Calmurid HC Cream

1. Name Of The Medicinal Product

Calmurid HC 10%/5%/1% Cream

2. Qualitative And Quantitative Composition

Urea 10.0% w/w

Lactic Acid 5.0% w/w

Hydrocortisone 1.0% w/w

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Cream for topical (cutaneous) use.

4. Clinical Particulars

4.1 Therapeutic Indications

To be used topically for the treatment of atopic eczema, Besniers prurigo, acute and chronic allergic eczema, neurodermatitis and other hyperkeratotic skin conditions with accompanying inflammation.

4.2 Posology And Method Of Administration

For external use only.

Adults, elderly and children:

Apply twice daily to the affected area after bathing or washing. Moist lesions should be treated as to dry them before using Calmurid HC.

4.3 Contraindications

Skin tuberculosis, viral infections accompanied by dermal manifestations e.g. herpes simplex, vaccinia, chicken pox and measles. Syphilitic skin lesions. In concurrent mycotic infections, the cream should be complemented with antimycotic treatment. Hypersensitivity to any constituent of the product.

4.4 Special Warnings And Precautions For Use

In infants, high surface area in relation to mass raises the likelihood of uptake of excessive amounts of steroid from the cream, even without occlusion, thus adrenal suppression is more likely. In infants, long term continuous topical therapy should be avoided.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no specific data available regarding the use in pregnant women and during lactation.

Pregnancy:

Evidence from animal studies suggests that prolonged intensive therapy with steroids during pregnancy should be avoided.

Lactation:

Given the slow uptake of hydrocortisone from the skin and the rapid destruction of hydrocortisone by the body, there would seem to be little risk of significant transfer at lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

If applied to open wounds or mucous membranes the hypertonic and acidic nature of the preparation may produce smarting. In such cases wash off with water. Where smarting is a barrier to therapy, dilute with an equal quantity of aqueous cream: after a week of treatment with this material, the normal strength should be tolerated.

4.9 Overdose

The barrier function in the skin to steroid uptake, the low toxicity of hydrocortisone and the nature mechanism for its rapid inactivation make overdose unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Corticosteroids, weak, other combinations

ATC code: D07XA

Urea at a concentration of 10% has keratolytic, anti microbial, anti pruritic and hydrating effects on the skin, properties also attributable to Lactic acid. Hydrocortisone 1% is the normal concentration of the drug used as a dermatological anti-inflammatory agent. In some patients with eczema, Calmurid HC cream may be as effective as fluorinated steroid creams.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Urea, lactic acid and hydrocortisone are long established materials, whose pre-clinical profile is known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glyceryl Monostearate

Betaine Monohydrate

Diethanolamine Cetylphosphate ("Amphisol")

Hard Fat

Cholesterol

Sodium Chloride

Purified Water

6.2 Incompatibilities

Do not mix with other preparations, as the effect on the stability of each is unknown. Do not pack in alloy containers as they may react with the lactic acid.

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

Polypropylene tubes.

Package sizes: 15, 30, 50g 100 g.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Galderma (UK) Limited,

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

8. Marketing Authorisation Number(S)

PL 10590/0010

9. Date Of First Authorisation/Renewal Of The Authorisation

23^rd February 2006

10. Date Of Revision Of The Text

September 2009