IODOFLEX Impregnated dressing Ref.[50120] Active ingredients: Cadexomer iodine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2003  Publisher: Smith & Nephew Pharmaceuticals Limited, P.O. Box 81, Hessle Road, Hull, HU3 2BN, England

4.3. Contraindications

Iodoflex is contraindicated in:

  • patients with known or suspected iodine sensitivity.
  • Hashimoto’s thyroiditis.
  • non-toxic nodular goitre.
  • children.

Iodoflex should not be used:

  • by pregnant or lactating women

4.4. Special warnings and precautions for use

Iodine may be absorbed systemically, especially when large wounds are treated. Patients with severely impaired renal function or a past history of any thyroid disorder are more susceptible to alterations in thyroid metabolism with chronic Iodoflex therapy.

In endemic goitre there have been isolated reports of hyperthyroidism associated with exogenous iodine.

It has been observed occasionally that an adherent crust can form when Iodoflex is not changed with sufficient frequency.

4.5. Interaction with other medicinal products and other forms of interaction

There is a potential risk of interaction with lithium, resulting in an increased possibility of hypothyroidism.

Iodoflex should not be used concomitantly with mercurial antiseptics, e.g. mercurochrome and thiomersal.

Since iodine may be absorbed systemically, the result of tests of the thyroid function can be influenced.

4.6. Pregnancy and lactation

Iodine crosses the placental barrier and is secreted into breast milk. Clinical experience of use in pregnant women is limited. Insufficient animal data are available. Iodoflex should therefore not be used in pregnant or lactating women.

4.7. Effects on ability to drive and use machines

It is unlikely to have an effect.

4.8. Undesirable effects

About 5% of the patients treated with Iodoflex experience a transient smarting or pain within the first hour after application. Contact allergy, alteration in thyroid function and local oedema have been reported in rare cases. Minor reddening or swelling around the wound may occur without necessarily being an allergic reaction.

6.2. Incompatibilities

Iodoflex should not be used concomitantly with taurolidine, since there is a risk of metabolic acidosis.

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