Betadine 10% w/w Ointment

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Pieejams no:

Mundipharma Pharmaceuticals Limited

ATĶ kods:

D08AG; D08AG02

Deva:

10 percent weight/weight

Zāļu forma:

Ointment

Ārstniecības joma:

Iodine products; povidone-iodine

Autorizācija statuss:

Not marketed

Autorizācija datums:

1983-04-01

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE 10% W/W OINTMENT
Iodinated Povidone
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 10% w/w
Ointment 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 a 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 10% w/w Ointment straightaway and tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Betadine 10% w/w Ointment is and what it is used for
2.
Before you use Betadine 10% w/w Ointment
3.
How to use Betadine 10% w/w Ointment
4.
Possible side effects
5.
How to store Betadine 10% w/w Ointment
6.
Further information
1.
WHAT BETADINE 10% W/W OINTMENT IS AND WHAT IT IS USED FOR
Betadine 10% w/w Ointment contains Iodinated Povidone which kills a
wide range of germs including
bacteria, viruses, fungi and simple organisms.
Betadine 10% w/w Ointment is used as an antiseptic for the management
of minor damage or infection
of the skin.
2.
BEFORE YOU USE BETADINE 10% W/W OINTMENT
DO NOT USE BETADINE 10% W/W OINTMENT:
-
if you are allergic (hypersensitive) to Iodine, polyvinylpyrollidone
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 10% w/w Ointment 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 10% w/w Ointment to affect the function of your thyroid
-
on children under two years of age.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING BETADINE 10% W/W
OINTMENT:
-
If your skin is broken (for example, due to a b

Produkta apraksts

Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine 10% w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 10% w/w (yielding 1% w/w available iodine)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Smooth, uniform, dark brown ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic for management of minor trauma or infection of
the skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply to the affected area, once or twice daily for a maximum of 14
days.
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.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8, “Undesirable effects” for further
information.
Betadine Ointment can permanently discolour white gold jewellery and
it is recommended that this type of jewellery should be
removed before using Betadine Ointment.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Use with concurrent lithium therapy has been shown to exhibit additive
hypothyroidic effects. Absorption of iodine from
povidone iodine through either intact skin or broken skin may
interfere wit