Salatac gel инструкция на русском

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1. Name of the medicinal product

2. Qualitative and quantitative composition

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

3. Pharmaceutical form

Clear, colourless, collodion-like wart gel.

4. Clinical particulars

4.1 Therapeutic indications

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

4.2 Posology and method of administration

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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

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.

4.9 Overdose

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.

5. Pharmacological properties

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic 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.

5.3 Preclinical safety data

6. Pharmaceutical particulars

6.1 List of excipients

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

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

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

6.5 Nature and contents of container

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

6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text

What is it used for?

  • Verrucas.
  • Warts.
  • Calluses.
  • Corns.

    How does it work?

    Salatac gel contains the active ingredients salicylic acid and lactic acid. These are medicines called keratolytics. They work by breaking down keratin, a protein that forms part of the skin structure.

    The gel is applied directly to warts, verrucas, calluses and corns. It causes the skin cells in the affected area to soften and shed. It can take up to three months of treatment for the affected skin to be removed completely. If successful, the new skin that grows underneath will be healthy.

    How do I use it?

    • Salatac gel should be applied to the affected area(s) once a day, preferably at bedtime.
    • Each night before applying Salatac you should soak the wart, verruca, callus or corn for two to three minutes in warm water. Then dry the area with your own towel (sharing towels can spread the virus that causes the warts and verrucas to other people).
    • After soaking and drying the skin, gently squeeze the Salatac tube to carefully apply one or two drops of Salatac gel to the affected site. Allow the gel to dry over the surface.
    • Take care to avoid getting the gel on healthy areas of skin as this can cause pain and irritation. (You can use white soft paraffin or a specially designed plaster to protect the surrounding skin.)
    • The gel will form a water-resistant white film over the affected area of skin. This should be peeled off each night before re-applying the gel.
    • Wash your hands after applying the gel.
    • Once a week rub the top of the wart, verruca, corn or callus with a pumice stone, emery board or nail file. Rub carefully to avoid making it bleed; excessive rubbing will cause stinging when you apply the gel. Then apply Salatac gel as usual.
    • Stop treatment when the wart, verruca, corn or callus is completely gone and you can see the ridgelines of healthy skin.
    • You may not notice an improvement for one to two weeks and it can take up to 12 weeks for it to disappear altogether. It is important to persevere with the treatment every night.
    • If you can still see the wart, verruca, callus or corn after 12 weeks of treatment you should consult your pharmacist or doctor for advice.

      Warning!

      • Salatac gel is flammable. Do not apply it near naked flames and do not smoke while applying it.
      • Do not inhale the vapour produced by Salatac gel.
      • Salatac gel is for external use on the affected areas of skin only. It must not be taken by mouth.
      • Do not apply the gel to normal healthy areas of skin, moles or birthmarks. If it comes into contact with these areas of skin, wash it off with plenty of water.
      • Do not apply the gel to broken, irritated, infected, red or inflamed skin.
      • Take care to avoid getting the gel in the eyes, nose or mouth. If it accidentally gets in these areas, flush it out with water.
      • Do not use the pumice stone, emery board or nail file used to rub warts or verrucas on healthy skin or nails, as this may spread the infection.

        Not to be used in

        • This medicine is not recommended for children under two years of age.
        • Salatac gel is not suitable for warts on the face, warts affecting anal or genital areas, or warts with hair growing from them, red edges or an unusual colour. Get advice from a doctor if you have a wart of this type.

          This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

          If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

          Use with caution in

          • People with diabetes, poor blood circulation such as peripheral vascular disease, or nerve damage to the hands or feet. These people should only use this medicine under the supervision of a doctor.

            Pregnancy and breastfeeding

            Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

            • This medicine is unlikely to be harmful if used correctly by pregnant or breastfeeding mothers, because the amount absorbed into the bloodstream after application to small, localised areas of skin is minimal. However, you should get advice from your doctor before using this medicine if you are pregnant or breastfeeding, particularly if you have warts affecting large areas of skin.

              Side effects

              Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

              • Skin irritation at the application site. If your skin seems very irritated after using this gel you should stop using it and get advice from your doctor or pharmacist.
              • Temporary skin discolouration.

