VIDENE 10 % W/W ALCOHOLIC TINCTURE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IODINATED POVIDONE PH.EUR.

Available from:

Ecolab Limited

ATC code:

D08AG02

INN (International Name):

IODINATED POVIDONE PH.EUR.

Dosage:

10 %w/w

Pharmaceutical form:

Cutaneous Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

povidone-iodine

Authorization status:

Marketed

Authorization date:

2000-06-23

Patient Information leaflet

1.3.1
SPC, LABELLING AND PATIENT INFORMATION
CONFIDENTIAL
VIDENE 10% W/W ALCOHOLIC TINCTURE
ECOLAB
Page 1 of 3
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIDENE 10% W/W ALCOHOLIC TINCTURE
Iodinated 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
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 burns as it could produce
adverse effects such as changes in
blood chemistry and problems with t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Videne 10% w/w Alcoholic Tincture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated povidone 10% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
A dark reddish brown mobile liquid with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Videne 10% w/w Alcoholic Tincture is a broad-spectrum antiseptic for
topical application.
It is indicated for quick
drying pre-operative skin disinfection, particularly in orthopaedic
surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Videne 10% w/w Alcoholic Tincture is applied undiluted to the area to
be incised and painted on thoroughly using a
gauze swab.
The solution may be allowed to dry to form a protective film or may be
removed using a sterile gauze
swab.
_Neonates:_
Do not use on neonates, refer to Section 4.3.
_Children and Elderly:_
There are no special dosage recommendations for children or elderly
patients.
_Renal Impairment:_
Patients with renal impairment should refer to Section 4.4.
4.3 CONTRAINDICATIONS
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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be taken with known iodine-sensitive subjects, although
such people do not normally react to iodinated
povidone.
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