SALOFALK ENEMAS 4 G/60 ML [SIN10918P]

Product Info

SALOFALK ENEMAS 4 G/60 ML

[SIN10918P]

4.1 Therapeutic indications

Acute attacks of ulcerative colitis (a chronic inflammatory disease of the large bowel)

4.2 Posology and method of administration

Posology

Adults and elderly
The following dosage guidelines are generally applicable:
In patients with symptoms of acute inflammation, the content of 1 enema bottle (Salofalk 4 g/60 ml enemas) resp. 2 enema bottles (Salofalk 2 g/30 ml enemas) is administered into the intestine as an enema once daily at bedtime.

Children
There is little experience and only limited documentation for an effect in children.

Method of administration

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 at the top and bottom.

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• Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum.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 rectal suspension should be allowed to exert its effects all night.

4.3 Contraindications

Salofalk enemas must not be used in patients with

• known hypersensitivity to the active substance, to salicylates or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• severe impairment of hepatic or renal function