Bells Herbal Indigestion Remedy
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Indian Brandee
Bell’s Herbal Indigestion Remedy
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Co Rhubarb Tincture BP 5% v/v
Capsicum Tincture BPC 2.567% v/v
Glycerin BP 2% v/v
3. PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of flatulence, heartburn and colic. The product is taken orally in warm water.
4.2 Posology and Method of administration
Oral.
Adults:
One to two 5ml spoonfuls.
Children 5 to 12 years:
Half to one 5ml spoonful in warm water as required.
Do not give to children under 5 years of age unless told by your doctor.
Pregnancy and lactation. Ileus.
Renal disorders.
4.4 Special warnings and special precautions for use
Keep out of reach of children.
Shake bottle.
If symptoms persist consult your doctor.
4.5 Interactions with other medicinal products and other forms of interaction
Not compatible with salicylates and ferrous sulphate.
4.6 Pregnancy and lactation
Data on a large number of exposed pregnancies indicate no adverse effects of Indian Brandee on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Caution should be exercised when prescribing to pregnant women.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Although not to be expected unless the recommended dosage is grossly exceeded, treatment would be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Capsicum has a carminative action.
Rhubarb is a mild anthraquinone purgative exerting an astringent action after purgation.
Glycerin is demulcent and mildly laxative.
5.2 Pharmacokinetic properties
Little is published on the pharmacokinetics of the active ingredient of capsicum--capsaicin-or the ingredients of rhubarb which include glycosides, flavonoids, phenolic carboxylic acids and tannins.
Glycerin is readily absorbed from the gastro-intestinal tract and undergoes extensive metabolism in the liver. It may also be excreted unchanged in the urine.
5.3 Preclinical safety data
None available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose BP
Nipasept (parahydroxybenzoate esters)
Water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months in unopened container.
6.4 Special precautions for storage
Store away from heat and direct sunlight at room temperature.
6.5 Nature and contents of container
Amber glass bottle with wadless plastic cap Sizes 28 ml, 50 ml, 56 ml, 100 ml.
6.6 Instructions for use/handling
None.
7 MARKETING AUTHORISATION HOLDER
Bell, Sons & Co (Druggists) Ltd
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
8. MARKETING AUTHORISATION NUMBER
PL 03105/0055
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of grant 18 August 1997 Date of renewal 16 April 1999
10.
DATE OF REVISION OF TEXT
29/09/2015