SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Baritop 100

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Barium Sulphate 100 %w/v

3.    PHARMACEUTICAL FORM

Barium Sulphate Suspension

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Baritop 100 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 examination methods	in accordance with	the parts to be	examined and
Adults and Elderly
Part of GI Tract	Method	Volume (ml)	Concentration (% w/v)
Oesophagus	Oral	10-150	50-100
Stomach & Duodenum	Oral, DoubleContrast, 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. Contra-Indications

Suspected perforation of intestinal organs: Haemorrhage in digestive organs.

Suspected perforation of intestinal organs: Haemorrhage in digestive organs: Extreme exhaustion.

4.4. Special Warnings and Special Precautions for Use

Baritop 100 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 etc).

Water and laxatives should be given to patients to prevent constipation.

4.5. Interaction with other Medicinal Products and other Forms of Interaction

None stated.

4.6. 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.    Pre-clinical 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.

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.

Tin free steel coated internally with vinyl resin on epoxy resin.

6.6. Instructions for Use, Handling and Disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

Sanochemia Diagnostics UK Ltd.

1 Friary Temple Quay Bristol BS16EA United Kingdom

8.    MARKETING AUTHORISATION NUMBER(S)

19088/0006

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/12/2010

10    DATE OF REVISION OF THE TEXT

25/07/2013