Salatac gel инструкция на русском

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Salicylic Acid 12.0% w/w; Lactic Acid 4.0% w/w.

Clear, colourless, collodion-like wart gel.

For the topical treatment of warts, verrucas, corns and calluses.

For adults, children and the elderly. Salatac Gel should be applied once daily. The gel should be applied once every night. Treatment can take up to twelve (12) weeks for resistant lesions to disappear, and it is necessary to persevere with treatment.

1. Every night, soak the affected site in warm water for 2 to 3 minutes.

2. Dry thoroughly with the patient’s own towel.

3. Carefully apply one or two drops of the gel to the lesion and allow to dry over its surface. Take care to avoid spreading on to surrounding normal skin. No adhesive plaster is necessary.

4. The following evening, carefully remove and discard the elastic film formed from the previous application, and reapply the gel. Occasionally, if removal of the elastic film proves difficult, carefully reapply the gel over it and allow to dry. This should help thicken the film to assist removal. If necessary, such re-application may be made on two or three successive days.

5. Once a week, gently rub away the treated surface using an emery board, as provided, or pumice stone used only for this purpose, before re-applying the gel.

6. The wart, verruca, corn or callus may take up to twelve (12) weeks to disappear and it is important to persevere with the treatment.

7. At the end of treatment, if the elastic film is difficult to remove, it may be allowed to remain on the skin until it sheds.

Not to be used on or near the face, intertriginous or anogenital regions, or by diabetics or individuals with impaired peripheral blood circulation. Not to be used on moles or on any other skin lesions for which the gel is not indicated. Not to be used in cases of sensitivity to any of the ingredients.

Keep away from the eyes, mucous membranes and from cuts and grazes. The gel should be applied carefully to the wart, verruca, corn or callus only, to avoid possible irritation of surrounding normal skin. Do not use excessively. Some mild, transient irritation may be expected, but in cases of more severe or persistent pain/irritation, treatment should be suspended and/or discontinued. See also Section 4.8. Avoid inhaling vapour, and keep cap 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 reach of children.

Salatac Gel may be irritant in certain patients, which in rare instances may appear as a temporary blemish on the skin. See also Section 4.4.

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.

Any excessive use of Salatac Gel could cause irritation of the skin. If this occurs, Salatac Gel should be used more sparingly or applied less frequently.

The active ingredients, salicylic acid and lactic acid, are well-established pharmacopoeial substances. In combination, they are routinely used in the treatment of verrucas, warts, corns and calluses for their 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 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, a mild irritant reaction, which may render the virus more prone to immunologic stimulation or response, may add to the mechanical removal of infected cells. The other active ingredient, lactic acid, enhances the availability of the salicylic acid from the dried collodion, in addition to having antiseptic and caustic properties.

Salatac Gel contains 12% salicylic acid and 4% lactic acid in an evaporative collodion-like gel which forms a cohesive and adhesive film on the skin.

The formulation is presented in a collapsible aluminium tube fitted with a special applicator nozzle allowing the formulation to be dispensed precisely to the affected areas only. This minimises the spread of the preparation onto the surrounding healthy skin which could otherwise lead to inflammation, irritation and poor patient compliance. The film-forming characteristics of the collodion-like gel vehicle also offer distinct advantages in clinical usage.

The gel quickly forms a surface film, well before it dries completely, thereby prolonging the period during which the keratolytic solution can properly infiltrate and achieve intimate contact with the surface layers of the thickened stratum corneum.

Furthermore, even when the film appears to have dried completely, the inclusion of the non-evaporative lactic acid ensures that a proportion of the salicylic acid remains in solution within the vehicle, thus permitting continued release of the keratolytic, which may otherwise be entrapped within the collodion-like film.

Systemic absorption of salicylic acid or lactic acid after application of the recommended daily dose of one or two drops of the preparation to small, circumscribed areas is exceedingly unlikely.

Camphor; Pyroxylin; Ethanol (96%); Ethyl Acetate.

Highly flammable — keep away from flames. Do not store above 25°C.

Collapsible tube containing 8 g, complete with special applicator, emery board and instructions. This is supplied as an original pack (OP).

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

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Adults, the elderly and children aged 2 years and over.

Apply daily to the affected areas only.

Children:

Children under the age of 12 years should be treated under supervision.

Treatment of infants under the age of 2 years is not recommended.

Duofilm should be applied to the wart once daily preferably at bedtime.

Procedure for application:

1. The wart should be soaked in warm water for 5 minutes and dried thoroughly with a clean towel.

2. The surface of the wart should be rubbed with a nail file, pumice stone, emery board or coarse washcloth, with care taken not to cause bleeding.

