Инструкция по применению AKIDO SALIKILIKO NA

SALICYLIC ACID NA 2% ointment
SALICYLIC ACID NA 5% ointment
SALICYLIC ACID NA 10% ointment
PHARMACOTHERAPEUTIC CATEGORY
Preparations for calluses and warts.
THERAPEUTIC INDICATIONS
- Treatment of psoriasis, acne vulgaris, seborrhea in adults and children;
- removal of warts and calluses in adults and children;
- local treatment of some forms of eczema and ichthyosis in adults.
CONTRAINDICATIONS
- Hypersensitivity to the active ingredient, salicylates or any of the excipients (patients hypersensitive to salicylates, such as acetylsalicylic acid, propyl salicylate, bromosalicylic acid, zinc salicylate, may also be hypersensitive to salicylic acid);
- children under 2 years of age;
- diabetes (see Undesirable effects);
- peripheral vasculopathy.
PRECAUTIONS FOR USE
The medicine must not be ingested.
Salicylic acid is irritating and may cause dermatitis (see Undesirable effects).
In the treatment of calluses and warts, the surrounding healthy skin must be protected to minimize
absorption of the active ingredient.
Salicylic acid must not be used for long periods of time, at high concentrations, on
extensive areas of the body, or on damaged or inflamed skin, as excessive absorption of the active
ingredient can cause systemic salicylate poisoning (see Interactions), especially in
children, which can be fatal.
Avoid contact with mouth, eyes, genitals and other mucous membranes.
Use with caution in children as experience with the use of salicylic acid in this population
is limited.

An improvement in the treated skin may be observed after 6 weeks of therapy or after 12
weeks in case of wart removal.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, even
those available without a prescription.
Salicylic acid may interact with the following medicines:
- Cumarin anticoagulants (acenocoumarol, dicoumarol, phenprocoumon and warfarin) and 1,3-indandione derivatives (anisindione, phenindione), as salicylic acid may inhibit platelet aggregation and displace them from their binding site with plasma proteins, thus increasing the risk of bleeding.
- Factor Xa inhibitors of coagulation (heparins and heparinoids), as in the case of neuroaxial (spinal or epidural) anesthesia, the concomitant use of salicylic acid may cause a rapid increase in the risk of bleeding and hematoma.
- Gliburide, as, for an unknown mechanism, excessive hypoglycemia may occur.
- Probenecid, as salicylic acid may reverse the uricosuric effects of this drug.
- Acetazolamide, as the side effects of salicylate may be increased.
- Varicella vaccine, as salicylic acid may increase the risk of developing Reye's syndrome. In addition, salicylic acid should not be used simultaneously with tamarind (a tropical tree belonging to the Fabaceaefamily) and Salvia miltiorrhiza or Tan-Shen (a plant of the Labiataefamily), as a rapid increase in plasma salicylate levels may occur, resulting in increased toxicity.
SPECIAL WARNINGS
The medicine may be flammable. Do not use or store near open flames or
any source of heat (see Expiry date and storage).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
There are no adequate data regarding the use of salicylic acid in pregnant and
breastfeeding women. Therefore, salicylic acid solutions and ointments should not be used during
pregnancy and breastfeeding unless absolutely necessary.
Studies conducted on animals have shown reproductive toxicity. While, the potential risk
to humans is unknown.

However, it should be considered that although used locally, salicylic acid is absorbed
systemically, easily crosses the placenta and is found in higher concentrations in
fetal plasma and is excreted in breast milk.
Effects on ability to drive and operate machinery
Salicylic acid does not impair the ability to drive vehicles or operate machinery.
Important information on some excipients: not applicable.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Apply a minimal amount of ointment locally to the area to be treated with a
light massage.
Start treatment by applying the medicine only to a small area of skin
or once a day, so as not to irritate the skin.
OVERDOSE
Cases of overdose with salicylic acid applied locally have not been reported.
However, in case of excessive absorption of the active ingredient (e.g. prolonged application to extensive
areas of the body or on damaged and inflamed skin), a state of salicylism may occur. The symptoms of
salicylism are: nausea, vomiting, tinnitus and dizziness. Rarely, the following may occur:
gastric ulcer, asthma, hepatotoxicity, renal failure and pancreatic toxicity.
In case of accidental ingestion/intake of an excessive dose of SALICYLIC ACID NA
immediately notify your doctor or go to the nearest hospital.
If you have any doubts about the use of SALICYLIC ACID NA, ask your doctor or
pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, SALICYLIC ACID NA can cause side effects, although not everyone
experiences them.
The following are the undesirable effects of salicylic acid. Insufficient data are available
to establish the frequency of individual effects listed.
Metabolism and nutrition disorders
Hypoglycemia.

Skin and subcutaneous tissue disorders
Irritation, dermatitis, burning, itching, erythema, skin scaling, facial scarring.
If any of the side effects worsen, or if you notice any side effect
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the medicine in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
Storage conditions
Do not store at temperatures above 25°C.
Keep the medicine in a tightly closed container, protected from light, away from heat or
open flames.
After the first opening of the container, the medicine must be used within 30 days.
After this period, any remaining medicine must be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
SALICYLIC ACID NA 2% ointment
100 g of ointment contains:
Active ingredient: salicylic acid 2 g
Excipients: white petrolatum.

SALICYLIC ACID NA 5% ointment
100 g of ointment contains
Active ingredient: salicylic acid 5 g
Excipients: white petrolatum.
SALICYLIC ACID NA 10% ointment
100 g of ointment contains
Active ingredient: salicylic acid 10 g
Excipients: white petrolatum.
PHARMACEUTICAL FORM AND CONTENT
Ointment.
2% - 5% - 10% : tube of 30 g
MARKETING AUTHORISATION HOLDER
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Lovanio, 5 - Milan
MANUFACTURER
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via G. Pascoli, 1 - Gorgonzola - Milan
DRUG:
AIFA determination of 01 December 2011.

- Страна регистрации
- Форма выпускаOintment, 2%
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги AKIDO SALIKILIKO NAФорма выпуска: Injectable solution, 150 MGДействующее вещество: ТралокинумабПроизводитель: LEO PHARMA A/SОтпускается по рецептуФорма выпуска: Soft capsule, 10 MGДействующее вещество: АлитретиноинПроизводитель: DIFA COOPER S.P.A.Отпускается по рецептуФорма выпуска: Topical solution, 2%Действующее вещество: МиноксидилПроизводитель: IDI FARMACEUTICI S.R.L.Отпускается без рецепта
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AKIDO SALIKILIKO NA производится компанией INDUSTRIA FARMACEUTICA NOVA ARGENTIA S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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