DUPHALAC (Lactulose Syrup) Available Dosage: 240 ml/120 ml
DUPHALAC
(Lactulose Syrup)
Read all of this leaflet carefully before you
start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your
doctor or pharmacist. This medicine has been
prescribed to you personally and you should not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
Duphalac is a clear, viscous, colourless to brownish yellow
solution (liquid) for oral administration containing 667 g lactulose per 1000 ml.
Duphalac oral solution does not contain any excipients,
but may contain small amounts of related sugars (e.g.
lactose, galactose, epilactose, fructose) derived from the route of synthesis.
Composition:
100ml Duphalac contains: 66.7g lactulose U.S.P.
Indications
• Constipation: regulation of the colonic physiological rhythm
• When soft stool is considered of medical benefit
(haemorrhoids, post colonic/anal surgery)
• Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma
Dosage and administration
Always take Duphalac oral solution exactly as your doctor
has told you. If you have any questions, you should check
with your doctor or pharmacist.
You may take Duphalac oral solution diluted or undiluted.
Take your dose of lactulose in one swallow; do not hold
the solution in your mouth for any length of time.
Your doctor will adjust the dosage according to your response to the medicine.
If you have been prescribed a single daily dose, alway take
it at the same time of day, e.g. during breakfast.
During therapy with laxatives it is important for you to
drink su cient amounts of fluids (1.5 – 2 litres, equal to
6-8 glasses) during the day.
Dosing in constipation or where a soft stool is considered
of medical benefit:
Duphalac may be given as a single daily dose or in two
divided doses. Your doctor will tell you which frequency to use.
For Duphalac in a bottles the measuring cup may be used.
Based upon treatment response your doctor may adjust
the starting dose to the maintenance dose after a few
days. Several (2-3) days of treatment may be needed
before treatment e ect occurs.
Duphalac oral solution in bottles:
Dosing in HE (for adults only):
Starting dose: 3 to 4 times daily 20-30 g or 30-45ml.
This dose may be adjusted by your doctor to the
maintenance dose to achieve 2 to 3 soft stools per day.
Pediatric population:
The safety and e cacy in children (newborn to 18 years
of age) with HE have not been established.
No data are available.
Elderly patients and patients with renal or hepatic
insu ciency:
No special dosage recommendations exist, since systemic
exposure to lactulose is negligible.
Contraindications
Do not take Duphalac oral solution in:
• Hypersensitivity to the active substance or to any of the ingredients.
• Galactosaemia
• Gastrointestinal obstruction, digestive perforation or risk of digestive perforation
Special warnings and precautions for use
Consultation of a physician is advised in case of:
- Painful abdominal symptoms of undetermined cause before the treatment is started
- Insu cient therapeutic e ect after several days.
Lactulose should be administered with care to patients
who are intolerant to lactose (see ‘'List of excipients’')
The dose normally used in constipation should not pose a
problem for diabetics. The dose used in the treatment of
HE is usually much higher and may need to be taken into
consideration 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 small
amounts of fructose. Therefore, patients with the rare
hereditary problem of galactose or fructose intolerance,
the Lapp lactase deficiency or glucosegalactose
malabsorption should not take this medicine.
Paediatric population
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.
Interactions with other medicinal products and other forms of interation
No interaction studies have been performed.
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
No e ects during pregnancy are anticipated, since
systemic exposure to lactulose is negligible.
Duphalac can be used during pregnancy.
Lactation
No e ects on the breastfed newborn/infant
are anticipated, since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Duphalac can be used during breast-feeding.
Fertility
No e ects are to be expected, since systemic exposure to lactulose is negligible.
Effects on ability to drive and use machines
Lactulose has no or negligible influence on the ability to drive and use machines.
Undesirable e ects
Summary of the safety profileFlatulence 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 diarrhoea may occur. In such a case the dosage should be decreased.
If high doses (normally only associated with Hepatic encephalopathy, HE) are used for an extended period of
time, the patient may experience anelectrolyte imbalance due to diarrhoea.
Important information about the ingredients
Duphalac oral solution contains lactose monohydrate. If
you have been told by your doctor that you have an intolerance to some sugars, especially lactose, contact your doctor before taking this medicinal product.
Tabulated list of adverse reactions
The following undesirable e ects have been experienced with the below indicated frequencies in lactulose-treated
patients in placebo-controlled clinical trials [very common (≥/10); common (≥/100 to <1/10); uncommon (≥/1,000 to <1/100); rare (≥/10,000 to <1/1,000); very rare (<1/10,000)].
