Salicylic acid NA

INSTRUCTIONS FOR USE

SALICYLIC ACID NA 2% ointment, 5% ointment, 10% ointment

THERAPEUTIC CATEGORY
Preparations for corns and warts.
THERAPEUTIC INDICATIONS

• Treatment of psoriasis, acne vulgaris, and seborrhea in adults and children;
• Removal of warts and corns in adults and children;
• Local treatment of certain forms of eczema and ichthyosis in adults.

CONTRAINDICATIONS

• Hypersensitivity to the active substance, salicylates, or any of the excipients (patients hypersensitive to salicylates such as acetylsalicylic acid, propylsalicylate, bromosalicylic acid, zinc salicylate, may also be hypersensitive to salicylic acid);
• Children under 2 years of age;
• Diabetes (see Undesirable effects);
• Peripheral vascular disease.

PRECAUTIONS FOR USE
This medicine must not be ingested.
Salicylic acid is irritating and may cause dermatitis (see Undesirable effects).
When treating corns and warts, surrounding healthy skin should be protected to minimize absorption of the active substance.
Salicylic acid must not be used for prolonged periods, at high concentrations, over large body surface areas, or on damaged or inflamed skin, as excessive absorption of the active substance may lead to systemic salicylate poisoning (see Interactions), particularly in children, which may be fatal.
Avoid contact with mouth, eyes, genitals, and other mucous membranes.
Use with caution in children, as experience with salicylic acid in this population is limited.

Improvement of treated skin may be observed after 6 weeks of therapy, or after 12 weeks in the case of wart removal.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those without a prescription.
Salicylic acid may interact with the following medicines:

• Coumarin anticoagulants (acenocoumarol, dicoumarol, phenprocoumon, and warfarin) and 1,3-indandione derivatives (anisindione, phenindione), as salicylic acid may inhibit platelet aggregation and displace these drugs from their plasma protein binding sites, thereby increasing the risk of bleeding.
• Activated factor X inhibitors (heparins and heparinoids), since concomitant use of salicylic acid during neuraxial anesthesia (spinal or epidural) may rapidly increase the risk of bleeding and hematoma formation.
• Gliburide, as excessive hypoglycemia may occur via an unknown mechanism.
• Probenecid, as salicylic acid may reverse the uricosuric effects of this drug.
• Acetazolamide, as adverse effects of salicylates may be increased.
• Varicella vaccine, as salicylic acid may increase the risk of developing Reye's syndrome. Additionally, salicylic acid should not be used concurrently with tamarind (a tropical tree belonging to the Fabaceae family) or Salvia miltiorrhiza (also known as Tan-Shen, a plant of the Labiatae family), as this may rapidly increase plasma salicylate levels, leading to increased toxicity.

SPECIAL WARNINGS
The medicine may be flammable. Do not use or store near open flames or any heat source (see Expiry and storage).
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
There are insufficient data on 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.
Animal studies have shown reproductive toxicity. However, the potential risk in humans is unknown.

Nevertheless, although applied locally, salicylic acid is systemically absorbed, readily crosses the placenta (reaching higher concentrations in fetal plasma), and is excreted in breast milk.
Effects on ability to drive and use machines
Salicylic acid does not impair the ability to drive vehicles or operate machinery.
Important information about certain excipients: not applicable.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Apply the smallest amount of ointment necessary to the affected area with gentle massage.
Begin treatment by applying the medicine to only a small area of skin or once daily to avoid skin irritation.
OVERDOSAGE
No cases of overdose with topically applied salicylic acid have been reported.
However, excessive absorption of the active substance (e.g., prolonged application over large body surface areas or on damaged and inflamed skin) may lead to salicylism. Symptoms of salicylism include: nausea, vomiting, tinnitus, and dizziness. Rarely, gastric ulcer, asthma, hepatotoxicity, renal failure, and pancreatic toxicity may occur.
In case of accidental ingestion/overdose of SALICYLIC ACID NA, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of SALICYLIC ACID NA, consult your doctor or
pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, SALICYLIC ACID NA can cause undesirable effects, although not everyone experiences them.
The following are undesirable effects associated with salicylic acid. There are insufficient data to determine the frequency of the individual effects listed.
Metabolism and nutrition disorders
Hypoglycemia.

Skin and subcutaneous tissue disorders
Irritation, dermatitis, burning, itching, erythema, skin desquamation, facial scarring.
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsens, or if you notice any effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the medicine in unopened, properly stored packaging.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Do not store above 25°C.
Keep the medicine in its tightly closed container, protected from light, and away from heat sources or open flames.
After first opening, the medicine should be used within 30 days.
After this period, any remaining medicine should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in 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 substance: salicylic acid 2 g
Excipients: white vaseline.

SALICYLIC ACID NA 5% ointment
100 g of ointment contains:
Active substance: salicylic acid 5 g
Excipients: white vaseline.
SALICYLIC ACID NA 10% ointment
100 g of ointment contains:
Active substance: salicylic acid 10 g
Excipients: white vaseline.
PHARMACEUTICAL FORM AND CONTENT
Ointment.
2% - 5% - 10%: 30 g tube
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
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA):
AIFA Decision of 01 December 2011.