Nystaform

Nystaform HC Ointment

Nystatin/Chlorhexidine acetate/Hydrocortisone 100,000 units/g/1%/1% Ointment

The product contains nystatin 100,000 I.U./g, chlorhexidine acetate 1.0% w/w and hydrocortisone 1.0% w/w in a water-repellent base.

For the full list of excipients, see section 6.1.

A yellow ointment containing a water-repellant base for topical application.

Nystaform HC Ointment is indicated for the treatment of infected dermatoses where fungal (particularly monilial) and/or bacterial infections are present.

Posology

Adults and Children:

Apply to infected areas 2-3 times daily.

Treatment should be for a maximum period of 7 days.

Method of adminstration

For topical application only.

Tuberculous lesions of the skin. Known hypersensitivity to the active substances, 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.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

Paediatric population

In infants, long-term continuous topical steriod therapy should be avoided. Adrenal suppression can occur even without occlusion. As with other topical corticosteroids, systemic absorption may occur when extensive areas are treated, particularly under occlusion.

Nystaform HC Ointment 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 HC Ointment 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.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. The relevance of this finding to humans has not been established. However, topical steroids should not be used extensively in the first trimester of pregnancy and nystatin only with caution. The use of Nystaform HC Ointment requires that the anticipated benefits outweigh the possible risks.

None stated.

Skin Disorders and Subcutaneous Tissue Disorders

Frequency not known (cannot be estimated from available data): Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters. Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4)

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 Scheme 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. Hydrocortisone exercises a vasoconstrictive effect, thus reducing inflammation and oedema and also has an antipruritic effect.

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

Hydrocortisone is absorbed through the skin and is metabolised by the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

None stated.

White soft paraffin BP

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 00551/0020

13^th June 2000

04/11/2022