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f. Whafifis and whafit is used for

This product, referred to as Videne Antiseptic Solution in this label-leaflet, contains povidone-iodine as the active substance. It is used to by a doctor or nurse to disinfect skin (e.g. prior to surgery, biopsies, injections, punctures, blood taking, bladder catheterisations) or mucous membranes such as the mouth, eye, bowel and female genitals. It can also be used by a patient for self-treatment as an antiseptic treatment for wounds, superficial and limited bums and infected skin. Videne Antiseptic Solution gradually releases iodine to help destroy bacteria, fungi and some viruses.

2. What you need to know before use Do not use:

•    If you have hyperthyroidism (an over-active thyroid gland) or other thyroid disorders.

•    If you have Duhring's disease (a skin disease with severe itching and blistering).

•    Before or immediately after radioiodine therapy.

•    If you know that you are sensitive to iodinated povidone

_ or any of the ingredients.

ForFegularofprolbncfed periods if you are taking lithium (an anti-depressant). Warnings and precautions: Talk to your doctor, nurse or pharmacist before using Videne Antiseptic Solution.

Due to the risk of hypothyroidism, consult your doctor before use:

■ On infants under 6 months old.

•    On elderly patients.

•    If you are prone to, or have been treated in the past for hyperthyroidism or thyroid diseases.

•    If you intend to use the solution for longer than 5 days or on a large area of skin.

•    If you have thyroid swelling (bland multinodular goitre)

In these cases, the doctor should be vigilant for early symptoms of possible hyperthyroidism for up to 3 months after therapy has been discontinued and, where necessary, thyroid function should be monitored. In infants up to the age of 6 months, after applying Videne Antiseptic Solution thyroid function should be checked. In the case of hypothyroidism, early treatment with thyroid hormones must be carried out until thyroid function becomes normal. Accidental

[oral intake"by the nursing infant must be avoided. jOther medicines and Videne Antiseptic Solution

|* Tell your doctor if you are i using, have recently taken or ¹ might use any other | medicines, specifically: j- Other wound treatments.

>- Other skin disinfectants.

|- Certain antiseptics, as dark i discolouration can occur at | the areas treated.

^L Lithium (see 'Do not use’), i* False positive results may ¹ occur in certain stool or | urine tests.

j» The results of certain thyroid i tests may be affected, pregnancy, breast-feeding and fertility jlf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before [use. Videne Antiseptic Solution should only be used with jextreme caution if you are pregnant or breast-feeding.

|3. How to use this product Always use exactly as described }n this leaflet or as your doctor bas told you. Check with your jdoctor if you are unsure. Do not iuse for longer than 5 days, or on

alarge"area ofskin, wfthouffifsfi consulting your doctor. The ¹ frequency and duration of application depends on the i indication for use. Videne Antiseptic Solution, freshly i prepared for each use, can be j applied once or several    ,

times daily.    ¹

To use as a skin disinfectant, i as an antiseptic treatment of ¹ superficial wounds or burns: j

•    Apply to the skin undiluted. ¹ Apply enough to wet the area, to be treated completely but i do not allow pools of solution j to form under the patient or im skin folds.

•    If applied around the mouth i and throat, avoid breathing it j in. It should not be swallowed.i

•    For use as a skin disinfectant, the solution i should be applied at least 1 j minute before the procedure , for areas with very few sweat' glands (such as back of the j arms) and at least 10 minutesi before for areas with many j sweat glands such as the i hands or feet.

For healthcare professionals i only: To use as an antiseptic irrigation, or for washes and , baths, or as a mucosal    ¹

antiseptic, including application j [to the eye see further information!

'in fhe technicaFinTormation af the. iend of this leaflet.    ¹

[The brown colouration is normali iand shows that it is working ¹ 'properly. Do not use if the jsolution is not brown.    i

'If you have used Videne i lAntiseptic Solution in a bath or ' 'sink you should clean up [immediately after use. Videne ' Antiseptic Solution can jgenerally be washed out of    i

textiles or other materials with ' 'warm water and soap; jammonia solution or sodium ' thiosulphate may be needed if j [this does not work.    i

'Action to be taken if jswallowed: If you accidentally ' swallow Videne Antiseptic jSolution you should go to your i .nearest hospital immediately. ' [4. Possible side-effects    i

'Like all medicines, this medicine j jean cause side effects, although i inot everyone gels them. jSkin reactions, which may be ' 'delayed, are rare, affecting 1 to 10 j jusers in 10,000. Symptoms    i

.include itching, red skin and 'blisters. Also rarely, after    .

pre-operative disinfection, a pool ' 'may form under the patient jeausing irritation.    i

'Sudden serious allergic reactions,[ [which may be life-threatening, ' orcur very rarely, typically _ _

The FoMvflngnriformatibh Ts~ “ intended for medical or healthcare professionals only. Dilution of Videne Antiseptic Solution For antiseptic irrigation, washes and baths, or as a mucosal antiseptic, Videne Antiseptic Solution can be diluted in the following ratios:

•    wound irrigation and perioperatively 1:2 to 1:20

•    antiseptic washes 1:2 to 1:25

•    antiseptic partial baths approx. 1:25, antiseptic full baths approx. 1:100.

•    for eye irrigation dilution should be 1:2 giving a 5% solution

Normal tap water is suitable for dilution. Where conditions requiring isotonicity are desired, physiological saline or Ringer’s solution can be used. For application to the eye, dilution with phosphate buffered solutions or balanced salts solution is recommended. Incompatibilities Videne Antiseptic Solution may interact with protein and other organic substances.

The treatment area should be irrigated to remove as much blood as possible before using

Videne AnlisepficTSiblutTon.Tt Should not be used with Reducing agents, alkaloid salts, tannic acid, salicylic acid, silver, (mercury and bismuth salts, taurolidine and hydrogen beroxide. Absorption of iodine from povidone-iodine through either healthy or damaged skin (nay interfere with thyroid function tests. Videne Antiseptic Solution may also interfere with tests for haemoglobin or glucose in stool or urine samples. Treatment of overdose (The stomach should be washed out with dilute starch and (orotein-containing foods or a 1 % (solution of sodium thiosulphate. Dialysis should be carried out to (educe serum iodine levels and thyroid function should be tmonitored. Other possible symptoms such as metabolic acidosis or renal dysfunction Should be treated as appropriate.