Nystaform

Nystaform Cream

Nystatin/Chlorhexidine hydrochloride 100,000 units/g/1% Cream

The product contains nystatin 100,000 I.U./g, chlorhexidine hydrochloride 1.0% w/w in a water-miscible base.

Excipient(s) with known effect:

Cetostearyl alcohol 100 mg per gram of cream

Benzyl alcohol 10 mg per gram of cream

For the full list of excipients, see section 6.1.

A light yellow cream in a water-miscible base for topical application.

Nystaform cream is indicated for the treatment of infected skin conditions where fungal (particularly monilial) and/or bacterial infections are present.

Posology

Adults and Children:

Apply to infected areas 2-3 times daily. Continue application for 1 week after lesions have healed.

The patient should be advised that if the condition has not improved within seven days, to return to the surgery for further consultation. If the condition does not improve within 14 days of starting treatment, then an alternative treatment should be substituted.

Method of adminstration

For topical application only.

Known hypersensitivity to the active substance, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8), or to any of the excipients listed in section 6.1.

For external use only. Avoid contact with eyes. If sensitivity occurs, or if new infection appears, discontinue use and institute alternative therapy.

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

This medicine contains 10 mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.

Nystaform Cream contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Nystaform Cream should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).

None stated.

As with all drugs, nystatin should be administered with caution during the early months of pregnancy and its use requires that the anticipated benefits outweigh the possible risks.

None stated.

Skin disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Immune disorders

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Nystatin is poorly absorbed from the gastro-intestinal tract. In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed as soon as possible after ingestion.

Nystatin is a fungistatic and fungicidal medicine primarily effective against Candida albicans. Chlorhexidine has activity against a wide range of bacteria.

Nystatin is poorly absorbed from the gastro-intestinal tract. It is not absorbed through the skin or mucous membranes when applied topically.

None stated.

None stated.

3 years.

Do not store above 25°C.

30g resin-lined aluminium tubes with polyethylene caps contained in an outer cardboard carton.

For external use only. Avoid contact with eyes.

Typharm Limited

Unit 1

39 Mahoney Green

Rackheath

Norwich

NR13 6JY

PL 00551/0018

12/05/2005

04/11/2022