Otosporin Ear Drops

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

POLYMYXIN B, SULFATE, HYDROCORTISONE, NEOMYCIN SULFATE

Dostupné z:

The Wellcome Foundation 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC kód:

S02CA03

INN (Medzinárodný Name):

POLYMYXIN B SULFATE 10000 U/ml HYDROCORTISONE 1 % (W/V) NEOMYCIN SULFATE 3400 U/ml

Forma lieku:

EAR DROPS, SUSPENSION

Zloženie:

POLYMYXIN B SULFATE 10000 U/ml HYDROCORTISONE 1 % (W/V) NEOMYCIN SULFATE 3400 U/ml

Typ predpisu:

POM

Terapeutické oblasti:

OTOLOGICALS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2006-01-09

Príbalový leták

READ ALL OF THIS LEAFLET CAREFULLY  
BEFORE YOU START USING THIS MEDICINE.
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your
doctor or pharmacist.
•  This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
•  If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET: 
1  What Otosporin is and what it is used for
2  Before you use Otosporin
3  How to use Otosporin
4  Possible side effects
5  How to store Otosporin
6  Further information
1  WHAT OTOSPORIN IS  
AND WHAT IT IS USED FOR
The name of your ear drops is Otosporin.
It is used to treat ear infections.
•  Otosporin contains three medicines called:
polymyxin B sulphate, neomycin sulphate and
hydrocortisone.
•  Polymyxin B sulphate and neomycin sulphate
belong to a group of medicines called
antibiotics. They kill the germs that can cause
ear infections.
•  Hydrocortisone belongs to a group of medicines
called steroids. It helps to reduce the swelling
and irritation caused by the infection.
2  BEFORE YOU USE OTOSPORIN
DO NOT USE OTOSPORIN:
•  if you are allergic (hypersensitive) to polymyxin B
sulphate, neomycin sulphate, hydrocortisone or
any of the other ingredients of Otosporin (See
section 6: Further information)
•  if you are allergic (hypersensitive) to
aminoglycoside antibiotics such as framycetin,
kanamycin or gentamicin
•  if you have a perforated ear drum
•  if you have either a viral, fungal or tubercular
(TB) infection
•  for a child under 3 years old.
Do not use if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist
before using Otosporin.
TAKE SPECIAL CARE WITH OTOSPORIN
Check with your doctor or pharmacist before
using your medicine if:
•  you have kidney problems. Your doctor may
change how often you use

Súhrn charakteristických

 
Page 1 of 6 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Otosporin Ear Drops 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Polymyxin B Sulphate EP 10,000 units per ml 
Neomycin Sulphate EP 3,400 units per ml 
Hydrocortisone EP 1.0% w/v 

3. 
PHARMACEUTICAL FORM 

Ear drops, suspension 

CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Otosporin Ear Drops are indicated for the treatment of otitis externa due to, or complicated 
by, bacterial infection. 

Route of Administration 

Topical 

In Vitro Activity 

Otosporin Ear Drops are active against a wide range of bacterial pathogens.  The range of 
activity includes:- 

GRAM-POSITIVE ORGANISMS: 

_Staphylococcus Epidermis_ and _Staphylococcus Aureus:_ 

GRAM-NEGATIVE ORGANISMS: 

_Enterobacter Spp. _

_Escherichia Spp. _
_ _
_Haemophilus Spp. _
_ _
_Klebsiella Spp. _
_ _
_Proteus Spp. _

Page 2 of 6 

_ _
_Pseudomonas Aeruginosa _

Otosporin Ear Drops are not expected to be active against streptococci, including 
_Streptococcus Pyogenes_ 

Hydrocortisone possesses anti-inflammatory, anti-allergic and antipruritic activity. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

ADULTS 

Following cleansing and drying of the external auditory meatus and canal as appropriate, 
three drops should be instilled into the affected ear three or four times daily.  Alternatively, a 
gauze wick may be introduced into the external auditory canal and kept saturated with the 
solution; the wick may be left in place for 24 to 48 hours. 

Treatment should not be continued for more than 7 days without medical supervision. 

Soap should not be used for cleansing of the external auditory meatus and canal as it may 
inactivate the antibio