DuphaCare

A clear, viscous liquid, colourless to brownish yellow with plum aroma.
DuphaCare oral solution contains 667 g lactulose per 1000 ml flavoured with plum aroma.
Substance with known effect: DuphaCare oral solution flavoured with plum aroma contains 14.37 mg Propylene glycol (E1520) in each dose of 15 ml which is equivalent to 0.96 mg per ml.
Excipients/Inactive Ingredients: DuphaCare contains plum aroma and no further excipients and may contain small amounts of related sugars (e.g. lactose, galactose, epilactose, tagatose, fructose) from the route of synthesis.
Plum aroma contains a substance with known effect: Propylene glycol (E1520).

Pharmacotherapeutic group: Osmotically acting laxatives. ATC code: A06AD11.
Pharmacology: Pharmacodynamics: In the colon lactulose is broken down by colonic bacteria into low-molecular organic acids. These acids lower the pH in the colonic lumen and increase the volume of the colonic contents via an osmotic effect. These effects stimulate the peristalsis of the colon and return consistency to the stool. Constipation is corrected and the physiological rhythm of the colon is reinstated.
Lactulose as a prebiotic substance promotes the growth of normal flora, like Bifidobacterium and lactobacillus.
Pharmacokinetics: Lactulose is poorly absorbed after oral administration and reaches the colon unchanged. There it is metabolised by the colonic bacterial flora. Metabolism is complete at dose up to 25-50 g or 40-75 ml; at higher dosages, a proportion may be excreted unchanged.
Toxicology: Preclinical safety data: The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity.
In reproduction and teratology experiments in rabbits, rats or mice no adverse effects were found.

Constipation: regulation of the physiological rhythm of the colon.
When a soft stool is considered of medical benefit (haemorrhoids, post colonic/anal surgery).

Lactulose solution may be administered diluted or undiluted.
The posology should be adjusted according to the individual needs of the patient.
A single dose of lactulose should be swallowed in one, and should not be kept in the mouth for an extended period of time.
In case of single daily dose is prescribed, this should be taken at the same time, e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 litres, equal to 6-8 glasses) during the day.
For DuphaCare in bottles the measuring cup may be used.
Dosing in constipation or where soft stool is considered of medical benefit: Lactulose may be taken as a single daily dose or in two divided doses; the measuring cup may be used.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs. (See Table 1.)

Click on icon to see table/diagram/image

Special populations: Elderly patients and patients with renal or hepatic insufficiency: No special dosage recommendations exist, since systemic exposure to lactulose is negligible.

If the dose is too high, the following symptoms may occur: diarrhea and abdominal pain.
Recommended treatments include the cessation of treatment or dose reduction and correction of electrolyte disturbances when extensive fluid loss secondary to diarrhea or vomiting has occurred.

Hypersensitivity to the active substance or to any of the ingredients.
Galactosaemia.
Gastrointestinal obstruction, digestive perforation or risk of digestive perforation.

Do not use if you have abdominal pain or nausea, vomiting.
Consultation of a physician is advised in case of: Painful abdominal symptoms of undetermined cause before the treatment is started; Insufficient therapeutic effect after several days.
With regard to sugar content, the dose normally used to treat constipation should not pose a problem for diabetics. Chronic use of unadjusted doses and misuse can lead to diarrhea and disturbance of the electrolyte balance.
This product contains lactose, galactose and fructose from the route of production. Therefore, patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Lactulose should be administered with care to patients who are intolerant to lactose. (see Description).
This medicine contains propylene glycol (E1520). Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Effects on ability to drive and use machine: Based on its pharmacological properties, lactulose is likely to have no or negligible influence on the ability to drive and use machines.
Use in Children: Use of laxatives in children should be exceptional and under medical supervision.
It should be taken into account that the defaecation reflex could be disturbed during the treatment.

Pregnancy: No effect during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
DuphaCare can be used during pregnancy.
Lactation: No effects on the breastfed newborn/infant are anticipated since systemic exposure of lactulose to the breast-feeding woman is negligible.
DuphaCare can be used during breast-feeding.
Fertility: No effects are to be expected, since systemic exposure to lactulose is negligible.

Summary of the safety profile: Flatulence may occur during the first few days of treatment. As a rule, it disappears after a few days.
When dosages higher than instructed are used, abdominal pain and diarrhea may occur. In such case the dosage should be decreased.
If high doses are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhea.
Hypersensitivity reactions mainly limited to the skin have been observed and identified as potential adverse reactions during postapproval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.*
Tabulated list of adverse reactions: The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients in placebo-controlled clinical trials [very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000)] or have been reported spontaneously during post-approval use [frequency not known (a precise frequency cannot be estimated from the available data)]. (See Table 2.)

Click on icon to see table/diagram/image

Paediatric population: The safety profile in children is expected to be similar as in adults.

No interaction studies have been performed.

Incompatibilities: Not applicable.

Do not store above 30°C. Store in the original package.
Shelf life: 2 years.

Laxatives, Purgatives

A06AD11 - lactulose ; Belongs to the class of osmotically acting laxatives.

NDD