This information is intended for use by health professionals

1. Name of the medicinal product

GLUTAROL™ 10% w/v CUTANEOUS SOLUTION

2. Qualitative and quantitative composition

Glutaraldehyde 10.0% w/v.

3. Pharmaceutical form

Colourless, evaporative cutaneous solution.

4. Clinical particulars
4.1 Therapeutic indications

For the topical treatment of warts, especially plantar warts.

4.2 Posology and method of administration

For adults, children and the elderly:

1. Gently rub the surface of the wart with a piece of pumice stone or manicure emery board, or pare down any hard skin.

2. Using the applicator provided, carefully apply a few drops of the paint to the wart, taking care to localise the application to the affected area. Allow each drop to dry before the next is applied.

3. Repeat twice daily.

4. On subsequent days, repeat steps 1 to 3. It is not necessary to cover the treated wart(s) with an adhesive plaster.

4.3 Contraindications

Not to be used in cases of sensitivity to any of the ingredients. Not to be used on the face, anal or perineal region. Not to be used on moles or on any other skin lesion for which it is not indicated.

4.4 Special warnings and precautions for use

Keep away from the eyes and mucous membranes. Avoid spreading onto surrounding uninvolved skin. Avoid spillage. Avoid inhaling vapour. Replace cap tightly after use. For external use only.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

No special precautions.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Undesirable effects occur very occasionally and mostly involve mild local skin rashes and irritation. Very rarely, a severe reaction may occur particularly on the hands or when the product is used excessively and allowed to spread onto surrounding normal skin. If mild irritation should occur, apply a reduced amount (taking special care to avoid spreading beyond the wart or verruca) and apply less often. If the irritation is severe, patients should stop treatment immediately and seek medical advice.

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.

4.9 Overdose

Accidental oral ingestion should be treated immediately by gastric lavage with 2 to 5% aqueous sodium bicarbonate solution. Fluid and electrolyte balance should be monitored and appropriate supportive measures should be provided. Symptoms include headache, nausea, vomiting, diarrhoea and respiratory depression.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Glutaraldehyde is virucidal and thus inactivates the wart virus. On the skin, it also acts as an anhidrotic, drying the warts and surrounding skin, thus reducing the spread of lesions and simplifying the removal of persistent warts by curettage.

As glutaraldehyde stains the outer layer of the skin brown, treatment can be seen to be carried out. This stain soon disappears after cessation of treatment.

5.2 Pharmacokinetic properties

Addition of ethanol to the formulation stabilises the glutaraldehyde against irreversible polymerisation during storage but at the same time diminishes its activity. However, when the aqueous ethanolic solution is applied to the skin, the alcohol rapidly evaporates leaving a concentrated aqueous solution of glutaraldehyde which is highly reactive and attacks the wart before it has time to polymerise. Thus, the ethanolic formulation is stable in storage, as confirmed by stability tests, but is immediately activated when applied to the skin and the alcohol is allowed to evaporate.

5.3 Preclinical safety data

No relevant information additional to that contained elsewhere in the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

IMS; Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf life

48 months.

6.4 Special precautions for storage

Flammable. Keep away from flames. Keep upright. Do not store above 25°C.

6.5 Nature and contents of container

10 ml amber glass bottle with plastic screw cap, incorporating a specially designed spatula for ease of application.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing authorisation number(s)

00173/0022.

9. Date of first authorisation/renewal of the authorisation

15 September 2005.

10. Date of revision of the text

December 2016.