Laxette Dry And Laxette 10 g/3,3 g/5 mL Solution

Lactulose is indicated in the management of constipation, particularly in association with laxative habituation and in post-surgical and obstetric patients, as well as in children.

For the management of hyperammonaemia in patients with chronic hepatic encephalopathy, including stages of hepatic pre-coma and coma.

Posology

An effect may only be obtained after 24 - 48 hours.

LAXETTE DRY:

Constipation:

• Adults: Initial dose: 10 to 30 g given daily as a single dose or in 2 divided doses for three (3) days. Maintenance dose: Adjust according to the patientu2019s needs. Dosage may be increased to 40 g daily if there is no response, or should be decreased if diarrhoea occurs.
• Children (7 - 14 years): Usual dosage: 10 g taken daily. Dosage should be adjusted according to individual response.
• Children (1 - 6 years): Usual dosage: 5 to 10 g taken daily. Dosage should be adjusted according to individual response.

Portal System Encephalopathy: Initial dosage: 60 to 120 g given daily in 3 or 4 divided doses. Maintenance dose: Dosage should be adjusted to produce 2 or 3 soft stools each day.

LAXETTE SOLUTION:

Constipation: Initial dose should be taken for three (3) days in all age groups.

• Adults: Usual initial dose: 30 mL Maintenance dose: 15 - 30 mL
• Children (6 - 14 years): Usual initial dose: 15 mL Maintenance dose: 10 - 15 mL
• Children (1 - 5 years): Usual initial dose: 10 mL Maintenance dose: 5 - 10 mL
• Infants: Usual initial dose: 5 mL Maintenance dose: 2.5 - 5 mL

Portal System Encephalopathy: Initial dose: 30 - 50 mL three times daily. Subsequently adjust the dose to produce two or three soft stools daily.

Method of administration

LAXETTE DRY can be taken with drinks e.g., tea, coffee, fruit juice or milk, or with breakfast cereals. Drink a full glass of liquid or more, with each dose of LAXETTE DRY.

• Patients with known hypersensitivity to Lactulose or to any of the excipients used in the formulation of LAXETTE (see section 6.1).
• Lactulose should not be administered to patients with abdominal obstruction, appendicitis, undiagnosed rectal bleeding, congestive heart failure or hypertension.
• Galactosaemia including patients on a low galactose diet should not use lactulose.
• Hyperosmotic laxatives should not be prescribed to colostomy or ileostomy patients.

If you have noticed a sudden change in bowel habits that has persisted for more than 2 weeks, consult a doctor before using this medication.

Care should be taken in patients with lactose intolerance or in diabetic patients, because of the presence of free lactose and galactose. LAXETTE contains sugars such as fructose, galactose and lactose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take LAXETTE. Laxatives should not be given to children younger than 6 years, unless prescribed by a medical practitioner.

Do not take within 2 hours of other medications. Chronic use and the overuse of laxatives may interfere with the potassium retaining effects of potassium-sparing diuretics and may reduce serum potassium concentrations by promoting excessive potassium loss from the intestinal tract. Blood glucose concentrations may be elevated after extended use of laxatives.

Pregnancy
There is no data concerning the effect of LAXETTE in pregnant women.

Breastfeeding
There is no data concerning the effect of LAXETTE in breastfeeding.

Fertility:
There is no data concerning the effect of LAXETTE on fertility.

LAXETTE has no or negligible effect on the ability to drive or use machines.

The use of lactulose may result in abdominal discomfort associated with flatulence and cramps. Nausea and vomiting have been reported, especially with higher doses. Prolonged use or excessive dosage may cause diarrhoea, excessive loss of fluid and electrolytes, particularly potassium; and hypernatraemia. Hepatic encephalopathy may also be exacerbated.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 and to Cipla Medpro (Pty) Ltd at [email protected] or telephone 080 222 6662 (toll free).

Prolonged use or excessive dosage may result in diarrhoea, with excessive loss of water and electrolytes. Treatment is symptomatic and supportive.