Drug Description

Presentation

Indications

Symptomatic treatment of constipation in adults and children aged 8 years and above.

An organic disorder should have been ruled out before initiation of treatment.

Dulcobalance should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-month treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated.

Adult Dosage

Oral use

1 to 2 sachets per day, preferably taken as a single dose in the morning. Each sachet should be dissolved in a glass of water just before use.

The effect of Dulcobalance becomes apparent within 24 to 48 hours after its administration.

In children, treatment should not exceed 3 months due to a lack of clinical data for treatment lasting longer than 3 months. Treatment-induced restoration of bowel movements will be maintained by lifestyle and dietary measures.

The daily dose should be adapted according to the clinical effects and may range from one sachet every other day (especially in children) up to 2 sachets a day.

Contra Indications

 - severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic stenosis,

- digestive perforation or risk of digestive perforation

- ileus or suspicion of intestinal obstruction,

- painful abdominal syndromes of indeterminate cause,

- hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients.

Special Precautions

Warnings

The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet, for example:

- increased intake of liquids and dietary fibre,

- appropriate physical activity and rehabilitation of the bowel reflex.

Patients with hereditary problems of fructose intolerance should not take this medicinal product.

In case of diarrhoea, caution should be exercised in patients who are prone to a disturbance of water electrolyte balance (e.g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.

Precautions for use

Very rare cases of hypersensitivity reactions (rash, urticaria, oedema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported.

Dulcobalance does not contain a significant quantity of sugar or polyol and can be prescribed to diabetic patients or patients on a galactose-free diet.

Interactions

Not applicable.

Adverse Reactions

Adults:

Undesirable effects reported during clinical trial involving almost 600 patients with the following frequencies have always been minor and transitory and have mainly concerned the gastrointestinal system:

- common (1/100, <1/10): abdominal distension and/or pain, nausea, diarrhoea,

- uncommon (> 1/1000, <1/100): vomiting, and the more common consequence of diarrhoea: urgency to defaecate and faecal incontinence.

Additional information from post-marketing surveillance included:

- very rare (< 1/10000) cases of hypersensitivity reactions: pruritus, urticaria, rash, face oedema, Quincke oedema and an isolated case of anaphylactic shock,

- unknown frequency of diarrhoea leading to electrolyte disorders (hyponatremia, hypokalaemia) and/or dehydration, especially in elderly patients.

Excessive doses may cause diarrhoea, which generally disappears when the dosage is reduced or treatment temporarily interrupted

Children:

Undesirable effects reported during clinical trials involving 147 children aged from 6 months to 15 years with the following frequencies. These effects have always been minor and transitory and have concerned the gastrointestinal system.

Gastrointestinal disorders:

- common (> 1/100, <1/10): diarrhoea and abdominal pain,

- uncommon (> 1/1000, <1/100): bloating, vomiting and nausea.

There is no additional information from the post-marketing surveillance: hypersensitivity reactions have not been reported in children so far. Nevertheless, such reactions may occur as reported in adults.

Excessive doses may cause diarrhoea which generally disappears when the dosage is reduced or treatment temporarily interrupted. Diarrhoea may cause perianal soreness.

Manufacturer

Drug Availability

Updated