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:

Mawdsley-Brooks & Company Ltd

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

_S1717 LEAFLET Otomize 20171201 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
OTOMIZE EAR SPRAY
(DEXAMETHASONE, NEOMYCIN SULPHATE, GLACIAL ACETIC
ACID)
Your medicine is Otomize ear spray but will be referred to as
Otomize throughout the following 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.
IN THIS LEAFLET:
1.
What Otomize does
2.
Check before you use Otomize
3.
How to use Otomize
4.
Possible side effects
5.
How to store Otomize
6.
Further information
1. 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 sulfate is a broad spectrum antibiotic to
fight infections and acetic acid is an antibacterial agent that also
helps to clear infections.
2. CHECK BEFORE YOU USE OTOMIZE
DO NOT USE OTOMIZE:

IF YOU HAVE EVER HAD AN ALLERGIC REACTION to dexamethasone,
neomycin sulfate, 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.
3. HOW TO USE OTOMIZE
BE