Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Ecolab Deutschland GmbH, Ecolab-Allee 1, D-40789 Monheim am Rhein, Germany
Videne 10% w/w Alcoholic Tincture must never be administered orally, and is contra-indicated in neonates, and during pregnancy and lactation.
Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy.
Hypersensitivity to any of the ingredients.
Care should be taken with known iodine-sensitive subjects, although such people do not normally react to iodinated povidone.
Videne 10% w/w Alcoholic Tincture must not be used on broken skin because of the intense stinging caused by the alcohol present.
The application of povidone-iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function.
It is to be expected that povidone-iodine reacts with protein and various other organic substances such as blood and pus components, for example. This interaction may impair efficacy.
As a result of oxidation, the concomitant application of Videne 10% w/w Alcoholic Tincture and enzymatic wound treatment agents weakens the action of the enzyme components of both drugs. The latter is also true of hydrogen peroxide and taurolidine as well as of disinfectants containing silver (formation of silver iodide).
Videne 10% w/w Alcoholic Tincture must not be used concomitantly or immediately following disinfectants containing mercury (risk of chemical burns due to the formation of mercury iodide).
Videne 10% w/w Alcoholic Tincture must not be used concomitantly with or immediately after the application of octenidine-based antiseptics to the same or adjacent areas as transient dark discolouration can occur at the areas concerned.
In patients receiving concomitant lithium therapy, regular application of Videne 10% w/w Alcoholic Tincture should be avoided as, especially in the case of application of povidone-iodine to extensive areas, larger amounts of iodine may be absorbed. In exceptional cases, this can induce (transient) hypothyroidism. In this special situation, a synergistic effect might also occur as lithium may also induce hypothyroidism.
Due to the oxidising action of povidone-iodine, when patients are undergoing treatment with Videne 10% w/w Alcoholic Tincture various diagnostic agents can give false-positive results (inter alia toluidine and guaiac resin for the determination of haemoglobin or glucose in the stools or urine).
During the application of povidone-iodine uptake of iodine by the thyroid gland may be reduced; this can lead to disturbances in thyroid scanning, PBI (protein-bound iodine) determination and radioiodine diagnostics and make planned radioiodine therapy impossible. A waiting period of at least 1-2 weeks should be observed after discontinuing the povidone-iodine treatment before conducting a new thyroid scan.
Videne 10% w/w Alcoholic Tincture is not recommended for use during pregnancy because of the possibility of absorption through broken skin and subsequent interference with tests of neonatal thyroid function.
Videne 10% w/w Alcoholic Tincture should not be used in neonates or during lactation. Refer to Section 4.3.
None stated.
In very rare instances Videne 10% w/w Alcoholic Tincture may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment.
| System Organ Class | Very Common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1,000 to <1/100) | Rare (≥1/10,000 to <1/1,000) | Very Rare (<1/10,000) | Not known (cannot be estimated from the data available) |
|---|---|---|---|---|---|---|
| Skin and Subcutaneous Tissue Disorders | Skin irritation |
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Povidone-iodine is incompatible with reducing agents, alkaloid salts, tannic acid, salicylic acid, silver, mercury and bismuth salts, taurolidine and hydrogen peroxide (see also 4.5).
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