Betadine Alcoholic 100 mg/ml Cutaneous Solution

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:

1983-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION
Povidone Iodine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING BETADINE
ALCOHOLIC 100 MG/ML CUTANEOUS
SOLUTION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects become serious, or if you notice any side
effect not listed in this leaflet,
stop using Betadine Alcoholic Solution straightaway and tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Betadine Alcoholic Solution is and what it is used for
2.
Before you use Betadine Alcoholic Solution
3.
How to use Betadine Alcoholic Solution
4.
Possible side effects
5.
How to store Betadine Alcoholic Solution
6.
Further information
1.
WHAT BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION IS AND WHAT IT IS
USED FOR
Betadine Alcoholic Solution contains povidone iodine which kills a
wide range of germs including
bacteria, viruses, fungi and simple organisms. Betadine Alcoholic
Solution is used as an antiseptic for
pre-operative and post-operative treatment of skin.
2.
BEFORE YOU USE BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION
DO NOT USE BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION:
-
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 Alcoholic Solution 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 Alcoholic Solution to affect the function of your
thyroid
-
on children under two years of age.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING BETADINE ALCOHOLIC 100
MG/ML CUTANEOUS
SOLUTION

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 Alcoholic 100 mg/ml Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of cutaneous solution contains 100 mg of Iodinated Povidone
(10% w/v).
This yields 10 mg/ml of available Iodine (1% w/v).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A dark brown coloured solution with an odour of alcohol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for pre- and post-operative treatment of skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply directly as required.
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. When used prior to
a procedure which involves the use of an
electrosurgical unit, do not allow pooling of the fluid to occur, and
ensure that the skin and surrounding drapes are dry to
reduce the risk of fires and burns.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Betadine Alcoholic Solution can permanently discolour white gold
jewellery and it is recommended that this type