Betadine 100 mg/ml Antiseptic Paint

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iodinated povidone

Available from:

Mundipharma Pharmaceuticals Limited

ATC code:

D08AG; D08AG02

INN (International Name):

Iodinated povidone

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Cutaneous solution

Therapeutic area:

Iodine products; povidone-iodine

Authorization status:

Not marketed

Authorization date:

1978-03-15

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE 100 MG/ML ANTISEPTIC PAINT
Povidone Iodine
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Betadine Antiseptinc
Paint carefully to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice
-
You must contact your doctor if your symptoms worsen or do not improve
-
If any of the side effects become serious, or if you notice any side
effects not listed in this
leaflet, stop using Betadine Antiseptic Paint straightaway and tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Betadine Antiseptic Paint is and what it is used for
2.
Before you use Betadine Antiseptic Paint
3.
How to use Betadine Antiseptic Paint
4.
Possible side effects
5.
How to store Betadine Antiseptic Paint
6.
Further information
1.
WHAT BETADINE 100 MG/ML ANTISEPTIC PAINT IS AND WHAT IT IS USED FOR
Betadine Antiseptic Paint contains povidone iodine which kills a wide
range of germs including
bacteria, viruses, fungi and simple organisms. Betadine Antiseptic
Paint is used for the prevention and
treatment of skin infections such as cold sores, and in grazes,
abrasions, cuts and wounds.
2.
BEFORE YOU USE BETADINE 100 MG/ML ANTISEPTIC PAINT
DO NOT USE BETADINE 100 MG/ML ANTISEPTIC PAINT:
-
if you are allergic (hypersensitive) to povidone iodine or any of the
other ingredients listed
-
if you currently have or have ever had a thyroid problem, including
swelling (nodular colloid
goitre, endemic goitre or Hashimoto’s thyroiditis), as using
Betadine Antiseptic Paint in these
circumstances can further affect the function of your thyroid
-
if you are currently having lithium therapy for depression as this
type of medicine can interact
with Betadine Antiseptic Paint to affect the function of your thyroid
-
on children under two years of age.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING BETADINE 100 M

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine 100 mg/ml Antiseptic Paint
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 10% w/v (yielding 1.1% w/v available iodine).
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
Glass bottle with applicator brush containing a brown coloured
solution with an odour of alcohol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic in the prevention and treatment of topical
cutaneous infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply to the affected area once or twice daily or as directed.
Apply directly to the affected area and allow to dry. Cover with a
dressing if desired.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient.
History of abnormal thyroid function or goitre (in particular
nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis).
Use in children under two years of age. Regular use should
be avoided in patients on concurrent lithium therapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of this preparation may interfere with tests of thyroid function.
Iodine is absorbed through burns and broken skin and to a
lesser extent through intact skin and may lead to toxic levels of
iodine in the blood, particularly in patients with renal
insufficiency. If symptoms occur suggesting changes in thyroid
function, these should be investigated. In patients with
impaired renal function, blood levels of iodine should be monitored.
This preparation contains alcohol and is flammable. Allow to dry after
use and avoid exposure to sources of ignition.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Betadine Antiseptic Paint can permanently discolour white gold
jewellery and it is recommended that this type of jewellery
should be removed before using