Duphalac

1. Name Of The Medicinal Product

Lactulose Solution BP /Duphalac®.

2. Qualitative And Quantitative Composition

Lactulose 3.35 g/5 ml.

For excipients, see 6.1

3. Pharmaceutical Form

A colourless to brownish yellow, clear or not more than slightly opalescent liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

1. For the treatment of constipation.

2. For the treatment of hepatic encephalopathy (portal systemic encephalopathy); hepatic coma.

4.2 Posology And Method Of Administration

Constipation:

Adults (including the elderly):	initially 15 ml twice daily
Children 5 to 10 years:	10 ml twice daily
Children under 5 years:	5 ml twice daily
Babies under 1 year:	2.5 ml twice daily

All dosages should subsequently be adjusted to the needs of the individual. Each dose may if necessary be taken with water or fruit juices, etc.

Hepatic encephalopathy:

Adults (including the elderly): Initially 30 - 50 ml (6-10 x 5 ml spoonfuls) three times a day. Subsequently adjust the dose to produce two or three soft stools each day.

Children: no dosage recommendations for this indication.

4.3 Contraindications

Contraindicated in patients with galactosaemia and in cases of gastro-intestinal obstruction.

4.4 Special Warnings And Precautions For Use

Lactulose should be administered with care to patients who are intolerant to lactose (see 6.1).

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 may need to be taken into consideration for diabetics.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

It should be taken into account that the exoneration reflex could be disturbed during the treatment.

In case of insufficient therapeutic effect after several days, consultation of a physician is advised.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Limited data on pregnant patients indicate neither malformative nor foeto/neonatal toxicity.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

The use of lactulose may be considered during pregnancy if necessary.

Lactation

No effects 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.

4.7 Effects On Ability To Drive And Use Machines

Not known.

4.8 Undesirable Effects

Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased. See also overdose section 4.9.

If high doses (normally only associated with portosystemic encephalopathy, PSE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea. Dosage should then be adjusted to obtain two or three formed stools per day.

Gastrointestinal disorders

Flatulence, abdominal pain, nausea and vomiting. If dosed too high, diarrhoea.

Investigations

Electrolyte imbalance due to diarrhoea.

4.9 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.

No specific antidote. Symptomatic treatment should be given.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The active ingredient, lactulose, is metabolised in the colon by the sacchrolytic bacteria, producing low molecular weight organic acids, mainly lactic acid, which lower the pH of the colon contents, promote the retention of water by an osmotic effect, thus increasing peristaltic activity.

5.2 Pharmacokinetic Properties

Lactulose is minimally absorbed; therefore, the kinetics of the absorbed material are not relevant to the principal therapeutic action.

5.3 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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

None known.

6.3 Shelf Life

HDPE: 2 years. Other containers: 3 years.

6.4 Special Precautions For Storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5 Nature And Contents Of Container

Brown glass and white HDPE bottles containing 200, 300, 500 and 1000 ml; polyethylene bottles containing 5 litres; 15 ml foil sachets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Solvay Healthcare Limited/Solvay Healthcare Ltd trading as Mansbridge Pharmaceuticals

Mansbridge Road

West End

Southampton

SO18 3JD

8. Marketing Authorisation Number(S)

PL 00512/5001R

9. Date Of First Authorisation/Renewal Of The Authorisation

14.03.88 / 23.07.99

10. Date Of Revision Of The Text

19/08/2010