Otomize ear spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone; Neomycin sulfate; Acetic acid glacial

Available from:

DE Pharmaceuticals

ATC code:

S02CA06

INN (International Name):

Dexamethasone; Neomycin sulfate; Acetic acid glacial

Dosage:

1mg/1gram ; 5mg/1gram ; 20mg/1gram

Pharmaceutical form:

Spray

Administration route:

Auricular

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 12010100

Patient Information leaflet

PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU
START USING THIS MEDICINE. This medicine is
available on prescription only.
- Keep this leaflet you may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
Your medicine is called Otomize Ear Spray but will
be referred to as Otomize throughout the leaflet.
IN THIS LEAFLET:
What Otomize does
Check before you use Otomize
How to use Otomize
Possible side effects
How to store Otomize
Further information
WHAT OTOMIZE DOES
OTOMIZE IS USED TO TREAT INFECTION AND
INFLAMMATION OF THE OUTER EAR.
Otomize contains three active ingredients.
Dexamethasone is a topical corticosteroid medicine
which is used to control inflammation. Neomycin
sulphate is a broad spectrum antibiotic to fight
infections and glacial acetic acid is an antibacterial
agent that also helps to clear infections.
CHECK BEFORE YOU USE OTOMIZE
DO NOT USE OTOMIZE:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION to
dexamethasone, neomycin sulphate, glacial
acetic acid or to any of the other ingredients (listed
in Section 6).
•
ANYWHERE OTHER THAN IN THE EAR. Do not inhale in
the mouth or nose or spray near the eyes.
•
IF YOU HAVE A PERFORATED EAR DRUM or have a
grommet fitted in the affected ear.
•
in children under 2 years of age.
TAKE SPECIAL CARE WITH OTOMIZE
•
Excessive use (high doses or prolonged use)
of this product on open wounds or damaged
skin may cause deafness. This is particularly
important to consider when used on children.
•
DO NOT SWALLOW ANY OF THE SPRAY. If swallowed
(especially by a child) contact your DOCTOR OR
CASUALTY DEPARTMENT IMMEDIATELY.
•
Contact your doctor if you experience blurred
vision or other visual disturbances.
PREGNANCY AND BREAST FEEDING
Talk to your doctor before using Otomize if you are
PREGNANT, TRYING TO BECOME PREGNANT, or BREAST
FEEDING.
OTOMIZE CONTAINS PARAHYDROXYBENZOATES AND
STEARYL ALCOHOL
Contains methyl and propyl parahydroxybenzoates
(E218 and E216) which may cause allergic reactions
(possibly delayed).
Contains