Regulose Plum Flavoured Lactulose Solution

1. Name Of The Medicinal Product

REGULOSE ® Plum Flavoured Lactulose 66.6% w/v

2. Qualitative And Quantitative Composition

Lactulose BP 66.6% w/v

For excipients see 6.1

3. Pharmaceutical Form

Oral solution.

The product is a clear, colourless to brownish yellow viscous liquid with a plum odour and taste

4. Clinical Particulars

4.1 Therapeutic Indications

Chronic constipation.

Chronic portal systemic encephalopathy.

4.2 Posology And Method Of Administration

Adults

Initially: 15-30ml daily for first 2 – 3 days (45ml may be given in obstinate cases).

Maintenance: 10-15ml daily or according to the need of the patient.

Children

Initially: 10-25ml daily for first 2-3 days.

Maintenance: 5-15ml daily or according to the need of the patient.

Dosage does not appear to be related to the age or weight of the child and should be adjusted to produce the required response.

Chronic Portal Systemic Encephalopathy

Initially 30-50ml three times daily according to the requirements of the patient for adequate acidification of the colonic contents.

Use in the Elderly

No evidence exists that elderly patients require different dosages or show different side-effects from younger patients.

4.3 Contraindications

In common with other preparations used for the treatment of constipation, Lactulose solution should not be used in patients with gastro-intestinal obstruction. Lactulose solution should not be given to patients with galactosaemia or lactose intolerance.

4.4 Special Warnings And Precautions For Use

Prolonged use of Lactulose in children may contribute to the development of dental caries. Patients should be instructed to pay careful attention to dental hygiene.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions involving Lactulose.

4.6 Pregnancy And Lactation

Lactulose solution should be used with caution during the first trimester of pregnancy.

4.7 Effects On Ability To Drive And Use Machines

There is no evidence that Lactulose affects driving ability.

4.8 Undesirable Effects

Side-effects rarely occur after the administration of Lactulose solution. Mild transient effects such as abdominal distension of cramps and flatulence, which subside after the initial stages of treatment, have occasionally been reported. High doses may provoke nausea in some patients. This can be minimised by administration with water, fruit juice or with meals.

4.9 Overdose

No cases of intoxication due to deliberate or accidental overdosage with Lactulose solution have been reported to the company.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The active principle, lactulose, is neither broken down nor absorbed in the stomach and small intestine. In the colon, it acts as a substrate for and promotes the growth of naturally occurring glycolic micro-organisms, and is broken down to lactic acid. The pH of the intestinal contents is lowered, the growth of acidophilic flora is promoted and the putrefactive micro-organisms are lowered, the growth of acidophilic flora is promoted and the putrefactive micro-organisms are suppressed. This reduces the formation of ammonia and amines and their absorption from the gut, thus leading to a fall in blood ammonia levels (responsible for hepatic encephalopathy). By normalising the intestine flora gatinar ensures the passage of normal stools, without excessive peristalsis.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no other clinically relevant pre-clinical safety data in addition to those mentioned in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Other sugars (lactose, galactose, tagatose, and other ketoses)

Plum natural flavour

Demineralised water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

PET bottles, amber glass or HDPE (colourless or white) bottles in pack sizes of 200ml, 300ml, 500ml and 1000ml.

6.6 Special Precautions For Disposal And Other Handling

For oral administration

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

Trading style: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

4 September 2000

10. Date Of Revision Of The Text

19 September 2003.

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