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Forest Laboratories UK Limited
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL
Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 27/04/2012
SPC Otomize

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 27/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


section 7 & 8 updated to reflect change in MAH to Forest Laboratories UK Ltd
Updated on 13/01/2011 and displayed until 27/04/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   06-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Addition of dosing information not suitable for infants and neonates under 2 years of age

Section 4.4 - Addition of the following information:-
    - discontinue if rash or irritation occurs
    - exclude chronic alternate diagnoses
    - use beyond 7 days may lead to extension of infection due to the masking effect of the steroid
    - theoretical risk of adrenal suppression in children
    - immature renal function in children may lead to toxicity from neomycin, so should be used with care
    - aminoglycosides may cause deafness which is dose related and enhanced by renal or hepatic impairment which should be considered in children
    - contains E218 and E216 which may cause allergic reactions
    - contains stearyl alcohol which may cause local skin reactions

Section 4.6 - Addition of fetal ototoxicity if aminoglycosides are administered during pregnancy and the section on lactation
Updated on 18/12/2009 and displayed until 13/01/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 (contra-indications) has been re-worded to include the following information:

Hypersensitivity to neomycin sulphate, dexamethasone, glacial acetic acid or to any of the excipients.

The product should not be used in patients where a perforated tympanic membrane has been diagnosed or is suspected or where a tympanostomy tube (grommet) is in situ.
Updated on 19/12/2003 and displayed until 18/12/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  dexamethasone
  glacial acetic acid
  neomycin sulphate