Betadine Dry Powder 25 mg/g cutaneous spray

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Povidone-iodine

Disponible depuis:

Ayrton Saunders Ltd

Code ATC:

D08AG; D08AG02

DCI (Dénomination commune internationale):

Povidone-iodine

Dosage:

25 milligram(s)/gram

forme pharmaceutique:

Cutaneous spray, powder

Type d'ordonnance:

Product not subject to medical prescription

Domaine thérapeutique:

Iodine products; povidone-iodine

Statut de autorisation:

Not marketed

Date de l'autorisation:

1986-01-17

Notice patient

Pharmaserve N W est
24pp Kleerform Bookle t
30x98m m
30x70mm(folded), 30x138mm(unfolded)
Ashton
24.05.2017
24
For information in large print, audio CD or
braille please
contact the Marketing
Authorisation Holder.
This leaflet was last revised: July 2017
_Betadine is a registered trademark._
_PA/501/006/004_
4
1. WHAT BETADINE DRY POWDER SPRAY IS AND WHAT IT IS USED FOR
Betadine Dry Powder Spray contains povidone iodine,
which kills a wide range of germs, including bacteria,
viruses, fungi and simple organisms. Betadine Dry
Powder Spray is used as an antiseptic for the treatment
and prevention of infection in minor skin trauma
including burns, cuts and other minor injuries.
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5.
HOW TO STORE BETADINE DRY POWDER SPRAY
Keep this medicine
out of the sight and reach of children.
Do not use this medicine after the expiry date which is
printed on the bottom of the aerosol can.The expiry date
refers to thelast day of that month. Do not store above
25°C. Store away from direct heat and sunlight. Do not
puncture, break or burn the can even if apparently
empty. Do not expose to temperatures exceeding 50°C.
Do not throw away any medicines via wastewater or
household waste.
8
as using Betadine Dry Powder Spray in these
circumstances may cause toxic levels of iodine to be
absorbed into your blood.
•
If you currently have or have ever had a kidney
problem as using Betadine Dry Powder Spray in these
circumstances may cause toxic levels of iodine to be
absorbed into your blood.
16
•
Allergic-type reactions, including difficulty breathing or
swallowing, a rash, swelling of the face, lips, throat or
tongue.
You may also experience the following side effects:
•
Betadine Dry Powder Spray could also cause itching
and burns on your skin (rarely).
•
local irritation
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•
Betadine Dry Powder Spray can permanently discolour
white gold jewellery and it is recommended that this type
of jewellery should be removed before using this product.
3. HOW TO USE BETADINE DRY POWDER SPRAY
Always use this medicine exactly as described in

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Dry Powder 25 mg/g cutaneous spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of powder contains 25mg povidone-iodine
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray, powder.
A reddish-brown powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antiseptic for the treatment and prevention of infection in minor skin
trauma including burns, cuts and other minor
injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical use only.
Adults and children aged 2 years and older
Shake the can well before use.
Spray the required area from a distance of 6-10 inches (15-25cm) until
a dusting of
powder is deposited.
If necessary, the treated area may be covered with a dressing.
Not to be used in children under 2 years of age, see section 4.3.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidone or any of the
excipients.
History of abnormal thyroid function or
goitre (in particular nodular colloid goitre, endemic goitre and
Hashimoto’s thyroditis).
Use in children under two
years of age.
Regular use should be avoided in patients on concurrent lithium
therapy.
Avoid inhaling or spraying into eyes.
Betadine Dry Powder Spray should not be used in serous cavities.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If no improvement occurs a doctor should be consulted.
Use in the management of severe burns or denuded skin will lead to
systemic absorption and may result in systemic
effects such as metabolic acidosis, thyroid dysfunction or renal
impairment.
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. In patients with impaired renal function, blood
levels of iodine should be monitored.
If symptoms occur suggesting changes in thyroid function, these should
be investigated