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Duphalac is a clear, viscous, colourless to brownish yellow aqueous 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.

Phosphalugel is an antacid. It reduces the acidity of the stomach

Pepsane is indicated for the treatment of stomach ache

Indications

– Constipation: regulation of the colonic physiological rhythm

– Where soft stool is considered of medical benefit (haemorrhoids, post colonic/anal surgery)

– Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma

Duphalac 667 g/l oral solution

Dosage and administration

You may take Duphalac oral solution diluted or undiluted, you also can use lactulose one dose daily or divide into two doses a day, using measuring cup.

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, always take it at the same time of day, e.g. during breakfast.

During therapy with laxatives it is important for you to drink sufficient amounts of fluids f 1.5 – 2 litres, equal to 6-8 glasses) during the day.

For Duphalac in bottles the measuring cup may be used For Duphalac in 15 ml single dose sachets the comer of the sachet should be tom off and contents taken immediately.

Dosing in constipation or where soft stool is considered of medical benefit

Duphalac may be taken as a single daily dose or in two divided doses, for Duphalac in 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 effect occurs.

Duphalac oral solution in bottles or 15 ml single dose sachets

Starting dose, daily Maintenance dose daily
Adults and adolescents 15 – 45 ml, corresponding to 1-3 sachets 15-30 ml, corresponding to 1-2 sachets
Children (7 – 14 years) 15 ml, corresponding to 1 sachets 10- 15 ml, corresponding to 1 sachets
Children (1-6 years) 5- 10 ml 5 – 10 ml
infants under 1 year up to 5 ml up to 5 ml

* If the maitenance dose is below 15 ml, Duphalac in bottles should be used

For a precise dosing for infants and children up to 7 years, Duphalac in bottles should be used.

Dosing in HE ( for adults only )

Starting dose: 30 – 45 ml or 2 – 3 sachets, three to four times daily

This dose may be adjusted to maintenance dose to achieve 2 to 3 soft stools per day.

Paediatric population

The safety and efficacy in children (newborn to 18 years of age) with ME have not been established. No data are available.

Elderly patients and patients with renal or hepatic insufficiency

No special dosage recommendations exist, since systemic exposure to lactulose is negligible.

Contraindications

Do not take Duphalac oral solution

– If you are hypersensitive (allergic) to lactose or to any of the ingredients of Duphalac oral solution

– if you suffer from galactosactnia

– Gastrointestinal obstruction, digestive perforation or risk of digestive perforation

Warnings and special precautions for use 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.

Patients who arc intolerant to lactose should take Duphalac oral solution with care (because it contains lactose, see section Important information about the ingredients).

The dose normally used in constipation should not pose a problem for diabetics. However, the dose used in the treatment of HE is usually much higher and sugar content of the medicine should 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 problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose 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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

No interaction studies with other medications have been performed.

Pregnancy, lactation and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

During pregnancy, no effects to the feotus arc anticipated, since systemic exposure of lactulose to the pregnant woman is negligible. Duphalac can be used during pregnancy.

Lactation

No effects on the breastfed newbom/infani are anticipated since the systemic exposure of lactulose to the breast-feeding woman is negligible. Duphalac can be used during breastfeeding.

Fertility

No effects are to be expected, since systemic exposure to lactulose is negligible.

Effects on ability to drive and use machines

Duphalac has no or negligee influence on the ability to drive and use machines.

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,

Undesirable effects

Inform your doctor about undemrable effects when using this medicine.

Like all medicines, Duphalac oral solution may cause side effects, although not everyone experiences them.

If you notice any side effects not mentioned in this leaflet, or if any of the side effects gets serious, please inform your doctor or pharmacist.

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 a case the dosage should be decreased (see section Overdose).

If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhea.

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 (>=l/1000 to <1/100); rare (>=l/10000 to

<1/1000); very rare (<1/10000)]

Frequency category
Very common Common Uncommon Rare
Gastro

intestinal

disorders

Diarrhea Flatulence, Abdominal

pain, nausea.

vomiting

Investigations Electrolyte imbalance due to diarrhea

Paediatric population

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

Overdose

If you have taken too high a dose you may experience the following symptoms: diarrhoea and/or abdominal pain. Under these circumstances, the treatment should be stopped or the dosage reduced sufficiently for the symptoms to subside.

Extensive fluid loss by diarrhoea or vomiting may require the intake of extra electrolytes. Please ask your doctor or pharmacist for advice.

Pharmacodynamics

Pharmacotherapeutic group: Osmotically acting laxatives

The following is a detailed description of how Duphalac oral solution works. If you would like an explanation or further information regarding this information, please consult your doctor.

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 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 effect 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 effect 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 probiotic 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.

Shelf life and storage conditions

3 years from the manufacturing date.

Do not store above 25°C.

Store in the original package.

Do not use this medicine after the expiry date stated on the carton and sachet or bottle.

Keep this medicine out of the reach and sight of children.

Pack sizes

Duphalac oral solution comes in

– Sachets containing 15 ml, are made of a polyester/ aluminium/polyethylene laminate.

– Bottles containing 200, 500 or 1000 ml are made of HDPE with polypropylene closures and come with a polypropylene measuring cup. The graduations on the measuring cup are: 2.5 ml, 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and 30 ml.

Not all pack sizes may be marketed.

Further information No special requirements.

The information in this leaflet is limited. For further information, please contact your doctor or pharmacist.

Date of information July 2013

Read all of this leaflet carefully before you start takin£ this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. Always take this medicine exactly as described in this leafet or as your , doctor or pharmacist has told you. You must talk to a doctor if you do not feel better or if you feel worse after several days.

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