Betadine 2.5% dry powder spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Povidone-Iodine

Available from:

Aspire Pharma Ltd

ATC code:

D08AG02

INN (International Name):

Povidone-Iodine

Dosage:

25mg/1gram

Pharmaceutical form:

Spray

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13110400; GTIN: 5028268000735

Patient Information leaflet

BETADINE
DRY POWDER 25MG/G TOPICAL SPRAY
POVIDONE IODINE.
6
2. BEFORE YOU USE BETADINE DRY POWDER SPRAY
DO NOT USE BETADINE DRY POWDER SPRAY:
•
If you are allergic (hypersensitive) to povidone
iodine or any of the other ingredients listed in
section 6 of this leaflet.
•
If you currently have or have ever had, a thyroid
problem, including swelling (nodular colloid goitre,
endemic goitre or Harishimoto’s thyroiditis), as using
2
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 Dry Powder
Spray carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask a doctor or pharmacist if you need more
information or advice.
8
TAKE SPECIAL CARE WITH BETADINE DRY POWDER SPRAY:
•
If your skin is broken (for example, due to a burn)
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
4
IN THIS LEAFLET:
1. WHAT BETADINE DRY POWDER SPRAY IS AND WHAT IT IS
USED FOR
2. BEFORE YOU USE BETADINE DRY POWDER SPRAY
3. HOW TO USE BETADINE DRY POWDER SPRAY
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BETADINE DRY POWDER SPRAY
6. FURTHER INFORMATION
10
USING OTHER MEDICINES
Please tell a doctor or pharmacist if you are taking, or
have recently taken, any other medicines, including
medicines obtained without a prescription, before
you use Betadine Dry Powder Spray. In particular, you
should tell your doctor if you are taking the following:
•
Lithium (for depression) can interact with Betadine
7
Betadine Dry Powder Spray in these circumstances
can further affect the function of your thyroid.
•
On children under two years of age.
•
Betadine Dry Powder Spray should not be used in
serious cavities.
If you are not sure whether any of the above apply to
you, speak to your doctor or pharmacist before using

Summary of Product characteristics

OBJECT 1
BETADINE DRY POWDER SPRAY
Summary of Product Characteristics Updated 26-Jan-2017 | Aspire Pharma
Ltd
1. Name of the medicinal product
Betadine Dry Powder Spray.
2. Qualitative and quantitative composition
Povidone iodine 2.5 %w/w.
For excipients, see section 6.1
3. Pharmaceutical form
Pressurised aerosol spray.
4. Clinical particulars
4.1 Therapeutic indications
Antiseptic for the treatment and prevention of infection in wounds
including ulcers, 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 on children under 2 years of age.
4.3 Contraindications
Hypersensitivity to iodine, polyvinylpyrrolidine 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. Avoid
inhaling or spraying into the eyes. Betadine Dry Powder Spray should
not be used in serious cavities.
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 for further information.
Betadine Dry Powder Spray can permanently discolour white gold
jewellery and it is recommended that
this type of jewellery should be removed be