1. Name Of The Medicinal Product
Lemon/Lime Flavour Regulan.
2. Qualitative And Quantitative Composition
Lemon/Lime Flavour Regulan contains 3.4g of Ispaghula Husk, BP.
3. Pharmaceutical Form
Premeasured, single-dose sachets containing a lemon/lime flavoured beige, fine ground powder, which when reconstituted with water is intended for oral administration.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of constipation and for patients who need to increase their daily fibre intake.
4.2 Posology And Method Of Administration
The measured dosage should be poured into a glass and 150m1 (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.
4.3 Contraindications
Not to be given to patients with intestinal obstruction, faecal impaction, colonic atony or hypersensitivity to ispaghula.
4.4 Special Warnings And Precautions For Use
Lemon/Lime 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.
It may be advisable to supervise treatment in the elderly or debilitated and patients with intestinal narrowing or decreased motility, as rare instances of g astrointestinal obstruction have been reported with mucilloid preparations when taken, contrary to the administration instructions, with insufficient liquid.
Each sachet contains 26 mg 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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Gastroi ntestinal 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:
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.
4.9 Overdose
No instances of true overdosage have been reported. If overdosage should occur there is no specific treatment and symptomatic measures should be employed.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Note stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Contains:
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Regulan is sugar free and gluten free. Each sachet contains 0.23 mmol of sodium.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Store in a dry place not above 25°C.
6.5 Nature And Contents Of Container
Paper/foil/polyethylene sachets. The product is available in pack sizes of 30 sachets.
6.6 Special Precautions For Disposal And Other Handling
A patient leaflet is provided with details of use and handling of the product.
7. Marketing Authorisation Holder
Procter & Gamble (Health & Beauty Care) Limited
The Heights
Brooklands
Weybridge
Surrey
KT13 0XP
U.K.
8. Marketing Authorisation Number(S)
PL 00129/0113
9. Date Of First Authorisation/Renewal Of The Authorisation
15th September 1992 / 6th March 1998
10. Date Of Revision Of The Text
01/08/2009
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