Paediatric population
The safety profile in children is expected to be similar as in adults.
Overdose
If the dose is too high, the following may occur:
Symptom: diarrhoea and abdominal pain.
Treatment: cessation of treatment or dose reduction.
Extensive fluid loss by diarrhoea or vomiting may require
correction of electrolyte disturbances.
Under these circumstances, the treatment should be
stopped or the dosage reduced su ciently for the
symptoms to subside.
Extensive fluid loss (dehydration) secondary to diarrhoea
or vomiting may require the intake of extra electrolytes.
Please ask your doctor or pharmacist for advice.
Pharmacodynamics
Pharmacotherapeutic group: Osmotically acting laxatives
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 e ect. These e ects stimulate peristalsis of the colon and return normal consistency to the stool.
Constipation is corrected and the physiological rhythm of the colon is reinstated.
In Hepatic encephalopathy (HE), the e ect has been attributed to suppression of proteolytic bacteria by an
increase of acidophilic bacteria (e.g. lactobacillus),
trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the
colon as well as an osmotic e ect and
alteration of
bacterial nitrogen metabolism by
stimulating the bacteria
to utilize ammonia for bacterial protein synthesis. Within this context, however, it should be realized that hyperammonemia alone cannot explain the neuropsychiatric manifestations of HE. The ammonia might, however, serve as a model compound for other nitrogenous substances.
Lactulose as a prebiotic substance strengthens the growth of health promoting bacteria, like Bifidobacterium and Lactobacillus, whereas potentially pathogenic bacteria,
like Clostridium and Escherichia coli may be suppressed.
This may lead to a more favorable balance of the intestinal flora.
Pharmacokinetics
The following is a detailed description of how Duphalac oral solution is metabolized in the body. If you would like an explanation or further information regarding this information, please consult your doctor.
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
doses up to 25 - 50 g or 40 - 75 ml; at higher dosages, a
proportion may be excreted unchanged.
Incompatibilities
Not applicable.
Storage Conditions
Store between 10°C to 25°C. Protect from light.
Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solution and does not a ect therapeutic action.
More Information
Further information is available on request.
Presentation
1. Bottle of 120 ml. - W153
2. Bottle of 240 ml. - W153
To be sold on the prescription of a registered medical practitioner only.
Keep all medicines out of the reach of children.
(Lactulose Syrup)
Read all of this leaflet carefully before you
start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your
doctor or pharmacist. This medicine has been
prescribed to you personally and you should not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
Duphalac is a clear, viscous, colourless to brownish yellow
solution (liquid) for oral administration containing 667 g lactulose per 1000 ml.
Duphalac oral solution does not contain any excipients,
but may contain small amounts of related sugars (e.g.
lactose, galactose, epilactose, fructose) derived from the route of synthesis.
Composition:
100ml Duphalac contains: 66.7g lactulose U.S.P.
Indications
• Constipation: regulation of the colonic physiological rhythm
• When soft stool is considered of medical benefit
(haemorrhoids, post colonic/anal surgery)
• Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma
Dosage and administration
Always take Duphalac oral solution exactly as your doctor
has told you. If you have any questions, you should check
with your doctor or pharmacist.
You may take Duphalac oral solution diluted or undiluted.
Take your dose of lactulose in one swallow; do not hold
the solution in your mouth for any length of time.
Your doctor will adjust the dosage according to your response to the medicine.
If you have been prescribed a single daily dose, alway take
it at the same time of day, e.g. during breakfast.
During therapy with laxatives it is important for you to
drink su cient amounts of fluids (1.5 – 2 litres, equal to
6-8 glasses) during the day.
Dosing in constipation or where a soft stool is considered
of medical benefit:
Duphalac may be given as a single daily dose or in two
divided doses. Your doctor will tell you which frequency to use.
For Duphalac in a bottles the measuring cup may be used.
Based upon treatment response your doctor may adjust
the starting dose to the maintenance dose after a few
days. Several (2-3) days of treatment may be needed
before treatment e ect occurs.
Duphalac oral solution in bottles:
Dosing in HE (for adults only):
Starting dose: 3 to 4 times daily 20-30 g or 30-45ml.
This dose may be adjusted by your doctor to the
maintenance dose to achieve 2 to 3 soft stools per day.
Pediatric population:
The safety and e cacy in children (newborn to 18 years
of age) with HE have not been established.
No data are available.
Elderly patients and patients with renal or hepatic
insu ciency:
No special dosage recommendations exist, since systemic
exposure to lactulose is negligible.
