Powder containing chloramphenicol 4.024% w/w, hydrocortisone acetate 4.024% w/w, allantoin 2.415% w/w, butoxyethyl nicotinate 2.415% w/w and precipitated sulphur 32.193 w/w.

A pale yellow dry powder with a solvent for the preparation of a lotion for topical application.

For the treatment of acne vulgaris or other acneform conditions.

Adults & Children:

The lotion is applied to the affected area each night and morning for the first four days, after this, it is applied only at night and continued for three nights after the lesions have disappeared.

In patients who have a known hypersensitivity to any of the ingredients.

Avoid Actinac coming into contact with the eyes and mouth.

Early in the course of treatment, erythema may occur at the site of application and the patient may experience a sensation of warmth due to the vasodilator action of the nicotinate. In the unlikely event of a severe reaction, the patient is instructed to consult the doctor before further use of Actinac.

Not relevant

Systemic and topical administration to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established, but at present steroids should not be used extensively in pregnancy i.e, in large amounts or for prolonged periods.

Not relevant

Not relevant

Not applicable

Chloramphenicol is a broad spectrum antibiotic, particularly effective against propionobacterium acnes.

The additional active ingredients hydrocortisone acetate, allantoin, butoxyethyl nicotinate and precipitated sulphur suppress inflammation, dry the skin and consequently reduce the risk of scarring.

Two studies attached have demonstrated minimal systemic absorption of chloramphenicol from Actinac

Not applicable

The powder contains Tragacanth, Myrj 53, Syloid 244, Purified Talc and Titanium Dioxide. The solvent contains Benzoic Acid and Purified Water.

Not relevant.

36 Months unopened

21 days after reconstitution

Store between 2^o C – 8^o C

Each 20ml pack of Actinac contains 5g bottle of Actinac powder and one 16ml bottle of inert solvent. The two should be mixed together to produce 20ml of Lotion.

Each 25ml pack of Actinac contains 6.25g bottle of Actinac powder and one 20ml bottle of inert solvent. The two should be mixed together to produce 25ml of Lotion.

Each 40ml pack of Actinac contains twice the quantity of the 20ml pack i.e. 2x 5g bottle of Actinac powder mixed with 2x 16ml bottle of inert solvent

Each 50ml pack of Actinac contains twice the quantity of the 25ml pack.

None

Peckforton Pharmaceuticals Ltd

Crewe hall,

Crewe,

Cheshire,

CW1 6UL

PL 15760/0001

3 June 1999

May 2000