INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ADCO-LIQUILAX* SYRUP

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ADCO-LIQUILAX* SYRUP

COMPOSITION:
Each 5 mL contains
lactulose 3,3 g.

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives

PHARMACOLOGICAL ACTION:
Lactulose is a synthetic disaccharide derivative of lactose. Lactulose is broken down by colonic bacteria mainly into acetic and lactic acids which exert a local osmotic effect in the colon resulting in increased faecal bulk and stimulation of peristalsis.

INDICATIONS:
For the relief of occasional constipation and of chronic portal hypertension and hepatic encephalopathy.

CONTRA-INDICATIONS:
Sensitivity to the ingredient.
Galactosaemia, including patients on a galactose-free diet. Patients with intestinal obstruction.

WARNINGS:
This medicine should not be used in the presence of abdominal pain, nausea or vomiting. Frequent or prolonged use of this preparation may result in dependence on laxatives and loss of normal bowel function.
If you have noticed sudden change in bowel habits that persist over a period of greater than 2 weeks, consult a doctor before using the laxative.
If the recommended use of this product for 1 week has had no effect, discontinue use and consult a doctor.
Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult a doctor. Drink a full glass of liquid with each dose to prevent dehydration.

DOSAGE AND DIRECTIONS FOR USE:
1. Constipation:
  Dosage can vary widely with the severity of the condition. A relatively large initial dose should be followed by a gradually reduced maintenance dose after the first three days of treatment. Only one dose daily needs to be taken, preferably after breakfast.
Recommended dosages are as follows:
Usual starting dose:
Adults:                15 - 30 mL
Children         
        6-12 years: 15 - 20 mL
        1-5 years: 10 mL
Infants under 1 year: 5 mL

Maintenance Dose:
Adults:                10 - 15 mL
Children         
        6-12 years: 10 - 15 mL
        1-5 years: 5 - 10 mL
Infants under 1 year: 2,5 - 5 mL

2. Hepatic Encephalopathy:
  Initial dose of 30 - 50 mL, 3 times daily. Subsequently adjust the dose to produce 2 or 3 soft stools daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
ADCO-LIQUILAX
may cause abdominal discomfort associated with flatulence or cramps. Nausea and vomiting have been reported on the high initial dosages used.
Prolonged use or over-dosage may result in diarrhoea with excessive loss of water and electrolytes, particularly potassium.
Care should be taken in patients with lactose intolerance and in diabetic patients, because of the presence of free galactose and lactose.

KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and Special Precautions".
Treatment is symptomatic and supportive.

IDENTIFICATION:
A colourless to amber syrupy liquid. Odourless, clear or not more than slightly opalescent, with a sweet taste.

PRESENTATION:
50 mL, 100 mL, 150 mL, 200 mL, 350 mL and 500 mL packed in amber glass or PVC bottles, and 2,5 L packed in blue, or amber or green HDPE containers.

STORAGE INSTRUCTIONS:
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/11.5/136

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
2021
RSA.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 July 1992

New addition to this site: April 2004
Source: Pharmaceutical Industry

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