Active ingredients: Lactulose
DUPHALAC 66.7g / 100ml syrup
Why is Duphalac used? What is it for?
What is it
Laxative with osmotic action. Duphalac carries out a laxative action in a physiological way: it draws water, forming soft and voluminous stools that are easy to evacuate, and normalizes the altered bacterial flora in case of constipation.
Why is it used
Short-term treatment of occasional constipation.
Contraindications When Duphalac should not be used
Hypersensitivity to the active substance or to any of the excipients.
In the presence of acute abdominal pain or of unknown origin, nausea or vomiting, gastrointestinal obstruction or stenosis (other than normal constipation), rectal bleeding of unknown origin, severe dehydration.
Galactosemia (congenital disease characterized by galactose accumulation), perforation of the digestive tract or risk of perforation of the digestive tract.
Precautions for use What you need to know before taking Duphalac
The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.
Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks or when the use of the laxative fails to produce effects.
It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine.
Duphalac does not contain absorbable sugars in the gastrointestinal tract and has no caloric value so its administration is compatible in patients on reduced calorie diets.
Consult your doctor or pharmacist before taking Duphalac if you have any type of medical condition, especially:
- if you suffer from unexplained stomach pains
- if you are unable to digest lactose
Lactulose should be administered with caution to lactose intolerant patients.
DUPHALAC may contain traces of lactose, galactose, epilactose, fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you have diabetes and are being treated for hepatic encephalopathy, your Duphalac dosage will be higher and it will contain more sugar. Therefore, the dosage of the anti-diabetes medicinal products may need to be adjusted.
Interactions Which drugs or foods can modify the effect of Duphalac
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally.
Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.
Broad spectrum antibiotics, administered orally at the same time as Duphalac, can decrease the effects exerted by the product on the intestinal microflora.
In case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids, the onset of dehydration or hypokalemia is possible, which can lead to cardiac or neuromuscular dysfunction (see paragraph "It is important to know that").
The lowering of the pH in the intestine, characteristic of the mechanism of action of lactulose, can cause the inactivation of drugs that have a pH-dependent release profile of the intestine (eg 5-ASA drugs).
Warnings It is important to know that:
It should be taken into account that the reflex to evacuate may be altered during treatment. Frequent or prolonged use or with excessive doses (in the presence of 2-3 bowel movements with soft stools per day), can cause constipation, persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors.
During treatment with laxatives you should drink a sufficient amount of fluids (approximately 1.5 - 2 liters per day, equivalent to 6-8 glasses).
If you take DUPHALAC for several days (2-3 days) and you do not notice any improvement in your condition but your symptoms get worse, talk to your doctor.
In severe cases it is possible the onset of dehydration or hypokalaemia (decrease in potassium in the blood) which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
Since Duphalac has a pleasant taste, keep it in a place inaccessible to children.
When it can be used only after consulting your doctor
It is also advisable to consult your doctor in cases where these disorders have occurred in the past.
In children under the age of 12, the medicine can only be used after consulting your doctor.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Duphalac can be used during pregnancy and breastfeeding.
No effects on fertility are expected.
Effects on ability to drive and use machines
Lactulose has no or negligible effects on the ability to drive or use machines.
Health education notes
First of all it must be borne in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can permanently solve the problem of constipation.
Many people think they suffer from constipation if they fail to evacuate every day.
This is a mistaken belief as this situation is completely normal for a large number of individuals.
Consider, instead, that constipation occurs when the bowel movements are reduced compared to one's personal habits and are associated with the emission of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
Dosage and method of use How to use Duphalac: Dosage
How many
Warning: do not exceed the indicated doses.
Warning: do not exceed the indicated doses without medical advice. The correct dose is the minimum sufficient to produce easy evacuation of soft stools.
It is advisable to initially use the minimum doses provided.
After a few days the starting dose can be changed to the maintenance dose based on the response to treatment.