Contraindications
Do not take Duphalac oral solution in:
• Hypersensitivity to the active substance or to any of the ingredients.
• Galactosaemia
• Gastrointestinal obstruction, digestive perforation or risk of digestive perforation
Special warnings and precautions for use
Consultation of a physician is advised in case of:
- Painful abdominal symptoms of undetermined cause before the treatment is started
- Insu cient therapeutic e ect after several days.
Lactulose should be administered with care to patients
who are intolerant to lactose (see ‘'List of excipients’')
The dose normally used in constipation should not pose a
problem for diabetics. The dose used in the treatment of
HE is usually much higher and may need to be taken into
consideration 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 small
amounts of fructose. Therefore, patients with the rare
hereditary problem of galactose or fructose intolerance,
the Lapp lactase deficiency or glucosegalactose
malabsorption should not take this medicine.
Paediatric population
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.
Interactions with other medicinal products and other forms of interation
No interaction studies have been performed.
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
No e ects during pregnancy are anticipated, since
systemic exposure to lactulose is negligible.
Duphalac can be used during pregnancy.
Lactation
No e ects on the breastfed newborn/infant
are anticipated, since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Duphalac can be used during breast-feeding.
Fertility
No e ects are to be expected, since systemic exposure to lactulose is negligible.
Effects on ability to drive and use machines
Lactulose has no or negligible influence on the ability to drive and use machines.
Undesirable e ects
Summary of the safety profileFlatulence 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 diarrhoea may occur. In such a case the dosage should be decreased.
If high doses (normally only associated with Hepatic encephalopathy, HE) are used for an extended period of
time, the patient may experience anelectrolyte imbalance due to diarrhoea.
Important information about the ingredients
Duphalac oral solution contains lactose monohydrate. If
you have been told by your doctor that you have an intolerance to some sugars, especially lactose, contact your doctor before taking this medicinal product.
Tabulated list of adverse reactions
The following undesirable e ects have been experienced with the below indicated frequencies in lactulose-treated
patients in placebo-controlled clinical trials [very common (≥/10); common (≥/100 to <1/10); uncommon (≥/1,000 to <1/100); rare (≥/10,000 to <1/1,000); very rare (<1/10,000)].
Paediatric population
The safety profile in children is expected to be similar as in adults.
Overdose
If the dose is too high, the following may occur:
Symptom: diarrhoea and abdominal pain.
Treatment: cessation of treatment or dose reduction.
Extensive fluid loss by diarrhoea or vomiting may require
correction of electrolyte disturbances.
Under these circumstances, the treatment should be
stopped or the dosage reduced su ciently for the
symptoms to subside.
Extensive fluid loss (dehydration) secondary to diarrhoea
or vomiting may require the intake of extra electrolytes.
Please ask your doctor or pharmacist for advice.
Pharmacodynamics
Pharmacotherapeutic group: Osmotically acting laxatives
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 e ect. These e ects stimulate peristalsis of the colon and return normal consistency to the stool.
Constipation is corrected and the physiological rhythm of the colon is reinstated.
In Hepatic encephalopathy (HE), the e ect has been attributed to suppression of proteolytic bacteria by an
increase of acidophilic bacteria (e.g. lactobacillus),
trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the
colon as well as an osmotic e ect and
alteration of
bacterial nitrogen metabolism by
stimulating the bacteria
to utilize ammonia for bacterial protein synthesis. Within this context, however, it should be realized that hyperammonemia alone cannot explain the neuropsychiatric manifestations of HE. The ammonia might, however, serve as a model compound for other nitrogenous substances.
Lactulose as a prebiotic substance strengthens the growth of health promoting bacteria, like Bifidobacterium and Lactobacillus, whereas potentially pathogenic bacteria,
like Clostridium and Escherichia coli may be suppressed.
This may lead to a more favorable balance of the intestinal flora.
Pharmacokinetics
The following is a detailed description of how Duphalac oral solution is metabolized in the body. If you would like an explanation or further information regarding this information, please consult your doctor.
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
doses up to 25 - 50 g or 40 - 75 ml; at higher dosages, a
proportion may be excreted unchanged.
Incompatibilities
Not applicable.
Storage Conditions
Store between 10°C to 25°C. Protect from light.
Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solution and does not a ect therapeutic action.
More Information
Further information is available on request.
Presentation
1. Bottle of 120 ml. - W153
2. Bottle of 240 ml. - W153
To be sold on the prescription of a registered medical practitioner only.
Keep all medicines out of the reach of children.
DUPHALAC (Lactulose Syrup)
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