Composition
- Each 15 ml syrup contains: Lactulose 10g added as Lactulose Concentrate.
- Each sachet contains: 10 g Lactulose.
Excipients
- Syrup: Sorbic Acid, Sodium Hydroxide and Flavour.
- Powder: E110 and flavour.
Properties
Lactulose is broken down by the intestinal flora into organic acids of low molecular weight. These organic acids occur normally in the colon where they promote bowel movement and ensure the formation of soft stool…Lactulose is not absorbed significantly and has no calorific value.
Duphalac initiates return to normal physiology of the colon. It may therefore take up to 48 hours before normal defecation occurs. Duphalac can be safely taken during pregnancy and by diabetics. Duphalac does not cause habituation.
Indications
Duphalac is used in the treatment of:
- Chronic constipation.
- Hepatic encephalopathy (portal systemic encephalopathy).
Contraindications
Duphalac is contraindicated in case of gastrointestinal obstruction.
Precautions
Duphalac contains next to lactulose, galactose and lactose. This should be taken into account in the treatment of patients who are on a lactose and galactose free diet.
Interactions with other drugs
Neomycin and other antibiotics may decrease lactulose effectiveness by eliminating bacteria needed to transfer it into the active form. Non-absorbable antacids also decreases its activity due to prevention of decrease in pH of colon.
Warnings
Do not administer with other laxatives because the loose stools produced may give false interpretation that an adequate dose of lactulose has been achieved.
Dosage and Administration
The total daily dose is taken preferably during breakfast. Duphalac can be taken alone, with water or fruit juices.
Chronic constipation
The dosage for constipation can be varied according to the individual response, but the following serves as a guide:
Adults
Starting dose for 3 days
- Severe cases: 30-45 ml Per day
- Moderate cases: 15-25 ml Per day
- Mild cases: 15 ml
Maintenance dose
- Severe cases: 15-25 ml Per day
- Moderate cases: 10-15 ml Per day
- Mild cases: 10 ml
Children
Starting dose for 3 days
- 6-14 years: 15 ml Per day
- Under 6 years: 5-10 ml Per day
- Infants: 5 ml Per day
Maintenance dose
- 6-14 years: 10 ml Per day
- Under 6 years: 5-10 ml Per day
- Infants: 5 ml Per day
Hepatic encephalopathy (portal systemic encephalopathy)
Adults
- Initial dose: 30-50 ml three times daily.
- Maintenance dose: To be adjusted to the individual response; diarrhea must be prevented.
Children
- No dosage recommendation for this indication.
- Each sachet of Duphalac Powder is equivalent to 15 ml of Duphalac Syrup.
Overdosage
No specific antidote, symptomatic treatment should be given.
Side Effects
- Lactulose may cause abdominal discomfort associated with flatulence or cramps. Nausea, vomiting or diarrhea have occasionally been reported following high doses.
- Consult your Physician or Pharmacist if any side effect is observed.
Directions for powder use
- Tear off the top of the sachet.
- The dose can be taken from a spoon or tipped directly onto the tongue and then washed down with a drink of water or other fluid.
- The powder may also be sprinkled on food or mixed with water or other fluids before swallowing..
- Lactulose can be mixed with hot or cold drinks.
Pharmaceutical Precautions
- Keep at room temperature (15-30 °C).
- Do not freeze.
- Do not use beyond the expiry date or if the product shows any visible sign of deterioration.
Presentation
- Bottle of 300 ml.
- Carton of 20 Sachets 10 g each.
This is a medicament
- Medicament is a product which affects your health and its.
- consumption contrary to instructions is dangerous for you.
- Strictly follow the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
- Keep medicament out of reach of children.
