Nystaform HC Cream

Summary of Product Characteristics Updated 14-Feb-2024 | Typharm Limited

1. Name of the medicinal product

Nystaform HC Cream

Nystatin/Chlorhexidine hydrochloride/Hydrocortisone 100,000 units/g/1% /0.5% Cream

2. Qualitative and quantitative composition

The product contains nystatin 100,000 I.U./g, chlorhexidine hydrochloride 1.0% w/w and hydrocortisone 0.5% 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.

3. Pharmaceutical form

A light yellow cream for topical application.

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration


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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

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.

Long term 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.

The label will state mild steroid.

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 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 HC 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).

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, pregnancy and lactation

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 Cream requires that the anticipated benefits outweigh the possible risks.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

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 in the Google Play or Apple App Store.

4.9 Overdose

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibiotics in combination with corticosteroids, ATC code: D01AA20.

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

Hydrocortisone is a mildly potent corticosteroid and exercises a vasoconstrictive effect, thus reducing inflammation and oedema and also has an antipruritic effect.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

Cetostearyl alcohol


Polysorbate 60

Sorbitan stearate

Cetyl esters wax

Benzyl alcohol

Purified water

Ph. Eur

Ph. Eur

Ph. Eur

Ph. Eur

Ph. Eur

Ph. Eur

Ph. Eur

6.2 Incompatibilities

None stated.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25° C.

6.5 Nature and contents of container

15g and 30g resin-lined aluminium tubes with polyethylene caps contained in an outer cardboard carton.

6.6 Special precautions for disposal and other handling

For external use only. Avoid contact with eyes.

7. Marketing authorisation holder

Typharm Limited

Unit 1

39 Mahoney Green



NR13 6JY

8. Marketing authorisation number(s)

PL 00551/0019

9. Date of first authorisation/renewal of the authorisation


10. Date of revision of the text


Company Contact Details
Typharm Limited

Unit 1, 39 Mahoney Green, Rackheath, Norwich, Norfolk, NR13 6JY


+44 (0)1603 722480

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