SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Brulidine Cream Lloyds Anticeptic Cream

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Dibrompropamidine isethionate B.P. 0.15% w/w

3.    PHARMACEUTICAL FORM

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.

4.3 Contraindications

Brulidine Cream should not be used in patients with known hypersensitivity to dibrompropamidine or any of the other ingredients

4.4. Special Warnings and Special Precautions for Use

Prolonged use may interfere with healing and cause skin necrosis in infants.

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.

4.9    Overdose

The 25g tube of Brulidine 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

Dibrompropamidine isethionate 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-aminobenzoic acid. In addition it has useful activity against certain species of pathogenic fungi. Brulidine Cream is well tolerated and rarely gives rise to sensitisation reactions or contact dermatitis.

5.2. Pharmacokinetic Properties

No data available.

5.3. Pre-clinical 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.

6.3.    Shelf-Life

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. Instruction for Use, Handling and 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 15833/0002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 September 1997/22 December 2010

10 DATE OF REVISION OF THE TEXT

12/06/2015