Betadine Antiseptic Paint 10% w/v

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

POVIDONE, IODINE

Commercializzato da:

Mundipharma Pharmaceuticals Limited 13 Othellos Street, Dhali Industrial Zone, Nicosia, Cyprus

Codice ATC:

D08AG02

INN (Nome Internazionale):

POVIDONE-IODINE 10 % (W/V)

Forma farmaceutica:

CUTANEOUS SOLUTION

Composizione:

POVIDONE-IODINE 10 % (W/V)

Tipo di ricetta:

OTC

Area terapeutica:

ANTISEPTICS AND DISINFECTANTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2006-05-26

Foglio illustrativo

PILBPNTMT01v2.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE
® ANTISEPTIC PAINT 10%W/V
Povidone-Iodine
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 pharmacist
have 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 pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BETADINE
® ANTISEPTIC PAINT
is and what it is used for
2.
What you need to know 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.
Contents of the pack and other information
1.
WHAT
BETADINE
® ANTISEPTIC PAINT IS AND WHAT IT IS USED FOR
BETADINE
® ANTISEPTIC PAINT
is an
antiseptic liquid that contains the active ingredient
povidone-iodine, which belongs to the pharmaceutical group of
antiseptics. The product is
indicated for the treatment of herpes simplex, herpes zoster, grazes,
abrasions, cuts and
wounds or any break in the skin which requires protection from
infection.
BETADINE
®
ANTISEPTIC PAINT
is effective in the treatment of dermal infections caused by bacteria,
fungi,
yeasts and viruses.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETADINE
® ANTISEPTIC PAINT DO NOT USE BETADINE
® ANTISEPTIC PAINT
-
If you are allergic to iodine or any of the other ingredients of this
medicine (listed in
section 6).
-
If you are hypersensitive to iodine or any other of the ingredients
listed at section 6 of this
leaflet.
-
If you suffer with hyperthyroidism or other thyroid disorders (in
particular nodular colloid
goiter, endemic goiter and Hashimoto’s thyroiditis).
-
If you are taking lithium
-
before during and after radioiodine administration.
-
in patients using products containin

Scheda tecnica

Page 1 of 8
SPCBPNTMT01v2.01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRADEMARK
BETADINE
®
Antiseptic Paint 10% w/v
GENERIC (INN) NAME
Povidone-Iodine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-Iodine Ph. Eur. 10% w/v.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Paint.
For topical administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BETADINE
® ANTISEPTIC PAINT
is indicated for the treatment of herpes simplex, herpes zoster,
grazes, abrasions, cuts and wounds or any break in the skin, which
requires protection from
infection. It is effective in the treatment of dermal infections
caused by bacteria, fungi, yeasts,
viruses and protozoa.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
BETADINE
® ANTISEPTIC PAINT
is contraindicated in children below the age of 1 year (see
section 4.3).
Method of administration
For topical use only.
BETADINE
® ANTISEPTIC PAINT
can be applied directly to affected areas using the integral
nylon brush two or more times daily and can be covered with dressing
if desired. Rinse the
brush thoroughly after use.
Highly inflammable alcohol solution. Solution has to dry totally
before devices (in particular
high frequency surgical devices) can be used.
Page 2 of 8
SPCBPNTMT01v2.01
_ _
4.3
CONTRAINDICATIONS
Contraindicated in:
•
Hypersensitivity to iodine or povidone or any other of the excipients
listed in section
6.1.
•
Hyperfunction of the thyroid (hyperthyroidism), thyroid dysfunction or
other manifest
thyroid diseases
esp. nodular colloidal goitre, endemic goitre, Hashimoto’s
thyroiditis,
as well as before and after radioiodine therapy for hyperthyroidism,
until a lasting cure
has been obtained.
•
Not to be used on patients on concurrent lithium therapy.
•
Before, during and after radioiodine administration(see section 4.5).
•
Products containing mercury, should not be used concomitantly due to
formation of a
substance which can damage the skin.
•
Not be used in child