WARTEX OINTMENT - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Wartex Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid BP 50.00%

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Ointment

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of hard and ragged warts.

4.2 Posology and method of administration

Posology

Adults:

Apply a trace of ointment on to wart only for several days. Rub the surface gently with file or pumice stone once weekly. Repeat treatment daily.

Paediatric population

Wartex Ointment should not be used on children.

Method of administration

For topical use.

4.3 Contraindications

Hypersensitivity to the active substance or to 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 wart is infected or the surrounding skin is broken or inflamed.

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 Wartex is not indicated.

4.4 Special warnings and precautions for use

Keep away from the eyes, mucous membranes and from cuts and grazes. If contact occurs with the eyes, flush with water for 15 minutes.

The ointment should be applied carefully to the wart only, to avoid possible irritation of the surrounding skin. Remove immediately any surplus ointment from normal skin tissue. Do not apply Wartex to soft warts or moist or tender parts of the body.

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 (see section 4.8).

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 Wartex 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 Wartex during pregnancy and lactation, the safety has not been established. Wartex should therefore be used with caution or following professional advice.

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

4.8 Undesirable effects

May be irritant in certain patients, which in rare instances may appear as a temporary blemish on the skin (see section 4.4).

This may be controlled by temporarily discontinuing the use of Wartex and by being careful to apply it only to the wart when treatment is resumed.

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

Reporting of suspected adverse reactions

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 the 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 Wartex is used as indicated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Wart and anti-corn preparations ATC code: D11AF

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 Wartex.

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

White soft paraffin BP

Glycerol BP

Liquid paraffin BP

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 freeze.

6.5 Nature and contents of container

6g printed collapsible aluminium tube with membrane nozzle.

6.6 Special precautions for disposal

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