Manx Antiseptic 0.15% W/W Cream
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Manx Antiseptic 0.15%w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dibrompropamidine isetionate 0.15%w/w For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth, white cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Indications
(a) First aid dressing for minor burns, scalds, abrasions and other open injuries and their routine treatment.
(b) For the treatment of surface infections due to susceptible organisms, particularly in cases with penicillin resistant Staphylococci or certain Gram-negative bacilli.
(c) Treatment of ringworm of the scalp (Microsporum canis) and other superficial fungal infections.
(d) Treatment of pyodermias, including sycosis barbae.
(e) Treatment of otitis externa.
(f) Treatment of nappy rash.
4.2 Posology and method of administration
Adults: apply to the affected area, either directly or on a light dressing, two or three times a day.
Elderly and children: no specific recommendations.
For cutaneous use.
4.3 Contraindications
Manx Antiseptic 0.15%w/w Cream should not be used in patients with known hypersensitivity to dibrompropamidine or any of the other ingredients.
4.4 Special warnings and precautions for use
Prolonged use may interfere with healing and cause skin necrosis in infants. This medicine contains the following excipients:
• Methyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed)
• Castor oil may cause skin reactions
• Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
There is no evidence of the drug’s safety in human use nor is there any evidence from animal work that it is free from hazard. Avoid unless considered essential.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
There is always the possibility, although rare, of a sensitisation reaction or contact dermatitis occurring: in such an event, treatment should be discontinued immediately.
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
4.9 Overdose
The 25g tube of Manx Antiseptic 0.15%w/w Cream contains 37.5mg of dibrompropamidine, the 30g contains 45mg and the 50g contains 75mg. No toxic effects are likely to occur even if the contents of a full tube are accidentally ingested. Similarly, the ingredients of the base are unlikely to have toxic effects in the quantities present.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: D08AC01
Dibrompropamidine isetionate is an antibacterial agent active against pathogenic Streptococci and Staphylococci, including penicillin resistant strains, and has some activity against a number of Gram negative bacilli. Its antibacterial action is not inhibited by pus, blood or p-aminabenzoic acid. In addition, it has useful activity against certain species of pathogenic fungi. Manx Antiseptic 0.15%w/w Cream is well tolerated and rarely gives rise to sensitisation reactions or contact dermatitis.
5.2 Pharmacokinetic properties
No data available.
5.3 Preclinical safety data
No relevant data.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Castor oil, virgin
Cetostearyl alcohol
Polyethylene glycol 600 monostearate
Methyl parahydroxybenzoate
Silicone MS Antifoam A
Purified water
6.2 Incompatibilities
Not applicable.
Shelf life
6.3
36 months.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and Contents of Container
Collapsible aluminium internally lacquered tube with extended nozzle containing 25g, 30g or 50g cream. Polythene plug seal cap.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Manx Pharma Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 15833/0027
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/08/2009
10 DATE OF REVISION OF THE TEXT
16/07/2015