Package leaflet: Information far the patient Povidone-Iodine 10% w/w Alcoholic Tincture lodir atari povidone

Read allot 1 hie leaflet carefully before you sla rl using this medicine because it contains important intormation tor you,

Always cm ihH medic-ne exactly as described in this leaflet or as your doctor or nurse has told you.

-    Keep this leaflet-You may need to reao it egan,

-    Askyaur phairTiatet ir you rmed more infarmalfan or advice.

-    If you get any side effects, talk :o your doclo' ornurse. This includes any possible side effects not listed ir tbs leaflet. See sect on4

What is in this leaflet

1.    Wnal it Is and what It is used for

2.    Whal you need to know before use

3.    How to use

4.    Possible Side effects

5.    blow lo store

6.    Contents or the peel; and oilier

nformeticn

1,    What it is and what it is used for

This product, referred to as Povidone-lodlne Alcoholic Tincture in this labaueaflat, contains iodinated povidone as the active substance. It is an antsepnc skin cleanser for use as aeuick-cryfag hM septic far p-s-aperalivie s*n disinfection, partlcdterty in wlhooajedic surgery Solutions of iodinated povicone gradually minase- odlre to kill cr stop ihe growth of

micrc-DrganiarTis (bacteria, 'ungi. vimaaa. protozoa, oysla and spores).

2,    What you need to know before you use

Do not use:

*    On newborn chidren.

*    During pregnancy and

breastfeeding.

*    If you are sensitive to iodine or any or the oilier ingredients el this medicine (listed in section 0).

*    For tegular or prolonged periods n you have thyroid protHcms or if you are taking lithium

(an anti-depressantl-

*    On broken skin as the alccnoi Could cause st nc ng.

*    Forextetnaluseoiky.

Do not swallow.

Warnings and precautions:

Tak to your doctor or nurse before using Povidone-Iodine Alcohotc Tincture h:

•    You are usirg on lame wounds or severe bums as it could produce adverse effects such as changes in blood chemistry and problems yzlh me kidneys.

■    Ydu are ptene fa. Or have aver been inerted in the past far hyperthyroidism,

Other medicines and Povidone-Iodine Alcoholic Tincture

» Talk fa your doctor cr no's®

bclcnc u&ng Povidone-iodine Afcobulic Tincture if yen are taking any olhe-madicines. specklcally:

-    Wound traaJrnerttS.

-    Other-skin disinfectants.

-    Certain antiseptics, as dad;

discdoiral an can occur aL the areas Irearteo.

-    Lithium (see ‘Do not use').

■    False posit ve resuha may cccur

ir certain stool or trine tests.

*    The results a! oertair thyroid lasts may ba affected.

Pregnancy and breast-feeding

Da not use Povidone-Iodine Alcoholic Tincture iF you ara pregnant or bneasl-Faadng.

3. How to use

Apply thoroughly to the skin undiluted using ;i gauze swab. Do net allow pools Of Solution Id form under the petient or in skin folds. There are no special recummerdations far the amounts used or children or ekteify caflents.

Action lo be taken if swallowed:

If Fnvidane-lcdine Alcoholic Tincture is accidentally swallowed go lo the accident and emergency

decarlmehl of you¹ rsarest hospital.

n. Possible side eflects

Lika all medicines, this meric na can causa side sffECIa, although not everybody gels them.

■ Skin reacliarrs maiy occur buf these are very rare affeclinq fewer than 1 in 10,000 people.

* The absorption ol iodine through intact o^r damaged skn may

interfere with A^oid function tests.

Reporting of side effects

If you gel any sde effecis. talk to your dcctor or nurse. This Includes any possible aide effects rot listed in this, leaflet. Ycu can also repod side effects directly via the Ydlcw Card Scheme. Website: www.rftira..gnvjult'yellnwdard. By reporting side effects you can help provide rone information cm Ihe safety of Ihis madeine

5.    Howto store

Keepoul ofthesghtand reach of children. Uo not store above 25-C. □b not usd after ffie expiry date On the front label. Ask your phamnaasl how to Arrow away medicines you no longer use. These measures will help protect Ihe environment,

6.    Contents of iHe pack

and other infprmatron

Povidone-lodira Alcoholic "Tincture contains 10% w/yr of the aclive

substance lodnaied povitiorc

equivalent to 11 rng/rrl iodine. The other irgnediErts are alkyl phanol ether sulphate tammonium sell}, irvfustnal methylated spirit (SSH), cltnc acid, anhydrous diaodiLtn hydrogen phosphate arid purified water

Puvidtme-lodirte Alcufulic Tincture is a dark reddish brown liquid, supplied in a 500 ml HDPE aottte sealed with a plastic screw cap.

MA Holder end EEA site of batch relo.nso: Ecolafr Ltd, Lotherton Way, Garforth, Leeds, LS2S 5JY, UK.

Tost revrseJ November 2013.

The following information is

Intended for medical or

healthcare pmlesEionals only.

Incompatibilities

Povidone-iodine Alcoholic Tincture

may interact with protein and other organic aucatances.

The treatment area shauU be irrigated lo remove as much blood aa possible before using Pov done-iodine Alcoholic Tincture, It should not be used with reducing agents alkaloid salts tannic acio. salicylic acid, diver, mercury and bismuth salts, taurolidlneeivl hydrogen peroxide. Absorption of iodine frem povidone- adine through either hesfrtny or damaged skin may interfere with thyreid function teste Pov done-iodine Alcoholic Tincture may also interfere with tesla far haemoglobin or glucose in stoo or urine samples.

Treatment of overdose

The stomach shcrJd be washed out with dilute slarch and prctetn-oontalnlng toeds or a 1 % Solution bf sodu.m thiosulphate. Diniyss should he named cut fro reduce serum iodine levels and thyroid funeton should be monkored. Olhsr nose hie symptoms such as melaholii: acidoss or renal dystiincfron should be treated as appronr ate.