Salofalk 4 g/60 mL Mesalazine Enemas 7 Count

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• • Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum.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.