Description
PIC Farmaiod 10% is a cutaneous solution based on povidone-iodine, indicated for the disinfection of the skin in the presence of small superficial wounds; disinfection of intact skin; delimitation of the operating field.
PHARMACOTHERAPEUTIC CATEGORY:
Antiseptics and disinfectants - iodine derivatives.
ACTIVE INGREDIENTS:
100 g contain: povidone-iodine (10% available iodine) 10.00 g of active ingredient.
For the full list of excipients, see section 6.1.
EXCIPIENTS:
Ethoxylated alcohol, disodium phosphate, anhydrous citric acid, glycerin, sodium hydroxide, purified water.
DOSAGE:
The product should be used as is on damaged and intact skin (see paragraph 4.1); dab the skin with cotton wool soaked in plenty of solution; repeat, if necessary, for a maximum of 3-4 times a day.
DO NOT EXCEED THE RECOMMENDED DOSES.
WARNINGS:
The product is for external use only.
Do not ingest.
Ingestion or inhalation can cause serious, sometimes fatal, consequences.
Avoid contact with eyes.
Do not use for prolonged treatments: the use, especially if prolonged, of products for local use, can give rise to hypersensitivity phenomena, in which case interrupt the treatment and start the appropriate symptomatic treatment.
Avoid use on excessively large surfaces and do not apply with occlusive dressing.
Extensive absorption of iodine associated with the use of iodine povidone, which cannot be eliminated through the renal route, nor metabolised, may cause systemic adverse effects (e.g. metabolic acidosis, neutropenia), including those well known on thyroid function, such as transient hypothyroidism, or, in cases of latent hyperthyroidism, the risk of destabilisation and thyrotoxic crisis.
If prolonged use or use on large surfaces is necessary, thyroid function tests should be performed, especially in patients with thyroid dysfunction and in younger subjects.
Discontinue treatment at least 10 days before performing a scintigraphy with labeled iodine.
Iodine absorption may interfere with thyroid function tests or tests for occult blood in feces and urine, due to the highly oxidative properties of iodine.
In pediatric age use only in case of real need.
Cases of hypothyroidism following the application of povidone-iodine in newborns have been reported.
In neonates, it has been observed that the application of topical iodinated antiseptics, at term and preterm, may cause transient thyroid dysfunction (see section 4.3).
Heating the solution above 43 degrees C.
causes the release of toxic iodine vapors, due to a weakening of the bond between iodine and povidone.
After a short period of treatment without appreciable results, medical evaluation is necessary.
CONSERVATION:
Store at a temperature not exceeding 30 degrees C in the original packaging to protect the product from light.
CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1; children under 6 months; hyperthyroidism; do not apply to mucous membranes, skin
severely damaged and on large surfaces (see paragraph 4.4); do not use for peritoneal lavage in the treatment of purulent peritonitis: in these situations, iodine concentrations in the blood and consequently in the urine may increase significantly.
INTERACTIONS:
Avoid the simultaneous use of other antiseptics and/or detergents.
Do not use soaps or ointments containing mercury or benzoin compounds on the treated area at the same time.
SIDE EFFECTS:
Undesirable effects may occur with an unknown frequency (the frequency cannot be estimated from the available data), following which it is necessary to discontinue the treatment.
Treatment: intolerance (burning or irritation); allergic reactions (such as tuberous dermatitis, dermatitis, etc.); iodism (see paragraphs 4.4 and 4.9); delayed healing of damaged tissue; interference with thyroid function tests.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the relationship
benefit/risk of the medicine.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
PREGNANCY AND BREASTFEEDING:
Use only if clearly needed and under direct medical supervision.
