SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Polyfax Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Polymyxin B Sulfate 10,000 IU Bacitracin zinc 500 IU

3. PHARMACEUTICAL FORM

Ointment

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Topical antibacterial agent. Polyfax Ointment is indicated for the treatment of infected wounds, burns, skin grafts, ulcers, pyoderma, sycosis barbae, impetigo, and in secondarily infected skin lesions of scabies, pediculosis, tinea pedis and contact and allergic dermatitis.

4.2 Posology and method of administration

ADULTS

Polyfax Ointment should be applied thinly over the affected area, which is best left exposed. Two or more applications a day may be necessary, depending on the severity of the condition.

CHILDREN As for adults.

USE IN THE ELDERLY

No specific studies have been carried out in the elderly, however, it may be advisable to monitor renal function in these patients and if there is any impairment then caution should be exercised.

4.3 Contraindications

Hypersensitivity to bacitracin, Polymyxins or cross-sensitising substances.

4.4 Special warnings and precautions for use

The following statements take into account the possibility that the constituent drugs of Polyfax Ointment may be absorbed to a significant degree after topical application. However, the normal use of Polyfax is unlikely to present any risk of systemic toxicity unless the application were excessive e.g. more than 200 g per day in adults or proportionately less in children and in patients with compromised renal function.

Following significant systemic absorption polymyxin B sulfate and bacitracin zinc have nephrotoxic potential and polymixin B sulfate has neurotoxic potential.

As with all antibacterial preparations prolonged use may result in the overgrowth of non-susceptible organisms including fungi.

4.5 Interactions with other medicinal products and other forms of interaction

Following significant systemic absorption, polymyxin B can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.

4.6 Pregnancy and lactation

Due to lack of detailed information, the use of Polyfax Ointment during pregnancy and lactation cannot be recommended in circumstances where significant systemic absorption of the active ingredients may occur.

No information is available regarding the excretion of the active ingredients of their metabolites in human milk.

4.7 Effects on ability to drive and use machines

None known.

4.8    Undesirable effects

Allergic reactions following topical application of polymyxin B and bacitracin zinc have rarely been reported.

Anaphylactic reactions have been reported, as rare events, following topical application of zinc bacitracin.

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

In the unlikely event of significant systemic absorption of the active ingredients of Polyfax Ointment occurring, signs of neurotoxicity and nephrotoxicity may be noted. In such an event, the patient's general status and renal function should be monitored and blood levels of polymyxin B and zinc bacitracin determined.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Polymyxin and Bacitracin zinc are both bactericidal antibiotics. The former exerts its action by binding with the cellular membrane and the latter by inhibiting bacterial cell wall development.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.

PHARMACEUTICAL PARTICULARS

6.1    List of excipients

White soft paraffin, B.P.

6.2    Incompatibilities

None known.

6.3    Shelf Life

5 years.

6.4    Special precautions for storage

Store below 25 °C.

6.5    Nature and content of container

Lacquered aluminium tubes with polyolefin screw caps. Pack sizes: 4g, 20g, 90g

6.6    Instruction for use and handling

No special instructions.

7    MARKETING AUTHORISATION HOLDER

Pliva Pharma Ltd Ridings Point Whistler Drive

Castleford West Yorkshire WF10 5HX UK

8. MARKETING AUTHORISATION NUMBER

PL 10622/0155

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/04/2003 / 21/03/2005

10 DATE OF REVISION OF THE TEXT

22/06/2016