SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Carnation Verruca Caps Tesco Medicated Verruca Treatment

2.    Qualitative and Quantitative Composition

Salicylic Acid    10% w/w

3. PHARMACEUTICAL FORM

Self adhesive plaster with central well containing Salicylic Acid paste.

4.    CLINICAL PARTICULARS

4.1    Therapeutic Indications

Treatment of Verrucas

4.2 Posology and Method of Administration

A medicated dressing is applied to the verruca with the paste well over the verruca. Retain in place for 2 days and remove. Any loose skin is gently scraped away, the area cleaned and thoroughly dried and a fresh medicated dressing applied. Repeat this procedure over an eight day period. Apply protective plaster dressing to area to prevent infection and allow healing. If verruca still present after four weeks repeat treatment. Treatment suitable children over 6 years and adults. Adults over 50 years and children under 6 years are advised to consult their doctor prior to treatment.

4.3 Contra-Indications

Not to be used by diabetics, people with severe circulation problems should seek medical advice before use.

Do not use if skin close to verruca is inflamed or broken.

4.4 Special Warnings and Special Precautions for Use

Dressing should be removed if excess discomfort felt, or if patient is sensitised to dressing adhesive or central medication.

Verrucas are uncommon in patients over 50 years. The incidence of ischaemia in this group is much higher, which-can result in lesions and growths being mistaken for plantar warts. Patients over 50 years should consult a doctor before use.

Not to be used if patient has incipient gangrene.

4.5 Interactions with other Medicinal Products and other Forms of Interaction

None known with other medicaments.

Absorbed Salicylic acid may theoretically interfere with Assays for Theophylline at low concentration.

4.6 Pregnancy and Lactation

No data is currently available.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable Effects

Mild discomfort or soreness may be experiences especially when used on weight bearing surfaces, e.g. heel or ball of foot.

Overdose

Do not treat more than 3 warts at the same time. Whilst absorption is low via this route, it is beneficial to limit treatment to 3 warts in case undesirable sensitisation occurs.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic Properties

Salicylic acid has keratolytic properties. Applied externally it attacks the intercellular matter between keratin molecules causing the cornified Epithelium to swell, soften and shed.

The epidermis desquamates making the underlying layer more accessible to debridement.

5.2 Pharmacokinetic Properties

Formulation is designed to provide gradual release of Salicylic acid to restricted area of the verruca. It is absorbed into the outer epidermis.

5.3 Pre-clinical Safety Data

No preclinical studies were initiated by the company because the product contains an established therapeutic substance, Salicylic acid, the use of which is well described in standard texts. (Martindale, The Extra Pharmacopoeia; British National Formulary)

It is well known as a treatment for warts when applied topically (Martindale, The Extra Pharmacopoeia; Neale, Common Foot Disorders; FDA Federal Register 1982 vol. 47 No. 2 525-526).

6. PHARMACEUTICAL PARTICULARS

6.1    List of Excipients

Cosmolloid 70 Softisan 378

Incompatibilities

None known.

6.3    Shelf-Life

60 months

6.4    Special Precautions for Storage

Store away from direct sources of heat or humidity. Store at less than 30°C.

6.5    Nature and Content of Container

4 medicated and 1 non-medicated dressing in individual heat sealed sachets, enclosed in a printed cardboard box.

6.6    Instruction for Use, Handling and Disposal

Apply a medicated dressing over the verruca and leave in place for 2 days. After 2 days remove plaster and scrape away loose skin. Apply a fresh medicated plaster. Repeat until all medicated plasters are used. Apply protective plaster and keep in place for as long as possible.

ADMINISTRATIVE DATA

7. MARKETING AUTHORISATION HOLDER

Cuxson Gerrard & Company Limited

125 Broadwell Road

Oldbury

West Midlands

United Kingdom

B69 4BF.

MARKETING AUTHORISATION NUMBER(S)

PL 00089/0008

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14^th July 1988 / 17^th September 1998

10 DATE OF REVISION OF THE TEXT

31/07/2013