Package Leaflet

Zeta Farmaceutici S.p.A.
Trichloroacetic Acid Zeta 50% Cutaneous Solution
Pharmacotherapeutic Category
Preparations for warts and calluses
Therapeutic Indications
Trichloroacetic acid is used for the treatment of warts.
Contraindications
Hypersensitivity to the active substance or to any of the excipients, or to substances closely related from a chemical standpoint.
Precautions for Use
Trichloroacetic acid is a caustic and corrosive agent that may cause irreversible damage. In case of contact with eyes or skin, immediately and thoroughly rinse with running water. Seek medical advice if necessary.
Avoid prolonged use on the same area of skin. Due to the corrosive nature of the medicinal product, severe burns may occur in areas where application is not carefully controlled.
When applying with a cotton swab, remove any excess liquid by pressing the swab onto an absorbent material.
Since trichloroacetic acid is strongly caustic and corrosive, extreme caution must be exercised during application to avoid inhalation of the medicinal product and contact with eyes, mucous membranes, and intact skin.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those not requiring a prescription.
Do not use together with strong bases, alcoholates, or amines, as this may generate intense heat.
Special Warnings
Pregnancy
Consult your doctor or pharmacist before taking any medicinal product.
There are insufficient adequate data on the use of trichloroacetic acid in pregnant women. The potential risk to the human fetus is unknown. When used as directed, the medicinal product is negligibly absorbed and therefore does not produce systemic effects. Animal studies in which trichloroacetic acid was administered orally have shown reproductive toxicity. Therefore, caution is required when prescribing this medicinal product to pregnant women.
Lactation
There are no available data on the use of trichloroacetic acid during breastfeeding, and it is not known whether this active substance is excreted in breast milk. However, since absorption of the drug is considered negligible, it is highly unlikely that significant amounts would reach breast milk.
Caution is required when prescribing the medicinal product during breastfeeding.
Effects on Ability to Drive and Operate Machinery
Not applicable.
Dosage, Method and Duration of Administration
Apply to the affected area of the skin using a cotton-tipped applicator.
Particular care must be taken to avoid contact with surrounding healthy skin areas, which should be adequately protected.
There are no data supporting the use of trichloroacetic acid in children.
Trichloroacetic Acid Zeta 50% Cutaneous Solution

Package leaflet

Zeta Farmaceutici S.p.A.
Overdose
Excessive application of the medicinal product may cause severe burns.
Acute exposure
Accidental ingestion may cause gastrointestinal irritation and corrosion, with severe pain in the mouth,
throat and abdomen, violent vomiting, haematemesis and diarrhoea.
Acute inhalation may cause coughing, suffocation, dizziness and weakness, followed by dyspnoea, pulmonary
edema, frothy sputum, cyanosis, hypotension, tachycardia, and increased red blood cell count and
haematocrit.
Chronic exposure
Chronic inhalation may cause dental enamel erosion, jaw necrosis, bronchial irritation, chronic cough,
frequent episodes of pneumonia, and gastrointestinal disorders.
The formation and accumulation of trichloroacetic acid may cause solvent encephalopathy observed in
some patients chronically exposed to trichloroethylene.
In case of accidental ingestion/overdose of acido tricloroacetico Zeta, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of acido tricloroacetico Zeta, consult your doctor or pharmacist.
Undesirable effects
Like all medicines, acido tricloroacetico Zeta can cause undesirable effects, although not everybody experiences them.
Due to the corrosive nature of the medicinal product, significant burns may occur at the site of application.
Following the instructions provided 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 date and storage
Expiry date: see the date indicated on the packaging.
The expiry date refers to the product kept in its original, unopened packaging and stored correctly.
WARNING: do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions
Store in a tightly closed container, protected from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.
Composition
100 g of solution contain
Active substance: trichloroacetic acid 50 g
Excipients: purified water
Pharmaceutical form and contents
Cutaneous solution
Glass bottle of 10 ml with applicator
Acido tricloroacetico Zeta 50% cutaneous solution

Package leaflet

Zeta Farmaceutici S.p.A.
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. Via Mentana, 38 – 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. Via Galvani, 10 – 36066 Sandrigo (VI)
AIFA Decision of 29/07/2011