When necessary, the dose can then be increased, but without ever exceeding the maximum indicated.
Elderly and patients with hepatic and renal insufficiency There are no particular indications for dosage.
When and for how long
The dose can be taken in one administration per day, or it can be divided into two times. In the case of a single daily dose, this must always be taken at the same time, for example at breakfast.
It may take a few days (2-3 days) for the treatment effect to manifest itself. Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires prescription of the doctor after adequate evaluation of the individual case.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
Warning: use only for short periods of treatment.
Like
Duphalac can be taken diluted or as it is together with an adequate quantity of water (a large glass). A diet rich in liquids (about 1.5 - 2 liters per day equal to 6-8 glasses) favors the effect of the medicine.
Use the measuring cup for administration, referring to the tick marks on it.
Swallow the medicine quickly. Don't keep it in your mouth.
What to do if you have forgotten to take one or more doses
If you have forgotten to take a dose of Duphalac, take the next dose at the usual time. Do not take a double dose to make up for the forgotten one.
What to do if you stop taking the medicine
Do not stop or change treatment before consulting your doctor.
If you have any questions about the use of Duphalac, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Duphalac
Excessive doses, generally associated with hepatic encephalopathy, can cause abdominal pain and diarrhea; in this case treatment must be interrupted or the dose reduced. The resulting loss of fluids and electrolytes must be replaced. In case of accidental ingestion / intake of a dose. of Duphalac, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Duphalac
Like all medicines, Duphalac can cause side effects, although not everybody gets them.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation and flatulence during the first days of treatment which normally disappears after a few days.
When taking more than the prescribed dose, abdominal pain and diarrhea may occur. In this case the dosage must be reduced.
If excessive doses (normally associated with hepatic encephalopathy) are taken for long periods, the patient may experience electrolyte decompensation due to diarrhea.
Flatulence, abdominal pain, nausea and vomiting; diarrhea (mainly following excessive dosages).
Electrolyte imbalance due to diarrhea.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili.” By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Other information
Composition
100 ml of syrup contain:
- Active ingredient: lactulose 66.7 g.
- Excipients: purified water.
How it looks
Duphalac comes in the form of a syrup for oral use packaged in a 200 ml bottle.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DUPHALAC
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of syrup contain:
Active principle: lactulose 66.7 g.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Syrup.
Clear, viscous, colorless or yellow-brown liquid
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term treatment of occasional constipation.
04.2 Posology and method of administration
Use the measuring cup for administration, referring to the tick marks on it. The lactulose solution can be administered diluted or as it is together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine. Preferably take in the evening.
Adults
The recommended dose is 15ml per day.
Children
The recommended dose is on average 10 ml per day and 5 ml per day for infants.
Do not exceed the recommended dose.
The correct dose is the minimum sufficient to produce easy evacuation of soft stools.
It is advisable to initially use the minimum doses provided.
When necessary, the dose can then be increased, but without ever exceeding the maximum indicated.
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Contraindicated in subjects with galactosemia.
Laxatives are contraindicated in subjects with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.
Generally contraindicated during pregnancy and lactation (see section 4.6).
Generally contraindicated in pediatric age (see section 4.4).
04.4 Special warnings and appropriate precautions for use
Warnings
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors.
In severe cases, the onset of dehydration or hypokalaemia is possible, which can cause cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
Precautions for use
In children under the age of 12, the medicine can only be used after consulting your doctor.
It should be taken into account that the reflex to evacuate may be altered during treatment.
The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.
Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks or when the use of the laxative fails to produce effects.
It is also advisable for elderly people or those who are not in good health to consult their doctor before using the medicine.
Lactulose is absorbed to a very small extent and has no caloric value. In addition to lactulose, DUPHALAC also contains traces of galactose, lactose and tagatose. This must be taken into account in the treatment of diabetic patients and in patients on low calorie diets.
Lactulose should be administered with caution to lactose intolerant patients.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed.