                For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

                How can this medicine affect other medicines?

                Salatac gel can enhance the absorption of other medicines that are applied to the same area of skin. You should not use other medicines on the area of skin treated with Salatac.

                Other medicines containing the same active ingredients

                  There are many other footcare preparations available that contain salicylic acid as the main active ingredient. These include the following:

                    Last updated

                    Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
                    Send request.

                    Active ingredient:

                    SALICYLIC ACID ; LACTIC ACID

                    Available from:

                    PCO Manufacturing

                    ATC code:

                    D11AF

                    INN (International Name):

                    SALICYLIC ACID ; LACTIC ACID

                    Dosage:

                    12.0/4.0 %w/w

                    Pharmaceutical form:

                    Gel

                    Prescription type:

                    Product not subject to medical prescription

                    Therapeutic area:

                    Wart and anti-corn preparations

                    Authorization status:

                    Authorised

                    Authorization date:

                    2013-08-08

                    Описание основано на официальной инструкции, утверждено компанией-производителем

                    Описание препарата Холисал® (гель стоматологический) основано на официальной инструкции, утверждено компанией-производителем в 2018 году

                    Дата согласования: 13.08.2018

                    Особые отметки:

                    Отпускается без рецепта

                    Содержание

                    • Фотографии упаковок
                    • Действующее вещество
                    • ATX
                    • Фармакологическая группа
                    • Нозологическая классификация (МКБ-10)
                    • Состав
                    • Описание лекарственной формы
                    • Фармакологическое действие
                    • Фармакодинамика
                    • Фармакокинетика
                    • Показания
                    • Противопоказания
                    • Способ применения и дозы
                    • Побочные действия
                    • Взаимодействие
                    • Передозировка
                    • Особые указания
                    • Форма выпуска
                    • Производитель
                    • Условия отпуска из аптек
                    • Условия хранения
                    • Срок годности
                    • Аналоги (синонимы) препарата Холисал®
                    • Заказ в аптеках Москвы

                    Фотографии упаковок

                    Холисал®: гель стомат. , туб. алюм. 10 г - пач. картон.

                    13.08.2018

                    Действующее вещество

                    ATX

                    Фармакологическая группа

                    Состав

                    Гель стоматологический 1 г
                    активные вещества:  
                    холина салицилат 87,1 мг
                    цеталкония хлорид 0,1 мг
                    вспомогательные вещества: гиэтеллоза — 20 мг; метилпарагидроксибензоат — 1,5 мг; пропилпарагидроксибензоат — 0,8 мг; глицерол — 50 мг; аниса обыкновенного семян масло — 1,61 мг; этанол 96%  — 390 мг; вода — до 1000 мг  

                    Описание лекарственной формы

                    Прозрачная бесцветная однородная масса с запахом масла анисового.

                    Фармакологическое действие

                    Фармакологическое действие

                    противовоспалительное местное, обезболивающее.

                    Фармакодинамика

                    При местном применении холина салицилат быстро всасывается через слизистую оболочку полости рта, оказывая анальгезирующее, противовоспалительное и жаропонижающее действие.

                    Тормозит активность ЦОГ, функции макрофагов и нейтрофилов, продукцию ИЛ-1 и угнетает синтез ПГ. Обладает также противомикробным и противогрибковым действием (в кислой и щелочной среде).

                    Цеталкония хлорид — антисептик, действует на бактерии, а также грибы и вирусы.

                    Гелевая этанолсодержащая адгезивная основа обеспечивает быстрое развитие эффекта и длительно удерживает на слизистой оболочке ДВ. Анальгезирующее действие наступает через 2–3 мин, при этом его продолжительность составляет 2–8 ч.

                    Фармакокинетика

                    При нанесении на слизистые оболочки хорошо всасывается.

