Summary of Product Characteristics (SmPC) - Baritop 100
1 NAME OF THE MEDICINAL PRODUCT
BariClear® 100% w/v Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Barium Sulphate 100 %w/v
3 PHARMACEUTICAL FORM
Barium Sulphate Suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
BariClear® 100% w/v Suspension is an X-ray contrast medium for use in the radiological examination of the gastrointestinal tract.
4.2 Posology and method of administration
Oral or by enema in accordance with the parts to be examined and examination methods
Adults and Elderly
Part of GI Tract Method Volume
(ml)
Concentration
(% w/v)
Oesophagus Oral 10-150 50-100
Stomach &
Duodenum
Oral, Double-
Contrast,
Distension
Filling & Relief
10-300 30-100
Small Intestine Oral 100-300 30-100
Colon Enema 200-2000 20-100
Children
As for adults but in proportion to body weight.
Infants
As for adults but in proportion to body weight.
4.3 Contraindications
Oral Use: Suspected perforation of intestinal organs: Haemorrhage in digestive organs.
Enema Use: Suspected perforation of intestinal organs: Haemorrhage in digestive organs:
Extreme exhaustion.
4.4 Special warnings and precautions for use
BariClear® 100% w/v Suspension should be used with great caution in:
Oral use:
Suspected or known fistula in digestive organs.
Stricture or signs suggesting obstruction.
Suffering from extreme exhaustion.
Enema use:
Suspected or known fistula in digestive organs.
Stricture or signs suggesting obstruction: Diseases of internal organs that could lead to perforation (e.g. appendicitis, diverticulitis, ulcerative colitis, invagination tumour, parasitic disease).
Water and laxatives should be given to patients after investigation to prevent constipation.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, Pregnancy and lactation
At the discretion of the physician.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
May cause constipation, transient diarrhoea, abdominal pain, anal pain and bleeding.
4.9 Overdose
Treat symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No formal preclinical studies have been undertaken.
Barium sulphate is a well established pharmaceutical substance that has been available for many years. It is also the subject of a recognised Pharmacopoeial Monograph.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carmellose sodium
Tragacanth
Sodium saccharin
Glycine
Sodium ascorbate
Silicon resin emulsion
Sodium benzoate
Sodium dehydroacetate
Cream soda essence flavour
Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None stated.
6.5 Nature and contents of container
300ml sealed can
Steel body and bottom with an aluminium top. The top is coated internally with polyester film laminate and the body and bottom with epoxy resin.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Red Knights Pharma Ltd.
5300 Lakeside
Cheadle Royal Business Park,
Cheadle SK8 3GP
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 55644/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/12/2010
10 DATE OF REVISION OF THE TEXT
10/02/2025