3. A thin layer of Duofilm should be applied directly to the wart. Care should be taken to avoid the healthy surrounding skin.

4. The solution should be allowed to dry thoroughly. The wart should be covered with a plaster (dressing) if it is large or if it is on the foot to help penetration of ingredients.

It is recommended that treatment continues until whichever of the following occurs first:

— Warts have been treated for 12 weeks

— The wart is completely cleared and the normal ridgelines of the skin have been restored.

For warts, clinically visible improvement should occur in 1-2 weeks, but the maximum effect may be expected after 4-8 weeks.

If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their pharmacist or doctor.

Consider alternative treatments if warts cover a large area of the body (more than 5 cm²) (see Warnings and Precautions).

Patients should be advised to consult a pharmacist or doctor if skin irritation develops.

Due to the flammable nature of Duofilm, patients should avoid smoking or being near an open flame during application and immediately after use.

Do not use on open wounds, irritated or reddened skin, or any area that is infected.

Duofilm should not be used on the face, anogenital regions, moles, birthmarks, mucous membranes, warts with hair growing from them, red edges or an unusual colour. Avoid applying to normal skin.

Duofilm contains colophony which may cause allergic contact dermatitis.

Duofilm may cause eye irritation. Avoid contact with eyes and other mucous membranes. In case of accidental contact with the eyes or other mucous membranes, flush with water for 15 minutes.

Avoid exposure to healthy skin (see Adverse Reactions). Duofilm may cause skin irritation. If undue skin irritation develops treatment should be discontinued.

Consider alternative treatments if warts cover a large area of the body (more than 5 cm²) due to the potential risk of salicylate toxicity.

Duofilm is not recommended in patients with diabetes, circulatory problems or peripheral neuropathy except under the supervision of a doctor.

Oral salicylates taken during or immediately after a viral illness have been associated with Reye’s syndrome and hence there is a theoretical risk with topical salicylates.

Therefore, use is not advised in children or teenagers during or immediately after chickenpox, influenza, or other viral infections.

It has been reported that salicylates are excreted via breastmilk (see Pregnancy and Lactation).

Patients should be advised not to inhale the vapour.

Keep out of the sight and reach of children.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.

Clinical Trial Data

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.

Symptoms and Signs

In the event of accidental oral ingestion symptoms of salicylate toxicity may occur.

The risk of developing symptoms of salicylate poisoning or salicylism is increased if Duofilm is used excessively or if it is used for prolonged periods of time. Therefore, duration of use and recommended frequency compliance is very important.

Treatment

Management should be as clinically indicated.

ATC Code

Pharmacotherapeutic group: Wart and anti-corn preparations.

ATC code: D11AF

Lactic acid affects the keratinisation process, reducing the hyperkeratosis which is characteristic of warts. At high concentrations it can cause epidermolysis, leading to the destruction of the keratotic tissue of the wart and of the causative virus. It also has antiseptic properties.

Flexible collodion provides a viscous vehicle that allows accurate application of the active ingredients to the wart. It also forms a film that helps to hydrate and promote the destruction of wart tissue.

Salicylic acid is keratolytic, producing desquamation by solubilising the intercellular cement in the stratum corneum resulting in the shedding of skin scales.

Absorption

Salicylic acid is absorbed through the skin; where detectable, maximum plasma levels are found 6 to 12 hours after application. Systemic absorption of salicylic acid has been reported to range from 9% to 25% after topical application of other salicylic acid-containing preparations. The extent of absorption is variable depending on the duration of contact and the vehicle. Despite percutaneous absorption, the systemic exposure is low given the low dose topically administered to small, localised areas of hyperkeratotic tissue.

Human abdominal skin in a flow-through diffusion system was used to assess the in vitro percutaneous absorption of lactic acid. At a pH of 3, the amount of radioactivity detected in the receptor fluid, stratum corneum, epidermis, and dermis was 3.6, 6.3, 6.6, and 13.9%, respectively.

Distribution

Following percutaneous absorption, salicylic acid is distributed in the extracellular space; approximately half of which is protein bound to albumin.

Metabolism

Salicylates are metabolised in the liver by microsomal enzymes to salicyluric acid and phenolic glucuronides of salicylic acid. That which is not metabolised is excreted in the urine as unchanged salicylic acid.

Elimination

Within 24 hours of salicylic acid being absorbed and distributed in the intercellular space, approximately 95% of the absorbed dose can be recovered in the urine.