                    Показания

                    Лечение заболеваний пародонта, повреждений слизистой оболочки полости рта, заболеваний, протекающих с воспалительной реакцией и болью (для местного применения на слизистые оболочки полости рта в качестве обезболивающего и противовоспалительного средства):

                    • стоматиты различной этиологии;
                    • гингивиты;
                    • пародонтиты;
                    • повреждения слизистой оболочки полости рта при ношении зубных протезов;
                    • травмы слизистой оболочки полости рта;
                    • боль при прорезывании зубов у детей;
                    • хейлиты;
                    • кандидоз слизистой оболочки полости рта;
                    • небольшие оперативные вмешательства в полости рта;
                    • красный плоский лишай слизистой оболочки рта;
                    • поражение слизистой оболочки полости рта при синдроме Стивенса-Джонсона (в составе комплексной терапии).

                    Противопоказания

                    Повышенная чувствительность к салицилатам и другим компонентам препарата.

                    С осторожностью: беременность, период лактации, детский возраст до 1 года.

                    Способ применения и дозы

                    Реклама: ООО «РЛС-Патент», ИНН 5044031277, erid=4CQwVszH9pUkpHxmQQo

                    Местно. Холисал® применяют 2–3 раза в день до еды (с целью обезболивания) или после еды и перед сном. Полоску геля длиной 1 см для взрослых и 0,5 см для детей выдавливают на чистый палец и втирают легкими массирующими движениями в пораженный участок слизистой оболочки полости рта. При заболеваниях пародонта гель вводится в карманы, применяется в виде компрессов или осторожно втирается в десны 1–2 раза в день.

                    Побочные действия

                    Кратковременное легкое жжение в местах нанесения препарата, проходящее самостоятельно. Аллергические реакции.

                    Взаимодействие

                    Реклама: ООО «ВЕДАНТА», ИНН 7714886235, erid 4CQwVszH9pUkKJ7jUDd

                    Реклама: ООО «РЛС-Библиомед» ИНН 7714758963

                    Реклама: ООО «ВЕДАНТА», ИНН 7714886235, erid 4CQwVszH9pUkKJ7jUDd

                    Реклама: ООО «РЛС-Библиомед» ИНН 7714758963

                    При приеме препарата возможно усиление действия других противовоспалительных, жаропонижающих и анальгезирующих средств.

                    Передозировка

                    Случаи передозировки не выявлены.

                    Особые указания

                    При появлении первых признаков побочного действия препарата необходимо сразу сообщить об этом лечащему врачу. Использовать препарат только для местного применения. Холисал® не содержит сахара.

                    Влияние на способность к управлению транспортным средством и обслуживанию движущихся механизмов. Препарат не ограничивает психофизическую активность, способность к управлению транспортными средствами и обслуживанию движущихся механизмов.

                    Форма выпуска

                    Гель стоматологический. По 10 или 15 г в алюминиевых тубах с мембраной и колпачками из полимерного материала (с прошивником). Тубу помещают в картонную пачку.

                    Производитель

                    Фармзавод Ельфа А.О., 58-500 Еленя Гура, ул. В. Поля 21, Польша.

                    Держатель регистрационного удостоверения: ООО «ВАЛЕАНТ», Россия, 115162, Москва, ул. Шаболовка, 31, стр. 5.

                    Претензии потребителей направлять в ООО «ВАЛЕАНТ» по адресу: Россия, 115162, Москва, ул. Шаболовка, 31, стр. 5.

                    Тел./факс: (495) 510-28-79.

                    RUS-DRM-ARG-PAN-07-2018-1234

                    Условия отпуска из аптек

                    Без рецепта.

                    Условия хранения

                    При температуре не выше 25 °C.
                    Не замораживать.

                    Хранить в недоступном для детей месте.

                    Срок годности

                    3 года.

                    Не применять по истечении срока годности, указанного на упаковке.

                    Дата обновления: 14.12.2022

                    Аналоги (синонимы) препарата Холисал®

                    Заказ в аптеках

                    Выбор региона:

                    Представленная информация о ценах на препараты не является предложением о продаже или покупке товара.

                    Информация предназначена исключительно для сравнения цен в стационарных аптеках, осуществляющих деятельность в
                    соответствии со статьей 55 Федерального закона «Об обращении лекарственных средств» от 12.04.2010 № 61-ФЗ.

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