain lying down in this position for at least 30 minutes to allow the contents of the enema to spread throughout the rectum.
If possible, the enema fluid should be allowed to exert its effects all night.
Gastro-resistant prolonged release granules: 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.