ORANGE FLAVOUR REGULAN

Active substance: ISPAGHULA HUSK

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Orange Flavour Regulan.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Orange Flavour Regulan contains 3.4g of Ispaghula Husk, BP.

3

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

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.

When preparing the product for administration, it is important to try to avoid inhaling
any of the powder in order to minimise the risk of sensitisation to the active
ingredient.

4.3

Contra-indications
Known hypersensitivity to ispaghula or any of the ingredients (See 4.4 Special
Warnings and Special Precautions for Use).
Not to be given to patients with intestinal obstruction, faecal impaction, colonic
atony or hypersensitivity to ispaghula.or any of the ingredients.
Do not give to children under 6 years of age, unless on the advice of a doctor

4.4

Special Warnings and Special Precautions for Use
It is important to take the product with sufficient fluid. Orange Flavour Regulan
should always be taken as a liquid suspension and should be drunk immediately after
mixing. The product should not be taken if you have difficulty swallowing unless on
the advice of a doctor. The last dose should not be taken immediately before going to
sleep since impaired or reduced gastric motility may impair the intestinal passage and
then cause sub-obstruction. The product should be taken ½ to 1 hour before or after
intake of other oral medicines. 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 gastrointestinal
obstruction have been reported with mucilloid preparations when taken, contrary to
the administration instructions, with insufficient liquid.
Warning on hypersensitivity reactions
In individuals who have continued occupational contact with the product (powder) ie.
healthcare workers, caregivers etc, allergic sensitisation may occur due to inhalation;
this is more frequent in atopic individuals. This sensitisation usually leads to
hypersensitivity reactions which could be serious (See 4.8 Undesirable effects).
It is recommended to assess clinically the possible sensitisation of individuals at risk
and, if justified, to perform specific diagnostic tests.
In case of proven sensitisation leading to hypersensitivity reactions, exposure to the
product should be stopped immediately and avoided in the future (See 4.3 Contraindications)

Each sachet contains 25 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.
If symptoms persist consult your doctor
Keep out of reach and sight of children.

4.5

Interactions with other Medicinal Products and other forms of
Interaction
There are no known clinical relevant interactions.

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
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:
Ispaghula contains potent allergens. The exposure to these allergens is possible
through oral administration, contact with the skin and, in the case of powder
formulations, also by inhalation.
As a consequence to this allergic potential, individuals exposed to the product can
develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and
in some cases, anaphylaxis (very rare, <1 in 10,000). Cutaneous symptoms such as
skin rashes, allergic dermatitis, urticaria and/or pruritus have also very rarely been
reported (<1 in 10,000). Special attention should be given to individuals handling the
powder formulations routinely (See 4.4 Special warnings and precautions for use).

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
None

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
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.

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

6.6.

Instructions for Use/Handling
A patient leaflet is provided with details of use and handling of the product.
See 4.2 Posology and Method of Administration

7

MARKETING AUTHORISATION HOLDER
Procter & Gamble (Health & Beauty Care) Limited
The Heights, Brooklands,
Weybridge,
Surrey, KT13 0XP
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 0129/0114

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15 September 1992

10

DATE OF REVISION OF THE TEXT
18/05/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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