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Videne Alcoholic Tincture


Uidene

10% w/w Alcoholic Tincture

(lodlnated Povidone)


Videne Alcoholic Tincture Is an antiseptic skin cleanser, for use as a quick-drying antiseptic for pre-operative skin disinfection, particularly In orthopaedic surgery.

Contains 10% w/w povidone-iodine. Also contains alkyl phenol ether sulphate (ammonium salt), industrial methylated spirit (95%), citric acid, anhydrous disodlum hydrogen phosphate, purified water.

ALCOHOL CONTENT 30%


Read leaflet before use. Cutaneous solution.

For external use only.

Keep out of the reach and sight of children. Do not store above 25I>C. Warning: This product is flammable.


500 ml


MA Holder E colab Ltd.

Lotherton Way. Qarforth Leeds LS25 2JY England Tel:+44 (0)113 232 0066



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Package leaflet:

Information for the patient Videne Alcoholic Tincture

10% w/w lodinated povidone

Read all of this leaflet carefully before you start using this medicine because It contains Important Information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or nurse has told you.

-    Keep this leaflet. You may need to read It again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed In this leaflet. See section 4.

What Is In this leaflet

1.    What it Is and what it is used for

2.    What you need to know before use

3.    How to use

4.    Possible side effects

5.    How to store

6.    Contents of the pack and other information


0    3037430

PL04509/0040

3037430F/27APRKVGB



1. What It Is and what It Is used for

This product, referred to as Videne Alcoholic Tincture In this label-leaflet, contains iodinated povidone as the active substance. It Is an antiseptic skin cleanser for use as a quick-drying antiseptic for pre-operative skin disinfection, particularly in orthopaedic surgery. Solutions of iodinated povidone gradually release iodine to kill or stop the growth of micro-organisms (bacteria, fungi, viruses, protozoa, cysts and spores).

2.    What you need to know before you use

Do not use:

•    On newborn children.

•    During pregnancy and breastfeeding.

•    If you are sensitive to iodine or any of the other ingredients of this medicine (listed in section 6).

•    For regular or prolonged periods if you have thyroid problems or if you are taking lithium (an

anti-depressant).

•    On broken skin as the alcohol could cause stinging.

•    For external use only.

Do not swallow.

Warnings and precautions:

Talk to your doctor or nurse before using Videne Alcoholic Tincture if:


•    You are using on large wounds or severe bums as it could produce adverse effects such as changes in blood chemistry and problems with the kidneys.

•    You are prone to, or have ever been treated in the past for hyperthyroidism.

Other medicines and Videne Alcoholic Tincture

•    Talk to your doctor or nurse before using Videne Alcoholic Tincture if you are taking any other medicines, specifically:

-    Wound treatments.

-    Other skin disinfectants.

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

-    Lithium (see ‘Do not use").

•    False positive results may occur in certain stool or urine tests.

•    The results of certain thyroid tests may be affected.

Pregnancy and breast-feeding

Do not use Videne Alcoholic Tincture if you are pregnant or breast-feeding.

3. how to use

Apply thoroughly to the skin undiluted using a gauze swab. Do not allow pools of solution to form under the patient or in skin folds.


There are no special recommendations for the amounts used on children or elderly patients.

Action to be taken If swallowed:

If Videne Alcoholic Tincture is accidentally swallowed go to the accident and emergency department of your nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

•    Skin reactions may occur but these are very rare affecting fewer than 1 in 10,000 people.

•    The absorption of iodine through intact or damaged skin may interfere with thyroid function tests.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme, website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.


5.    How to store

Keep out of the sight and reach of children. Do not store above 25°C. Do not use after the expiry date on the front label. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other Information

Videne Alcoholic Tincture contains 10% w/w of the active substance iodlnated povidone equivalent to 11 mg/ml iodine. The other ingredients are alkyl phenol ether sulphate (ammonium salt), industrial methylated spirit (95%), citric acid, anhydrous disodium hydrogen phosphate and purified water.

Videne Alcoholic Tincture is a dark reddish brown liquid, supplied in a 500 ml HDPE bottle sealed with a plastic screw cap.

MA Holder and EEA site of batch release: Ecolab Ltd, Lotherton Way, Garforth,

Leeds. LS25 2JY, UK.

Text revised April 2016.


The following Information Is intended for medical or healthcare professionals only.

Incompatibilities

Videne Alcoholic Tincture may interact with protein and other organic substances.

The treatment area should be irrigated to remove as much blood as possible before using Videne Alcoholic Tincture. It should not be used with reducing agents, alkaloid salts, tannic acid, salicylic acid, siver, mercury and bismuth salts, tauroiidine and hydrogen peroxide. Absorption of iodine from povidone-iodine through either healthy or damaged skin may Interfere with thyroid function tests. Videne Alcoholic Tincture 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 protein-containing foods or a 1 % solution of sodium thiosulphate. Dialysis should be carried out to reduce serum iodine levels and thyroid function should be monitored. Other possible symptoms such as metabolic acidosis or renal dysfunction should be treated as appropriate.



Videne0

10% w/w Alcoholic Tincture

(Iodlnated Povidone)


Videne Alcoholic Tincture is an antiseptic skin cleanser, for use as a quick-drying antiseptic for pre-operative skin disinfection, particularly in orthopaedic surgery.

Contains 10% w/w povidone-iodine. Also contains alkyl phenol ether sulphate (ammonium salt), industrial methylated spirit (95%), citric acid, anhydrous disodium hydrogen phosphate, purified water.

ALCOHOL CONTENT 30%

Read leaflet before use.

Cutaneous solution.

For external use only.

Keep out of the reach and sight of children. Do not store above 25°C. Warning: This product is flammable.


500ml

MA Holder Ecolab Ltd.

Lotherton Way. Garforth Leeds LS25 2JY England Tel: +44 (0)113 232 0066 E    3037430

PL04509/0040 3037430F/27APR16/GB



028163 037431