Bismuth Subgallate Compound Suppositories Bp 80
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bismuth Subgallate Compound Suppositories BP 80
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Bismuth Subgallate BP 1980 200mg
Zinc Oxide BP 120mg
3. PHARMACEUTICAL FORM
Suppository
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Treatment of Haemorrhoids and anal pruritus
4.2. Posology and Method of Administration
For the elderly, adults and children over 6 years of age, one suppository to be inserted into the rectum at night and morning and after defaecation.
Note: Not suitable for children under 6 years of age.
4.3. Contra-Indications
Hypersensitivity to the constituents.
4.4. Special Warnings and Special Precautions for Use
If symptoms persist consult a doctor.
Prolonged application should be avoided.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
None known.
4.6. Pregnancy and Lactation
No adverse reports.
4.7. Effects on Ability to Drive and Use Machines
No adverse effect.
4.8. Undesirable Effects
None reported.
4.9. Overdose
Not thought possible/
5.
5.1.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Bismuth subgallate and zinc oxide are well known, long established soothing agents. The witepsol base will contribute some emollient effect.
5.2. Pharmacokinetic Properties
No in-vivo data available. These are topically acting mildly soothing agents.
5.3. Pre-clinical Safety Data
No additional data of relevance to the prescriber.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Castor Oil BP Resorcinol BP Witepsol S55 Witepsol E85
6.2. Incompatibilities
None Known
6.3. Shelf-Life
3 years (36 Months)
6.4. Special Precautions for Storage
Store Below 25°C. Protect from light Keep out of the reach of children
6.5. Nature and Contents of Container
Suppositories sealed into printed plastic cavaties. 2 strips of 6 suppositories are packed into a carton. Pack size available 12 suppositories.
6.6. Instructions for Use, Handling and Disposal
Remove the wrapping and insert 1 suppository into the anus. The suppository may be retained in position by crossing the legs or lying on the side. If necessary they may be lubricated with a small quantity of olive oil before insertion.
7. MARKETING AUTHORISATION HOLDER
Martindale Pharmaceutical Ltd
Bampton Road
Romford
RM3 8UG
England
8. MARKETING AUTHORISATION NUMBER(S)
PL 0156/0046
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/04/2009
10 DATE OF REVISION OF THE TEXT
24/11/2003