SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Oxy 5

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: Hydrous Benzoyl Peroxide Ph Eur to give benzoyl peroxide 5% w/w.

3.    PHARMACEUTICAL FORM

Lotion for topical administration

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Oxy 5 is indicated for the treatment of spots and acne.

4.2.    Posology and Method of Administration

Shake well before use. Wash affected areas. Rinse, then dry with a soft, clean towel.

Use fingertips to apply to the areas affected with spots. Massage gently until the lotion has vanished. Wash hands after use.

With very fair or sensitive skin apply cautiously for the first few days to avoid redness and peeling.

For the first week apply the product once daily. If no irritation or discomfort occurs, apply twice daily or as directed by your doctor.

The product is unlikely to be used by the elderly, but the above directions will apply.

Do not use continuously for more than three months without consulting your doctor.

Contra-indications

Hypersensitivity to benzoyl peroxide or any of the other ingredients.

4.4.    Special warnings and precautions for use

Avoid contact with the eyes, lips and mouth.

Caution: People with a known intolerance to benzoyl peroxide should not use OXY 5; if you are unsure or have not used this product before, rub in OXY 5 to a small area of the lower arm above the wrist at least 48 hours before use. If swelling or itching occurs with severe redness do not use OXY 5.

Mild burning or tingling may be felt when OXY 5 is applied. Mild to moderate redness and peeling sometimes arise with continued use. This indicates that OXY 5 is working. If the reaction is excessive, decrease the quantity and frequency of application.

If a reaction persists, see your doctor.

Avoid prolonged or excessive exposure to sunlight/UV light.

Keep tightly closed.

May bleach coloured fabrics.

4.5.    Interactions with other Medicaments and other forms of Interaction

None known.

4.6.    Pregnancy and Lactation

Use during pregnancy and lactation is not contraindicated. However, as with all medicines in pregnancy caution should be exercised.

4.7.    Effects on Ability to Drive and Use Machines

None known.

Undesirable effects

In normal use a mild burning or tingling sensation may be felt when Oxy 5 is applied and a mild to moderate reddening and peeling of the skin may sometimes arise with continued use. Excessive irritation may occur in certain individuals. Face oedema or swelling, skin burn with or without blistering, itching, pain, change in skin pigmentation and photosensitisation may occur.

4.9. Overdose

Over-use would cause excessive localised redness and peeling due to the drying action of benzoyl peroxide. These would subside on withdrawal of the product. Where treatment is indicated, relief would be obtained from gently swabbing the area with gauze or white lint soaked in vegetable oil. Rarely, the application of a cream or ointment containing corticosteroid may be necessary.

It is most unlikely that even the most excessive use of the product would lead to sufficient percutaneous absorption of active ingredients to cause systemic effects.

Treatment

Treatment after withdrawal of the product the treatment is symptomatic.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Benzoyl peroxide acts by reducing the number of propionibacterium acnes with consequent reduction in both non-inflamed and inflamed lesions. Clinical data demonstrate that Oxy 5 produces more than 90% reduction in Propionibacterium acnes count in 24 hours compared to placebo. Also the drug has a direct effect in decreasing the non-inflamed lesions by producing keratolysis.

5.2. Pharmacokinetic Properties

Benzoyl peroxide absorbed through the skin is mostly metabolised to benzoic acid which is then rapidly excreted in the urine.

5.3. Preclinical Safety Data

There is no preclinical data of relevance to the prescriber which are additional to that already oncluded in other sections of the SPC

6.1. List of Excipients

Glycerol Cetyl Alcohol Colloidal Anhydrous Silica Propylene Glycol

Self-Emulsifying Glyceryl Monostearate Citric Acid, Monohydrate Sodium Citrate Sodium Lauryl Sulphate Methyl Parahydroxybenzoate Propyl Parahydroxybenzoate Purified Water

6.2. Incompatibilities

None known

6.3. Shelf Life

Three years

6.4. Special Precautions for Storage

Store in a cool place

6.5. Nature and Contents of Container

Low density polyethylene opaque white bottles with a polypropylene closure. Each 30ml bottle is packed in a boxboard carton.

6.6. Instruction for Use/Handling Not applicable.

7    MARKETING AUTHORISATION HOLDER

The Mentholatum Company Limited

1 Redwood Avenue

Peel Park Campus

East Kilbride

G74 5PE

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 00189/0034

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 August 2005

10 DATE OF REVISION OF THE TEXT

02/05/2012