Procter & Gamble (Health & Beauty Care) Ltd.

Orange Flavour Regulan.

Orange Flavour Regulan contains 3.4g of Ispaghula Husk, BP.

Premeasured, single-dose sachets containing a orange flavoured beige, fine ground powder, which when reconstituted with water is intended for administration as an oral solution.

For the relief of constipation and for patients who need to increase their daily fibre intake.

The measured dosage should be poured into a glass and 150ml (¼ pint) of cool water, milk, fruit juice or other liquid added, stirred, and taken immediately. Additional liquid may be taken if required. Adequate fluid intake should be maintained.

Adults and children over 12 years

Usual dosage is the entire contents of one sachet taken one to three times daily.

Elderly

No alteration in dosage necessary.

Children 6-12 years

A reduced dosage based upon age of the child should be given. ½ - 1 level teaspoonful one to three times daily.

Not to be given to patients with intestinal obstruction, faecal impaction, colonic atony or hypersensitivity to ispaghula or any of the excipients.

Orange Flavour Regulan should always be taken as a liquid suspension and should be drunk immediately after mixing. The last dose should not be taken immediately before going to bed since impaired or reduced gastric motility may impair the intestinal passage and then cause sub-obstruction. The drug may cause allergic reactions in people sensitive to inhaled or ingested ispaghula powder or with hypersensitivity to any of the excipients.

It may be advisable to supervise treatment in the elderly or debilitated and patients with intestinal narrowing or decreased motility, as rare instances of gastrointestinal obstruction have been reported with mucilloid preparations when taken, contrary to the administration instructions, with insufficient liquid.

Each sachet contains 26mg of phenylalanine and this should be considered in phenylketonuric patients.

The colouring agent, Sunset Yellow, can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

None known.

Controlled studies in pregnant and lactating women are not available, but the product has been in wide use for many years without apparent ill consequence and animal studies have shown no hazard. Ispaghula is not thought to be absorbed nor is it thought to enter breast milk. Nevertheless the benefits of therapy should be weighed against the possible risks if used during pregnancy and lactation.

None known.

Gastrointestinal disorders: Regulan (Ispaghula), as with other bulk laxatives, may temporarily increase flatulence and abdominal distension when the product is first used. Other symptoms including nausea, diarrhoea and abdominal discomfort or pain have rarely been reported (<1 in 1000).

Intestinal obstruction and faecal impaction may occur very rarely (<1 in 10,000), especially if the product is taken with insufficient fluid.

Immune system disorders SOC: There are very rare reports (<1 in 10,000) of allergic or hypersensitivity reactions associated with the ingestion or inhalation of Ispaghula including skin rashes or allergic dermatitis, rhinitis, urticaria, bronchospasm and anaphylactic reactions.

No instances of true overdosage have been reported. If overdosage should occur there is no specific treatment and symptomatic measures should be employed.

The active constituent, ispaghula husk, is the epidermis and collapsed adjacent layers removed from the dried ripe seeds of plantago ovata, containing mucilage and hemicelluloses.

The ispaghula husk is not absorbed and produces its effect as a bulking agent by physical means alone.

Not applicable.

Not stated.

Contains maltodextrin, citric acid, orange flavour, aspartame (E951), and Sunset Yellow FCF (E110). Orange flavour Regulan is sugar free and gluten free. Each sachet contains 0.23 mmol of sodium.

None known.

Three years.

Store in a dry place not above 25°C.

Paper / aluminium foil / polyethylene sachets. The product is available in packs of 30 sachets.

A patient leaflet is provided with details of use and handling of the product.

Procter & Gamble (Health & Beauty Care) Limited

The Heights, Brooklands,

Weybridge,

Surrey, KT13 0XP

UK

PL 0129/0114

PA 441/34/2

15 September 1992

June 2009