Alliance Pharmaceuticals Ireland

Naseptin 0.1% & 0.5% w/w Nasal Cream

Excipients: Contains 8% w/w (80mg/g) cetostearyl alcohol

For a full list of excipients, see section 6.1.

Nasal cream.

White, non-greasy, water-miscible nasal cream.

Naseptin is an antimicrobial cream intended for application to the nares. It is used for eradicating staphylococcal infections, and carriage in the nose.

A small amount of Naseptin is placed on the little finger and applied to the inside of each nostril.

For prophylaxis: Naseptin is applied as above, twice daily, to prevent patients from becoming carriers and to inhibit the dispersion of staphylococci.

For eradication of infection: Naseptin is applied four times daily for 10 days to eliminate organisms from the nares.

Hypersensitivity to chlorhexidine and neomycin or to any of the excipients.

Some patients have shown a hypersensitivity reaction to neomycin or chlorhexidine, although such reactions are extremely rare.

For nasal application only. Keep out of the eyes and ears.

Topical application of neomycin preparations can cause skin sensitisation in a small number of patients. Prolonged use of neomycin can lead to ototoxicity and nephrotoxicity.

If no improvement occurs or there is aggravation, stop use and consult the physician.

See section 6.2.

No special precautions are necessary.

No precautions are necessary.

Local irritation and hypersensitivity can occasionally occur.

Prolonged use may lead to skin sensitisation to neomycin.

Anaphylaxis to chlorhexidine has been reported rarely.

Accidental ingestion

Accidental ingestion of the contents of a Naseptin tube is not likely to have any adverse effect on the patient.

Pharmacotherapeutic group: Other antibiotics for topical use

ATC code: D06AX

Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is inactive against bacterial spores except at elevated temperatures.

Neomycin is a rapidly bactericidal aminoglycoside antibiotic effective against Gram positive organisms including staphylococci and a wide range of Gram negative organisms. Strains of Pseudomonas aeruginosa are resistant to neomycin, as are fungi and viruses.

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found in man following oral use and percutaneous absorption, if it occurs at all, is insignificant.

Neomycin is either not absorbed or is absorbed only minimally through intact skin. Any neomycin which is absorbed will be rapidly excreted by the kidneys in an unchanged state.

Chlorhexidine and neomycin are drugs on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.

Cetostearyl alcohol

Medium-chain triglycerides

Cetostearyl alcohol/ethylene oxide condensate

Purified water

Chlorhexidine is incompatible with soap and other anionic agents.

3 years.

Do not store above 30^ºC. Keep the tube tightly closed. Keep the tube in the outer carton.

Internally lacquered aluminium tube (15g).

No special requirements.

Alliance Pharmaceuticals Limited

Avonbridge House

2 Bath Road

Chippenham

Wiltshire SN15 2BB

United Kingdom

PA 943/2/1

Date of first authorisation: 01 April 1983

Date of last renewal: 01 April 2008

March 2011