Summary of Product Characteristics (SmPC) - Proflavine cream 0.1%
1 NAME OF THE MEDICINAL PRODUCT
Proflavine Cream 0.1%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Proflavine hemisulphate BPC 0.1 % w/w
Excipient(s) with known effect
Wool Fat (Lanolin) BP 5.0 % w/w
Chlorocresol BP 0.1 % w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For treatment of infected wounds and for skin disinfection
4.2 Posology and method of administration
Posology
For topical use
Adults, including the elderly and children over 2 years of age
Method of administration
To be applied to the affected part 2 - 3 times daily or as directed by a medical practitioner.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
The bottle should be well shaken before use
Prolonged use should be avoided
The product contains Lanolin
External use only
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not totally remove it.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Can be used during pregnancy and lactation
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
None stated
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
If the product is accidentally ingested, an emetic should be given and medical advice sought.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Proflavine hemisulphate is an acridine derivative with slow acting disinfectant activity. It is bacteriastatic against many Gram-positive bacteria
5.2 Pharmacokinetic properties
None stated
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Liquid Paraffin BP
Yellow Beeswax BP
Wool Fat (Lanolin) BP
Chlorocresol BP
Phenoxyethanol BP
Purified Water BP
6.2 Incompatibilities
None known
6.3 Shelf life
2 years in unopened containers Use within 3 months of initial opening
6.4 Special precautions for storage
Store below 25°C
Do not freeze
6.5 Nature and contents of container
100 and 200ml pack sizes: amber glass with plastic cone lined caps 500ml and 2 litre pack sizes: amber high density polyethylene bottles and plastic caps
6.6 Special precautions for disposal
Use as indicated on the label
7 MARKETING AUTHORISATION HOLDER
Northumbria Pharma Ltd
Netpark
Thomas Wright Way
Sedgefield
County Durham
TS21 3FD
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 48259/0029
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25 July 1990
10 DATE OF REVISION OF THE TEXT
10/10/2019