Salofalk Dosage/Direction for Use

Patients should always use Salofalk exactly as prescribed. Patients should check with their doctor or pharmacist if they are unsure.
Patients who think that the effect of Salofalk is too strong or too weak should talk to their doctor or pharmacist.
Patients who forget to use Salofalk should not use a double dose to make up for a forgotten dose.
Patients should not stop using this product until they have talked to their doctor.
Method of administration: Gastro-resistant prolonged-release granules: Salofalk granules are for oral use only.
Salofalk granules should not be chewed. Patients should take the Salofalk granules by placing the granules directly on the tongue and then swallowing them with plenty of liquid without chewing.
Enema: This medicine may only be used rectally. It is not intended to be taken by mouth. Do not swallow. Salofalk 4g/60ml Enema should be administered preferably at bedtime.
Patients should empty their bowels if necessary and wash their hands.
The bottle should be shaken for at least 30 seconds, then the protective cap removed from the applicator, and the bottle held by its upper end.
Patients should lie down on their left side with their left leg outstretched and their right leg bent.
The applicator, which is coated with a lubricant for easy insertion, should be inserted into the rectum, the bottle being held pointed towards the navel.
Whilst holding the bottle tightly, it should be squeezed slowly.
The applicator should be removed from the rectum when the bottle is empty but this position should be maintained for at least 30 minutes to allow the enema to spread throughout the lower part of the large intestine.
Patients should wash their hands again and try not to empty their bowels again until the next morning.
Suppository: This medicine may only be used rectally. It is not intended to be taken by mouth. Do not swallow.
Dosage: Gastro-resistant prolonged-release granules: See table.

Click on icon to see table/diagram/image

Adults and the elderly: Unless otherwise prescribed by the doctor, the normal dosage for the treatment of acute episodes of ulcerative colitis is, depending on the clinical requirements in the individual case, 3 sachets of Salofalk 1000mg granules (equivalent to 3 g mesalazine per day) once daily preferably in the morning or 1 sachet of Salofalk 1000mg granules three times daily (in the morning, at midday, in the evening).
To prevent a relapse of ulcerative colitis, the normal dosage to prevent further episodes of ulcerative colitis is 1 sachet of Salofalk 500mg granules three times daily (equivalent to 1.5 g mesalazine per day). If upon the decision of the doctor the patient is at increased risk for recurrence, the dosage for prevention of further episodes of ulcerative colitis is 3 sachets of Salofalk 1000mg granules once daily preferably in the morning (equivalent to 3 g mesalazine per day).
Use in children: There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older: The doctor will advise the precise dosage of Salofalk granules for the child.
In acute episodes, to be determined individually, starting with 30-50 mg mesalazine per kg body weight per day that should be given once daily preferably in the morning or in divided doses. The maximum dose is 75 mg mesalazine per kg body weight per day. The total dose should not exceed the maximum adult dose.
To prevent a relapse, to be determined individually, starting with 15-30 mg mesalazine per kg body weight per day that should be given in divided doses. The total dose should not exceed the recommended adult dose.
It is generally recommended that half the adult dose should be given to children up to a body weight of 40 kg and the normal adult dose to those above 40 kg.
Duration of treatment: The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The doctor will decide how long patients need to continue the treatment with this medicine. This will depend on the patient's condition.
To obtain the maximum benefit from this medicine, patients should use Salofalk granules regularly and consistently both during the acute episode of inflammation and also as long-term treatment, as directed.
Enema: Adults and the elderly: Unless otherwise prescribed by the doctor, the recommended dose for the treatment of acute episodes of ulcerative colitis is one enema a day to be used at bedtime.
Use in children and adolescents: There is little experience and information about the effect of this medicine when used in children.
Duration of treatment: The duration of use depends upon the condition. The doctor will decide how long patients are to continue the medication.
Patients should follow the treatment with Salofalk 4g/60ml enemas regularly and consistently, because this is the only way to achieve the desired therapeutic effect.
Suppository: Adults and the elderly: For the treatment of acute symptoms of inflammation, insert 2 Salofalk 250mg 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 250mg suppository into the rectum 3 times daily (equivalent to 750 mg mesalazine daily).
Use in children: There is little experience and only limited documentation for an effect in children.
Duration of treatment: The doctor will decide how long patients need to continue the treatment with this medicine. The duration of use depends upon the nature, severity and progression of the condition.
Patients should follow the treatment with Salofalk 250mg Suppositories regularly and consistently, because this is the only way to achieve the desired therapeutic effect.