- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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.
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.
Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.
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).
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.
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
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.
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 antibiotic 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.
White soft paraffin BP
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.
14D Wendover Road
Rackheath Industrial Estate
13th June 2000
14D Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk, NR13 6LH
+44 (0)1603 263804
+44 (0)1603 722480
+44 (0)1603 722480
+44 (0)2037 694160
+44 (0)1603 722480