Tablet: Adults and elderly:
Depending upon the clinical requirements in individual cases, the following daily doses are recommended: See table.
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Salofalk 500 mg 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.
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 500 mg gastro-resistant tablets were excreted undissolved with the faeces due to the too fast intestinal passage. In case of this observation, please contact the 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.
Granules: Adults and the Elderly: Treatment of Acute Episodes of Ulcerative Colitis:
Once daily, 1-2 sachets of Salofalk 1.5 g granules (equivalent to mesalazine 1.5-3 g 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 3 divided doses if this is more convenient to the patient.
Maintenance of Remission of Ulcerative Colitis:
The standard treatment is mesalazine 0.5 g 3 times daily (in the morning, at midday and in the evening) corresponding to a total dose of mesalazine 1.5 g/day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of 3 daily doses, the dosing schedule can be adapted to mesalazine 3 g given as a single daily dose, preferably in the morning.
There is only limited documentation for an effect in children (6-18 years).
Children ≥6 years: Active Disease:
To be determined individually, starting with 30-50 mg/kg body weight/day once daily preferably in the morning or in divided doses. Maximum Dose: 75 mg/kg body weight/day. The total dose should not exceed the maximum adult dose.
To be determined individually, starting with 15-30 mg/kg body weight/day in divided doses. The total dose should not exceed the recommended adult dose.
It is generally recommended that ½ the adult dose may be given to children up to a body weight of 40 kg and the normal adult dose to those >40 kg.
Unless otherwise prescribed, the contents of 1 enema bottle (60-g suspension) are instilled in the rectum once every evening before bedtime. The best results are achieved if the bowels are evacuated prior to instillation of Salofalk 4 g/60 mL enema.
Suppository: Adults and Elderly:
For the treatment of acute symptoms of inflammation, insert 2 Salofalk 250 mg suppositories into the rectum 3 times daily (in the morning, at midday and at bedtime) (equivalent to 1500 mg mesalazine daily).
In long-term treatment to prevent recurrences, insert 1 Salofalk 250 mg suppository into the rectum 3 times daily (equivalent to 750 mg mesalazine daily).
Missed Dose: Do not take larger amount than normal dose of Salofalk 250 mg suppository, continue treatment at the prescribed dosage.
Use in Children:
There is little experience and only limited documentation for an effect in children.
Duration of Treatment:
Physician will decide how long does the patient need to continue the treatment with this medicine. This will depend on the patient's condition.
To obtain the maximum benefit from this medicine, use Salofalk 250 mg suppositories regularly and consistently, as directed.
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 with sufficient liquid.
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.
Shake well before use to homogenize the suspension.
Remove the protective cap and hold the vial vertically to avoid spilling the contents. Lie on the left side, stretch out the left leg and pull the right leg in at an angle to keep balance. Insert the applicator, which is coated with a lubricant for easy insertion into the rectum, holding the vial pointed towards the navel.
Holding the vial tightly, bend slightly so that the applicator is pointing towards the back.
Press the plastic vial slowly to avoid triggering off a passage of stool. After use, remove the empty vial from the rectum.
Keep lying in the same position for 30 min to enable the enema to spread evenly into the intestines. The best effect is obtained by letting the enema work overnight.
The duration of therapy is determined by the physician.
In general, the acute attack disappears after 8-12 weeks. Do not use Salofalk enemas after the acute attack is over.
This medicine may only be used rectally, so it has to be inserted through the anus. Do not take by mouth.