duphalac for regulation of the colonic physiological rhythm

667 g/l, oral solution

Duphalac IS a clear, VISCOUS ,liquid, colourless 10 brownish yellow aqueous solution for oral administration containing 667 9 lactulose perl000ml.
Duphalac oral solution does not cootain any exapients, but may contain smal amounts of related. sugars (e.g. ladose, galactose, epilactose) from the route of synlhesis.

Indications :

– constipation : regulation of the colonic physiological rhythm
When soft stool is conedered of medical benefit (haemorrhoids, post colonic /anal surgery).

– portal systemic encephalopathy (pse) : treatment and prevention of hepatic coma or precoma

Dosage and administration:

always take Duphalac oral solution exactly as your doctor has told you. H you teve any questions, you should check with your doctor or pharmacist You may take Duphalac oral solution diluted or undiluted. You may take lactulose as a single daily dose or in two divided doses using the 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 to your individual needs if you have been prescribed asingle daily dose, always like it et the same time of day e,g during breakfast

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

Duphalac oral solution
Starting dose                 Maintenance dose
Adults                                            15-45 ml                            15- 30 mI

Children (7-14 years)                    15 ml                                10- 15 ml
Children(1-6 years)                       5-10 ml                            5-10 ml
Babies                                              5 ml                                   5 ml

Dosing In precoma and coma hepatlcum (for adults only):

Starting dose: 30-45 mJ, three to fourtimesdaily. The maintenance dose should be adjusted so that soft stools are produced 2·3 times per day.

Contraindications :

Do not take Duphalac oral solution
If you are hypersensitive (allergic)tolactoseuto any of the excipients of Duphalac oral solution . if you suffer from galactosaemia.

Warnings and apecial precautions for use :

If the desired results are not Observed after several days of treatrr:ent, consult your doctor. Patients who are intolerant to lactose should take Duphalac oral solution
with.care because it contains lactose (see “Important information about the Ingredients”). The dose normally used in constipation should not pose a problem for diabetics. The dose used in the treatment of (pre) coma hepaticum is usually much higher and should be taken into consideration for diabetics.
Laxatives (of any kind) should be used onty wnen absolutely necessary and only after consutting a cIoctor. Faecal retention abilities could be disturbed during treatment with duphalac oral solution you may want to take protective measures such as using diapers for your small child
Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


No interaction Stuc:f18S with oth6r medications have been performed.
Please tell your doctor or pharmacist. if you are .taking or have recently taken a0Y other medicines including rnedcines obtained without prescription.

Pregnancy and lactation:

Ask your cIoctor or phannacist for advice before laking any medicine.
There is only limited data on pregnant patirots taki1g!his medicine. The available data indicates neither maIformative nor foeto / neonatal toxicity. (toxicity to the foetus or the newborn child). Animal studies do not indicate direct 01″ indirect harmful effects with respectto pregnancy, embryonallloelal development! parturiifon or postnatal development. The use of Duphalacoral sotubon may be coroSidered during pregnancy and lactation if necessary.

Effects on ability to drive and use machines :

Duphalac oral solution has no or negligible Illluenceon!he ability 10 drive and use


Undesirable effects :

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 efficts gets serious please inform your doctor or pharmacist
flatulence may occur during the first few days of treatment as arule it disappears after acouple of days diarrhoea and abdominal pain may be experierad if you take a higher dose than instructed If this occurs the dosage should be decreased to reflect therecommended dosage If you are laking a high do§e (norma!/y only I.iSed for mIC
encephalopathy, PSE) for an extended period of time you may experience an electrolyte imbalaoce (not enough electrolytes in your blood due to diarrhoea

Gastrointestinal disorders :

flatulence , abdominal pain, nausea and or vomiting may be experienced
If taken in too high a dose, diarrhoea may also occur


Electrolyte imbalance (not enough electfotytes in your bloode ) due to diarrhoea may also occur

Pharmacodynamics :

Pharmacolherapeutic group : Osmotically acting laxatives . the following is adetailed description of how Duphalac oral solution works if you would like an explanation or further information regarding this information please consult your doctor
Information for the doctor : In the colon lactlose is broken down by colonic bacteria Into klw-molecular organic aciIs These aads lead to a lowering 01 pH in !he coIoric lumen and via an osmoticelfed lOan increase of the volume 0f the colonic contents. These effects stimulate the perislalsis of the colon and rensn the consistency of the stools. the constalsis of cleared and the physiological rhythm of the colon is reinstated


The following is adetailed description of how Duphalac oral solution is metabolized in the body if you would like an explanayion or further information regarding this information please consult your doctor

Shelf life and storage conditions :

3 years..
Store at temperature not exceeding 30 C.
Store in the original package

Pack sizes:

In 120 and 200 ml  bottles, which are made of PET with HDPE cap.

Manufactured by :

Pharco Pharmaceuticals
“under license of : Iti>ott Healthcare Products B.V: The Netherlands.

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