Product Description:

Salofalk 4g/60ml enemas contain the active substance mesalazine:

• An anti-inflammatory agent used to treat inflammatory bowel disease.


• Salofalk 4g/60ml enemas are used for the treatment of:


• inflammation of the large intestine (colon) and rectum (back passage) known by doctors as ulcerative colitis.


• It may be used alone or, particularly in the acute phase, with corticosteroids.


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

How To Use:

Adults and elderly:

• In patients with symptoms of acute inflammation, the content of one enema bottle (60 g rectal suspension) is administered into the intestine as a clyster once daily at bedtime.

 Children and adolescents:

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

General instructions for use:

• Salofalk enemas are used once daily at bedtime.


• Treatment with Salofalk enemas must be administered regularly and consistently, because only in this way can healing be successfully achieved.


• The duration of use is determined by the physician.

Method of administration:

Rectal use.

The best results are achieved if the bowel is emptied before administration of the Salofalk enema.

Preparation:

• The bottle should be shaken for 30 seconds.


• Then the protective cap of the applicator is 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 rectal suspension 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• Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum.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.

Warnings And precautions:

• Blood tests (differential blood count; liver function parameters like ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician.


• As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks.


• If the findings are normal, follow-up tests should be carried out every 3 months.


• If additional symptoms occur, these tests should be performed immediately.

Caution is recommended in patients with impaired hepatic function.

• Salofalk enemas should not be used in patients with impaired renal function.


• Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.


• Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk enemas.


• Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance on commencement of a course of treatment with Salofalk enemas.


• Should Salofalk enemas cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.


• Due to their potassium metabisulphite content, Salofalk enemas can provoke allergic reactions with anaphylactic symptoms and bronchial constriction (bronchospasm) in sensitive patients, particularly in those with asthma or a history of allergies. 


• Because the product contains sodium benzoate, it may provoke hypersensitivity reactions in suitably predisposed patients in the form of irritation of the skin, eyes and mucous membranes. 

Ingredients:

• MESALAZINE (5-aminosalicylic acid) 4g/60ml.

Product Details: