PICKLES OINTMENT - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Pickles Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

50 % Salicylic Acid

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Keratolytic ointment

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

To treat Corns and Hard Skin.

4.2 Posology and method of administration

For Adults, Elderly and Children.

Hard Skin: Apply a little ointment to Hard Skin for 4 nights, bathe, and allow treated skin to cast itself Wash hands after use.

Corns: Fix a corn ring over the corn and apply a little ointment through the hole directly onto it. Leave in place for 3 days then bathe the area. Replace the treatment if corns persist.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Not to be used on or near the face, neck, intertriginous or anogenital regions.

Not to be used by patients with diabetes or those with severe circulatory disorders or peripheral neuropathy except following a doctor’s permission or recommendation.

Do not use if the callous/corn is infected or surrounding skin is inflamed or broken.

Do not use on broken skin, moles, birthmarks, warts with hair growing out of them, red edges, or an unusual colour or any other skin lesions for which Pickles Ointment is not indicated.

4.4 Special warnings and precautions for use

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Keep away from the eyes, mucous membranes and from cuts and grazes.

The ointment should be applied carefully to the corn or callus only, to avoid possible irritation of the surrounding skin. Remove immediately any surplus ointment from normal skin tissue

Do not use excessively. Excessive prolonged use of topical salicylic acid may result in symptoms of salicylism and therefore topical salicylic acid should not be used for prolonged periods, in high concentrations, on large areas of the body

Some mild, transient irritation may be expected, but in cases of more severe or persistent pain/irritation, the treatment should be suspended and/or discontinued.

Avoid inhaling vapour and keep the tin firmly closed when not in use.

Contact with clothing, fabrics, plastics and other materials may cause damage and should be avoided.

For external use only.

Keep all medicines out of the sight and reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

There are no known interactions when used as indicated. However, salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Pickles Ointment and other topical medicines should therefore be avoided.

4.6 Fertility, pregnancy and lactation

Whilst there are no known contra-indications to the use of Pickles Ointment during pregnancy and lactation, the safety has not been established. Pickles Ointment should therefore be used with caution or following professional advice.

4.7 Effects on ability to drive and use machines None known.

4.8 Undesirable effects

May be irritant in certain patients, which in rare instances may appear as a temporary blemish on the skin.

This may be controlled by temporarily discontinuing the use of Pickles Ointment and by being careful to apply it only to the callous/corn when treatment is resumed.

High concentrations of salicylic acid can cause skin ulceration or erosion.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms of acute systemic salicylate poisoning have been reported after application of salicylic acid to large areas of skin and for prolonged periods. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion. In children drowsiness and metabolic acidosis commonly occur, hypoglycaemia may be severe.

Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Pickles Ointment is used as indicated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for Topical Use

ATC code: D01AE12

The active ingredient, salicylic acid, is a well-established pharmacopoeial substance, which has been used extensively in dermatological therapy for its keratolytic properties.

When applied topically, and in high enough concentrations, salicylic acid acts by achieving a slow, painless destruction of the thickened stratum corneum. It softens and destroys the thickened stratum corneum of the affected tissue by reducing the adhesiveness of the corneocytes while causing the cornified epithelium to swell, soften, macerate and finally desquamate. In the treatment of warts and verrucae, a mild inflammatory reaction, which may render the virus more prone to immunological attack, may assist resolution of the condition.

The use of topical salicylic acid formulated in simple dosage forms at high concentrations and in evaporative vehicles designed to concentrate in use, thereby localising the keratolytic precisely over circumscribed small areas of skin, is commonplace. It has become exceedingly popular with doctors and patients alike, where its safety and efficacy have been very well established through widespread use over many decades.

5.2 Pharmacokinetic properties

Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Pickles Ointment.

5.3 Preclinical safety data

No other information relevant to the prescriber other than that already stated in other sections of the SmPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

50 % yellow petroleum jelly.

6.2 Incompatibilities

None stated.

6.3 Shelf life

60 months.

6.4 Special precautions for storage

Do not store above 25°C. Do not refridgerate or freeze.

6.5 Nature and contents of container

Slip lid tins of printed tin-plate containing 12 and 28g.

6.6 Special precautions for disposal

Any unused medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Optima Consumer Health Limited

27 Victoria Mews

Cottingly

Bingley

BD16 1PY

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 40575/0006

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28 September 2004