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally.
Therefore, avoid ingesting laxatives at the same time as other drugs: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.
Broad-spectrum antibiotics can reduce the bacterial flora responsible for the degradation of lactulose, with a possible decrease in its therapeutic efficacy.
The lowering of the pH in the intestine, characteristic of the mechanism of action of lactulose, can cause the inactivation of drugs that have a pH-dependent release profile of the intestine (eg 5-ASA drugs).
04.6 Pregnancy and breastfeeding
There are no adequate and well-controlled studies on the use of the drug in pregnancy or lactation. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.
04.7 Effects on ability to drive and use machines
Lactulose has no or negligible effects on the ability to drive or use machines.
04.8 Undesirable effects
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation and flatulence during the first days of treatment which normally disappears after a few days.
Gastrointestinal disorders
Flatulence, abdominal pain, nausea and vomiting; diarrhea (with excessive dosages)
Diagnostic tests
Electrolyte imbalance due to diarrhea
04.9 Overdose
Symptoms
Excessive doses can cause abdominal pain and diarrhea. See also what is reported in section 4.4 about laxative abuse.
Treatment
Treatment interruption or dose reduction. The resulting loss of fluids and electrolytes must be replaced.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: laxatives with osmotic action.
ATC code: A06AD11.
Lactulose in the colon, acting as a prebiotic substance, promotes the growth of bacteria useful to humans, such as Bifidobacterium and Lactobacillus, and can inhibit potentially pathogenic bacteria, such as Clostridium and Escherichia Coli. In this way, a more favorable balance of the intestinal flora can be obtained.
In the colon, lactulose is split from the saccharolytic flora which favors the development to the detriment of the proteolytic one, in organic acids with low molecular weight, especially lactic acid, which lower the intestinal pH and activate peristalsis, also normalizing the consistency of the fecal mass. The action of lactulose can be summarized as follows: it favors the development of the saccharolytic flora (Lactobacillus acidophilus. Bifidobacterium bifidum) decreases the absorption of ammonia from the intestine to the blood by lowering the intestinal pH which determines the transformation of ammonia (NH3 ) in non-absorbable ammonium ion (NH4 +); the acidification of the intestinal contents also favors the recall of ammonia from the blood to the intestine; decreases the formation of ammonia and other toxic products of protein degradation due to the relative decrease in proteolytic activity ; lactulose therefore reduces the production of toxic substances processed by the proteolytic flora, including ammonia, and favors their evacuation.
05.2 Pharmacokinetic properties
DUPHALAC contains lactulose, that is a synthetic disaccharide (betagalactosidofructose) which is practically not absorbed, since there is no specific enzyme in the small intestine that hydrolyzes lactulose into the monosaccharides that compose it and arrives unchanged in the colon where it is metabolized by the bacterial flora. dosages up to 40-75 ml, lactulose is completely metabolized; at higher dosages a part is eliminated unchanged.
05.3 Preclinical safety data
On the basis of acute and chronic toxicity studies performed on various animal species, it is possible to document the absence of toxicity of DUPHALAC at doses / kg of body weight much higher than those used in humans. The LD50 values determined in various animal species (rat, adult rat, mouse, hamster) have always been greater than 28 ml / kg of body weight. Similarly, both fetal toxicity and carcinogenic activity can be excluded.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
purified water.
06.2 Incompatibility
Not applicable.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Packaging containing a 200 ml polyethylene (HDPE) bottle with guarantee closure, equipped with drip catcher and measuring cup.
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with current legislation
07.0 MARKETING AUTHORIZATION HOLDER
Abbott Healthcare Products B.V. - Weesp, The Netherlands.
Sales licensee for Italy: Abbott S.r.l. S.R. 148 Pontina km 52- 04011 Campoverde di Aprilia (LT)
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 022512014.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
30-12-1972 / 31-05-2010.
10.0 DATE OF REVISION OF THE TEXT
January 2012
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